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146-591: A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill , capsule , tablet , powder, or liquid. A supplement can provide nutrients either extracted from food sources, or that are synthetic (in order to increase the quantity of their consumption). The classes of nutrient compounds in supplements include vitamins , minerals , fiber , fatty acids , and amino acids . Dietary supplements can also contain substances that have not been confirmed as being essential to life, and so are not nutrients per se, but are marketed as having

292-675: A nasal spray , or topically , as a lotion applied to the skin, do not qualify. FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain vitamins , nutritionally essential minerals , amino acids , essential fatty acids and non-nutrient substances extracted from plants or animals or fungi or bacteria , or in the instance of probiotics , are live bacteria. Dietary supplement ingredients may also be synthetic copies of naturally occurring substances (for example: melatonin ). All products with these ingredients are required to be labeled as dietary supplements. Like foods and unlike drugs, no government approval

438-551: A plant-based diet of whole foods, minimizing ultra-processed food , salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle. The regulation of food and dietary supplements by the U.S. Food and Drug Administration (FDA) is governed by various statutes enacted by the United States Congress . Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation,

584-474: A 2017 review found that supplementation with DHA and AA does not appear to be harmful or beneficial to formula-fed infants. Dietary supplements can be manufactured using intact sources or extracts from plants, animals, algae, fungi or lichens, including such examples as ginkgo biloba , curcumin , cranberry , St. John's wort , ginseng , resveratrol , glucosamine and collagen . Products bearing promotional claims of health benefits are sold without requiring

730-464: A Compaction Simulator reduces the amount of powder required for product development. Tablet presses , also called tableting machines, range from small, inexpensive bench-top models that make one tablet at a time (single-station presses), with only around a half-ton pressure, to large, computerized, industrial models (multi-station rotary presses) that can make hundreds of thousands to millions of tablets an hour with much greater pressure. The tablet press

876-503: A Roman ship that wrecked in 140 BC. However, these tablets were meant to be pressed on the eyes, not swallowed. A caplet is a smooth, coated, oval-shaped medicinal tablet in the general shape of a capsule . Many caplets have an indentation running down the middle, so they may be split in half more easily. Consumers have viewed capsules as the most effective way to take medication ever since they first appeared. For this reason, producers of drugs such as OTC analgesics wanting to emphasize

1022-466: A beneficial biological effect, such as plant pigments or polyphenols . Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled. Creating an industry estimated to have

1168-696: A claim then the FDA stipulates the exact wording of the QHC to be used on labels and in marketing materials. The wording can be onerous: "One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women." Protein-containing supplements, either ready-to-drink or as powders to be mixed into water, are marketed as aids to people recovering from illness or injury, those hoping to thwart

1314-665: A combination of ingredients in manufactured vitamins, minerals or other supplement products, with 92% of tested herbal supplements containing lead and 80% containing other chemical contaminants. Using undercover staff, the GAO also found that supplement retailers intentionally engaged in "unequivocal deception" to sell products advertised with baseless health claims, particularly to elderly consumers. Consumer Reports also reported unsafe levels of arsenic , cadmium , lead and mercury in several protein powder products. The Canadian Broadcasting Corporation (CBC) reported that protein spiking, i.e.,

1460-436: A combination of simple failure and erosion tests, and more sophisticated engineering tests. The simpler tests are often used for quality control purposes, whereas the more complex tests are used during the design of the formulation and manufacturing process in the research and development phase. Standards for tablet properties are published in the various international pharmacopeias (USP/NF, EP, JP, etc.). The hardness of tablets

1606-637: A consumer center to assist reports of false health claims in product advertising for dietary supplements. In 2017, the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements. In the United States, manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce. Despite this caution, numerous adverse effects have been reported, including muscle cramps, hair loss, joint pain, liver disease , and allergic reactions , with 29% of

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1752-405: A dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite , constituent, extract , or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of

1898-489: A dietary supplement health claim for calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss. The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate . QHCs are supported by scientific evidence, but do not meet the more rigorous "significant scientific agreement" standard required for an authorized health claim. If dietary supplement companies choose to make such

2044-513: A disclaimer that the Food and Drug Administration (FDA) "has not evaluated the claim" and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease", because only a drug can legally make such a claim. The FDA enforces these regulations and also prohibits the sale of supplements and supplement ingredients that are dangerous, or supplements not made according to standardized good manufacturing practices (GMPs). In

2190-406: A final lubrication step is used to ensure that the tableting blend does not stick to the equipment during the tableting process. This usually involves low shear blending of the granules with a powdered lubricant, such as magnesium stearate or stearic acid . Whatever process is used to make the tableting blend, the process of making a tablet by powder compaction is very similar. First, the powder

2336-406: A general rule, dietary supplement labeling and marketing are not allowed to make disease prevention or treatment claims, the U.S. FDA has for some foods and dietary supplements reviewed the science, concluded that there is significant scientific agreement, and published specifically worded allowed health claims. An initial ruling allowing a health claim for calcium dietary supplements and osteoporosis

2482-437: A high amount of alcohol. An ointment is a homogeneous, viscous, semi-solid preparation; most commonly a greasy, thick water-in-oil emulsion (80% oil, 20% water) having a high viscosity, that is intended for external application to the skin or mucous membranes. Ointments have a water number that defines the maximum amount of water that they can contain. They are used as emollients or for the application of active ingredients to

2628-399: A high rate of acceptance by patients. There is a great variation in ingredients, composition, pH, and tolerance among generic brands. Topical corticosteroid foams are suitable for treating a range of skin conditions that respond to corticosteroids. These foams are typically simple to apply, which can lead to better patient compliance and, in turn, improve treatment results for those who favor

2774-514: A higher percentage of fine granules, which can compromise the quality or create yield problems for the tablet. Dry granulation requires drugs or excipients with cohesive properties, and a 'dry binder' may need to be added to the formulation to facilitate the formation of granules. Hot melt extrusion is utilized in pharmaceutical solid oral dose processing to enable delivery of drugs with poor solubility and bioavailability . Hot melt extrusion has been shown to molecularly disperse poorly soluble drugs in

2920-615: A laboratory machine called a Tablet Compaction Simulator or Powder Compaction Simulator. This is a computer controlled device that can measure the punch positions, punch pressures, friction forces, die wall pressures, and sometimes the tablet internal temperature during the compaction event. Numerous experiments with small quantities of different mixtures can be performed to optimise a formulation. Mathematically corrected punch motions can be programmed to simulate any type and model of production tablet press. Initial quantities of active pharmaceutical ingredients are very expensive to produce, and using

3066-691: A license is issued when a supplement product has been proven by the manufacturer and government to be safe, effective and of sufficient quality for its recommended use, an eight-digit Natural Product Number is assigned and recorded in a Licensed Natural Health Products Database. The European Food Safety Authority maintains a compendium of botanical ingredients used in manufacturing of dietary supplements. Pill (pharmacy) Tablets are prepared either by moulding or by compression . The excipients can include diluents , binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to promote tablet break-up in

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3212-445: A low risk of sensitization due to having few ingredients beyond the base oil or fat, and low irritation risk. There is typically little variability between brands of drugs. They are often disliked by patients due to greasiness. The vehicle of an ointment is known as the ointment base . The choice of a base depends upon the clinical indication for the ointment. The different types of ointment bases are: The medicaments are dispersed in

3358-439: A membrane which may only have adhesive on the patch rim or drug release may be controlled by release from a polymer matrix. Cutting a patch might cause rapid dehydration of the base of the medicine and affect the rate of diffusion. Some medications are applied as an ointment or gel, and reach the mucous membrane via vaporization. Examples are nasal topical decongestants and smelling salt. Topical drug classification system (TCS)

3504-528: A moderate degree of evidence in favor of whey protein supplements use as a safe and effective adjunct to an athlete's training and recovery, including benefits for endurance , average power, muscle mass , and reduced perceived exercise intensity . According to US and Canadian Dietary Reference Intake guidelines, the protein Recommended Dietary Allowance (RDA) for adults is based on 0.8 grams protein per kilogram body weight. The recommendation

3650-872: A modest reduction of antibiotic-associated diarrhea and acute diarrhea in children taking probiotics. There is limited evidence in support of adults using mono-strain and multi-strain containing probiotics for the alleviation of symptoms associated with irritable bowel syndrome . Probiotic supplements are generally regarded as safe. A meta-analysis provided preliminary evidence that men treated with supplements containing selenium , zinc , omega-3 fatty acids , coenzyme Q 10 or carnitines reported improvements in total sperm count, concentration, motility, and morphology. A review concluded that omega-3 taken through supplements and diet might improve semen quality in infertile men. A 2021 review also supported selenium, zinc, omega-3 fatty acids, coenzyme Q 10 or carnitines, but warned that "excessive use of antioxidants may be detrimental to

3796-451: A more convenient and cleaner topical option. Foam can be typically seen with topical steroids marketed for the scalp. Gels are thicker than liquids. Gels are often a semisolid emulsion and sometimes use alcohol as a solvent for the active ingredient; some gels liquefy at body temperature. Gel tends to be cellulose cut with alcohol or acetone. Gels tend to be self-drying, tend to have greatly variable ingredients between brands, and carry

3942-475: A novel way. The sensory overload is treatable with oral potassium gluconate . In 2020, the American market for dietary supplements was valued at $ 140.3 billion, with the economic impact in the United States for 2016 estimated at $ 122 billion, including employment wages and taxes. A 2020 analysis projected that the global market for vitamins and dietary supplement products would reach $ 196.6 billion by 2028, where

4088-401: A polymer carrier increasing dissolution rates and bioavailability. The process involves the application of heat, pressure and agitation to mix materials together and 'extrude' them through a die. Twin-screw high shear extruders blend materials and simultaneously break up particles. The extruded particles can then be blended and compressed into tablets or filled into capsules. After granulation,

4234-452: A popular dietary supplement ingredient with claims made for sports performance, is technically not an amino acid. It is synthesized in the body from the amino acid cysteine . Fish oil is a commonly used fatty acid supplement because it is a source of omega-3 fatty acids . Fatty acids are strings of carbon atoms, having a range of lengths. If links are all single (C−C), then the fatty acid is called saturated ; with one double bond (C=C), it

4380-451: A popular means of administering some drugs for birth control , hormone replacement therapy , and prevention of motion sickness . One example of an antibiotic that may be applied topically is chloramphenicol . If defined strictly as having a local effect, the topical route of administration can also include enteral administration of medications that are poorly absorbable by the gastrointestinal tract . One poorly absorbable antibiotic

4526-550: A prescription in pharmacies , supermarkets , specialist shops, military commissaries , buyers clubs , direct selling organizations, and the internet. While most of these products have a long history of use in herbalism and various forms of traditional medicine, concerns exist about their actual efficacy, safety and consistency of quality. Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products. In 2019, sales of herbal supplements just in

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4672-498: A recommendation that women pregnant or lactating consume an additional 100 to 200 mg/day of DHA. In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA. Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease. Furthermore, studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes . In 2017,

4818-491: A remote control panel, a dehumidifier, and dust collectors. An explosion-proof design is required for applying coatings that contain alcohol. It is sometimes necessary to split tablets into halves or quarters. Tablets are easier to break accurately if scored, but there are devices called pill-splitters which cut unscored and scored tablets. Tablets with special coatings (for example, enteric coatings or controlled-release coatings) should not be broken before use, as this exposes

4964-544: A significant risk of inducing hypersensitivity due to fragrances and preservatives. Gel is useful for hairy areas and body folds. In applying gel one should avoid fissures in the skin, due to the stinging effect of the alcohol base. Gel enjoys a high rate of acceptance due to its cosmetic elegance. Lotions are similar to solution but are thicker and tend to be more emollient in nature than solution. They are usually oil mixed with water, and more often than not have less alcohol than solution. Lotions can be drying if they contain

5110-462: A simple hypernym is needed to intuitively cover all such oral dosage forms, the broad sense of the word pill is also widely used and includes both tablets and capsules — colloquially, any solid oral form of medication falls into the "pill" category (see pill § Usage notes ). An early example of a pill comes from ancient Rome. They were made of zinc carbonates, hydrozincite and smithsonite . The pills were used for sore eyes and were found aboard

5256-425: A simple base like an ointment, much less variation between manufacturers is common. In dermatology , the base of a topical medication is often as important as the medication itself. It is extremely important to receive a medication in the correct base, before applying to the skin. A pharmacist should not substitute an ointment for a cream, or vice versa, as the potency of the medication can change. Some physicians use

5402-435: A single vitamin, mineral, lipid product, and herbal product were less likely to cause adverse effects related to excess supplementation. Among general reasons for the possible harmful effects of dietary supplements are: a) absorption in a short time, b) manufacturing quality and contamination, and c) enhancing both positive and negative effects at the same time. The incidence of liver injury from herbal and dietary supplements

5548-549: A solution or cream base. The manufacturer of each topical product has total control over the content of the base of a medication. Although containing the same active ingredients, one manufacturer's cream might be more acidic than the next, which could cause skin irritation or change its absorption rate. For example, a vaginal formulation of miconazole antifungal cream might irritate the skin less than an athlete's foot formulation of miconazole cream. These variations can, on occasion, result in different clinical outcomes , even though

5694-409: A sponge has been used as a primitive contraception in some cultures. Cordran tape is an example of a topical steroid applied under occlusion by tape. This greatly increases the potency and absorption of the topical steroid and is used to treat inflammatory skin diseases. A tincture is a skin preparation that has a high percentage of alcohol. It would normally be used as a drug vehicle if drying of

5840-402: A thick ointment to replace the waterproof barrier of the inflamed skin in the treatment of eczema, and a cream might not accomplish the same clinical intention. There are many general classes, with no clear dividing line among similar formulations. As a result, what the manufacturer's marketing department chooses to list on the label of a topical medication might be completely different from what

5986-486: A value of $ 151.9 billion in 2021, there are more than 50,000 dietary supplement products marketed in the United States, where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product among types of dietary supplements. The United States National Institutes of Health states that supplements "may be of value" for those who are nutrient deficient from their diet and receive approval from their medical provider. In

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6132-503: A vital nutrient in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism and must be obtained from the diet. The term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for anthropoid primates, humans , guinea pigs and bats , but not for other mammals. Vitamin D

6278-435: A water-based solution needs to be shaken into suspension before use and includes the instructions: "Shake well before use". Medication may be placed in a solid form. Examples are deodorant, antiperspirants, astringents, and hemostatic agents. Some solids melt when they reach body temperature (e.g. rectal suppositories). Certain contraceptive methods rely on sponge as a carrier of a liquid medicine. Lemon juice embedded in

6424-405: Is vancomycin , which is recommended by mouth as a treatment for severe Clostridioides difficile colitis . A medication's potency often is changed with its base. For example, some topical steroids will be classified one or two strengths higher when moving from cream to ointment. As a rule of thumb, an ointment base is more occlusive and will drive the medication into the skin more rapidly than

6570-413: Is 100 μg (4,000 IU), but products are available without prescription at 10,000 IU. Minerals are the exogenous chemical elements indispensable for life. Four minerals – carbon , hydrogen , oxygen , and nitrogen – are essential for life but are so ubiquitous in food and drink that these are not considered nutrients and there are no recommended intakes for these as minerals. The need for nitrogen

6716-451: Is a health risk, require that the company conduct a recall. Only after a dietary supplement product is marketed, may the FDA's Center for Food Safety and Applied Nutrition (CFSAN) review the products for safety and effectiveness. The European Union 's (EU) Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity. Only those supplements that have been proven to be safe may be sold in

6862-684: Is about 16–20% of all supplement products causing injury, with the occurrence growing globally over the early 21st century. The most common liver injuries from weight loss and bodybuilding supplements involve hepatocellular damage with resulting jaundice , and the most common supplement ingredients attributed to these injuries are green tea catechins , anabolic steroids , and the herbal extract , aegeline . Weight loss supplements have also had adverse psychiatric effects . Some dietary supplements may also have adverse interactions with prescription medications that may enhance side effects or decrease therapeutic effects of medications. Work done by scientists in

7008-489: Is addressed by requirements set for protein, which is composed of nitrogen-containing amino acids. Sulfur is essential, but for humans, not identified as having a recommended intake per se. Instead, recommended intakes are identified for the sulfur-containing amino acids methionine and cysteine . There are dietary supplements that provide sulfur, such as taurine and methylsulfonylmethane . The essential nutrient minerals for humans, listed in order by weight needed to be at

7154-467: Is an essential piece of machinery for any pharmaceutical and nutraceutical manufacturer. Tablet presses must allow the operator to adjust the position of the lower and upper punches accurately, so that the tablet weight, thickness and density/hardness can each be controlled. This is achieved using a series of cams, rollers, or tracks that act on the tablet tooling (punches). Mechanical systems are also incorporated for die filling, and for ejecting and removing

7300-412: Is an ointment in which a powder is suspended. Powder is either the pure drug by itself (talcum powder), or is made of the drug mixed in a carrier such as corn starch or corn cob powder (Zeosorb AF – miconazole powder). Can be used as an inhaled topical ( cocaine powder used in nasal surgery). A shake lotion is a mixture that separates into two or three parts over time. Frequently, an oil mixed with

7446-413: Is called monounsaturated ; if there are two or more double bonds (C=C=C), it is called polyunsaturated . Only two fatty acids, both polyunsaturated, are considered essential to be obtained from the diet, as the others are synthesized in the body. The "essential" fatty acids are alpha-linolenic acid (ALA), an omega-3 fatty acid, and linoleic acid (LA), an omega-6 fatty acid . ALA can be elongated in

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7592-496: Is desirable as it is quicker. There is less processing, equipment, labor, and energy consumption. However, DC is difficult when a formulation has a high content of poorly compressible active ingredients. Wet granulation is a process of using a liquid binder to lightly agglomerate the powder mixture. The amount of liquid has to be properly controlled, as over-wetting will cause the granules to be too hard and under-wetting will cause them to be too soft and friable. Aqueous solutions have

7738-611: Is filled into the die from above. The mass of powder is determined by the position of the lower punch in the die, the cross-sectional area of the die, and the powder density. At this stage, adjustments to the tablet weight are normally made by repositioning the lower punch. After die filling, the upper punch is lowered into the die and the powder is uniaxially compressed to a porosity of between 5 and 20%. The compression can take place in one or two stages (main compression, and, sometimes, pre-compression or tamping) and for commercial production occurs very fast (500–50 mg per tablet). Finally,

7884-425: Is for local skin infection problems. Dermatological products have various formulations and range in consistency though the most popular dermal products are semisolid dosage forms to provide topical treatment. Topical drug absorption depends on two major factors – biological and physicochemical properties. The first factor concerns body structure effects on the drugs . The degradation of drugs can be affected by

8030-686: Is for sedentary and lightly active people. Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength, or conclude the opposite. The International Olympic Committee recommends protein intake targets for both strength and endurance athletes at about 1.2–1.8 g/kg body mass per day. One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg. The same protein ingredients marketed as dietary supplements can be incorporated into meal replacement and medical food products, but those are regulated and labeled differently from supplements. In

8176-435: Is for stimulating muscle protein synthesis. A review of the literature concluded this claim was unwarranted. In elderly people, supplementation with just leucine resulted in a modest (0.99 kg) increase in lean body mass. The non-essential amino acid arginine , consumed in sufficient amounts, is thought to act as a donor for the synthesis of nitric oxide, a vasodilator. A review confirmed blood pressure lowering. Taurine ,

8322-426: Is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes. As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat

8468-493: Is little evidence of benefit when vitamins are consumed as a dietary supplement by those who are healthy and have a nutritionally adequate diet. The U.S. Institute of Medicine sets tolerable upper intake levels (ULs) for some of the vitamins. This does not prevent dietary supplement companies from selling products with content per serving higher than the ULs. For example, the UL for vitamin D

8614-476: Is mainly by metabolic enzyme cytochrome P450 , and this enzyme is not active in skin. The CYP450 actively metabolized drugs can then maintain high concentration when being applied on skin. Despite CYP450 enzyme action, the partition coefficient (K) determines the activity of topical drugs. The ability of drug particles to go through the skin layer also affects the absorption of drugs. For transdermal activity, medicines with higher K value are harder to get rid of

8760-431: Is much broader now, from smoking cessation to beauty purposes. Nowadays, there are numerous dosage forms that can be used topically, including cream , ointment , lotion , patches , dusting powder and much more. There are many advantages for this drug delivery system – avoiding first pass metabolism which can increase its bioavailability , being convenient and easy to apply to a large area, being easy to terminate

8906-700: Is not an essential nutrient for people who get sufficient exposure to ultraviolet light , either from the sun or an artificial source, as they synthesize vitamin D in skin. Humans require thirteen vitamins in their diet, most of which are actually groups of related molecules, "vitamers", (e.g. vitamin E includes tocopherols and tocotrienols , vitamin K includes vitamin K 1 and K 2 ). The list: vitamins A, C, D, E, K, Thiamine (B 1 ), Riboflavin (B 2 ), Niacin (B 3 ), Pantothenic Acid (B 5 ), Vitamin B 6 , Biotin (B 7 ), Folate (B 9 ) and Vitamin B 12 . Vitamin intake below recommended amounts can result in signs and symptoms associated with vitamin deficiency. There

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9052-435: Is often used when the product to be granulated is sensitive to moisture and heat. Dry granulation can be conducted on a tablet press using slugging tooling or on a roll press called a roller compactor. Dry granulation equipment offers a wide range of pressures to attain proper densification and granule formation. Dry granulation is simpler than wet granulation, therefore the cost is reduced. However, dry granulation often produces

9198-628: Is proposed by the FDA . It is designed from the Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products which is very successful for decades. There are 3 aspects to assess and 4 classes in total. The 3 aspects include qualitative (Q1), quantitative (Q2) and similarity of in vitro release (IVR) rate (Q3). In the early 1970s, the Alza Corporation , through their founder Alejandro Zaffaroni , filed

9344-425: Is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring risk–benefit analysis to prove that the product can be sold like a drug, such assessment is only used by the FDA to decide that a dietary supplement is unsafe and should be removed from market. A vitamin is an organic compound required by an organism as

9490-405: Is the effect of the drug vehicle. The medium to carry the topical drugs can affect the penetration of the drug active ingredient and efficacy . For example, this carrier can have a cooling, drying, emollient or protective action to suit the required conditions of the application site such as applying gel or lotion for hairy areas. Meanwhile, scientists need to match the type of preparation with

9636-399: Is the most commonly seen dosage form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets. A tablet can be formulated to deliver an accurate dosage to a specific site in the body; it is usually taken orally, but can be administered sublingually , buccally , rectally or intravaginally . The tablet is just one of

9782-730: Is the principal measure of mechanical strength. Hardness is tested using a tablet hardness tester . The units for hardness have evolved since the 1930s but are commonly measured in kilograms per square centimetre. Models of testers include the Monsanto (or Stokes) Hardness Tester from 1930, the Pfizer Hardness Tester from 1950, the Strong Cob Hardness Tester and the Heberlain (or Schleeniger) Hardness Tester. Lubricants prevent ingredients from clumping together and from sticking to

9928-568: The Stokes–Einstein equation . The equation is: where Assuming concentration gradient is constant for all newly applied topical drugs and the temperature is constant (normal body temperature: 37 °C), the viscosity and radius of the drug determine the flux of diffusion. The higher the viscosity or the larger the radius of the drug is, the lower the diffusion flux of the drug is. There are many factors for drug developers to consider in developing new topical formulations. The first one

10074-552: The New York Attorney General (NY-AG) identified four major retailers with dietary supplement products that contained fraudulent and potentially dangerous ingredients, requiring the companies to remove the products from retail stores. According to the NY-AG, only about 20% of the herbal supplements tested contained the plants claimed. The methodology used by the NY-AG was disputed. The test involves looking for DNA fragments from

10220-589: The Recommended Dietary Allowance or Adequate Intake are potassium , chlorine , sodium , calcium , phosphorus , magnesium , iron , zinc , manganese , copper , iodine , chromium , molybdenum , selenium and cobalt (the last as a component of vitamin B 12 ). There are other minerals which are essential for some plants and animals, but may or may not be essential for humans, such as boron and silicon . Essential and purportedly essential minerals are marketed as dietary supplements, individually and in combination with vitamins and other minerals. Although as

10366-400: The lipid layer of skin cells . The trapped molecules then cannot penetrate into the skin. This reduces the efficacy of the transdermal drugs. The drugs target cells underneath the skin or need to diffuse into blood capillary to exert their effect. Meanwhile, the size of particles affects this transdermal process. The smaller the drug molecules, the faster the rate of penetration. Polarity of

10512-456: The sarcopenia of old age, to athletes who believe that strenuous physical activity increases protein requirements, to people hoping to lose weight while minimizing muscle loss, i.e., conducting a protein-sparing modified fast , and to people who want to increase muscle size for performance and appearance. Whey protein is a popular ingredient, but products may also incorporate casein , soy , pea , hemp or rice protein . A meta-analysis found

10658-417: The skin to provide topical therapeutic effects. As skin is one of the largest and most superficial organs in the human body, pharmacists utilise it to deliver various drugs. This system usually provides a local effect on certain positions of the body. In ancient times, people used herbs to put on wounds for relieving the inflammatory effect or as pain relievers. The use of topical drug delivery system

10804-513: The American Heart Association issued a science advisory stating that it could not recommend use of omega-3 fish oil supplements for primary prevention of cardiovascular disease or stroke, although it reaffirmed supplementation for people who have a history of coronary heart disease . Manufacturers have begun to include long chain polyunsaturated fatty acids DHA and arachidonic acid (AA) into their formula milk for newborns, however,

10950-676: The EU without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims. The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by

11096-445: The FDA and FTC had issued warning letters to dozens of companies advertising scam products, which were purported "to be drugs, medical devices or vaccines. Products that claim to cure, mitigate, treat, diagnose or prevent disease, but are not proven safe and effective for those purposes, defraud consumers of money and can place consumers at risk for serious harm" Examples of ongoing government research organizations to better understand

11242-683: The FDA as food products subject to compliance with current Good Manufacturing Practices (CGMP) and labeling with science-based ingredient descriptions and advertising. When finding CGMP or advertising violations, FDA warning letters are used to notify manufacturers of impending enforcement action, including search and seizure , injunction , and financial penalties . Examples between 2016 and 2018 of CGMP and advertising violations by dietary supplement manufacturers included several with illegal compositions or advertising of vitamins and minerals. The U.S. Federal Trade Commission , which litigates against deceptive advertising in marketed products, established

11388-443: The FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances. Dietary supplement manufacture is required to comply with the good manufacturing practices established in 2007. The FDA can visit manufacturing facilities, send Warning Letters if not in compliance with GMPs, stop production, and if there

11534-493: The FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods. Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives , added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which

11680-492: The Roman scholar Pliny, who lived from 23 to 79 AD, first gave a name to what we now call pills, calling them pilula . Pills have always been difficult to swallow, and efforts have been made to make them go down easier. In mediaeval times, people coated pills with slippery plant substances. Another approach, used as recently as the 19th century, was to gild them in gold and silver, although this often meant that they would pass through

11826-478: The United States alone were $ 9.6 billion, with the market growing at approximately 8.6% per year, with cannabidiol and mushroom product sales as the highest. Italy, Germany, and Eastern European countries were leading consumers of botanical supplements in 2016, with European Union market growth forecast to be $ 8.7 billion by 2020. Claimed benefits of using probiotic supplements are not supported by sufficient clinical evidence. Meta-analysis studies have reported

11972-687: The United States, "meal replacement" products are foods and are labeled as such. These typically contain protein, carbohydrates, fats, vitamins and minerals. There may be content claims such as "good source of protein", "low fat" or "lactose free". Medical foods, also nutritionally complete, are designed to be used while a person is under the care of a physician or other licensed healthcare professional. Liquid medical food products – for example, Ensure – are available in regular and high protein versions. Proteins are chains of amino acids . Nine of these proteinogenic amino acids are considered essential for humans because they cannot be produced from other compounds by

12118-412: The United States, it is against federal regulations for supplement manufacturers to claim that these products prevent or treat any disease. Companies are allowed to use what is referred to as "Structure/Function" wording if there is substantiation of scientific evidence for a supplement providing a potential health effect. An example would be "_____ helps maintain healthy joints", but the label must bear

12264-484: The United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term "dietary supplement" to mean a product (other than tobacco ) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid,

12410-577: The active ingredient is the same. No comparative potency labeling exists to ensure equal efficacy between brands of topical steroids (percentage of oil vs water dramatically affect the potency of topical steroid). Studies have confirmed that the potency of some topical steroid products may differ according to manufacturer or brand. An example of this is the case of brand name Valisone cream and Kenalog cream in clinical studies have demonstrated significantly better vasoconstrictions than some forms of this drug produced by generic drug manufacturers. However, in

12556-416: The active ingredient of a tablet is sensitive to acid, or is irritant to the stomach lining, an enteric coating can be used, which is resistant to stomach acid, and dissolves in the less acidic area of the intestines. Enteric coatings are also used for medicines that can be negatively affected by taking a long time to reach the small intestine , where they are absorbed. Coatings are often chosen to control

12702-417: The addition of amino acids to manipulate protein content analysis, was common. Many of the companies involved challenged CBC's claim. In some botanical products, undeclared ingredients were used to increase the bulk of the product and reduce its cost of manufacturing, while potentially violating certain religious and/or cultural limitations on consuming animal ingredients, such as cow, buffalo or deer. In 2015,

12848-449: The adulterated supplements were marketed for weight loss and sexual performance, with many containing prescription erectile dysfunction medication. Muscle building supplements were contaminated with anabolic steroids that can lead to health complications affecting the kidney, the heart, and cause gynecomastia . Multiple bodybuilding products also contained antidepressants and antihistamines . Despite these findings, fewer than half of

12994-508: The adulterated supplements were recalled. The European Commission has published harmonized rules on supplement products to assure consumers have minimal health risks from using dietary supplements and are not misled by advertising. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The U.S. Food and Drug Administration (FDA) monitors supplement products for accuracy in advertising and labeling. Dietary supplements are regulated by

13140-402: The advantage of being safer to deal with than solvent-based systems but may not be suitable for drugs which are degraded by hydrolysis. Low shear wet granulation processes use very simple mixing equipment, and can take a considerable time to achieve a uniformly mixed state. High shear wet granulation processes use equipment that mixes the powder and liquid at a very fast rate, and thus speeds up

13286-456: The adverse effects resulting in hospitalization, and 20% in serious injuries or illnesses. The potential for adverse effects also occurs when individuals consume more than the necessary daily amount of vitamins or minerals that are needed to maintain normal body processes and functions. The incidence of adverse effects reported to the FDA were due to "combination products" that contain multiple ingredients, whereas dietary supplements containing

13432-438: The amount will be lower. The exact amount delivered to the target action site determines the potency and bioavailability of the drugs. If the concentration is too low, the therapeutic effect is impeded; if the concentration is too high, drug toxicity may happen to cause side effects or even do harm to our body. For the topical drug delivery way, degradation of drugs in skin is very low compared to liver . The metabolism of drugs

13578-456: The area is desired. Topical solutions can be marketed as drops, rinses, or sprays, are generally of low viscosity, and often use alcohol or water in the base. These are usually a powder dissolved in alcohol, water, and sometimes oil; although a solution that uses alcohol as a base ingredient, as in topical steroids, can cause drying of the skin. There is significant variability among brands, and some solutions may cause irritation, depending on

13724-658: The base and are divided after penetrating the living cells of the skin. The water number of an ointment is the maximum quantity of water that 100g of a base can contain at 20 °C. Ointments are formulated using hydrophobic, hydrophilic, or water-emulsifying bases to provide preparations that are immiscible, miscible, or emulsifiable with skin secretions . They can also be derived from hydrocarbon (fatty), absorption, water-removable, or water-soluble bases. Evaluation of ointments: Properties which affect choice of an ointment base are: Methods of preparation of ointments: Paste combines three agents – oil, water, and powder. It

13870-484: The body to create other omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Plant oils, particularly seed and nut oils, contain ALA. Food sources of EPA and DHA are oceanic fish, whereas dietary supplement sources include fish oil, krill oil and marine algae extracts. The European Food Safety Authority (EFSA) identifies 250 mg/day for a combined total of EPA and DHA as Adequate Intake, with

14016-575: The diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug , antibiotic , or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition." Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including meal replacements ), medical foods , preservatives or pharmaceutical drugs . Products intended for use as

14162-807: The diet. Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts. During the COVID-19 pandemic in the United States, the FDA and Federal Trade Commission (FTC) warned consumers about marketing scams of fraudulent supplement products, including homeopathic remedies , cannabidiol products , teas, essential oils , tinctures and colloidal silver , among others. By August 2020,

14308-499: The digestive tract with no effect. In the 1800s, sugar coating and gelatin coating were invented, as were gelatin capsules . In 1843, the British painter and inventor William Brockedon was granted a patent for a machine capable of "Shaping Pills, Lozenges, and Black Lead by Pressure in Dies". The device was capable of compressing powder into a tablet without the use of an adhesive. A pill

14454-465: The digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually attractive or aid in visual identification of an unknown tablet. A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release rate of the active ingredient, to make it more resistant to the environment (extending its shelf life), or to enhance the tablet's appearance. Medicinal tablets were originally made in

14600-540: The disintegration time of the tablet coating and the tablet core, automatic disintegration testers are used which are able to determine the complete disintegration process of a tablet by measuring the rest height of the thickness with every upward stroke of the disintegration tester basket. There are two types of coating machines used in the pharmaceutical industry: coating pans and automatic coaters. Coating pans are used mostly to sugar coat pellets. Automatic coaters are used for all kinds of coatings; they can be equipped with

14746-428: The drugs . Topical application is an easy way for patients to tackle skin infections in a painless and non-invasive way. From a patient perspective, applying drugs on skin also provides stable dosage in blood so as to give the optimal bioavailability and therapeutic effects . In case of overdose or unwanted side effects, patients can take off or wash out the medicines quickly to eliminate toxicity by simply removing

14892-408: The drugs can affect this diffusion rate too. If the drug shows lower degree of ionization, it is less polar. Therefore, it can have a faster absorption rate. The definition of the topical route of administration sometimes states that both the application location and the pharmacodynamic effect thereof is local. In other cases, topical is defined as applied to a localized area of the body or to

15038-940: The early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies , and preventing conditions like neural tube defects by supplementation and food fortification with folic acid , no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful. For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants , vitamins, or minerals, do not help and some have been found to be harmful in some cases. In general, as of 2016, robust clinical data

15184-531: The first US patents describing transdermal delivery systems for scopolamine , nitroglycerin and nicotine . People found that applying medicines on the body surfaces is beneficial in many aspects. Skin medicines can give faster onset and local effect on our body as the surface cream can bypass first pass metabolism such as hepatic and intestinal metabolism. Apart from the absorption, dermal drugs effectively prevent oral delivery limitations such as nausea and vomiting and poor appliances due to unpalatable tastes of

15330-482: The form would normally be called. A cream is an emulsion of oil and water in approximately equal proportions. It penetrates the stratum corneum outer layer of skin wall. Cream is thicker than lotion, and maintains its shape when removed from its container. It tends to be moderate in moisturizing tendency. For topical steroid products, oil-in-water emulsions are common. Creams have a significant risk of causing immunological sensitization due to preservatives and have

15476-405: The greater the pressure applied during compression, and sometimes the harder the tablet. Tablets need to be hard enough that they do not break up in the bottle, yet friable enough that they disintegrate in the gastric tract. Tablets need to be strong enough to resist the stresses of packaging, shipping, and handling by the pharmacist and patient. The mechanical strength of tablets is assessed using

15622-511: The growth in market size is largely attributed to recent technological advancements in product manufacturing, increased demand for products advertised as healthy, increased product availability, and population aging . Over the period 2008 to 2011, the Government Accountability Office (GAO) of the United States received 6,307 reports of health problems (identified as adverse events ) from use of dietary supplements containing

15768-505: The handling of the tablet, must not make tablets stick together during the coating process, and must follow the fine contours of embossed characters or logos on tablets. Coatings are necessary for tablets that have an unpleasant taste, and a smoother finish makes large tablets easier to swallow. Tablet coatings are also useful to extend the shelf-life of components that are sensitive to moisture or oxidation. Special coatings (for example with pearlescent effects) can enhance brand recognition. If

15914-418: The human body and so must be taken in as food. Recommended intakes, expressed as milligrams per kilogram of body weight per day, have been established. Other amino acids may be conditionally essential for certain ages or medical conditions. Amino acids, individually and in combinations, are sold as dietary supplements. The claim for supplementing with the branched-chain amino acids leucine, valine and isoleucine

16060-399: The machine tooling used to produce them; a die plus an upper and a lower punch are required. This is called a station of tooling. The amount of tablet material and the placement of the punches in relation to one another during compression determine the thickness. Once this is done, we can measure the corresponding pressure applied during compression. The shorter the distance between the punches,

16206-435: The manufacturing process. Fluid bed granulation is a multiple-step wet granulation process performed in the same vessel to pre-heat, granulate, and dry the powders. It is used because it allows close control of the granulation process. Dry granulation processes create granules by light compaction of the powder blend under low pressures. The compacts so-formed are broken up gently to produce granules (agglomerates). This process

16352-590: The many forms that an oral drug can take such as syrups , elixirs , suspensions , and emulsions . Pills are thought to date back to around 1500 BC. Earlier medical recipes, such as those from 4000 BC, were for liquid preparations rather than solids. The first references to pills were found on papyruses in ancient Egypt and contained bread dough, honey, or grease. Medicinal ingredients, such as plant powders or spices, were mixed in and formed by hand to make little balls, or pills. In ancient Greece, such medicines were known as katapotia ("something to be swallowed"), and

16498-425: The medication and avoiding gastro-intestinal irritations. All these can increase the patient compliance. However, there are several disadvantages for this system – causing skin irritations and symptoms like rashes and itchiness may occur. Also, only small particles can pass through the skin, which limits the choice of drugs . Since skin is the main medium of topical drug delivery system, its conditions determine

16644-422: The mother and fetus . Although prenatal vitamins are not meant to substitute for dietary nutrition, prenatal supplementation may be beneficial for pregnant women at risk of nutrient deficiencies because of diet limitations or restrictions. The most common components in prenatal vitamins include vitamins B 6 , folate , B 12 , C , D , E , iron and calcium . Sufficient intake of vitamin B 6 can lower

16790-486: The mother's health other than a risk reduction on low pre-delivery serum folate and megaloblastic anemia. There is little evidence to suggest that vitamin D supplementation improves prenatal outcomes in hypertensive disorders and gestational diabetes . Evidence does not support the routine use of vitamin E supplementation during pregnancy to prevent adverse events, such as preterm birth, fetal or neonatal death, or maternal hypertensive disorders. Iron supplementation can lower

16936-411: The patch to stop the delivery of drugs. The site of putting the patches for topical drugs may get irritated and have rashes and feel itchy. Hence, some topical drugs including nicotine patches for smoking cessation are advised to change places for each application to avoid continuous irritation of the skin. Also, since the drug needs to penetrate the skin, some drugs may not be able to pass through

17082-739: The petitioners as unjustified restrictions of consumer choice . In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive referred to the European Court of Justice by the High Court in London. Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on

17228-536: The plants named as the dietary supplement ingredients in the products. One scientist said that it was possible that the extraction process used to create the supplements removed or destroyed all DNA. This, however, would not explain the presence of DNA from plants such as rice or wheat, that were not listed as ingredients. A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted pharmaceutical drugs , many of which could interact with other medications and lead to hospitalization. 86% of

17374-476: The potential clinical efficacy of supplements for maintaining health or lowering disease risk. As continual research on the properties of supplements accumulates, databases or fact sheets for various supplements are updated regularly, including the Dietary Supplement Label Database, Dietary Supplement Ingredient Database, and Dietary Supplement Facts Sheets of the United States. In Canada where

17520-850: The potential health properties and safety of dietary supplements are the European Food Safety Authority , the Office of Dietary Supplements of the United States National Institutes of Health , the Natural and Non-prescription Health Products Directorate of Canada, and the Therapeutic Goods Administration of Australia. Together with public and private research groups, these agencies construct databases on supplement properties, perform research on quality, safety, and population trends of supplement use, and evaluate

17666-434: The preservative(s) and fragrances used in the base. Some examples of topical solutions are given below: Transdermal patches can be a very precise time released method of delivering a drug. Cutting a patch in half might affect the dose delivered. The release of the active component from a transdermal delivery system (patch) may be controlled by diffusion through the adhesive which covers the whole patch, by diffusion through

17812-438: The rate of dissolution of the drug in the gastrointestinal tract. Some drugs are absorbed better in certain parts of the digestive system. If this part is the stomach, a coating is selected that dissolves quickly and easily in acid. If the rate of absorption is best in the large intestine or colon, a coating is used that is acid resistant and dissolves slowly to ensure that the tablet reaches that point before dispersing. To measure

17958-406: The rate of skin penetration leading to affecting the pharmacokinetics of the drug . The temperature , pH value and dryness of the skin need to be considered. There are some novel topical drugs in the market which can utilise the system as much as possible. This localized system provides topical therapeutic effects via skin, eyes , nose and vagina to treat diseases . The most common usage

18104-522: The risk of iron deficiency anemia for pregnant women. In 2020, the World Health Organization updated recommendations for adequate calcium levels during pregnancy to prevent hypertensive disorders . Individuals with hypokalemic sensory overstimulation are sometimes diagnosed as having attention deficit hyperactivity disorder (ADHD), raising the possibility that a subtype of ADHD has a cause that can be understood mechanistically and treated in

18250-429: The risk of early pregnancy loss and relieve symptoms of morning sickness . Folate is also an essential nutrient for pregnant women to prevent neural tube defects . In 2006, the World Health Organization endorsed the recommendation for women of child-bearing age to consume 400 micrograms of folate through the diet daily if planning a pregnancy. A 2013 review found folic acid supplementation during pregnancy did not affect

18396-400: The sale of vitamins and food supplements should be scrapped, he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health . ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of

18542-580: The same API dose is delivered with each tablet. Some APIs may be compressed into tablets as pure substances, but this is rarely the case; most formulations include pharmacologically inactive ingredients ( excipients ): Tablets can be made in virtually any shape, although the requirements of patients and tableting machines mean that most are round, oval, or capsule-shaped. More unusual shapes have been manufactured, but patients find these harder to swallow, and they are more vulnerable to chipping or manufacturing problems. Tablet diameter and shape are determined by

18688-400: The shape of a disk of whatever colour their components determined, but are now made in many shapes and colours to help distinguish different medicines. Tablets are often imprinted with symbols, letters, and numbers, which allow them to be identified, or a groove to allow splitting by hand. Sizes of tablets to be swallowed range from a few millimetres to about a centimetre. The compressed tablet

18834-408: The site of applications. Some studies discovered different Percutaneous absorption patterns. Apart from the place, age also affects the absorption as the skin structure changes with age. The lowered collagen and broadened blood capillary networks happen with ageing. These features alter the effectiveness of absorption of both hydrophilic and lipophilic substances into stratum corneum underneath

18980-409: The skin for protective, therapeutic, or prophylactic purposes and where a degree of occlusion is desired. Ointments are used topically on a variety of body surfaces. These include the skin and the mucous membranes of the eye (an eye ointment ), chest , vulva , anus , and nose . An ointment may or may not be medicated. Ointments are usually very moisturizing, and good for dry skin. They have

19126-454: The skin. Some drugs are then “wasted” and the bioavailability of the drug will decrease. Skin penetration is the main challenge for any topical dosage form. The drug needs to penetrate the skin in order to get into the body to apply its function. The drug follows the Fick's first law of diffusion. One of the most common versions of Fick's first law of diffusion is: where For D is described by

19272-420: The skin. Topical medications may also be inhalational , such as asthma medications , or applied to the surface of tissues other than the skin, such as eye drops applied to the conjunctiva , or ear drops placed in the ear, or medications applied to the surface of a tooth . The word topical derives from Greek τοπικός topikos , "of a place". Topical drug delivery is a route of administering drugs via

19418-580: The spermatic function and many of the over-the-counter supplements are not scientifically proven to improve fertility." There is low quality and insufficient evidence for the use of oral antioxidant supplements as a viable treatment for subfertile woman. A review provided evidence that taking dehydroepiandrosterone before starting an in vitro fertilization series may increase pregnancy rates and decrease miscarriage likelihood. Prenatal vitamins are dietary supplements commonly given to pregnant women to supply nutrients that may reduce health complications for

19564-448: The strength of their product developed the "caplet", a portmanteau of capsule-shaped tablet , in order to tie this positive association to more efficiently produced tablet pills as well as being an easier-to-swallow shape than the usual disk-shaped tablet. An orally disintegrating tablet or orodispersible tablet (ODT), is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. In

19710-418: The surface of a body part regardless of the location of the effect. By this definition, topical administration also includes transdermal application, where the substance is administered onto the skin but is absorbed into the body to attain systemic distribution. Such medications are generally hydrophobic chemicals, such as steroid hormones . Specific types include transdermal patches which have become

19856-456: The surface of skin. The skin surface integrity can also affect the permeability of drugs such as the density of hair follicles , sweat glands or disintegrated by inflammation or dehydration . The other factor concerns metabolism of medications on skin. When the percutaneous drug is applied on skin, it will be gradually absorbed down the skin. Normally, when the drugs are absorbed, they will be metabolised by various enzymes in our body and

20002-524: The tablet core to the digestive juices, circumventing the intended delayed-release effect. Topical medication A topical medication is a medication that is applied to a particular place on or in the body. Most often topical medication means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams , foams , gels , lotions , and ointments. Many topical medications are epicutaneous, meaning that they are applied directly to

20148-645: The tablet pressing process, the appropriate amount of active ingredient must be in each tablet. Hence, all the ingredients should be well mixed. If a sufficiently homogenous mix of the components cannot be obtained with simple blending processes, the ingredients must be granulated prior to compression to assure an even distribution of the active compound in the final tablet. Two basic techniques are used to granulate powders for compression into tablets: wet granulation and dry granulation. Powders that can be mixed well do not require granulation and can be compressed into tablets through direct compression ("DC"). Direct compression

20294-426: The tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between the solid and die wall, as well as between granules, which helps in uniform filling of the die. Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. In

20440-560: The tablet weight, thickness and hardness. Due to efforts to reduce rejects rates and machine down-time, automated tablet testing devices are used on-line with the tablet press or off-line in the IPC-labs. Many tablets today are coated after being pressed. Although sugar-coating was popular in the past, the process has many drawbacks. Modern tablet coatings are polymer and polysaccharide based, with plasticizers and pigments included. Tablet coatings must be stable and strong enough to survive

20586-440: The tablet-pressing process, it is important that all ingredients be fairly dry, powdered or granular, somewhat uniform in particle size, and freely flowing. Mixed particle sized powders may separate outsegregate during manufacture due to their different densities. This can result in tablets with poor drug or active pharmaceutical ingredient (API) content uniformity, but granulation should prevent this. Content uniformity ensures that

20732-586: The tablets from the press after compression. Pharmaceutical tablet presses are required to be easy to clean and quick to reconfigure with different tooling, because they are usually used to manufacture many different products. There are two main standards of tablet tooling used in pharmaceutical industry: American standard TSM and European standard EU. TSM and EU configurations are similar to each other but cannot be interchanged. Modern tablet presses reach output volumes of up to 1,700,000 tablets per hour. These huge volumes require frequent in-process quality control for

20878-450: The type of lesions. For example, they need to avoid oily ointments for acute weepy dermatitis . Chemists also need to consider the irritation or any sensitization potential to ensure that the topical application can be stable during storage and transport to maintain its efficacy. Another potential material is nanofiber-based dispersion to improve the adhesion of active ingredients on the skin. In order to enhance drug penetration into

21024-459: The upper punch is pulled up and out of the die (decompression), and the tablet is ejected from the die by lifting the lower punch until its upper surface is flush with the top face of the die. This process is repeated for each tablet. Common problems encountered during tablet manufacturing operations include: Consequently, permanent consistency checks are required during the manufacturing process. Tablet formulations are designed and tested using

21170-540: Was later amended to include calcium supplements with or without vitamin D, effective January 1, 2010. Examples of allowed wording are shown below. In order to qualify for the calcium health claim, a dietary supplement must contain at least 20% of the Reference Dietary Intake, which for calcium means at least 260 mg/serving. In the same year, the European Food Safety Authority also approved

21316-444: Was originally defined as a small, round, solid pharmaceutical oral dosage form of medication. The word's etymology reflects the historical concepts of grinding the ingredients with a mortar and pestle and rolling the resultant paste or dough into lumps to be dried. Today, in its strict sense, the word pill still refers specifically to tablets (including caplets) rather than capsules (which were invented much later), but because

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