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Acrylates
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Co-polymers of methacrylic acid derivatives used in the pharmaceutical industry to effect modified release or taste masking. The popularity of acrylate polymers stems from their flexibility to produce desired release profiles and the fact that many of the polymers can be processed using aqueous systems. Acrylate polymers can be classified in terms of their solubility in acidic and neutral media, and this solubility determines their usual application. Enteric polymers are insoluble in acidic media and soluble in neutral media (types L and S), Extended release polymers are insoluble in both media (types NE, RL and RS) and taste masking polymers are soluble in acidic media but insoluble in neutral media (type E).
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Amorphous lactose
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Amorphous lactose is found mainly in two types of lactose. In typical spray dried lactose (SuperTab® 11SD) it is present at a level of about 10%, and it results from the rapid drying of the portion of dissolved lactose processed through the spray drier. In milled lactose the amorphous portion depends on the degree of milling, but as a guide a commonly used grade for wet granulation (say Pharmatose® 200M) contains about 2% amorphous lactose at the time of manufacture. Exposure of amorphous alpha-lactose to atmospheric moisture causes its recrystallisation to lactose monohydrate.
Click here for the abstract: The effect of moisture content on the compression and bond formation properties of amorphous lactose: Sebhatu T, Ahlneck C and Alderborn G, Int J Pharm, (1997), 146, 101 - 114.
Measurement of amorphous technical bulletin.
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Amylopectin
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The major polysaccharide found in starches. Amylopectin consists of chains of alpha-glucose linked 1 - 4 with branches (1 - 6 links) every 20 to 30 glucose units. Amylopectin is a very large molecule with MW of about 107 to 109 Daltons. Both corn starch and potato starch contain about 75% amylopectin and about 25%% amylose.
Click here for the abstract: Starch—composition, fine structure and architecture: Richard F. Tester, John Karkalas, Xin Qi, Journal of Cereal Science 39 (2004) 151–165
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Amylose
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The minor polysaccharide found in starches. Amylose differs from amylopectin in that it is largely unbranched 1 - 4 linked alpha-glucose and it has molecular weight of about 105 to 106 Daltons.
Click here for the abstract: Starch—composition, fine structure and architecture: Richard F. Tester, John Karkalas, Xin Qi, Journal of Cereal Science 39 (2004) 151–165
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Abbreviated New Drug Application (ANDA)
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An application to market a generic drug in the USA. The application does not contain extensive preclinical (pharmacology & toxicology) or clinical data. Instead an ANDA for a typical tablet or capsule relies on therapeutic equivalence to the innovator product (or reference listed product), together with an extensive CMC section.
Please click here to find more information on the FDA website.
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Active Pharmaceutical Ingredient (API)
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Drug substance.
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Area Under the Curve (AUC)
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The area under the curve of a plot of drug concentration in plasma against time. AUC has units of concentration * time (for example ng.h/ml). The AUC taken to infinity can be used to determine the bioavailability of a drug product.