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 [..]

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 abs [..]

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 commo [..]

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 ( [..]

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 he [..]

Drug substance.

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.

A measure of the fraction of a drug that enters the systemic blood circulation after oral administration. The usual measure is the ratio of the AUC of two different formulations of the same drug, corrected for dose. If an intravenous injection of 1 mg of a drug gives an AUC of, say, 1000 ng.h/ml, and a 5mg tablet gives an AUC of, say, 3000 ng.h/ml, [..]

Two drug products are considered bioequivalent if they exhibit the "same" Cmax, Tmax and AUC in a properly powered pharmacokinetic study. In other words the two drug products have the plot of "drug concentration in plasma" against "time". The actual definition of "same" when applied to the pharmacokinetic par [..]

Difficulty in ejection of tablets from a die after compression. Binding is evident as exceesive ejection force, and it can sometimes be heard as a "sqeaking" noise during tableting. In extreme cases binding can result in tablet lamination. Increase in the amount of lubricant (magnesium stearate or talc) is a potential solution, as is prop [..]