Excipients

The quantitative analysis of bulk materials, drug formulations, drug products, impurities, and biological products containing pharmaceuticals and their metabolites is challenging in the field of pharmaceutical research. It is also complicated to choose the best method. Pharmacokinetic studies frequently make use of quantitative or qualitative studies of a drug and its metabolite. Developing a generic product with quantitative equivalence, which increases regulatory flexibility, seems to be the ultimate aim. Knowing the exact components of reference items and their concentrations is extremely helpful when developing generic formulations. The quantitative composition of the dosage forms is kept secret by the innovators. In such a situation, the quantitative formula of the dosage form is being decoded by generic manufacturers through reverse engineering. To quantify them, we need reliable, non-destructive analytical tools. In this article, we covered excipient quantification techniques, analytical data reports, challenges, and applications.

Cyclodextrins, the unique cyclic carbohydrates are successfully utilized as the potential complexing agents which form inclusion complex with insoluble drugs. “Inclusion complex”, this term refers to the dispersion of one or more actives ingredients in an inert carrier or matrix at molecular state. Now a day several drugs molecules are being introduced and many newer techniques have been developed for the formulation of dosage forms but when these drug molecules become more and more complex, sophistication has to find its way in the area of excipients, which are needed to formulate these drug substances optimally. One such versatile adjuvant, tailored with the help of advances in biotechnology and enzyme technology is cyclodextrin. Cyclodextrin are cyclic oligosaccharides which have been recognized as useful pharmaceutical excipients. The molecular structure of these glucose derivatives generates a hydrophilic exterior surface and a non polar cavity interior. Such cyclodextrin can interact with appropriate size drug molecules which lead to the formation of inclusion complexes. A comprehensive literature survey was made collect the rightful utilization of cyclodextrins as complexing, solubility enhancing agents and permeation enhancers. Key words: Inclusion complexes, Cyclodextrins, Excipients, Complexing agent, Hydrophilic exterior surface