Bhanu Teja

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.

Itraconazole is a potent triazole antifungal drug which has low solubility at physiological pH conditions. It is active in vitro against a wide variety of fungi with a spectrum of activity which qualitatively resembles that of ketoconazole, the first oral azole to gain widespread acceptance. Itraconazole binds more avidly to fungal cytochrome P-450 than does ketoconazole and unlike ketoconazole, has little effect on mammalian cytochrome P-450 enzyme systems.The purpose of present work was to explore the feasibility and preparation of the Itraconazole Hydrochloride salt to improve the solubility and dissolution rate of poorly soluble drug Itraconazole. Itraconazole Hydrochloride was synthesized by using addition reaction with hydrochloric acid. Then it was incorporated into a new derivative of cyclodextrins Sulfobutyl ether β-Cyclodextrin (CAPTISOL) and 2-Hydroxypropyl β-Cyclodextrin by using physical mixing, kneading and co-evaporation techniques. The solubility of prepared salt was found multifold than the solubility of itraconazole. The dissolution studies of itraconazole complexes exhibited high percentage drug dissolution than that of the pure drug which can be attributed to the increase in drug solubility provoked by the complexation technique. The results indicated Itraconazole HCL-Captisol (1:2 molar ratio) prepared by kneading method shows better characteristics when compared with pure drug and other formulations.