Importance Of Excipient Selection In The Process Of Oral Liquid Formulation Development

Excipient For Osiris Syrup

When developing an oral liquid dosage formulation, consideration is first given to the characteristics of the active drug. The major challenges in developing oral liquid dosage forms are i the stability of a drug in solution, ii the solubility of a drug at the required level, and iii an acceptable taste. It is the effective use of excipients, which allows for-mulators overcome these challenges. Additionally, an excipient's compatibility with a drug in the solid state cannot infer the same...

Food and Drug Administration Perspective on Regulation of Pharmaceutical Excipients

Division of Drug Information HFD-240 , Center for Drug Evaluation and Research CDER , United States Food and Drug Administration, Rockville, Maryland, U.S.A. The Food and Drug Administration FDA is generally recognized as one of the, if not the, premier therapeutic agent gatekeepers among nations. Consequently, the pharmaceutical and medical library stacks are laden with journals and manuals devoted to drug development and instructions on how to run the FDA gauntlet to reach the jackpot of drug...