Vol. 5, Issue 6 (2016)
Pharmaceutical excipients: A regulatory aspect
Surender Verma, Anupama Baghotia, Jitender Singh, Kamal Saroha, Sunil Kumar and Dinesh Kumar
The purpose of this study is to understand theregulatory aspects of pharmaceutical excipients and its role in a dosage form. In earlier days, excipients were considered as inactive ingredients but with the passage of time, the pharmaceutical scientists learned that excipients are not inactive and have an impact on the manufacture, quality, safety and efficacy of drug(s) in a dosage form. The active drug can’t be administered alone and the amount of excipients in a formulation is greater than that of drug(s). Hence, excipients act as important partner in a dosage form and affect various properties viz. absorption, efficacy, safety, bioavailability, solubility, stability, dissolution etc. in a formulation. Previous data revealed that the excipients can also produce some serious adverse effects but the regulatory control regarding the use of excipients are still not clear as compared to Active Pharmaceutical Ingredients (API’s). There is a strong need of regulation and legislation for excipients so as to avoid the unnecessary adverse effects and interaction with the drug(s). So, there is a strong need to evaluate the excipients with respect to toxicity, preclinical trial, compatibility studies etc. before inclusion in a formulation
How to cite this article:
Surender Verma, Anupama Baghotia, Jitender Singh, Kamal Saroha, Sunil Kumar, Dinesh Kumar. Pharmaceutical excipients: A regulatory aspect. Pharma Innovation 2016;5(6):124-127.