Related Experiment Video
Updated: Jul 9, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations
Ashwin Mali1, Vijaykumar Kuvar2, Saily Bharadwaj2
1Department of Drug Regulatory Affairs, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, 411038, India. ashwinjmali@rediffmail.com.
Abstract:
Since the awareness of adverse effects associated with pharmaceutical excipients in drug formulations, these excipients are no longer considered inert substances. Numerous countries have recognized the potential risks that they pose to patients and have implemented diverse regulations to evaluate their safety, compatibility, toxicity, and quality. Regulatory authorities have proactively implemented measures to evaluate excipients and have formulated comprehensive guidelines that manufacturers are obligated to follow. This review primarily highlights the different provisions governing the utilization of excipients in drug formulation by regulatory authorities worldwide. Nonetheless, it is worth noting that there are still many countries that do not perceive excipients as posing a potential threat.
More Related Videos
Related Concept Videos
Drug Regulation
Factors Influencing Drug Absorption: Pharmaceutical Parameters
Bioequivalence: Overview
Drug Control Governance: Regulatory Bodies and Their Impact
Drug Nomenclature
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...

