Kerala DC calls on IPEC to adopt US FDA guidance to ensure quality of excipients used in drug formulations

Mumbai, November22, 2021:

To ensure the proper performance of an excipient in a drug formulation, Kerala state drugs control department has called on International Pharmaceutical Excipients Council of India (IPEC India) to adopt US FDA’s guidance document for industry which mainly focuses on developing a safety database of pharmaceutical excipients.

Released by FDA in 2005, the document titled “Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients” provides guidance concerning development of safety profiles to support use of new excipients as components of drug or biological products. It is intended for use by reviewers within both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and by interested individuals in industry. It is also intended to foster and expedite the development of new excipients, communicate to pharmaceutical and excipient manufacturers current CDER and CBER recommendations on the nonclinical safety data that should be generated to support excipient development, and increase uniformity within CDER and CBER as to expectations for the nonclinical safety evaluation of excipients.

Speaking at a webinar “Critical role of excipients in formulations” held by AIDCOC Training Academy recently, KJ John Joseph, Kerala drugs controller has called upon IPEC India to adopt the guidance document in ensuring quality of excipients used in drug formulations.

The mission of IPEC India is to collaborate with all stakeholders in order to develop and implement standards and regulations that are harmonized with global standards throughout the supply chain.

“Excipients constitute a major part of all formulations which have important functions of guaranteeing dosage stability and bioavailability of active pharmaceutical ingredients. In the past the adverse drug reaction of excipients was underestimated. Now the system has changed entirely. The selection of excipients has become an important part of deciding drug formulations. Excipients' intercompatibility may alter physical, chemical, microbiological, therapeutic properties of drugs in its dosage forms,” he said.

For instance, Cofset-AT, a cough syrup manufactured by Kala Amb-based Digital Vision pharma company which has the presence of excipient diethylene glycol caused renal failure to a two-year-old girl. Similarly, there are reports of cardiotoxicity induced by excipient propylene glycol.

To address adverse effects of excipients in drug formulations, the US FDA adopted guidance for industry which mainly focuses on nonclinical studies for the safety evaluation of pharmaceutical excipients. It aims to develop a safety database that will support clinical use of excipients in drug formulations.

“It is important to perform risk-benefit assessments on proposed new excipients in drug products and to establish permissible and safe limits for these substances. This requires evaluation of a safety database,” said Kerala drugs controller.

There are over 8,000 excipients in use. It can represent up to 95 per cent of the formulation. Excipients serve important functions in formulations. Excipients play an important role in manufacturing a drug. It improves process-ability and aesthetics- optimize product performance, acts as formulations, stability unit operations enhancers and improves machinability, maintains pH and osmolarity of formulations, modulates solubility and bioavailability of APIs and increases stability of APIs in finished formulations. PharmaBiz