Why using excipients compliant with compendial requirements is beneficial?

Ravindra Patil, Project Manager, Production Chemicals, Thermo Fisher, talks about the various benefits that excipients add to the functionality in drug formulations and how they can boost a pharma company’s competitive advantage

Excipients are essential components for the improvement of overall pharmaceutical activity and performance, both of which directly impact the characteristics of pharmaceutical formulations. Excipients have been recognized to provide better functionality and competitive advantage in drug formulations and this has contributed to their increased usage by pharmaceutical firms in recent years. An excipient in the right proportion can improve the shelf life and bioavailability of a formulation. These can also be used in drug delivery mechanisms such as sustained release and rapid release drugs.

The General Notices of the United States Pharmacopeia-National Formulary (USP-NF), states, “Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients (Compendial grade) complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.” Compliance with compendial requirements is a legal and regulatory requirement as per Pharmacopeia of the respective regions. While there is good awareness of compendial requirements for drug products and APIs, there is less understanding by excipient manufacturers related to compliance to pharmacopoeial monograph. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements.

Ongoing research, and discovery of ideal or near ideal substances that can be used in drug formulations and delivery, has given the market a definite boost. Another factor that contributes toward global growth is that most pharmaceutical firms have been busy in development of more sophisticated excipients with enhanced role in drug delivery. There is a rising demand for novel substances that support nanoparticle drug delivery for oncological medications to provide better stability and adoption of medicines. This is also likely to propel the market. Patent expiry of blockbuster drugs is also expected to boost the market at a significant pace.

  • Currently, companies are working on optimization of excipients in drug formulations and delivery. They are also engaged in the development of such formulations. These factors are expected to have a major impact on the development and marketing of these products in future. Furthermore, the emergence of multifunctional and co-processed excipients, shifting focus of pharmaceutical manufacturing to emerging markets, and the growing biosimilars industry present significant opportunities for the growth of excipients. However, the increasing regulatory stringency, cost and time-intensive drug development process, and the quality concerns of excipient manufacturers represent a significant challenge to the market growth.
  • The global excipients demand exceeded 600,000 tons in 2016 and is expected to grow at a moderate rate from 2017 to 2025, Owing to high market demand, polymer excipients accounted for the largest revenue share in 2016 and the segment can be anticipated to dominate the market for the coming years as well.