Last month I hosted a virtual fireside chat with generic drug development expert, Professor Arvind Bansal. Professor Bansal is Head of the department of pharmaceutics at India’s National Institute of Pharmaceutical Education and Research (NIPER).
Here are the top five takeaways from our discussion.
Deformulation and stability go hand-in-hand
Stability is a critical quality attribute that informs decision-making in drug development. In order to match the stability of a generic to a reference-listed drug (RLD) product, you must first understand the composition of the RLD. Armed with this information you can start to quantify innovator API and excipients and ensure your generic is a match, both in terms of composition and stability.
Particle size analysis is key to successful deformulation
Particle size reduction is the go-to strategy for innovators when they need to modulate the dissolution of their new drug product. It is therefore one of the most important characteristics that generic drug manufacturers ask NIPER to work on.
Deformulation studies must be handled with care
The solid form of an active pharmaceutical ingredient (API) can change during processing and this also applies to any processing that happens during deformulation studies. This is a big challenge where the RLD has a low drug loading, because the lower the drug loading, the more difficult it is to extract the API. NIPER has been able to successfully extract API from RLDs with a drug loading of less than 2%. However, it’s not always possible to separate the API from the excipient.
The gap between industry and academia is getting slimmer all the time.
Professor Bansal has been working at NIPER for over 20 years and during that time he has seen the boundaries between industry and academia becoming thinner and he predicts that the distinction will eventually disappear.
Drug companies are increasingly trying to increase their flexibility by outsourcing. For large pharmaceutical companies, this is about increasing capacity or adding specialist knowledge. For smaller companies, it’s about access to specific knowledge. Consequently, contract research organizations are increasingly focusing on increasing their depth of knowledge. The reason that generic drug companies look to organizations like NIPER and Malvern Panalytical for help is because of the cumulative depth of knowledge that they have.
NIPER graduates are in high demand
Not only are NIPER graduation in great demand, but the institution has a 100% placement rate every year! Professor Bansal puts this down to the fact that their courses combine scientific concepts with a robust understanding of regulatory affairs as they apply to formulation development and skills like time management. This is a potent combination for students to succeed in the industry because it helps them translate academic knowledge into the industry to add value.