Bengaluru : Pharma industry needs novel excipients as it plays a central role in drug development process, said Dr Allen Guy, technical director, Pharmaceutical Group, IMCD.
Novel excipients are rationally obvious and now expected to be robust, consistent and science-based. For instance, MCC, Lactose, Mannitol to name a few, will probably adequately succeed in 70-80% of most formulation challenges. It is the other 20% where we make compromises in quality expectations. This is where we need to ensure innovation brings something better than a compromise on our health, he added.
We should support FDA and the pilot programme on novel excipients. He suggested to de-couple CP (co-processing) excipients from the novel excipient definition and restrictions. This should incentivize USP and other pharmacopeia especially European Pharmacopoeia to act quickly and support new ingredients more efficiently, said Dr Guy at a recently concluded event organized by IPEC India in collaboration with IMCD India.
Speaking on ‘Novel Excipients: A Boon or Bane for the Pharmaceutical Industry’, Dr Guy said, “We need Pharmacopoeia and Finished Dose Formulation manufacturers to engage more with the excipient innovation and delivery process. This is because the industry has 20+ years of evidence available and excipient manufacturers are working to bring great excipients to meet the needs of modern drug delivery.”
Working with just the existing or pragmatic excipients alone will not solve all the problems. CP and genuinely novel excipients should be explored. Since 2000, lots of co-processing has taken place and one notable new excipient was derived known as ‘Soluplus’. In addition IPEC too has produced many guides, including composition guide and the co-processing guide.
The acceptance of novel excipients has challenges encountered during approval of new chemical entities (NCEs). Then there is the issue of two or more compendia/non-compendia excipients, where ratios of components may vary and physically modified properties are not achieved by physical mixing, he stated.
In order to tackle excipient composition, Dr Guy said that expectations by companies are well laid out by the regulators. In fact the IPEC guidance which is the Co-Processed Excipient Guide of 3.6.2. suggests independent review in the event as the bridging studies could not exclude new chemistry. This might involve an in vivo safety evaluation. Therefore first a review by toxicology experts helps to assess the likelihood of acceptance by regulatory authorities. Second, toxicology data must be sought wherever it may come from and viewed rationally. Animal studies too are useful to understand IID (inactive ingredient database) of the individual components and recommendations to plan the studies appropriately.
Among the new chemical excipients, Soluplus is literally the only one in this category. The barriers to entry for truly new chemical excipients are very high. Benefits to use must have a clear NPV (Net Present Value) when considering the cost to bring to market. Therefore, there are headwinds for new chemical entity excipients, Dr Guy concluded.