President and CEO Clearview Pharma Solutions LLC Plano, Texas
Preformulation comprises of all studies enacted on a new drug substance to produce useful information for formulation development of a stable and biopharmaceutically suitable drug product. The line between preformulation and formulation is often a gray zone and keeping them separate leads to great rewards. Forced degradation on the active needs to be performed as early as possible to develop robust analytical methods needed for degradation studies. The information from drug discovery like pKa, logP(D), NMR, Hi-resolution Mass Spec, Elemental Analysis, HPLC, IR/UV-vis, initial solubility/stability information, hygroscopicity needs to be shared. Preformulation at different levels is performed in early development for the selection and characterization of the drug candidate, in late development for the formulation development and must include excipients’ compatibility studies. Most of the drug development surprises come from the impurities in excipients.
A summary from forced degradation studies is required by ICH M4Q(R1). The Brazilian ANVISA’s resolution RDC 53/2015 (articles 4, 5 and 6) includes requirements on specific forced degradation experimental conditions and extent of degradation to which the pharmaceutical companies must comply for registration filing. The forced degradation results are used in several sections of the CTD, 3.2.S.7 Drug Substance Stability, 3.2.P.8 Drug Product Stability, 3.2.S.2.6 DS Manufacturing Process Development, 3.2.S.3 Characterization, 3.2.S.4.3 Validation of analytical procedures, 3.2.P.2 Pharmaceutical Development. Some of the tests might not be relevant for drug product stability, but important for manufacturing or analytical and pharmaceutical development.
Learning Objectives:
Upon completion, participant will be able to understand the importance of the preformulation for a robust formulation and analytical development, and the effect of impurities in the formulation excipients.
Upon completion, participant will be able to take home the key learnings and apply to the drug development programs.
Upon completion, participant will be able to introduce innovation ideas at their companies.