Applications of Complementary Polymers in HPMC Hydrophilic Extended Release Matrices

In the post Hatch-Waxman Act 1984 era, developing an extended release (ER) formulation of a new chemical entity with extended patent life has become very crucial to innovator companies. Patent, market share protection, and extension of a product’s life cycle are of utmost importance. While multiple ER technology platforms are being developed, an important area that has not experienced significant change throughout the years is new pharmaceutical excipients for ER applications. This has been attributed mainly to the regulatory and safety framework, which hinders approval of new excipients outside the context of a new drug application (NDA) or abbreviated new drug application (ANDA). The net result is the very slow pace of global development and commercialization of ER excipients. Using blends of approved polymers may be a powerful strategy to overcome this regulatory barrier, but still brings resolution to current challenges (size limitations for high dose APIs, oncedaily dose, burst effect with high solubility APIs, and potential food effect) in ER formulations. The following specifically examines the application of co-formulation of polymers in developing ER hydrophilic matrix systems to overcome these challenges and discusses its advantages in drug release modulation from matrices.