Mark A Costello, Joseph Liu, Louise Kuehster, Yan Wang, Bin Qin, Xiaoming Xu, Qi Li, William C Smith, Nathaniel A Lynd, Feng Zhang
Long-acting injectable formulations based on poly(lactide- co -glycolide) (PLGA) have been commercialized for over 30 years in at least 20 FDA-approved products. These formulations offer several advantages, including reduced dosing frequency, improved patient compliance, and maintenance of therapeutic levels of drug. Despite extensive studies, the inherent complexity of the PLGA copolymer still poses significant challenges associated with the development of generic formulations having drug release profiles equivalent to those of the reference listed drugs...
November 13, 2023: Molecular Pharmaceutics