Akinalytics Publication Highlights PLGA Analysis Methods and Capabilities for ‘Sameness’ Determination

In addition to providing for polymer products through the PolySciTech division, Akina, Inc. also provides for analysis of materials through the Akinalytics group (http://www.akinalytics.com/). A series of collaborations with the Food and Drug Administration Office of Generic Drugs have generated a great deal of data and methodology expertise in the realm of understanding the characterization of PLGA. This developed further understanding of a commonly used polymer can be applied both for formulation development as well as for establishing ‘sameness’ between a reference listed product and a proposed generic. Read more here: Kinam Park, Sarah Skidmore, Justin Hadar, John Garner, Haesun Park, Andrew Otte, Bong Kwan Soh, Gwangheum Yoon, Dijia Yu, Yeonhee Yun, Byung Kook Lee, Xiaohui Jiang (Jeff), Yan Wang. “Injectable, long-acting PLGA formulations: Analyzing PLGA and understanding microparticle formation.” Journal of Controlled Release (2019). https://www.sciencedirect.com/science/article/pii/S0168365919302512

“Abstract: Injectable, long-acting depot formulations based on poly(lactide-co-glycolide) (PLGA) have been used clinically since 1989. Despite 30 years of development, however, there are only 19 different drugs in PLGA formulations approved by the U.S. Food and Drug Administration (FDA). The difficulty in developing depot formulations stems in large part from the lack of a clear molecular understanding of PLGA polymers and a mechanistic understanding of PLGA microparticles formation. The difficulty is readily apparent by the absence of approved PLGA-based generic products, limiting access to affordable medicines to all patients. PLGA has been traditionally characterized by its molecular weight, lactide:glycolide (L:G) ratio, and end group. Characterization of non-linear PLGA, such as star-shaped glucose-PLGA, has been difficult due to the shortcomings in analytical methods typically used for PLGA. In addition, separation of a mixture of different PLGAs has not been previously identified, especially when only their L:G ratios are different while the molecular weights are the same. New analytical methods were developed to determine the branch number of star-shaped PLGAs, and to separate PLGAs based on L:G ratios regardless of the molecular weight. A deeper understanding of complex PLGA formulations can be achieved with these new characterization methods. Such methods are important for further development of not only PLGA depot formulations with controllable drug release kinetics, but also generic formulations of current brand-name products. Keywords PLGA Long-acting depot L:G ratio Glucose-PLGA Star-shape Q1/Q2”

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