Since 1989, with the approval of Zoladex (Goserelin acetate) and Lupron Depot (Leuprolide acetate) for the treatment of prostate cancer and breast cancer. The use of PLA and PLGA microspheres based delivery systems have made it possible to create extended-release formulations, that can lower the frequency of dosing and lesser side effects from medications.
For instance, Risperdal Consta (Risperidone), the first long-acting injectable atypical antipsychotic approved by the U.S. Food and Drug Administration, has been shown to have superior efficacy compared to oral atypical antipsychotics, with a low-level of treatment-emergent side effects and favorable patient acceptance. It is indicated for the maintenance treatment of bipolar disorder as monotherapy. Improved compliance with a therapy resulting from the administration of the long-acting, injectable PLGA microsphere formulation on a daily basis is largely responsible for its important part in the treatment paradigm.
Despite this market potential, no generic versions of PLA/PLGA products are available, even for products whose patent protection has expired. This demonstrates the inherent complexity of producing a PLA/PLGA-microsphere product to the reproducible and exacting standards of Good Manufacturing Practices (GMP) required for FDA approval while also meeting desired parameters for drug loading, dose-release profiles, route of administration, and cost-effective drug development.
We at Nomisma Healthcare, the first Indian generic company have done this complex challenge with extraordinary scientific views and talents.