The prostate gland is an organ in reproductive anatomy. This small gland sits directly below the bladder and plays a role in producing seminal fluid, which is a component of semen. It also plays a role in hormone production and helps regulate urine flow. Changes in the prostate gland can lead to urinary problems.
Prostate problems are common, especially in older men. The most common include an inflamed prostate, an enlarged prostate, and prostate cancer.
Prostate cancer is the most common form of cancer in males after skin cancer. It affects around 1 in 8 males during their lifetime.
On average, people receive a prostate cancer diagnosis at age after 50.
To cure prostate cancer, one of the medicines approved by the FDA is Leuprolide acetate and its depot injection.
In the depot content, one of the major components commonly used is Biodegradable Polymer Namely Poly-lactic co-glycolic acid.
Across the globe, there are very few manufacturers who make this polymer and supply it to pharma industries for the same.
Nomisma Healthcare Pvt. Ltd. based in INDIA is one the commercial manufacturer of Biodegradable Polymer Poly-lactic co-glycolic acid to cater to pharma industries across the globe.
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.