Introduces Sterile PLGA 50:50 for Treptorelin Depot Formulation

Introduces Sterile PLGA 50:50 for Treptorelin Depot Formulation

Nomisma Healthcare is excited to announce the introduction of our innovative Sterile PLGA5050/">PLGA 50:50, designed specifically for use in Treptorelin Depot formulations. This advancement promises to enhance the delivery and efficacy of Treptorelin, providing substantial benefits to both patients and healthcare providers.

What is Sterile PLGA5050/">PLGA 50:50?

Poly(lactic-co-glycolic acid) (PLGA) 50:50 is a well-known biodegradable polymer utilized in drug delivery systems for its ability to provide controlled and sustained release of active pharmaceutical ingredients (APIs). By ensuring the sterility of PLGA 50:50, Nomisma Healthcare has elevated its suitability for sensitive and critical applications, such as in Treptorelin Depot formulations.

Advantages of Using Sterile PLGA5050/">PLGA 50:50 in Treptorelin Depot:

  1. Improved Safety and Compliance: Sterilization minimizes the risk of contamination, making the formulation safer for patient use and ensuring compliance with stringent regulatory standards.
  2. Controlled Release: PLGA5050/">PLGA 50:50 allows for a controlled and sustained release of Treptorelin, leading to more consistent therapeutic effects and improved patient adherence to treatment regimens.
  3. Regulatory Support: We provide a comprehensive technical dataset that meets regulatory requirements, facilitating easier approval processes for our customers.

Why Nomisma Healthcare?

Nomisma Healthcare is at the forefront of pharmaceutical innovation, dedicated to enhancing drug delivery systems through advanced materials and technologies. Our sterile PLGA 50:50 formulation is a testament to our commitment to quality, safety, and efficacy. By partnering with us, you gain access to cutting-edge solutions designed to improve patient outcomes and streamline regulatory approvals.

Access Our Technical Dataset:

For regulatory customers and formulators seeking detailed technical information about our Sterile PLGA 50:50, we offer an extensive dataset to support your formulation and regulatory needs. Contact us to gain access and learn how our product can benefit your Treptorelin Depot formulations.

Get in Touch:

Visit our website at Nomisma Healthcare to discover more about our innovative solutions and to connect with our team. Stay informed about our latest advancements and how we are driving improvements in healthcare delivery.

Nomisma Healthcare – Innovating for a healthier tomorrow.

Bioresorbable solid implants for peptides : Goserelin acetate

Bioresorbable solid implants for peptides : Goserelin acetate

Hot-melt extrusion(HME)

The molecule in its solid state is mixed with the thermoplastic polymer that is heated (at a temperature above the PLGA/PLA glass transition temperature) and forced through a small orifice called a die to form a rod with a defined diameter.

Process limitations: Low API loading; high temperatures; shear stresses.

Example of manufactured product: Zoladex® (Goserelin acetate)

Nomisma`s Products for Zoladex® (Goserelin acetate): DLG50-2A (PLGA 50:50), DLG50-3A (PLGA 50:50)

PLGA microspheres

PLGA microspheres

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.