Pharmaceutical Product Development: Micropellet Formulation
In the pharmaceutical industry, developing a therapeutic formulation requires not only selecting the right formulation but also optimizing the manufacturing process to ensure sustained, controlled drug release. This project focused on developing an injectable formulation that provides extended release over a period of months, allowing patients to receive only one or a maximum of two injections annually. The process was streamlined and optimized as follows:
• Formulation Development and Selection of Micropellets: The decision to use micropellets as the dosage form was based on their ability to provide controlled, sustained release of the API over an extended period. Micropellets offer excellent control over release kinetics, ensuring prolonged therapeutic effects while reducing the need for frequent injections.
• Process Simplification through Micropellet Production vs. Cryogenic Milling: Instead of employing a complex cryogenic milling process, which involves multiple steps and potential material losses, a direct micropellet production method was implemented. This involved a continuous extrusion and pellitization process, significantly simplifying the manufacturing process while ensuring high-quality, uniform micropellets.
• Process Scale-Up and Manufacturing at Commercial Scale: The entire process was successfully scaled from laboratory to industrial scale. This included scaling the extrusion and Pellitization processes, The production line was designed to meet cGMP standards for consistency and regulatory compliance.
• Process Validation and Optimization of Release Profiles: To achieve the desired extended release of the API, extensive stability and release studies were conducted. These studies evaluated the release kinetics of the micropellets in simulated body fluids to ensure the consistent and predictable release of the drug over months.
• Commercial Scale-Up and GMP-Compliant Implementation: Following successful optimization, the process was scaled up according to GMP guidelines and prepared for market launch. The micropellets were produced at full commercial scale and underwent clinical testing to confirm their efficacy and release profile, ensuring a reliable, long-term therapeutic solution for patients.
This approach not only simplifies the production process but also enhances patient compliance by reducing the frequency of injections while maintaining high-quality, sustained drug release.
