Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms
Exploring key points for manufacturing Highly Potent Oral Solid Dosage Forms:
*Challenges of Highly Potent Oral Solid Dose (HPOSD) Manufacturing:
The increasing development and market presence of highly potent oral solid dose drugs implies evolving regulatory expectations.
Challenges include occupational safety and health considerations during development, manufacturing, and downstream processes.
*Definition of Highly Potent Active Pharmaceutical Ingredients (HPAPIs):
HPAPIs are defined by possessing one or more of the following characteristics:
- Biological activity at approximately 150 μg/kg of body weight or below in humans
- En OEL at or below 10 μg/m3 of air as an 8-hour time-weighted average
- Sex hormones and certain other steroids
- High selectivity with the potential to cause cancer, mutations, developmental defects or reproductive toxicity at low doses
- A novel compound of unknown potency and toxicity
*Threefold Approach to Safety in HPOSD Manufacturing:
Safety considerations encompass the well-being of operators, product quality within the system, and prevention of product segregation.
Regulatory bodies, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), impose minimizing exposure to HPAPIs through appropriate containment processes.
*Evolution of Regulatory Models:
Two main regulatory models exist: the "traditional" model and the health-based model. Both models focus on containment and compliance but differ in approaches to segregation and cleaning validation.
*Key Considerations in HPAPI Handling and Manufacturing:
- Upholding building codes and occupational health and safety standards, with airlocks, room pressure control, efficient ventilation, safe-change of filters inside isolators, real-time monitoring
- Ensure right processes are in place: runing risk analysis, defining containment strategies, implementing comprehensive training for personnel
*Despite regulatory challenges, the use of containment technologies, expertise, and controls can ensure safe and compliant manufacturing of high-potency drug products
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