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Biodegradable Polymer-Based Microspheres for Depot Injection-Industry Perception
Anand Kyatanwar1, Mangal Nagarsenker2, Bala Prabhakar3
1Bharat Serums and Vaccines Ltd., R&D Center, Airoli, Navi-Mumbai, India.
Recent Advances in Drug Delivery and Formulation
|January 19, 2023
Summary
Developing biodegradable polymer microspheres for therapeutic protein delivery faces challenges. Overcoming issues like poor drug entrapment and sterilization is key for commercial success of these controlled-release systems.
Area of Science:
- Pharmaceutical Sciences
- Biomaterials Engineering
- Drug Delivery Systems
Background:
- Therapeutic protein discovery necessitates advanced drug delivery systems.
- Biodegradable polymer microspheres offer controlled-release depot injections for proteins.
- Despite decades of research, commercial success of microsphere systems is limited.
Purpose of the Study:
- To identify and analyze the key challenges in developing biodegradable polymer-based microsphere drug delivery systems.
- To review the regulatory landscape pertinent to these advanced delivery systems.
- To map the current status and future directions for microsphere-based therapeutic protein delivery.
Main Methods:
- Literature review of existing microsphere-based drug delivery systems.
- Analysis of technical hurdles including drug entrapment, burst release, and sterilization.
- Examination of in vitro-in vivo correlation and scale-up challenges.
- Assessment of regulatory requirements for pharmaceutical product development.
Main Results:
- Significant technical hurdles impede the commercialization of microsphere delivery systems.
- Key issues include poor drug entrapment, premature burst release, and inadequate sterilization methods.
- Lack of robust in vitro testing and poor in vitro-in vivo correlation are critical limitations.
- Scale-up complexities and regulatory compliance add further development challenges.
Conclusions:
- Successful development requires simultaneous resolution of multiple technical and regulatory challenges.
- Addressing poor drug entrapment, burst release, and sterilization is paramount.
- Advancements in formulation, manufacturing, and testing are needed for wider adoption of microsphere drug delivery systems.
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