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Polymer-based sustained-release dosage forms for protein drugs, challenges, and recent advances
AAPS Pharmscitech
|December 17, 2008
Summary
Developing polymer-based sustained-release drug delivery systems for proteins remains challenging. Recent formulation strategies focus on overcoming protein denaturation, burst release, and low encapsulation for successful commercialization.
Area of Science:
- Biomaterials Science
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Polymer-based sustained-release systems for protein therapeutics are highly desired but face significant commercialization hurdles.
- Key challenges include protein instability during formulation and release, burst/incomplete release, low encapsulation efficiency, and formulation complexity.
Purpose of the Study:
- To review recent formulation strategies for polymer-based sustained-release protein delivery systems.
- To highlight practical industrial solutions addressing technical difficulties.
- To discuss the physicochemical basis of challenges and compare formulation methods.
Main Methods:
- Review of recent scientific literature on sustained-release protein delivery systems.
- Selection and introduction of representative formulation strategies: degradable hydrophobic polymer microspheres, water-soluble polymer microspheres, and in vivo gelling systems.
- Discussion of physicochemical principles underlying formulation challenges and methods.
Main Results:
- Recent advances focus on comprehensive strategies to mitigate protein denaturation and control release profiles.
- Specific formulation approaches, including microsphere technologies and in vivo gelling systems, are being developed to improve encapsulation and reduce release issues.
- The review synthesizes findings to guide industrial development.
Conclusions:
- Overcoming technical challenges in protein drug formulation is crucial for successful sustained-release delivery systems.
- Emerging formulation strategies offer promising avenues for industrial application.
- A deeper understanding of physicochemical principles is essential for optimizing these advanced delivery systems.
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