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Recent Progress in Drug Release Testing Methods of Biopolymeric Particulate System
Yejin Kim1,2, Eun Ji Park3, Tae Wan Kim1
1College of Pharmacy, Chung-Ang University, Seoul 06974, Korea.
Pharmaceutics
|August 28, 2021
Summary
This review explores in vitro drug release testing methods for biopolymeric microparticles, crucial for long-term formulations. It highlights the importance of in vitro-in vivo correlation (IVIVC) for product development.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Biopolymeric microparticles are utilized for sustained release of short half-life drugs and peptides.
- Accurate characterization of drug release is vital for ensuring product quality and therapeutic efficacy.
- Currently, no standardized official method exists for long-term release parenteral dosage forms.
Purpose of the Study:
- To review and summarize in vitro drug release testing methods for biopolymeric particulate systems.
- To discuss the characteristics of these methods, including their relevance to in vivo performance.
- To explore the development of in vitro-in vivo correlation (IVIVC) and accelerated release testing.
Main Methods:
- Review of recent research articles on in vitro drug release testing methodologies.
- Categorization of methods into sample and separate, dialysis membrane, and continuous flow (flow-through cell) approaches.
- Analysis of factors influencing drug release, such as formulation characteristics and testing conditions.
Main Results:
- In vitro drug release testing provides critical insights into the in vivo behavior of drug products.
- Establishing in vitro-in vivo correlation (IVIVC) can reduce the need for extensive in vivo studies.
- Various methods exist, each with specific advantages and limitations for characterizing release profiles.
Conclusions:
- Standardized in vitro release testing methods are needed for parenteral formulations.
- In vitro-in vivo correlation (IVIVC) is essential for efficient drug product development and regulatory approval.
- Further research into accelerated release testing and drug stability within microparticles is warranted.
Keywords:
accelerated in vitro release testing methodsbiopolymeric microparticlesdrug release testingin vitro–in vivo correlationpoly(lactide-co-glycolide)More Related Videos
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