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Formulation optimization of serratiopeptidase-loaded PLGA microspheres using selected variables.
Deependra Singh1, V K Dixit, Swarnlata Saraf
1Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, India.
PDA Journal of Pharmaceutical Science and Technology
|July 29, 2009
Summary
Researchers developed controlled-release serratiopeptidase-loaded poly (D,L-lactic-co-glycolic acid) (PLGA) microspheres. Optimized formulation achieved high entrapment efficiency, maintaining peptide bioactivity for sustained drug delivery.
Area of Science:
- Biomaterials Science
- Drug Delivery Systems
- Polymer Chemistry
Background:
- Serratiopeptidase is a proteolytic enzyme with anti-inflammatory properties.
- Effective delivery systems are needed to enhance serratiopeptidase stability and therapeutic efficacy.
- Poly (D,L-lactic-co-glycolic acid) (PLGA) microspheres are a promising platform for controlled drug release.
Purpose of the Study:
- To prepare and characterize serratiopeptidase-loaded PLGA microspheres.
- To investigate the impact of polymer concentration and external aqueous phase volume on microsphere properties.
- To evaluate the in vitro release profile and bioactivity of encapsulated serratiopeptidase.
Main Methods:
- Modified double emulsion method for microsphere preparation.
- 3(2) full factorial experimental design to study process variables.
- Analysis of Variance (ANOVA) for statistical significance (P < 0.05).
- In vitro release studies and proteolytic activity assays.
Main Results:
- Microsphere size ranged from 19.08-41.14 µm, with entrapment efficiency between 15.37-79.86%.
- PLGA concentration significantly influenced microsphere size and yield.
- External aqueous phase volume significantly affected entrapment efficiency.
- Optimal formulation (300 mg PLGA, 100 mL EAP) yielded 75.86% entrapment.
- Sustained in vitro release observed, with intact serratiopeptidase bioactivity.
Conclusions:
- Controlled-release serratiopeptidase-loaded PLGA microspheres were successfully prepared using experimental design.
- The study identified key formulation parameters influencing microsphere characteristics.
- The developed microspheres offer a viable, economical approach for sustained serratiopeptidase delivery.
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