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Development of Clindamycin Loaded Oral Microsponges (Clindasponges) for Antimicrobial Enhancement: In Vitro
Rana M F Sammour1, Gazala Khan2, Sandy Sameer3
1Pharmaceutics Department, Dubai Pharmacy College for Girls.
Abstract:
Clindamycin phosphate (CLP) is a broad-spectrum antibiotic that is used widely for different types of infections. It has a short half-life and hence it should be taken every six hours to ensure adequate antibiotic blood concentration. On the other hand, microsponges are extremely porous polymeric microspheres, offering the prolonged controlled release of the drug. The present study aims to develop and evaluate innovative CLP-loaded microsponges (named Clindasponges) to prolong and control the drug release and enhance its antimicrobial activity, consequently improving patient compliance. The clindasponges were fabricated successfully by quasi-emulsion solvent diffusion technique using Eudragit S100 (ES100) and ethyl cellulose (EC) as carriers at various drug-polymer ratios. Several variables were optimized for the preparation technique including the type of solvent, stirring time, and stirring speed. The clindasponges were then characterized in terms of particle size, production yield, encapsulation efficiency, scanning electron microscopy, Fourier Transform Infrared Spectroscopy analysis, in vitro drug release with kinetic modeling, and antimicrobial activity study. Moreover, in vivo, pharmacokinetics parameters of CLP from the candidate formula were simulated based on the convolution method and in vitro-in vivo correlation (IVIVC-Level A) was built up successfully. Uniform spherical microsponges with 82.3 µm mean particle size with a porous spongy structure were evident. ES2 batch exhibited the highest production yield and encapsulation efficiency (53.75 and 74.57%, respectively) and it was able to exhaust 94% of the drug at the end of 8 h of the dissolution test. The release profile data of ES2 was best fitted to Hopfenberg kinetic model. ES2 was significantly (p < 0.05) effective against Staphylococcus aureus and Escherichia coli compared to the control. Also, ES2 displayed a twofold increase in the simulated area under the curve (AUC) compared to the reference marketed product.
Insights
New Clindasponges, loaded with clindamycin phosphate (CLP), offer prolonged drug release and enhanced antimicrobial activity. This innovation improves patient compliance by reducing dosing frequency for infections.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Microencapsulation Technology
Background:
- Clindamycin phosphate (CLP) is a broad-spectrum antibiotic with a short half-life, requiring frequent administration.
- Microsponges offer a solution for prolonged and controlled drug release, potentially improving therapeutic outcomes.
- Current CLP formulations necessitate frequent dosing, impacting patient compliance.
Purpose of the Study:
- To develop and evaluate novel clindamycin phosphate-loaded microsponges (Clindasponges).
- To enhance antimicrobial activity and prolong drug release for improved patient compliance.
- To establish an in vitro-in vivo correlation for the developed formulation.
Main Methods:
- Fabrication of Clindasponges using quasi-emulsion solvent diffusion with Eudragit S100 and ethyl cellulose.
- Optimization of preparation variables including solvent type, stirring time, and speed.
- Characterization via particle size, yield, encapsulation efficiency, SEM, FTIR, in vitro release studies, and antimicrobial assays.
Main Results:
- Spherical microsponges with a porous structure (mean particle size 82.3 µm) were successfully prepared.
- The ES2 batch showed high production yield (53.75%) and encapsulation efficiency (74.57%).
- ES2 demonstrated sustained drug release (94% in 8h), best fitted to the Hopfenberg model, with enhanced antimicrobial activity and a twofold increase in simulated AUC compared to the reference.
Conclusions:
- Clindasponges represent a promising drug delivery system for clindamycin phosphate.
- The developed formulation enhances antimicrobial efficacy and prolongs drug release, improving patient compliance.
- A successful Level A in vitro-in vivo correlation was established for the Clindasponge formulation.
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