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QbD-Enabled Systematic Development of Ileo-Colonic Targeted Novel Mucoadhesive Microspheres of Flurbiprofen
Saikat Pande1, Janu Vashi1, Ajay Solanki1
1Department of Pharmaceutics, A. R. College of Pharmacy and G.H. Patel Institute of Pharmacy, Vallabh Vidyanagar, Anand, India.
Background:
Flurbiprofen (FLBP), used in the treatment of ulcerative colitis, has a short biological half-life. Frequent intake of FLBP may lead to some serious gastric complications, which makes FLBP an ideal candidate for sustained release preparation to the Ileo-colonic region of the gastrointestinal tract (GIT).
Objective:
The objective of this study was to investigate the potential of Eudragit coated chitosan microspheres in delivering Flurbiprofen in a sustained manner to the Ileo-colonic region of the GIT for treatment of ulcerative colitis.
Methods:
In the present study, mucoadhesive chitosan microspheres were prepared using the emulsion solvent evaporation method by varying different process parameters. Optimized chitosan microspheres were coated with Eudragit L-100 and Eudragit S-100. A 32 full factorial design was applied for optimization. The effect of independent variables (Eudragit L-100 to Eudragit S-100 ratio and stirring speed) on dependent variable i.e. percentage cumulative drug release (%CDR) at 3 h and 24 h was evaluated. The optimized batch was evaluated by FT-IR, DSC study, XRD study and SEM analysis.
Results:
Discrete spherical shape chitosan microspheres with entrapment efficiency of up to 95.4% were obtained and selected for coating. Chitosan microspheres were coated successfully with different ratios of Eudragit L-100 to Eudragit S-100. The release profile of the optimized batch matches with the desired release profile. FLBP was found to be stable and molecularly dispersed in the polymer matrix.
Conclusion:
Taken together it can be concluded that prepared microspheres may be considered as a suitable for delivering FLBP to the Ileo-colonic region of the GIT in the treatment of ulcerative colitis.
Insights
Eudragit coated chitosan microspheres offer sustained release of Flurbiprofen (FLBP) for ulcerative colitis treatment. This approach aims to improve drug delivery to the ileo-colonic region, reducing gastric complications.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Biomaterials
Background:
- Flurbiprofen (FLBP) has a short half-life, necessitating frequent dosing and potentially causing gastric issues.
- Sustained-release formulations are ideal for targeting the ileo-colonic region for ulcerative colitis treatment.
Purpose of the Study:
- To develop and evaluate Eudragit coated chitosan microspheres for sustained delivery of Flurbiprofen.
- To target the ileo-colonic region for effective ulcerative colitis therapy.
Main Methods:
- Chitosan microspheres prepared via emulsion solvent evaporation.
- Optimization using a 32 full factorial design with varying Eudragit ratios and stirring speed.
- Characterization of microspheres using FT-IR, DSC, XRD, and SEM.
Main Results:
- High entrapment efficiency (up to 95.4%) achieved with spherical chitosan microspheres.
- Successful coating with Eudragit L-100 and Eudragit S-100.
- Optimized batch demonstrated a desirable drug release profile, with stable and dispersed Flurbiprofen.
Conclusions:
- Eudragit coated chitosan microspheres show promise for sustained Flurbiprofen delivery.
- This formulation could be a suitable option for treating ulcerative colitis by targeting the ileo-colonic region.
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