Abstract
Background:
Bilastine is a second-generation antihistaminic drug with limited aqueous solubility, which can affect oral dissolution. SMEDDS can improve drug solubilization, while spray drying can convert liquid SMEDDS into a convenient solid dosage form.
Objective:
The present study aimed to develop and characterize a spray-dried solid SMEDDS (S-SMEDDS) of Bilastine from an optimized liquid SMEDDS and to evaluate its physicochemical properties, redispersibility and self-emulsification performance.
Methods:
Optimized liquid Bilastine-SMEDDS was converted into solid SMEDDS by spray drying using Aerosil 200. The S-SMEDDS was evaluated for micromeritic properties, drug content, moisture content, morphology (SEM), thermal behavior (DSC), crystallinity (PXRD), drug–excipient compatibility (FTIR), redispersibility and self-emulsification performance. In-vitro dissolution was also evaluated and compared with the plain drug.
Results:
Spray drying produced a satisfactory Bilastine S-SMEDDS with good powder characteristics, drug content, and redispersibility and self-emulsification performance. DSC, PXRD, FTIR and SEM were used to characterize the physicochemical properties of the formulation. The S-SMEDDS showed improved dissolution compared with the plain drug, demonstrating the potential of spray-dried SMEDDS for enhancing Bilastine dissolution.
Conclusion:
The developed spray-dried Bilastine S-SMEDDS provides a promising solid lipid-based drug delivery approach that combines the solubilization advantages of liquid SMEDDS with the handling advantages of a solid system. The findings support further development of the formulation into a solid oral dosage form, particularly hard gelatin capsules, for improved oral delivery of Bilastine.
Keywords:
Bilastine; Solid SMEDDS; Spray drying; Aerosil 200; Self-micro-emulsifying drug delivery system; Redispersibility; Dissolution; Oral drug delivery.
| Intend to be published in the IJPS ? | Yes |
|---|---|
| Has the manuscript been published | not published |
