FABRICATION AND EFFECT OF PROCESS VARIABLES OF SITAGLIPTIN MICROSPHERES
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i4.24068Keywords:
Sitagliptin, Factorial, Ethyl cellulose, Solvent diffusionAbstract
 Objective: The study is to formulate and assess the effects of different variables on the release profile of sitagliptin microspheres.
Methods: The microspheres were prepared by emulsion-solvent diffusion method and ionotropic gelation method using ethyl cellulose and sodium alginate as the polymers, respectively. The formulations are optimized by applying 23 factorial design based on the drug-polymer ratio, stirring speed, and method of preparation.
Results: The drug-polymer interaction was checked by the Fourier-transform infrared spectroscopy and differential scanning calorimetry the results of which indicated no incompatibility. The formulated sitagliptin microspheres were evaluated for shape, morphology, particle size, the degree of swelling, encapsulation efficiency, in vitro drug release studies for 12 h, and kinetics of drug release.
Conclusion: The results showed that the drug-polymer ratio and stirring speed affected the particle size and drug release. The release of the drug was found to be sustained, and diffusion path is following cube root law of Hixson-Crowell kinetics. The batch F3 was found to be desirable and was further characterized by scanning electron microscope for morphology.
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