Visualized analysis and evaluation of simultaneous controlled release of metformin hydrochloride and gliclazide from sandwiched osmotic pump capsule

Abstract

The aim of this study was to develop the Metformin Hydrochloride and Gliclazide (MH-GZ) sandwiched osmotic pump capsule which could overcome the problems associated with short half-life and burst release. The system could deliver drugs with different solubility simultaneously at zero-order rate, in which MH-GZ were filled in both sides of the push layer respectively. The single factor and orthogonal test were employed to obtain the optimized formulation with the evaluation index of similarity factor (ƒ₂). R language was used to visualized analyze the main influence factors of drug release and their correlations. Pharmacokinetic study was performed in beagle dogs compared to the marketed conventional product, which showed decreased C_max, prolonged T_max, and improved bioavailability, independent of pH and agitational speed but related to osmotic pressure differences across the semi permeable membrane. The designed sandwiched osmotic pump capsule proposed a promising substitute for the marketed product for the treatment of type 2 diabetes.

Keywords:

• Sandwiched osmotic pump capsule
• metformin hydrochloride
• gliclazide
• orthogonal design
• visualized analysis
• zero-order release

Acknowledgements

The authors thank Dr. Jun Shao of St. John’s University for his support in writing of the thesis.

Disclosure statement

The authors declared that they had no conflict of interest.

Additional information

Funding

This project was supported by the National Natural Science Foundation of China [No. 81973488, No. 81573615] and University Scientific Research Projects of Anhui Province [KJ2019A0451] and Project of Scientific Research Fund of Anhui University of Chinese medicine [No. 2017zryb002].