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Design, Optimization and In-Vitro Characterization of Metformin Hydrochloride Oral In-Situ Gel

Abstract

The two level 23 Factorial design was used to develop the control release in-situ oral gels of Metformin Hydrochloride based on the concept of temperature triggering system by incorporation of various polymers. Metformin Hydrochloride is an anti-diabetic drug. The formulations were designed with an objective to retain in stomach for an extended time period. The effect of different polymer concentrations of Xyloglucan and Pluronic F127on in-vitro drug release were used to characterize and optimize the formulation. gelation temperature, gel strength, in-vitro drug release studies of 1 hour,8 hour and 12 hour were taken as a responses. The FT-IR and DSC studies revealed that no interaction between drug and polymers. Optimized formulation showed release of drug up to 94.17% in 12 hours. The predicted values of gelation temperature, gel strength, drug release at 1hr, 8hr and 12hr are 25.9oC, 48.67min, 16.49%, 70..89%, 94.34% and actual values are found to be 25.9oC, 48.4min, 17.83%, 72.08%, and 94.17%. The drug release from optimized formulation was found to be zero order. Thus the release of the drug from the dosage form was found to be time independent. It also showed almost linear regression in Higuchi’s plot which conforms that diffusion is one of the mechanism for drug release and n value of Korsmeyer - Peppas plot was found to be 0.6 to 1 so, it indicates the drug release followed non-fickian diffusion controlled mechanism.

Keerthi Boggarapu, Prakash Rao B, Gunturu Abhilash, Reshmi Mathews, Beny Baby and Rajarajan S

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