FORMULATION AND EVALUATION OF ORAL ANTI-DIABETIC IN-SITU GEL SYSTEM OF PIOGLITAZONEAbstract
Pioglitazone is an oral anti-diabetic agent used in treating class – II diabetes mellitus. T1/2of pioglitazone was 3-6 hrs and is eliminated rapidly. Hence sustained release is needed to prolong its duration of action and to increase its oral bioavailability. The main aim of the study was formulation and evaluation of an in-situ gel system of Pioglitazone to increase its bioavailability as a convenient dosage form. Method of Ion-sensitive in-situ gelation was used in this study. Total 15 formulations were prepared with Guar gum, Xanthan gum, and Carbopol-934 in various combinations and assessed for physical appearance, pH, viscosity, in-vitro gelling capacity, drug content, and in-vitro drug release. FTIR, DSC for Pioglitazone, excipients used, and optimized formulation were conducted. In-vivo drug kinetic studies were conducted for optimized formulation. Formulations showed an optimum viscosity allowing ease of administration and swallowing. All formulations have shown pH between 6.9-7.3, floating lag time was 2-3sec and floated for >12 hrs. The x-ray image studies are also confirming the same thing. In- vitro drug release studies reporting that F15 showing drug release of 99.52% over a 12 hrs period. FTIR studies revealed no interaction between drugs and excipients used. The results of In-vivo kinetic studies are approving the better performance of the optimized formulation. In conclusion, the optimized formulation F15 showed maximum drug retardation for above 12 h. Hence it is concluding that the main objective of the study to increase its bioavailability as a convenient dosage form in the treatment of diabetes mellitus had been achieved.
B. Padmasri * and R. Nagaraju
Department of Pharmaceutical Technology, Sri Venkateswara College of Pharmacy, Etherla, Srikakulam, Andhra Pradesh, India.
21 March 2021
22 May 2021
02 June 2021
01 October 2021