Formulation And In-Vitro Evaluation Of Bilayer Tablets With Immediate Release Property Of Mefenamic Acid And Sustained Release Property Of Dicyclomine Hydrochloride

Abstract

Objective: The aim of present study was to reduce the dosing frequency, sustained the action of Dicyclomine Hydrochloride and reduce the number of drugs by formulating two drugs Mefenamic acid and Dicyclomine in a Bilayer form and evaluating the in-vitro parameters of its sustained release of Dicyclomine Hydrochloride tablets using different grades of HPMC as rate controlling polymer.

Introduction:  Dicyclomine Hydrochloride is water soluble Anticholinergic drug that is used in the Irritable Bowel Syndrome (IBS) and reduce the symptoms of stomach and intestinal cramping. Sustained release system is a widely employed approach to release the drug slowly over an extended period of time that can address many challenges associated with conventional oral delivery, including frequent dosing.

Mefenamic Acid is a poor water soluble Non Steroids Anti-inflammatory Drugs (NSAIDs) used to relive mild to moderate pain including menstrual pain.

Materials and methods: Sustained release (SR) layer of Dicyclomine Hydrochloride were prepared using different grades of HPMC and Immediate Release (IR) layer of Mefenamic Acid were prepared using different excipients like Lactose Monohydrate, Pregelatinized Starch, Tween 80, PVPK-90, Sodium Starch Glycollate (SSG), Aerosil, Magnesium Stearate and water by Double Sided Direct Press Method.   Pre-compression parameters (Angle of repose, bulk density, tapped density, Carrs’ Index and Hausners ratio) and post compression parameters (weight variation, thickness, hardness, friability, drug content and in-vitro drug release) were evaluated.

Results: A simple and sensitive UV-VIS method was developed and validated to quantify and study the release profile of Mefenamic Acid and Dicyclomine HCl Bilayer Tablet. The in-vitro results showed formulation F5 had a more controlled and limit abiding release profile compared to other 6 formulations. The percentage drug release of formulation F5 was 97.61% ± 1.62 at 24 hour for SR layer and 97.61% ± 1.6 for IR layer

Conclusion: The prepared Bilayer tablets containing 18% HPMC K15M and 22% HPMC K100M in SR layer similarly 23.23% Lactose Monohydrate, 17.45%  Pregelatinized Starch, 1.091%  Tween-80, 0.65%  PVPK-90, 2.18% SSG, 0.44% Aerosil and 0.44% of Magnesium Stearate (F5) could be a promising Bilayer drug delivery system with IR and SR profile and the method developed was very simple yet sensitive.