Design and Evaluation of Herbo-Allopathic Bilayer Tablet Formulation: An Integrated Therapeutic Approach

Abstract

Diabetes mellitus, a serious metabolic disease caused by absolute or relative inadequate insulin secretion and action that leads to micro and macrovascular problems, is characterized by elevated blood sugar levels. Metformin hydrochloride is considered the medication of choice, but compliance may be impacted by its frequent dosing and gastrointestinal side effects. Herbal medications Cissus quadrangularis has anti-inflammatory, anti-hyperlipidemic, anti-diabetic, and antioxidant qualities. Thus, the goal of this research was to design, produce, and evaluate a Herbo-allopathic bilayer pill that would release Cissus extract gradually and Metformin instantly for the treatment of type 2 diabetes. The proper solvents were used to extract the C. quadrangularis stems. Physicochemical, spectroscopic, and preliminary phytochemical screening were carried out. Compatibility between drugs and excipients was also evaluated. By employing the proper excipients and the direct compression method, metformin quick release and Cissus sustained release were accomplished. Parameters were assessed both prior to and following compressions. The USP dissolving apparatus II was used to conduct the dissolution test, and the outcomes were compared to those of the commercial products. Additionally, experiments of accelerated stability were conducted. This study demonstrated the ideal physicochemical and drug release features of the bilayer tablet formulation of Metformin HCl and Cissus extract. Therefore, it was determined that combining herbal and allopathic medications will help treat type 2 diabetes more effectively with fewer side effects and higher patient compliance because of less frequent dosing.