Formulation Design of Time-Controlled Release Formulation Containing Antidiabetic Drugs

Purpose

Type 2 diabetes mellitus (T2DM) is a silent killer disorder which is a public health challenge all over the world. The higher morbidity and mortality rate of T2DM hobble health care systems and the economy worldwide. Insulin resistance and relatively reduced insulin secretion are the main characteristics of T2DM. The present study was aimed to design and develop a bimodal release formulation of repaglinide and metformin hydrochloride to control the changes in blood sugar level according to daily routine and to maintaining it in an appropriate range using experimental design techniques.

Methods

The bilayer press-coated tablet showing time-controlled release was formulated using direct compression method by forming repaglinide immediate release layer and another of metformin hydrochloride as a time-controlled release layer. The 3² factorial design was applied for the press-coated layer of metformin hydrochloride by varying the concentration of polymers.

Results

Optimized composition was found to be shown the drug release of 62.44 % of repaglinide and above 98 % of that of metformin hydrochloride with a predesigned lag time. The patient-friendly formulation was found to be beneficial which mainly decreases dosing frequency, increases the therapeutic effect of both insulin-sensitizing drugs, and releases the drugs with a predetermined time pattern.

Conclusions

The work accomplished successfully developed a time-controlled, bilayer, bimodal release formulation for T2DM having immediate release of repaglinide and time-controlled release of metformin hydrochloride using press-coating technique. The formulation will increase patient compliance as compared to formulation containing individual drug available in the market.