FORMULATION AND OPTIMIZATION OF IMMEDIATE RELEASE VILDAGLIPTIN TABLETS BY FULL FACTORIAL DESIGN AND ITS IN-VITRO DRUG RELEASE STUDY.
Abstract
The conventional dosage forms some time fails to maintain postprandial blood sugar level. Therefore, modified drug delivery is used for overcoming these issues. The present research work is aimed at the formulation and development of an immediate-release tablet for treating Diabetes mellitus by QbD approach. 32 full factorial design was used for developing IR tablet. In, full factorial design two independent and two dependent variables were selected. The concentration of the superdisintegrant, sodium starch glycolate, and the binder, microcrystalline cellulose, was optimized to achieve desirable formulation characteristics. The selected quantities of these excipients were incorporated to enhance tablet disintegration, improve mechanical strength, and maintain the required drug release profile of the immediate-release dosage form. These two independent variables while two dependent variables or responses were considered. i.e., disintegration time and % of drug release at 45 min. According to selected design, 9 batches developed formulations were subjected to comprehensive evaluation of pre-compression parameters, particularly powder flow characteristics, to confirm the suitability and processability of the formulation blend for tablet production. The fabricated tablets were further assessed for critical post-compression quality attributes, including thickness, hardness, friability, weight uniformity, disintegration time, and in-vitro dissolution behaviour. Furthermore, the effect of formulation variables on the selected response parameters was investigated through response surface methodology, and the corresponding response surface plots were generated to demonstrate the relationship between independent variables and formulation performance. Percent drug release at 45 min. increases with increasing superdisintegrant concentration and decreasing binder concentration while disintegration time decreases with decreasing binder concentration and increasing superdisintegrant concentration. The prepared tablet met the requirements of immediate release tablet. From the above study, it can be concluded that, developed immediate-release vildagliptin tablets maintain the blood glucose level in type-II DM patients and provides a high degree of patient compliance.