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Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF DISPERSIBLE TABLET OF ANTI DIABETIC DRUG

Pankaj Kumar* Mr. Saurabh Jain, Dr. R.B. Goswami

Sagar Institute of Research Technology & Science–Pharmacy Ayodhya Bypass Road, Bhopal

ABSTRACT

Last few decades, the remarkable advancement in the drug delivery system has been done; the oral route remains the importance and picks up the safest route of drug delivery. Regardless of striking advancements in the oral route medication, Linagliptin an anti-diabetic drug belonging to BCS class-III, inhibits the enzyme, dipeptidyl peptidase-4 (DPP-4). The concept of formulating fast dissolving tablets containing linagliptin offers a suitable and practical approach in serving desired objective of faster disintegration and dissolution characteristics with increased bioavailability. Fast dissolving tablets of linagliptin were prepared by direct compression methods and blend was evaluated for the pre-compression parameters such as bulk density, compressibility, angle of repose etc. The tablets were prepared by using croscarmellose sodium and sodium starch glycolate, as superdisintegrants in different concentration along with microcrystalline cellulose. Total six formulations were prepared and evaluated for hardness, friability, weight variation, content uniformity, wetting time, water absorption ratio, disintegration time and invitro drug release. In-vitro dissolution studies are performed by using phosphate buffer pH 6.8 at 75 rpm by paddle method. Overall, the formulation F5 containing of croscarmellose sodium was found to be promising and has shown a disintegration time 53±5 sec. The stability studies were performed for two months (accelerated studies) as per ICH guidelines. The optimized formulation (F5) showed no significant variations for the tablets parameters and it was stable for the specified time period. Thus results conclusively demonstrated successful masking of taste and fastest disintegration of the formulated tablets in oral cavity.

Keywords: Linagliptin, Fast dissolving tablets, Superdisintegrants, Pre-compression.


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