Abstract

DEVELOPMENT AND OPTIMIZATION OF KETOPROFEN FAST DISSOLVING TABLETS USING PLANTAGO OVATA HUSK MUCILAGE AS A NATURAL SUPERDISINTEGRANT EMPLOYING BOX–BEHNKEN DESIGN

Jitendra Pratap Singh*, Rishabh Maurya, Tanushree Agnihotri

ABSTRACT

Fast dissolving tablets (FDTs) have emerged as an effective oral drug delivery system designed to improve patient compliance and provide rapid onset of therapeutic action. The present study aimed to formulate and optimize fast dissolving tablets of Ketoprofen using Plantago ovata husk mucilage (Isabgol) as a natural superdisintegrant through a Quality by Design (QbD) approach employing Box–Behnken Design (BBD). Plantago ovata mucilage was extracted, purified, and characterized for its physicochemical properties before incorporation into the tablet formulations. Ketoprofen FDTs were prepared by direct compression technique and optimized using a three-factor, three-level Box–Behnken experimental design. The concentration of Plantago ovata mucilage, microcrystalline cellulose (MCC PH102), and mannitol were selected as independent variables, while disintegration time, wetting time, and cumulative drug release were considered as dependent responses. The prepared formulations wereevaluated for pre-compression and post-compression parameters, including angle of repose, bulk density, tapped density, compressibility index, Hausner ratio, hardness, friability, weight variation, drug content, wetting time, water absorption ratio, and in vitro disintegration time. Drug-excipient compatibility was investigated using Fourier Transform Infrared Spectroscopy (FTIR). The optimized formulation demonstrated excellent tablet characteristics with rapid disintegration, enhanced dissolution profile, and acceptable mechanical strength. Statistical analysis revealed that Plantago ovata mucilage significantly influenced tablet disintegration and dissolution performance. The optimized formulation achieved rapid disintegration within seconds and released more than 95% of the drug within 15 minutes. The study concludes that Plantago ovata husk mucilage can serve as an effective natural superdisintegrant for the development of Ketoprofen fast dissolving tablets and that Box–Behnken Design provides a systematic approach for formulation optimization.

Keywords: Ketoprofen, Fast Dissolving Tablet, Plantago ovata, Isabgol, Natural Superdisintegrant, Box–Behnken Design, Optimization, Direct Compression, Quality by Design.