In vitro‐in vivo performance evaluation of treated Plantago ovata husk based fast dissolving tablets of glipizide: Flashtab technology

Abstract

Physicians suggest premeal administration of glipizide (30 min before a meal) because of longer disintegration time (approximately 15 min) of conventional tablet. Hence, the dosage form was developed, called as fast dissolving tablet (FDT), which disintegrates rapidly within a minute. FDTs by Flashtab technology is based on a swellable agent and a superdisintegrant. In the current study, treated Plantago ovata husk (TPOH), and microcrystalline cellulose were utilized as natural superdisintegrant and swellable agent, respectively. FDT formulations were prepared by direct compression and evaluated for in vitro tablet performance, such as disintegration time, wetting time, hardness, friability, swelling and percent drug release. On the basis of finding, formulation with 15% TPOH concentration (TPOH 7) was selected as optimized formulation. To evaluate the in vitro performance, the formulation TPOH 7 and the marketed tablets (glynase) were administered to rabbits. In the case of marketed tablet, the peak plasma‐concentration of glipizide was obtained in 2.83 h of administration whereas it was 2 h for TPOH 7 indicating immediate absorption and therefore faster onset of action of the prepared FDT formulation than the marketed one. Drug interaction studies, performed by using FTIR spectroscopy, X‐ray diffractometry and differential scanning calorimetric methods, indicate that the glipizide is compatible with the formulation components. The accelerated stability study (40°C ± 2°C/75% ±5% relative humidity) for the optimized formulation showed a negligible change over time for the in vitro parameters. The results suggest that TPOH has promising potential for faster disintegration and fulfills the requirement of FDTs. Key words: Direct compression, fast dissolving tablets, flashtab technology, glipizide, Plantago ovata husk, superdisintegrant