Preclinical Safety Assessment of Chemically Cross-Linked Modified Mandua Starch: Acute and Sub-Acute Oral Toxicity Studies in Swiss Albino Mice.

In the present era, 28 days of repeated-dose-toxicity study following the Organization for Economic Cooperation and Development (OECD) guidelines 407 is compulsory for every drug to go through phase 1 clinical trials. The increasing demand for high-resistant starch containing nutraceuticals and the applicability of modified starch in development of targeted drug delivery inspired us to investigate the toxic profile of mandua starch chemically cross-linked by epichlorohydrin and compare it with alkali-isolated starch in healthy adult Swiss albino mice, which can be the first step for exploring the use of epichlorohydrin-cross-linked mandua starch (ECC-MS) as a pharmaceutical excipient. Histopathological examinations of the kidney and liver did not expose noteworthy abnormalities in the treated mice. There were no clinical and mortality symptoms of toxicity observed during the repeated-dose-toxicity study. The oral consumption of ECC-MS did not pose any harm as it was neither lethal nor had any harmful hematological, biochemical, psychological, anatomical, and behavioral effects. The use of ECC-MS and alkali-isolated mandua starch (AMS) was found safe at a dose of 2000 mg/kg body weight in the acute toxicity study and at doses of 2000, 1500, and 1000 mg/kg body weight in the sub-acute toxicity study as no detrimental effects were observed after oral administration in mice for 14 and 28 days, respectively.

Preparation and in vitro characterization of solid dispersion floating tablet by effervescent control release technique with improved floating capabilities.

In this Research, an effort has been done for the development of effervescent controlled release floating tablet (ECRFT) from solid dispersions (SDs) of diclofenac sodium (DS) for upsurge the solubility and dissolution rate. ECRFT of DS was prepared by using SDs of DS and its SDs prepared with PEG as carrier using thermal method (Simple fusion). SDs of DS were formulated in many ratio (1:1, 1:2, 1:3 and 1:4). Prepared SDs was optimized for its solubility, % drug content and % dissolution studies. Tablets were formulated by using optimized SDs products and all formulation was evaluated for various parameters. A clear rise in dissolution rate was detected with entirely SD, amid that the optimized SD (SD4) was considered for ECRFT. Among all the tablet formulations, its F3 formulation was better in all the terms of pre compression and post compression parameters. It had all the qualities of a good ECRFT, based on this F3 formulation was selected as the best formulation. Data of in vitro release was fitted in several kinetics models to explain release mechanism. The F3 formulation shows zero order release. From this study we can concluded that ECRFT containing SDs of DS can be successfully used for achieving better therapeutic objective.