23 Full Factorial Design for Formulation and Evaluation of Floating Oral In Situ Gelling System of Piroxicam

Abstract

Piroxicam is an NSAID (non-steroidal anti-inflammatory drug) persisting antipyretic and analgesic effects and being usually implied in managing and treating osteoarthritis, rheumatoid arthritis, soft tissue disorders, ankylosing spondylitis, and acute gout and also in post-operative pain management. The present research was undertaken aiming to formulate Piroxicam encompassing floating oral in situ gels, in order to augment its anti-inflammatory activity and to alleviate its gastric ulceration potential. In the present work, a three-factor at two-level (23) factorial design was adopted to inspect the effects of three factors viz. sodium alginate [A], sodium bicarbonate [B], and sodium citrate [C] on the dependent variables like in vitro gelation, in vitro floating, percentage water uptake, and percentage drug release. All the formulations have exhibited pH ranging from 6.7 ± 0.25 to 7.4 ± 0.24. Percentage drug content was noted in the range of 96.3 ± 0.27 to 99.5 ± 0.28%. In vitro gelation was instantaneous post administration of the system, which remained intact for an extended time period. Percentage water uptake was in the range 9.01 ± 0.15 to 31.01 ± 0.25%; floating lag time was estimated around 7 ± 0.39 to 57 ± 0.36 s. Formulations F4 and F5 reflected floating even past 12 h. All the formulations have exhibited drug release of around 90% within 8 h. It was experiential that the chosen independent variables had significant effect on the dependent variables, justifying the robustness and aptness of design implied for optimization. The developed system may be a promising and alternative strategy to augment gastric retention of Piroxicam, thereby increasing its therapeutic efficacy. It even offers additional benefit of reducing the gastric irritation, tissue damage, and ulceration, by avoiding direct contact of drug with mucosa of stomach.