Formulation and evaluation of buccal films of piroxicam co-crystals
Anand Shripal Ammanage, Paul Rodriques, Amolkumar Ashok Kempwade, Ravindra Durdundayya Hiremath
Abstract
Abstract Background The aim of the present study was to enhance the solubility of piroxicam (BCS class II drug) using co-crystallization technique and formulate the buccal films of selected co-crystals for improved therapeutic utilization of drug. Co-crystals of drug with various co-formers (molar ratio 1:1) were prepared by solvent evaporation method and were screened for their aqueous solubility and percent drug content. The formation of co-crystals was confirmed by FTIR, DSC and XRD. Piroxicam co-crystals loaded buccal films were prepared and evaluated for in vitro drug release, ex vivo drug permeation while safety of formulation was determined by histopathological study. Results The co-crystals prepared with different co-formers have proved their potential to improve the solubility of the drug. Co-crystals of piroxicam-sucralose have shown six-folds more solubility than parent drug. FTIR analysis indicated shifting in characteristics peaks of piroxicam. DSC analysis showed an extra exothermic peak and alteration in characteristic endothermic peak. The powder x-ray diffraction pattern exhibited changes in 2 θ values of intense peaks. Thus, formation of co-crystal was confirmed. Physical characters of buccal films were found to be within limits. Formulation F6 showed highest mucoadhesive strength (5617 ± 636 dynes /cm 2 ) while formulation F2 showed highest in vitro drug release after 8 h, i.e., 94.557%. The ex vivo drug permeation of F2 was found to be 84.74%. The hisopathological study revealed that there was no damage to buccal mucosal tissue and was found to be intact. Conclusion The piroxicam-suralose co-crystals based mucoadhesive films of piroxicam could be a better formulation approach with improved solubility, safety, and therapeutic efficacy as compared to conventional tablets. Graphical abstract