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. 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 2θ 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 /cm2) 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. 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.

中文翻译：

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吡罗昔康共晶体口腔膜的配制和评价

本研究的目的是使用共结晶技术提高吡罗昔康（BCS II类药物）的溶解度，并配制所选共晶体的颊膜，以提高药物的治疗利用率。通过溶剂蒸发法制备了具有多种共形成物（摩尔比为1：1）的药物共晶体，并对其水溶性和药物含量进行了筛选。通过FTIR，DSC和XRD证实了共晶体的形成。制备载有吡罗昔康共晶体的颊膜，并评价其体外药物释放，离体药物渗透，同时通过组织病理学研究确定制剂的安全性。用不同的共形成物制备的共晶体已证明具有改善药物溶解性的潜力。吡罗昔康-三氯蔗糖的共晶体显示出比母体药物高六倍的溶解度。FTIR分析表明吡罗昔康的特征峰移动。DSC分析显示出额外的放热峰和特征吸热峰的改变。粉末X射线衍射图显示出强峰的2θ值变化。因此，证实了共晶的形成。发现颊膜的物理特性在极限范围内。制剂F6显示最高的粘膜粘附强度（5617±636达因/ cm 2），而制剂F2显示8小时后最高的体外药物释放，即94.557％。发现F2的离体药物渗透率为84.74％。组织病理学研究显示颊粘膜组织没有损伤，并且被发现是完整的。