Abstract
BackgroundThe 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.ResultsThe 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.ConclusionThe 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
Highlights
The aim of the present study was to enhance the solubility of piroxicam (BCS class II drug) using cocrystallization technique and formulate the buccal films of selected co-crystals for improved therapeutic utilization of drug
The highest solubility was observed with the co-crystals of Sucralose (60.73 ± 1.95 mg/100 ml), comprising 6 times to that of actual solubility of the bulk drug
The sweet taste of sucralose offers added advantage of taste masking which helps during buccal film preparation
Summary
The aim of the present study was to enhance the solubility of piroxicam (BCS class II drug) using cocrystallization 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. 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. Solubility is one of the major physicochemical properties which affect the therapeutic efficacy of any drug entity. Emulsification, micronisation, salt formation, use of co-solvents are various approaches adopted to overcome the problem of solubility [2, 3]. Oral administration of piroxicam is associated with adverse effects such as ulcerative colitis, GI irritation and peptic ulcers whereas severe pain and inflammation is observed with parenteral at injection
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