Design, physico-chemical assessment and pharmacokinetics of a non-toxic orodispersible film for potential application in musculo-skeletal disorder

Abstract

Development of an ideal drug delivery system to get maximum bioavailability with fewer side effects is a challenge. The objective of the present research was to prepare fast dissolving orodispersible films (ODFs) for simultaneous administration of BCS class II drug (meloxicam (MX)) and tizanidine (TZ) using solvent casting method to improve the bioavailability of both drugs. ODFs were prepared by synthetic (polyvinyl alcohol), semisynthetic (hydroxypropyl methyl cellulose, HPMC; hydroxyethyl cellulose, HEC) and natural (xanthan gum) polymers. The prepared formulations were investigated for physico-chemical parameters, mechanical strength, surface morphology and in vitro and in vivo drug release studies. The prepared ODFs were also evaluated through stability studies and histopathology. The results indicated that disintegration time, tensile strength, folding endurance and pH of film surface of all formulations are in the range from 20 to 60 s, 10.87–21.75, >100 times and 4.09–4.87, respectively. In vitro drug release study indicated a fast and maximum release of MX and TZ from all formulations within 5 min. Scanning electron microscopy (SEM) and visual observation of all formulations have shown a smooth surface with homogenous distribution of all ingredients. Stability study of formulations for six months did not show any significant imperfection except a decrease in disintegration and dissolution time of all formulations due to water absorbing capacity of the polymers. In vivo study indicated the enhanced bioavailability of the both drugs. After complete evaluation of all formulations, it is concluded that the reported method of the preparation of ODFs can be used to improve the morphology of the films as well as the pharmacokinetics parameters of the drugs.