Abstract
Objective: The present research work is mainly focused on solubility enhancement of domperidone which is a biopharmaceutical classification system Class II drug using natural and synthetic polymers.
 Methods: The solubility was enhanced by the kneading method with the drug: polymer (1:0.5, 1:0.75, and 1:1) using β-cyclodextrin. The fast dissolving films (FDFs) of domperidone were prepared by incorporating the solid dispersion (SD) SDK3 by solvent casting method using hydroxypropyl methylcellulose K15 M (HPMC) and gellan gum in various concentrations for preparing FDFs. Various pre- and post-compression parameters, drug and excipients compatibility studies were evaluated by Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), and X-ray diffraction analysis (XRD).
 Results: The maximum drug release of 98.86 % was achieved within 30 min for 1:1 ratio of solid dispersion using β-cyclodextrin, was optimized and taken for further development of FDFs. From the in vitro drug release studies films prepared with 10% w/w of HPMC K 15 (FH5) and 10% w/w of gellan gum (FG5) showed enhanced dissolution rate compared to other formulations. The formulation FHG with combination of polymers, namely, HPMC K 15 and gellan gum in 1:1 ratio showed drug release of 97.22% within 15 min only when compared with the optimized formulations. FTIR and DSC studies revealed that there were no interactions between drug and excipients. XRD studies revealed slight conversion of crystalline form to amorphous. The optimized formulation FHG found to be stable under accelerated stability studies.
 Conclusions: The polymers in combination are a potential candidate for use in the formulation of FDF.
Highlights
Among the different routes of administration, the oral route of administration continues to be most preferred route due to various advantages including ease of administration, avoidance of pain, versatility, and most importantly patient compliance [1]
The solubility of domperidone was initially enhanced by the kneading method (1:0.5, 1:0.75, and 1:1) using β-cyclodextrin
The solubility of domperidone was enhanced by increasing the concentration of β-cyclodextrins, and the complete drug release was achieved 98.86% within 30 min; this ratio is taken for further development of fast dissolving films (FDFs)
Summary
Among the different routes of administration, the oral route of administration continues to be most preferred route due to various advantages including ease of administration, avoidance of pain, versatility, and most importantly patient compliance [1]. Fast-dissolving oral delivery systems are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing. The film quickly hydrates, adheres, rapidly disintegrates and dissolves to release the medication for mucosal and intra gastric absorption when placed on the tongue or in the oral cavity to provide rapid local or systemic drug delivery [7,8]. This technology is applicable for administration of low dose drugs and unpalatable drugs (domperidone, atenolol etc.,) of Biopharmaceutical classification system (BCS) Class II drugs. The films are formulated using synthetic and hydrophilic polymers by employing kneading technique for solubility enhancement and solvent casting for the preparation of films [13]
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