Abstract
Darifenacin hydrobromide (DH) is the more recent uroselective M3 receptor antagonist for treating uncomplicated overactive bladder (OAB). This study was aimed to formulate DH as fast dissolving buccal films (FDBFs) using a solvent casting method to enhance patient’s compliance.
 Films were prepared by using polyvinyl alcohol (PVA) as a film forming polymer. Different types and concentrations of superdisintegrants (croscarmellose sodium, sodium starch glycolate, indion 414) were used to select the best formula by studying the physicochemical properties of the films, disintegration time (DT) and percent drug release.
 The results revealed that formula (F9) that containing 7.5mg DH, 2%w/v PVA, 30%w/w glycerol, 0.5%w/v tween 80, 4%w/w indion 414 was the preferred formula. F9 showed the shortest in-vitro disintegration time (31.28sec). In-vitro dissolution profile showed the lowest T80% of the drug in 3.05 min and the highest release of the drug (94%) within 5 min (D5min %).
 It was concluded that the FDBFs of DH could be considered as a promising drug delivery system with an enhanced disintegration and dissolution rate and better patient compliance.
Highlights
In the past few decades, development and imagination have ended up basic competence for making progress in the development of novel dosage forms
The oral solid dosage forms are characterized by ease of administration and exact dosing, but it is sometimes problematic because of decline in bioavailability, long onset time of action and swallowing difficulty especially for pediatric and geriatric [2].Most of pharmaceutical manufacturers have focused in their researches on developing new dosage form to achieve patient convenience
The membrane of mucosa cells is hydrophobic in nature and might be selective for hydrophobic molecules only, while the hydrophilic molecules pass the oral mucosal membrane through the para-cellular pathway since the cytoplasm and intercellular spaces are hydrophilic in nature
Summary
In the past few decades, development and imagination have ended up basic competence for making progress in the development of novel dosage forms. The oral solid dosage forms are characterized by ease of administration and exact dosing, but it is sometimes problematic because of decline in bioavailability, long onset time of action and swallowing difficulty especially for pediatric and geriatric [2].Most of pharmaceutical manufacturers have focused in their researches on developing new dosage form to achieve patient convenience. The oral cavity is a preferred site for drug administration because of drug application by patient and avoidance of possible drug degradation in the GIT in addition to bypassing first-pass hepatic metabolism [1]. The membrane of mucosa cells is hydrophobic in nature and might be selective for hydrophobic molecules only, while the hydrophilic molecules pass the oral mucosal membrane through the para-cellular pathway since the cytoplasm and intercellular spaces are hydrophilic in nature. The drug is transported through facial vein, which drains into general circulation, bypassing the liver, warn off drug from first pass metabolism [4]
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