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Abstract

DESIGN AND DEVELOPMENT OF ORAL THIN FILM OF ANTIHISTAMINIC DRUG FEXOFENIDINE

Astha Shrivas*, Ashish Jain, Pradeep Kumar Yadav and Akhlesh Kumar Singhai

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Abstract

Bioadhesive formulations have a wide scope of applications, for both systemic and local effects. The mucosa is relatively permeable with a rich blood supply. The oral transmucosal drug delivery bypasses first pass effect and avoids pre-systemic elimination in the GI tract. These factors make the oral mucosa a very attractive and feasible site for systemic drug delivery. A few drugs have been successfully administered via buccal route. The buccal region offers an attractive route of administration for systemic drug delivery. Fexofenadine, H1 antagonist, is a potent antihistamine. Buccal absorption studies of fexofenadine having partition coefficient less than 2 and have lipophilicity in nature, which offers advantages of buccal route over oral route. By observing the above points, it is inferred that fexofenadine has a need to formulate into buccal patches and the drug is suitable for it. Bioadhesive formulations have a wide scope of applications, for both systemic and local effect for management of diseases. Fexofenadine drug will be use for developing a dosage form for a very quick onset of action, which is beneficial in managing severe conditions of allergies, aiding in the enhancement of bioavailability, and is very convenient for administration, without the problem of swallowing and using water. In the present study, Fexofenadine HCl was used as a model drug candidate and nine fast-dissolving films formulations containing different polymer concentrations were prepared. Fast-dissolving films of Fexofenadine HCl were prepared by the solvent casting method on glass molds, using HPMC E15 and Xanthan gum, Sodium starch glycolate as disintegrating agent, glycerin as plasticizer and aspartame as sweetener and distilled water as a solvent. The effect of the nature of polymers was studied by preparing various formulations of oral dispersible films. The various formulations containing a combination of polymers, release was found to be in the following order: OTF7 > OTF8 > OTF9 and formulations OTF7, OTF1, and OTF4 were found to be the best formulations in terms of drug release. The results of the release kinetics study showed that all the formulations obeyed first order drug release profile more closely, i.e., the release rate depended upon the initial concentration of drug. The slope values of the Korsmeyer-Peppas plot showed that the mechanism was non-fickian or supercase II transport mechanism.

Keywords: Oral Thin Film, Fexofenidine, Antihistaminic Drug, HPMC E15 and Xanthan gum, Sodium starch glycolate.


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