Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING FILMS OF LORATADINE SOLID DISPERSIONS

*Kote Rupali Balasaheb and Argade Vaishali Punjahari

ABSTRACT

The major problem in formulation of oral films of Loratadine is that it belongs to BCS Class II moiety. Pharmacologically Loratadine is a second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria Present work aimed at preparing quick onset of action which is beneficial in allergic reactions, aiding in the enhancement of bioavailability and is very convenient for administration without the problem of swallowing and using water. The film were prepared by using polymers such as hydroxypropyl methyl cellulose (HPMC) and Maltodextrin, plasticizer such as PEG 400, by a solvent casting method. Nine formulations (F1- F9) of loratadine films were prepared and evaluated for their physical characteristics such as thickness, tensile strength, weight variation, folding endurance, drug content uniformity and surface pH and gave satisfactory results. The compatibility of the drug in the formulation was confirmed by FTIR studies. The formulations were subjected to disintegration, in vitro drug release studies and formulation F4 was found to be best formulation which contain HPMC+ Maltodextrin as film forming polymers along with loratadine solid dispersion with polyvinyl pyrollidone K30 at weight ratio of 1:4 showed excellent film forming Characteristics such as disintegration time of 20 sec and percentage drug release 92.33% within 6 minutes. The optimized batch was found to be stable for 1 month under specified stability conditions.

Keywords: Loratadine, Solid dispersions, Fast dissolving film, Maltodextrin and HPMC.