FORMULATION AND EVALUATION OF FAST DISSOLVING FILMS OF LORATADINE FOR SUBLINGUAL USE
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 8
Abstract
Loratadine is a second generation orally administered non-sedative antihistamine used in the symptomatic relief of allergy such as hay fever (allergic rhinitis), urticarial (hives) and other skin allergies. In the work undertaken, an attempt was made to prepare quick release films of loratadine with the purpose of developing a dosage form for very quick onset of action, which will be beneficial in managing severe condition of allergies, aiding in enhancement of bioavailability and very convenient for administration, without the problem of swallowing & without using water. The drug has salty taste and hence an attempt was made to mask the taste by using artificial sweetener aspartame which also acts as a saliva stimulant. The films of loratadine were prepared by using polymers such as hydroxypropyl methylcellulose (HPMC) & polyvinyl pyrrolidone (PVP) and hydroxypropyl cellulose (HPC) by solvent casting method. The IR studies showed no interaction between drug and polymer. They were evaluated for physicochemical tests such as thickness, uniformity of weight, uniformity of drug content, folding endurance, surface pH, tensile strength and % elongation, disintegration test, all of which showed satisfactory results. The formulations were also subjected for in vitro drug release by using USP dissolution apparatus. Ex vivo drug release was also carried out using porcine membrane as the model. All the formulation showed 70-92% release within 4 min by the in vitro method and 64-86% within 4 min during ex vivo drug release studies. The stability studies conducted showed that there was no appreciable change when stored at refrigeration temperature 2-8°C, room temperature 25-30°C and oven temperature 45-50°C.
Authors and Affiliations
Qadir Khanusiya , RN Charyulu , P Prabhu , S Bhatt , CS Shastry
Keywords
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