FORMULATION AND EVALUATION OF ORO-DISPERSIBLE FILMS CONTAINING DILTIAZEM HYDROCHLORIDE
Bhavya Shree T.*, Baby Lynthong, Krishnananda Kamath K., Shabaraya A.R.
ABSTRACT
Oro-dispersible film is the type of drug delivery systems which when placed in the oral cavity disintegrates or dissolves within few seconds without water intake. It is most advanced form of oral solid dosage form due to more flexibility and comfort. The present study was undertaken with the objective of formulating and evaluating Diltiazem HCl Oro-dispersible films (ODFs) to enhance the patient convenience and compliance specifically elderly and pediatric patients. Diltiazem HCl is one of the drugs used in the treatment of cardiac diseases like angina pectoris, hypertension etc. Oro-dispersible films of Diltiazem HCl were prepared by solvent casting method using water soluble film forming polymers of different concentrations such as HPMC E5, HPMC E15, and Pullulan. PEG 400 was used as plasticizer. Six formulations were prepared and evaluated for physico-chemical parameters such as weight uniformity, thickness uniformity, surface pH, tensile strength, drug content, disintegration time, in vitro dissolution studies and the best formulation was subjected into stability studies. All the formulations showed satisfactory results for the tested parameters. The formulation F3 containing 7.5%W/V of HPMC E15, was found to show maximum drug release i.e., 98.85±1.18% at the end of 180 seconds and found to disintegrate in 10±0.99seconds. Thus, ODFs are considered as an effective approach whenever immediate onset of action is required.
Keywords: Oro-dispersible film, Diltiazem HCl, Angina pectoris, Solvent casting method.
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