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Abstract

FORMULATION OF AN ORALLY FAST-DISSOLVING FILM USING DIPHENHYDRAMINE HYDROCHLORIDE AS THE MODEL DRUG BY SOLVENT CASTING METHOD

Alejandro, Samantha F., Antonio, Aldrin L., Buena, Princess Angeline L., Buiza,
Aimeriel M*., Perez, Arielle Grace A., Tubon, Nelson T, Valencia, Ara Mae B., Villespin, Vanessa Jae P.

ABSTRACT

This study focused on the formulation of an orally fast-dissolving film using diphenhydramine HCl as the model drug by solvent casting method, utilizing the most commonly found excipients available in the country. This will enhance a drug’s function for immediate release purposes and in cases wherein rapid action is required. The oral film was subjected to various physical and chemical quality control tests and pharmacokinetic tests such as the compatibility test of active ingredient and excipients. All of the ingredients except Acacia have two or more spots that signify no interaction between diphenhydramine HCl and the ingredients and therefore deemed compatible. The stability test for the physical parameter showed that the oral film is physically unstable at the 3rd month due to absorbance of moisture and loss of peppermint scent in light and relative humidity. The oral film is physically stable at temperatures of 2 to 8°C and 25 to 30°C but physically unstable to 40°C. They are rendered unstable because of their change in color, texture and scent. The stability for the chemical parameter showed that the oral film is chemically stable even under the varying influence of light, temperature and relative humidity during the 3-month duration of the stability study. The physical test of the oral film yielded an In-vitro disintegration time of 35.96 seconds, a mean weight of 0.3299g, and a mean thickness of 0.354 millimeters, folding endurance produced a mean of 20.5 folds, a mean swelling index of 31.25%, a mean linear expansion coefficient in water of 0.06% at 30 seconds and 0.23% at 60 seconds and lastly a mean percentage moisture loss of 57.0%.

Keywords: orally fast-dissolving films, formulation, solvent casting method, diphenhydramine HCl, disintegration, dissolution.


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