Design and development of rapidly dissolving films using ion exchange resin for taste masking

Abstract

Rapidly dissolving films have been introduced in the market recently as they provide convenience and ease of use over other dosage forms such as orally disintegrating tablets. In the present study, rapidly dissolving films of Cetirizine hydrochloride were formulated using Hydroxypropyl methyl cellulose E3 LV and Hydroxy propyl cellulose-LF as film forming polymers. Cetirizine hydrochloride is a bitter, water soluble drug. Ion exchange resin Tulsion 335 was used for the purpose of taste masking. The films exhibited satisfactory properties for thickness, tensile strength, % elongation and elastic modulus, in-vitro and in-vivo disintegration studies, in-vitro dissolution studies and surface morphology. The films were also tested for complex formation using Differential scanning calorimetry and X ray diffraction study. Simplex lattice design was utilized for batches D1 to D7 to study the effect of polymers and plasticizer on in-vitro disintegration time and mechanical properties. It was observed that increasing amount of polymers Hydroxypropyl methyl cellulose E3 LV and Hydroxy propyl cellulose-LF increased in-vitro disintegration time. Mechanical properties were affected significantly affected by the presence of plasticizer PEG 400. The optimized batch D3 was found to possess 192 μm thickness, in-vitro disintegration time 65 s and in-vivo disintegration time 30 s. Batch D3 was found to be stable for six months under specified stability condition 25°C/40%RH.