ABSTRACT

ABSTRACT

Objective: In the present research, rapidly dissolving films of Levocetirizine

dihydrochloride were developed using film forming polymer HPMC E-15LV and super

disintegrant crosspovidone by solvent casting method.

Methods: A 32 full factorial design was employed for the optimization of formulation

considering concentration of superdisintegrant and concentration of film former as

independent variables. The prepared films (F1 – F9) were evaluated for weight variation,

thickness, drug content, folding endurance, surface pH, in vitro disintegration time and in-

vitro drug release.

Results: FTIR studies showed no drug polymer interaction. The prepared films exhibited

good integrity and thickness. In vitro dissolution studies were performed as per the FDA

dissolution guidelines for about 10 minutes, the optimum formulation released complete

drug within 10 minutes. It was found that increasing the polymer concentration showed

negative effect on disintegration time and the drug release. But when the concentration of

the super disintegrant was increased, it had a positive impact on the disintegration time

and drug release.

Conclusion: Formulation F3 was considered optimum which contained 300 mg HPMC

E-15LV and 200 mg crosspovidone. The in vitro disintegration time of the optimized

formulation was found to be 19 seconds respectively and hence may help in rapid onset of

action that may lead to quick relief in different allergic conditions.

Keywords: Film forming Polymers, Superdisintegrant, Solvent Casting Method and

Factorial design.

DEPARTMENT OF PHARMACEUTICS - VIPW