Formulation and Evaluation of Olanzapine Oral Films by 32 Factorial Design

This experiment aimed to create a mouth dissolving film containing Olanzapine and basic adjuvants such as polymers, plasticizers, sweeteners, saliva stimulants, and flavorings were used. Solvent casting method was used created using to create films. HPMC E5 cps gave good thickness to the film. The films produced gave good tensile strength and folding endurance. The augmented formulation (F7) exhibited good mouth feel, folding endurance, immediate drug release, and strong mechanical properties. The F7 exhibited a disintegration time (DT) of 20 seconds and drug release of 99% within 10 minutes. Polynomial equations were derived for DT and percent drug dissolved 10 (PD10) using Design Expert 7 software. Disintegration time (DT) and percent drug dissolved in 10min (PD10) equations developed are as follows. Y1=36.00 +2.50 X1-5.00 X2+0.25X1X2-2.50X2-5X22(DT); Y3=90.75-3.70X1+2.50X2-0.00 X1X2–1.95X2+0.50 X2(PD10m).The positive sign for co-efficient of X1 in Y1 equations designates that as the concentration of HPMC rises, disintegrating time increases. The negative sign for co-efficient of X2 inY1equations indicates that as the enhancement in primojel concentration decreases the disintegrating time . To check the legitimacy of equation F10 was formulated with DT for 25 sec and PD10 for 90.00. The Final DT Values and PD10were found to be 25 sec and 90.64 % indicating the validity of equation. FTIR spectra indicated that API and adjuvants did not interact during the study. Thus Olanzapine mouth dissolving films could be successfully prepared using HPMC E5 and primojel using 32 Factorial Design.