Formulation, Optimizationandevaluation of Sublingual Film of Enalaprilmaleate Using 32 Full Factorial Design

Abstract

Objective: The purpose of this investigation was to formulate, optimize and evaluate sublingual film of Enalapril maleate for rapid management of Hypertension.
 Methods: Sublingual films were prepared by solvent casting method. Present investigation were formulated by using HPMC E 15 (X1) as polymer and Polyethylene glycol (X2) as plasticizer were chosen as independent variables in 32 full factorial design while Tensile strength (TS), Disintegration time (DT) and % Cumulative drug release at 10 min. (% CDR) were taken as dependent variables. The various physical parameters were evaluated for sublingual films such as thickness, tensile strength, folding endurance, disintegration time, surface pH and % CDR.
 Results: From the experimental study, it was concluded that the optimized batch F8 showed 98.6 %, the highest release of the drug. Stability study was performed by taking an optimized formulation and it was observed stable. The sublingual films showed acceptable results in all studies such as thickness, tensile strength, folding endurance, disintegration time, surface pH and % CDR at 10 min. R2 values for Tensile Strength (Y1), Disintegration time (Y2) and % cumulative drug release at 10 min. of Enalaprilmaleate(Y3) found to be 0.9852, 0.9829 and 0.9641 respectively. Thus, a good correlation between dependent and independent variables was developed.
 Conclusion: 32 full factorial design was successfully applied during preparation, optimization and evaluation of sublingual films of Enalapril maleate. The present investigation showed quick disintegration and fast release of the drug for rapid management of Hypertension.

Validation of an RP-HPLC Method for the Determination of Asenapine Maleate in Dissolution Media and Application to Study In Vitro Release from Co-Crystals

“…Several methods indicating the stability of the drug in bulk and pharmaceutical formulations were also developed [18][19][20][21][22][23]. In preformulation studies, during the development of various dosage forms, several spectrophotometric [24][25][26][27][28] and HPLC [1,5,6,24,[29][30][31] methods were used to determine drug loading and study in vitro release. Most of these studies just mention the kind of method without giving details.…”

Quality by Design (Qbd) as a Tool for the Optimization of Indomethacin Freeze-Dried Sublingual Tablets: In Vitro and in Vivo Evaluation

“…In addition, the absorption of the drug by the veins located in the mouth floor, leading directly to the superior vena cava [6] combined with a small thickness of 100-200 µm. Allows faster distribution of the drug through the bloodstream compared to that of orally administered drugs [6][7][8][9][10]. Freeze-dried sublingual tablets have attracted much attention from researchers as it offers tablets of high porosity which allows better exposure of the drug to the saliva in the mouth resulting in immediate disintegration and dissolution of the tablet when placed under the tongue [11][12][13][14][15][16].…”