Design and Evaluation of Sublingual fast Dissolving Niosomal Film for Prolonged effect of Anti hypertensive Drugs

Abstract

Preface of Thesis newlinex newlinePREFACE OF THESIS newlineThe aim of the present research work was to prepare and evaluate sublingual fast newlinedissolving niosomal films (Niofilm) containing Nebivolol, Valsartan loading dose newlineand Valsartan maintenance dose loaded Niosomes. Niosomes were utilized to newlineallow for prolonged release of the drug, whereas the films were used to increase newlinethe drug s bioavailability via the sublingual route. The formulation and process newlineparameters for niosomes were optimized by preparing placebo niosomes using newlineether injection method. Than Valsartan loaded niosomes were prepared by varying newlinethe concentration of span 60 and characterized for organoleptic properties, pH, newlinetotal drug content, entrapment efficiency, mean particle size and polydispersibility newlineindex, zeta potential and In-Vitro drug release. The selected optimized niosomal newlineformulation based on % entrapment efficiency results was further utilized for newlineformulation of Niofilms. The formulation and process parameters were optimized newlineby preparing placebo niofilms using solvent casting method. The medicated newlineniofilm formulations were manufactured by 32 full factorial design and finalized newlineby using knowledge acquired from Design of expert studies. The niofilms were newlinecharacterized for physical appearance and surface texture, tensile strength, % newlineelongation, folding endurance, in-vitro disintegration time, thickness, content newlineuniformity, % moisture loss, in-vitro drug release, morphology study and scanning newlineelectron microscopy. The optimized formulation had moderate tensile strength newline(6.758 N/mm2), satisfactory % elongation (218.23) and satisfactory in-vitro drug newlinerelease at 24 h (99.49 %). The Ex-vivo drug permeability study was performed for newlineoptimized formulation using modified franz diffusion cell and the data obtained newlinewas analyzed and value of flux and permeability co-efficient were calculated. The newlinestability study of optimized Niofilm formulation was carried out as per ICH Q1A newline(R2) guideline Stability testing of New drug substances and drug product.quot