Formulation and evaluation of oral fast dissolving thin films of lansoprazole and esomeprazole by using Synthetic and Natural Polymers

Abstract

newlineABSTRACT newlineAim of the present research is formulation and evaluation of mouth dissolving thin films newlineof proton-pump inhibitors lansoprazole (LZ) and esomeprazole (EZ), for treatment of newlinegastric disorders. Main objectives of the study are: newline1) To study the effect of synthetic polymers: Polyvinyl pyrrolidone (PVP), Polyvinyl newlineAlcohol (PVA) and natural polymers: Gelatin and / or maltodextrin and their combination newlineon the disintegration time of the lansoprazole mouth dissolving thin films (LZOTFs). newline2) To study the effect of synthetic polymer Hydroxy propyl methyl cellulose (HPMC newline15CPS) and natural polymers: Carrageenan and / or maltodextrin and / or Pectin on the newlinedisintegration time of the esomeprazole mouth dissolving thin films (EZOTFs). newlineLZ and EZ both are proton-pump inhibitors and are used in the treatment of gastric acid newlinedisorders. Both of them undergoes acid degradation when administered orally, hence newlinecommercially they are available as enteric coated formulations. Hence they are selected newlineas drug candidates for formulation and evaluation of mouth dissolving thin films. As a newlineresult, their dosing frequency and processing parameters for enteric coating can be newlinereduced. Patient compliance and oral bioavailability of these drugs can be increased. newlineFormulation and evaluation of lansoprazole oral dissolving thin films (LZTFs): The newlinefilms were prepared by solvent casting method, using natural and synthetic film forming newlinepolymers in different concentrations. PEG 400 is used as plasticizer, aspartame and newlinevanilla flavor as artificial sweetener and artificial flavor respectively. The prepared films newlinewere evaluated for weight uniformity, film thickness, folding endurance, dispersion test, newlinedrug content, and in vitro dissolution studies to ensure the physical stability of films. The newlineAndhra University, Visakhapatnam newline newlineformulation F11 with (PVP: PVA: Gelatin in the ratio of 2:1:1 respectively) has newlinephysicochemical, mechanical properties. F11 films exhibits lower values a t50, t90 of less newlinethan 2 min and 10 min respe