DEVELOPMENT OF AQUEOUS POLYMERIC DISPERSION (APD) OF EUDRAGIT E PO- PERFORMANCE CHARACTERIZATION FOR AQUEOUS BASED TASTE MASKING COATING SYSTEM

Abstract

The present research work was performed to develop an Aqueous Polymeric Dispersions (APD) of Eudragit E PO using emulsification solvent evaporation technology including optimization of solvent, emulsifier & stabilizer. The basis rationale for the present research is to develop water based coating system over organic solvent based coating systems to achieve certain advantages over organic solvents with respect to ecological, toxicological and manufacturing safety concerns, including Pollution, Explosion hazards, Risk of operators, High cost of organic solvents, solvent toxicity and many more. The APD of Eudragit E PO was developed by emulsification solvent evaporation technology including optimization of Ethyl Acetate as solvent, 1%w/w SLS as emulsifier & 4% w/v Polaxomer F127 as stabilizer. The Concentration of Eudragit E PO was optimized as 15%w/v among three APD formulations F1-5%, F2-10% & F3-15% by optimizing Particle size, pH & Viscosity parameters. The optimized APD (F3-15%w/v APD) was characterized for different parameters viz. Average Particle Size by TEM & found 732 nm, pH by electrode pH meter & found 6.8 & viscocity by brook's field viscometer & found 0.6 Pascle. The  Optimized APD (F3-15%w/v APD) was characterized for any possible interactions by DSC & FT-IR spectra. Three different free films were prepared with three different plasticizer viz. di-butyl phthalate, propylene glycol and tri-ethyl-citrate to plasticize optimized aqueous polymeric dispersion of Eudragit EPO (F3-15%w/v APD). Tri-ethyl-citrate 30%w/v of dry polymer was optimized for the development of the free films from an optimized APD(F3). The optimized aqueous polymeric dispersion of Eudragit EPO (F3-15%w/v APD) was used for the performance characterization for taste masking coating properties of ofloxacin tablets. APD (F3-15%w/v APD) coated Ofloxacin tablets were comparatively evaluated with Eudragit E PO Organic solvent coated Ofloxacin tablets for different parameters viz. (a.) Physical- Hardness, Friability, Wt. Variation etc (b.) in-vitro dissolution profile- In Distilled water & Simulated Gastric Fluid (SGF) (c.) Biological- Taste masking.  The accelerated stability study of optimized APD (F3-15%w/v APD) was also performed for 30 days evaluated for Particle size, Viscosity & Redispersibility. It was concluded that the APD was stable at room temperature & unstable at 4-8⁰C.

Key Word: APD, Eudragit E PO, In vitro release study, TEM, FT-IR, DSC, Polaxomer F127.