FORMULATION AND OPTIMIZATION OF PROPRANOLOL HYDROCHLORIDE MICROBALLONS USING DESIGN OF EXPERIMENTS

T. Usha Rani*, Dr. G. Tulja Rani, Nagaraja A. Akhila, B. Jeshwanth and D. Swetha

ABSTRACT

The formulation of Propranolol Hydrochloride loaded micro balloons involved the use of Ethyl Cellulose as Coating Agent, HPMC as a polymer, and Tween 80 as a Dispersing agent, Isopropyl alcohol as solvent. The micro balloons were prepared by an Solvent evaporation Technique using liquid paraffin, Hydrophilic non-ionic Surfactants, Methanol, as a processing medium. The Full Factorial design of experiments was utilized to get optimized formulation using a concentration of HPMC, Concentration of Ethyl Cellulose, Concentration of surfactant (C), and stirring speed (D) as an independent parameter while, Particle size (Y1), entrapment efficiency (Y2) and %buoyancy (Y3) using as a dependent parameter. For the optimized formulation, the mean particle size was 83.788 μm, entrapment efficiency was 88.70%, and buoyancy was 88% found. An image of the formulation taken using a scanning electron microscope (SEM) reveals discrete particles with a smooth surface texture, a hollow interior, a spherical shape, and a particle size of less than 200 μm. The FTIR study confirms there was no interaction between the drug and excipients. The in-vitro drug release study found that Propranolol Hydrochloride loaded micro balloons released the drug for up to 12 hours as compared to the pure drug. This was due to increasing the gastric residence time and absorption area in the stomach. The drug release kinetic study reveals that it follows the Higuchi model and the drug release mechanism was type II transport which was obtained from the Korsmeyer Peppas model. The stability study shows that there is no significant change in the optimized micro balloons for 30 days as per ICH guidelines.

Keywords: Drug release, Emulsion Solvent Diffusion, In-vitro drug release kinetics, Microballons, Scanning electron microscope.