Physical properties of proliposome for industrial quality control and reconstitution of proliposome in porcine intestinal mucosa

Abstract

© 2014,International Journal of Pharmacy and Pharmaceutical Sciences All Rights Reserved. Objective: The aim of this research was to examine the physical properties of proliposome granules for industrial quality control and to develop the proliposome tablet. The reconstitution of proliposome into liposome in porcine intestinal mucosa was also examined.Methods: Proliposome granules of bovine serum albumin (BSA) were prepared by granulation method with lecithin and cholesterol as coating lipid. The physical properties which were granular size, flow-ability, moisture content and adsorption isotherm of granules were examined and set as quality control (QC) standards. The obtained proliposome granules were further compressed into tablets with addition of filler/binders. Proliposome granules were also studied in porcine intestinal mucosa at specific time of 0, 5, 10 and 20 minutes to observe the reconstitution of proliposome into liposome.Results: Granular size was decreased regarding the drop of BSA while the amount of lipid had no obvious effect on granular size. Granular size with properties of fair flow-ability and the granular moisture of less than 1.5% was capable for the good tablet compression. These parameters could be set as the standard for quality control of proliposome granules. Proliposome granules displayed type V of BET adsorption isotherm which could be exploited as the fingerprint of proliposome formula and set as QC standard. The reconstitution of proliposome into liposome by mucus on surface of small intestine was clearly observed at 10 minutes onward. The addition of PVP as dry binder along with Avicel®increased the hardness of proliposome tablet, suitable for further experiment of an enteric coating.Conclusion: Industrial quality control of proliposome granules could be accessed by physical properties of granules. PVP combined with Avicel ®were the appropriate binders for proliposome tablet compression. The reconstitution of proliposome into liposome could be displayed on the surface of the small intestine.