COMPARATIVE-ANALYSIS OF ORAL DELIVERY SYSTEMS FOR LIVE ROTAVIRUS VACCINES

In this paper a comparison of delivery systems for a live rotavirus va ccine is presented. The loss of infectivity was estimated during incor poration into the delivery systems, and during the subsequent processi ng steps in the preparation of poly(DL-lactide-co-glycolide) microsphe res, alginate microcapsules, spray-coated non-pareil seeds, granules, and tablets. Incorporation of live rotavirus into DL-PLG microspheres or alginate microcapsules, as well as the application to the surface o f non-pareil seeds resulted in a complete or significant loss of rotav irus infectivity. In contrast, stabilization of the rotavirus vaccine with an excipient blend of cellulose, starch, sucrose and gelatin (30: 30:30:10), followed by incorporation into granules or tablets, produce d outstanding results with only minimal losses of infectivity. Of thes e two delivery systems tablets produced better results. However, the d osage form must be modified into a formulation suitable for immunizing infants.