Formulations Preserving Bioactivity and Methods of Their Preparation
AssigneeRPH Pharmaceuticals AB
InventorsPer Wikström, Tobias Bramer, Lilyan Yachoh
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Abstract
A pharmaceutical composition comprising an alginate hydrogel core where a bioactive agent is entrapped. The water content of the hydrogel is at least 10% of equilibrium water content. The beads have an enteric coating and are intended for oral administration. The bioactive agent is bioactive proteins, antibodies or viable cells and it is intended to exert its activity in the duodenum and the upper intestines.
Claims14
A pharmaceutical composition for oral or enteral administration comprising beads that admit a bioactive agent, liable to be degraded or inactivated at least when exposed to gastric fluids of the stomach cavity selected from the group of bioactive proteins, antibodies and viable cells, to exert its activity in the duodenum and the upper intestines, wherein the beads comprise at least one ionically cross-linked hydrogel core comprising alginate, b) the bioactive agent entrapped in the hydrogel gel pores, and c) an enteric coating that is water soluble above a threshold pH value between 4 and 7, wherein the water content of the hydrogel is at least 10% of its equilibrium water content.
Dependencies are inferred from the claim text.