System for delivery of protein in insoluble fibrillar or aggregate form
First Claim
1. A pharmaceutical composition, comprising a pharmaceutically acceptable carrier, diluent, excipient or auxiliary agent and, as active ingredient, either fibrils or insoluble aggregates of insulin, which fibrils or insoluble aggregates are capable of dissociating and releasing soluble monomers of insulin in therapeutically active form, where said fibrils or insoluble aggregates are (a) encapsulated in a lipidated glycosaminoglycan particle, which comprises the reaction product of at least one glycosaminoglycan with at least one lipid having a primary amino group, (b) coated with a multi-layer of at least two lipids and conjugates of one of said at least two lipids and at least one glycosaminoglycan, or (c) present as unencapsulated and uncoated fibrils or insoluble aggregates.
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Accused Products
Abstract
A pharmaceutical composition containing a therapeutic protein which is particularly amenable to oral administration by providing stability in the gastrointestinal tract. Insoluble fibrils or aggregates of the therapeutic protein in the pharmaceutical composition are encapsulated in a lipidated glycosaminoglycan particle, coated with a multi-layer of lipids and lipid-glycosaminoglycan conjugates, or present as unencapsulated and uncoated insoluble fibrils or aggregates.
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Citations
33 Claims
- 1. A pharmaceutical composition, comprising a pharmaceutically acceptable carrier, diluent, excipient or auxiliary agent and, as active ingredient, either fibrils or insoluble aggregates of insulin, which fibrils or insoluble aggregates are capable of dissociating and releasing soluble monomers of insulin in therapeutically active form, where said fibrils or insoluble aggregates are (a) encapsulated in a lipidated glycosaminoglycan particle, which comprises the reaction product of at least one glycosaminoglycan with at least one lipid having a primary amino group, (b) coated with a multi-layer of at least two lipids and conjugates of one of said at least two lipids and at least one glycosaminoglycan, or (c) present as unencapsulated and uncoated fibrils or insoluble aggregates.
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27. A scaffold for tissue engineering, comprising insoluble fibrils or aggregates of insulin encapsulated in a lapidated glycosaminoglycan particle, which comprises the reaction product of at least one glycosaminoglycan with a least one lipid having a primary amino group, or coated with a multi-layer of at least two lipids and conjugates of one of said at least two lipids and at least one glycosaminoglycan.
Specification