MULTI-LAYERED INJECTABLE SELF-ASSEMBLING PEPTIDE SCAFFOLD HYDROGELS FOR LONG-TERM SUSTAINED RELEASE OF HUMAN ANTIBODIES
First Claim
1. A sustained release formulation comprising;
- (i) a gel core comprising a gel forming first peptide and a therapeutic agent; and
,(ii) a first layer encapsulating said gel core wherein said first layer comprises a gel forming second peptide.
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Accused Products
Abstract
The invention relates to a pharmaceutical formulation for sustained delivery of a therapeutic agent, preferably a protein, polypeptide, an antibody or an antibody fragment, comprising one or more gel forming peptides wherein the formulation exhibits sustained delivery for at least two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, eight weeks, nine weeks, ten weeks, eleven weeks, twelve weeks or more. In one embodiment, the invention relates to a formulation comprising self-assembling peptides that undergo sol-gel transition in the presence of an electrolyte solution such as biological fluids and salts. The formulation can provide sustained release of antibody and antibody fragments, in particular, IgG. Antibody diffusivities can be decreased with increasing hydrogel nanofiber density, providing a means to control the release kinetics.
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Citations
35 Claims
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1. A sustained release formulation comprising;
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(i) a gel core comprising a gel forming first peptide and a therapeutic agent; and
,(ii) a first layer encapsulating said gel core wherein said first layer comprises a gel forming second peptide. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 23)
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17. A process for preparing a controlled release formulation comprising the steps of;
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a. preparing a first solution comprising a first self-assembling gel forming peptide, and an antibody or antibody fragment; b. forming a first self-assembled gel core; c. coating said first self-assembled gel core with a second self-assembling gel forming peptide solution; and
,d. forming a second gel encapsulating said first self-assembled gel core. - View Dependent Claims (18, 19, 20, 21, 22, 24, 25, 26, 32)
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27. A process for preparing a controlled release formulation comprising the steps of;
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a. preparing a first solution comprising a first self-assembling gel forming peptide, and a therapeutic agent; b. forming a first self-assembled gel core; c. coating said gel core with a second self-assembling gel forming peptide; and
,d. forming a second gel encapsulating said gel core. - View Dependent Claims (28, 29, 30, 31, 33, 34, 35)
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Specification