Formulations and methods of use for alpha connexin C-terminal (ACT) peptides
AssigneeFirststring Research, Inc.
InventorGautam Ghatnekar
Life of this patent
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Abstract
This invention relates to a topical gel drug product preparation containing a composition comprising an isolated polypeptide having a carboxy-terminal amino acid sequence of an alpha connexin (ACT peptide), peptide stabilizers, excipients, buffering agents, and the like. A formulation and preparation steps are disclosed for the manufacturing of a stable, elegant, and pourable topical gel. The resulting formulation possesses long term stability suitable for aesthetic as well as therapeutic applications including the prevention of scaring and accelerated healing of wounds. Methods for treatment of chronic wounds, including chronic ulcers, are also provided.
Claims18
A topical formulation comprising at least one alpha connexin polypeptide and hydroxyethylcellulose gel, wherein the hydroxyethylcellulose gel stabilizes the alpha connexin polypeptide.
A method of manufacturing a topical formulation comprising:
- a) mixing propylene glycol, glycerin, methylparaben and propylparaben until the parabens are completely dissolved;
- b) separately mixing purified water, EDTA, monobasic sodium phosphate, dibasic sodium phosphate and D-mannitol until a clear solution is obtained;
- c) adding the solution from a) to the solution from b), rinsing the container of the solution from a) with purified water, adding the rinse to the combined solutions, and mixing until the combined solutions are visually homogeneous;
- d) with homogenization mixing, adding hydroxyethyl cellulose into the combined solutions of c) and mixing until the polymer is fully dispersed;
- e) separately mixing purified water with an alpha connexin polypeptide until the peptide is completely dissolved;
- f) adding the solution from e) to the solution of d), rinsing the container of the solution from e) with purified water, adding the rinse to the combined solutions, and mixing until the combined solution are homogeneous.
Dependencies are inferred from the claim text.