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US 11,534,481 B2Granted
Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof
AssigneeHarrow IP, LLC
InventorsDennis Elias Saadeh, Mark L. Baum
Life of this patent
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Abstract
Pharmaceutical compositions for treating, mitigating or preventing autoimmune diseases and associated conditions are described herein. Methods for fabricating the compositions and using them are also described.
Claims9
A method for fabricating a pharmaceutical composition, the method consisting of combining a quantity of corticotropin, ACTH of a non-animal derivation, with:
- (a) a quantity of at least one water-soluble viscosity enhancing agent,
- (b) mannitol,
- (c) methionine,
- (d) optionally, an inactive component selected from the group consisting of a non-ionic poly(oxyethylene-co-oxypropylene) block copolymer, a polyoxyethylene sorbitan monolaurate, a polyoxyethylene sorbitan monopalmitate, a polyoxyethylene sorbitan monostearate, and a polyoxyethylene sorbitan monooleate;
- (e) optionally, hydrochloric acid;
- and
- (f) water,
- wherein the composition is free of gelatin and free of preservatives, wherein the methionine has a concentration of about 2 mg/mL to about 3 mg/mL, wherein the composition has a pH of 4.0-6.5, wherein the corticotropin comprises a recombinant polypeptide, and wherein the composition is potent for at least 180 days.
5 more elements
A method for fabricating a pharmaceutical composition, the method consisting of combining a quantity of corticotropin, ACTH of a non-animal derivation, with:
- (a) a quantity of at least one water-soluble viscosity enhancing agent,
- (b) mannitol,
- (c) methionine,
- (d) optionally, an inactive component selected from the group consisting of a non-ionic poly(oxyethylene-co-oxypropylene) block copolymer, a polyoxyethylene sorbitan monolaurate, a polyoxyethylene sorbitan monopalmitate, a polyoxyethylene sorbitan monostearate, and a polyoxyethylene sorbitan monooleate;
- (e) optionally, hydrochloric acid;
- and
- (f) water,
- wherein the composition is free of gelatin and free of preservatives, wherein the methionine has a concentration of about 3 mg/mL.
5 more elements
Dependencies are inferred from the claim text.