ADRENOCORTICOTROPIC HORMONE-BASED PHARMACEUTICAL FORMULATIONS AND METHODS FOR FABRICATING AND USING THEREOF
Pharmaceutical compositions for treating, mitigating or preventing multiple sclerosis, autoimmune diseases and associated conditions are described herein. Methods for fabricating the compositions and using them are also described.
1 . A pharmaceutical composition, comprising a quantity corticotropin of a non-animal derivation, wherein the composition is free of gelatin and free of preservatives.
2 . The pharmaceutical composition of claim 1 , wherein the corticotropin comprises a quantity of a recombinant polypeptide and optionally a quantity of a naturally occurring polypeptide.
3 . The pharmaceutical composition of claim 2 , wherein the corticotropin is free of the naturally occurring polypeptide.
4 . The pharmaceutical composition of claim 3 , wherein the recombinant polypeptide is the amino acid sequence selected from the group of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, and combinations thereof.
5 . The pharmaceutical composition of claim 4 , wherein the recombinant polypeptide is the amino acid sequence as set forth in SEQ ID NO: 1.
6 . The pharmaceutical composition of claim 1 , further comprising an amino acid selected from the group consisting of cysteine, methionine, and combinations thereof.
7 . The pharmaceutical composition of claim 6 , further comprising a water-soluble thickening agent selected from the group consisting of carboxymethyl cellulose, dextrose, mannitol, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, non-cross-linked or partially cross-linked polyacrylates, polyoxyethylene sorbitan monolaurates, polyoxyethylene sorbitan monopalmitates, polyoxyethylene sorbitan monostearates, polyoxyethylene sorbitan monooleates, and combinations thereof.
8 . The pharmaceutical composition of claim 7 , further comprising at least one non-ionic poly(oxyethlene-co-oxypropylene) block copolymer.
9 . The pharmaceutical composition of claim 6 , further comprising at least one non-ionic poly(oxyethlene-co-oxypropylene) block copolymer.
10 . The pharmaceutical composition of claim 1 , further comprising a water-soluble thickening agent selected from the group consisting of carboxymethyl cellulose, dextrose, mannitol, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, non-cross-linked or partially cross-linked polyacrylates, polyoxyethylene sorbitan monolaurates, polyoxyethylene sorbitan monopalmitates, polyoxyethylene sorbitan monostearates, polyoxyethylene sorbitan monooleates, and combinations thereof.
11 . The pharmaceutical composition of claim 10 , further comprising at least one non-ionic poly(oxyethlene-co-oxypropylene) block copolymer.
12 . The pharmaceutical composition of claim 1 , further comprising at least one non-ionic poly(oxyethlene-co-oxypropylene) block copolymer.
13 . The pharmaceutical composition of claim 1 , wherein the composition is ensconced within substantially spherical particles fabricated from a water soluble biodegradable polymer selected from the group consisting of poly(lactic acid-co-glycolic acid), poly(lactic acid), poly(glycolic acid), poly(caprolactone), and poly(hydroxybutyrate).
14 . The pharmaceutical composition of claim 13 , wherein the biodegradable polymer is poly(lactic acid-co-glycolic acid).
15 . A method for treating, preventing or alleviating a disease, condition, syndrome, symptom, pathology, or malady in a mammalian subject in need of such treatment comprising administering to the subject the composition of claim 1 .
16 . The method of claim 15 , wherein the administering is accomplished by intramuscular or subcutaneous injection.
17 . The method of claim 15 , wherein the disease being treated is selected from the group consisting of multiple sclerosis, autoimmune diseases, and rheumatic disorders.
18 . The method of claim 15 , wherein the condition, syndrome, symptom, pathology, or malady comprises infantile spasms, Addison's disease, Nelson's, Cushing's and West syndromes.
19 . A method for fabricating a pharmaceutical composition, comprising combining a quantity of corticotropin with a quantity of at least one water-soluble thickening agent, wherein the composition is free of gelatin and free of preservatives.
20 . The method of claim 19 , wherein corticotropin comprises a recombinant polypeptide and optionally a naturally occurring polypeptide.
21 . The method of claim 19 , wherein the corticotropin is free of a naturally occurring polypeptide.
22 . The method of claim 20 , wherein the recombinant polypeptide is the amino acid sequence selected from the group of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, and combinations thereof.
23 . The method of claim 22 , wherein the recombinant peptide is the amino acid sequence as set forth in SEQ ID NO: 1.