Parenteral formulations of a peptide for the treatment of...

A - Human Necessities – 61 – K

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A61K 38/00 (2006.01) A61K 47/40 (2006.01) A61K 51/10 (2006.01)

Patent

CA 2513331

The subject invention provides a pharmaceutical composition comprising an aqueous carrier; from 0.1 mg/ml to 20 mg/ml of the composition of a pharmaceutically acceptable salt of a peptide having the structural formula NH2-Gly Tyr Tyr Tip Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooH; and a substituted 13-cyclodextrin in an amount effective to dissolve the peptide in the aqueous carrier, wherein the composition ha.s a pH between 4 and 9, a process for preparation, and a method of alleviating symptoms of systemic lupus erythematosus (SLE) in a human subject comprising administering to the human subject the pharmaceutical composition.

L'invention concerne une composition pharmaceutique contenant un excipient aqueux, de 0,1 mg/ml à 20 mg/ml de la composition d'un sel acceptable d'un point de vue pharmaceutique d'un peptide représenté par la formule structurelle NH¿2?-Gly Tyr Tyr Tip Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooH, et une quantité suffisante d'une 13-cyclodextrine substituée pour dissoudre le peptide dans l'excipient aqueux, la composition ayant un pH situé entre 4 et 9. L'invention concerne également un procédé de préparation de ladite composition, ainsi qu'une méthode de soulagement des symptômes du lupus érythémateux systémique (SLE) chez un sujet humain, consistant à administrer ladite composition pharmaceutique au sujet.

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