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filingDate 2005-08-11-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_1bfa45ead80d017deb681a801cc4f4d5
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publicationDate 2006-04-19-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber EC-SP055960-A
titleOfInvention PARENTERAL FORMULATIONS OF A PEPTIDE FOR THE TREATMENT OF ERYTHEMATE SYSTEM LUPUS
abstract SUMMARY OF THE INVENTION The present invention provides a pharmaceutical composition comprising: An aqueous vehicle; 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 Trp Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooh ( SEQ ID NO: 1). A substituted cyclodextrin in an amount effective to dissolve the peptide in the aqueous vehicle, wherein the composition has a pH between 4 and 9. The subject invention also provides a pharmaceutical composition that also comprises: An aqueous vehicle; 0.1 mg / ml to 20 mg / ml of the composition of the acetate salt of a peptide having the structural formula NH2-Gly Tyr Tyr Trp Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooh ( SEQ ID NO: 1); and from 70 mg / ml to 170 mg / ml of the hepta-sulfobutyl ether-β-cyclodextrin composition, wherein the peptide and hepta-sulfobutylether-β-cyclodextrin are dissolved in the aqueous vehicle; and where the solution has a pH between 6.5 and 8.5. The subject invention also provides a method for alleviating the symptoms of systemic lupus erythematosus (SLE) in a human subject comprising administering to the human subject any of the above pharmaceutical compositions in an amount effective to alleviate the symptoms of SLE in the human subject. The subject invention also provides a method of manufacturing the above pharmaceutical composition comprising the following steps: a) Preparation of a solution of a substituted β-cyclodextrin in an aqueous vehicle at a predetermined concentration; b) Add a predetermined amount of a pharmaceutically acceptable salt of the peptide NH2-Gly Tyr Tyr Trp Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooh (SEQ ID NO: 1) to the solution of step a) ; c) Adjust the pH of the solution from step b) until the peptide dissolves in the solution; and d) if necessary, adjust the pH of the solution in step c) to a pH of 4-9, thereby manufacturing the pharmaceutical composition. The subject invention also provides a lyophilization process of the above pharmaceutical composition, comprising the steps of: a) Reducing the temperature of a pharmaceutical composition to -40 ° C; b) Hold the temperature at -40 ° C for a predetermined time; c) Raise the temperature of the solution to 20 ° C; d) Hold the temperature at 20 ° C for a predetermined time; and e) Reduce the pressure to 10 µbar, thereby freeze-drying the pharmaceutical composition. The subject invention also provides a lyophilization process of the above pharmaceutical composition, comprising the steps of: a) Reducing the temperature of the pharmaceutical composition to -45 ° C; b) Hold the temperature at -45 ° C for a predetermined time; c) Raise the solution temperature to -20 ° C; d) Raise the temperature of the solution to 25 ° C; and e) Hold the temperature at 25 ° C for a predetermined time, thereby freeze-drying the pharmaceutical composition.
priorityDate 2003-01-14-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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Total number of triples: 49.