Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K38/00—Medicinal preparations containing peptides
  • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
  • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
  • A61K38/22—Hormones
  • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/12—Carboxylic acids; Salts or anhydrides thereof

Definitions

• -5- consists substantially of a succinate buffer.
• Pharmaceutical formulations buffered with succinate cause less pain upon injection than similar formulations containing non-succinate buffers, such as citrate, phosphate or acetate buffers.
• the preferred concentration ranges of succinate buffer are less than about 100 mM, less than about 95 mM, less than about 90 mM, less than about 85 mM, less than about 80 mM, less than about 75mM, less than about 70 mM, less than about 65mM, less than about 60 mM, less than about 55 mM, less than about 50 mM, less than about 45 mM, less than about 40 mM, less than about 100 mM, less than about 95 mM, less than about 90 mM, less than about 85 mM, less than about 80 mM, less than about 75mM, less than about 70 mM, less than about 65mM, less than about 60 mM, less than about 55 mM, less than about 50 mM, less than about 45 mM, less than about 40 mM, less than about 100 mM, less than about 95 mM, less than about 90 mM, less than about 85 mM, less than about 80 mM,
• the concentration range is about 2-10 mM.
• the concentration of the succinate buffer is about 10 mM.
• pharmaceutically active agent is meant any pharmaceutically effective compound that is compatible with succinate buffer.
• Pharmaceutically active agents include, but are not limited to organic drugs, inorganic drugs, antibiotics, proteins, peptides, carbohydrates, lipids, fatty acids, nucleic acids and derivatives thereof.
• Agents of particular interest include, but are not limited to, IGF-I, Interleukin-2, Interferon- ⁇ , Fibroblast Growth Factors I and II, Epotein- ⁇ , growth hormone, CNTF, BNDF, TPA, and colony-stimulating factors, ampicillin, pennicillin, chloroquine hydrocholoride, amphotericin B, cephalothin, cefamandole, ceforandied, cefotaxime, cefepime, gentamycin, netilmicin, griseofulvin, clotrimazole, miconozole, betamethasone, cortisol, prednisolone, sumatripan, chlorpheniramine maleate, brompheniramine maleate, enalaprilat, amrinone, dobutamine, thiethylperazine, and the like.
• IGF-I can also be chemically prepared by the method of simultaneous multiple peptide synthesis. See, for example, Houghten (1985) Proc. Natl Acad. Sci. USA 82:5131-5135; and U.S. Patent No. 4,631,211. These references are herein incorporated by reference.
• the IGF-I pharmaceutical composition in accordance with the present invention may further comprise one or more other therapeutic agents that are effective in treating other disorders in the individual, as long as the biochemical actions of the additional therapeutic agents do not interfere with the efficacy of intended action of the IGF-I treatment.
• agents include, but are not limited to, antibiotics, anti-inflammatory agents, and the like.
• -17- dosing convenience such as pre-filled syringes, autoinjectors, blister packs, or needle-less systems, to make the administration or injection easier.
• the pharmaceutical composition comprising reconstituted IGF-I should be formulated in a unit dosage and in an injectable or infusible form such as solution, suspension, or emulsion. It can also be in the form of lyophilized powder, which can be converted into solution, suspension, or emulsion before administration.
• the pharmaceutical composition comprising reconstituted IGF-I is preferably sterilized
• Main Peak area percent is followed as a function of time under a given set of storage conditions. As rhIGF-I degrades, the Main Peak area percent is found to decrease as the area percent of peaks corresponding to rhIGF-I breakdown products is found to increase.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Engineering & Computer Science (AREA)
• Molecular Biology (AREA)
• Immunology (AREA)
• Endocrinology (AREA)
• Zoology (AREA)
• Gastroenterology & Hepatology (AREA)
• Dermatology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Diabetes (AREA)
• Proteomics, Peptides & Aminoacids (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Medicinal Preparation (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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Cited By (8)

Families Citing this family (3)

Citations (4)

Family Cites Families (14)

• 1999
  • 1999-04-02 AT AT99916414T patent/ATE367828T1/de not_active IP Right Cessation
  • 1999-04-02 ES ES99916414T patent/ES2288018T3/es not_active Expired - Lifetime
  • 1999-04-02 EP EP99916414A patent/EP1069912B1/en not_active Expired - Lifetime
  • 1999-04-02 AU AU34739/99A patent/AU3473999A/en not_active Abandoned
  • 1999-04-02 DK DK99916414T patent/DK1069912T3/da active
  • 1999-04-02 PT PT99916414T patent/PT1069912E/pt unknown
  • 1999-04-02 JP JP2000542042A patent/JP2002510653A/ja active Pending
  • 1999-04-02 WO PCT/US1999/007531 patent/WO1999051272A1/en not_active Ceased
  • 1999-04-02 DE DE69936638T patent/DE69936638T2/de not_active Expired - Fee Related
• 2007
  • 2007-07-03 US US11/773,184 patent/US20070249522A1/en not_active Abandoned

Patent Citations (4)

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