Formulations of human growth hormone comprising a non-naturally encoded amino acid

• US 8,163,695 B2
• Filed: 10/25/2007
• Issued: 04/24/2012
• Est. Priority Date: 12/22/2004
• Status: Expired due to Fees

• Current Assignee: Ambrx, Inc. (Johnson & Johnson)
• Original Assignee: Ambrx, Inc. (Johnson & Johnson)
• Inventors: Hays, Anna-Maria A., Buechler, Ying, Litzinger, David C.
• Primary Examiner(s): STOICA, ELLY GERALD
• Application Number:
  US11/924,154
• Publication Number:
  US 20080113912A1
• Time in Patent Office: 1,643 Days
• Field of Search: None
• US Class Current: 514/11.4
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 39/06 Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/06 of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
• CPC Class Codes: A61P 9/02 Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: C07K 14/61 Growth hormone [GH], i.e. somatotropin

Abstract

Formulations of modified human growth hormone polypeptides are provided.

Claims

1. A pharmaceutical formulation of a human growth hormone (hGH) variant comprising one or more non-naturally encoded amino acids wherein the non-naturally encoded amino acids are substituted at positions selected from the group consisting of 35, 92, 131, 134, 143 and 145 of SEQ ID NO:

2 and the non-naturally encoded amino acids have the structure;

2. A pharmaceutical formulation of a human growth hormone (hGH) variant comprising one or more non-naturally encoded amino acids wherein the non-naturally encoded amino acids are substituted at positions selected from the group consisting of 35, 92, 131, 134, 143 and 145 of SEQ ID NO:

2 and the non-naturally encoded amino acids have the structure;