Stabilized interferon compositions

Stabilized interferon compositions
Engineering Village
Publication number: US6994847

Patent number: 6994847

Patent authority: US

Kind: B2 - Utility Patent Grant (with pre-grant publication)

Title: Stabilized interferon compositions

Inventors: Wolfe, Sidney N. (US) ; Hora, Maninder S. (US)

Assignee: Chiron Corporation

Primary examiner: Andres, Janet

Attorney, Agent or Firm: Henry, Leslie;Suh, Gerald;Harbin, Alisa A.

Publication date: 02/07/2006

Publication year: 2006

Application number: 10010448

Unstandardized application number: 010448

Filing date: 11/07/2001

Abstract: Stabilized pharmaceutical formulations comprising IFN-? and highly purified mannitol are provided. The highly purified mannitol stabilizes the compositions by reducing the formation of IFN-? adducts in comparison with IFN-? formulated with mannitol that has not been highly purified. Methods for increasing the stability of IFN-? or a variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.

Field of search: 424/85.6 - 424/198.1 - 530/412 - 530/422 - 530/351 - 435/188

Document type: US Grant

IPC-8 Code: A61K 38/21 SECTION A HUMAN NECESSITIES
MEDICAL OR VETERINARY SCIENCE; HYGIENE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES bringing into special physical form ; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles ; compounds per se , , , ; soap compositions ; micro-organisms per se
Medicinal preparations containing peptides peptides containing beta-lactam rings ; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, ; ergoline-based peptides ; containing macromolecular compounds having statistically distributed amino acid units ; medicinal preparations containing antigens or antibodies ; medicinal preparations characterised by the non-active ingredients, e.g. peptidesas drug carriers, 6
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof 6
Interferons 6

A61K 39/00 SECTION A HUMAN NECESSITIES
MEDICAL OR VETERINARY SCIENCE; HYGIENE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES bringing into special physical form ; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles ; compounds per se , , , ; soap compositions ; micro-organisms per se
Medicinal preparations containing antigens or antibodies materials for immunoassay 2

C12N 9/96 SECTION C CHEMISTRY; METALLURGY
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF biocides, pest repellants or attractants, or plant growth regulators containing micro-organisms, viruses, microbial fungi, enzymes, fermentates, or substances produced by, or extracted from, micro-organisms or animal material ; food compositions , ; medicinal preparations ; chemical aspects of, or use of materials for, bandages, dressings, absorbent pads or surgical articles ; fertilisers ; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS preservation of living parts of humans or animals ; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA microbiological testing media 3
Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof preparations containing enzymes for cleaning teeth ; medicinal preparations containing enzymes or proenzymes ; enzyme containing detergent compositions ; Processes for preparing, activating, inhibiting, separating, or purifying enzymes preparation of malt 3
Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates 3

C07K 14/00 SECTION C CHEMISTRY; METALLURGY
ORGANIC CHEMISTRY such compounds as the oxides, sulfides, or oxysulfides of carbon, cyanogen, phosgene, hydrocyanic acid or salts thereof ; products obtained from layered base-exchange silicates by ion-exchange with organic compounds such as ammonium, phosphonium or sulfonium compounds or by intercalation of organic compounds ; macromolecular compounds ; dyes ; fermentation products ; fermentation or enzyme-using processes to synthesise a desired chemical compound or composition or to separate optical isomers from a racemic mixture ; production of organic compounds by electrolysis or electrophoresis , 2
PEPTIDES peptides in foodstuffs , e.g. obtaining protein compositions for foodstuffs ; preparations for medicinal purposes ; peptides containing -lactam rings ; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, ; ergot alkaloids of the cyclic peptide type ; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific, but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids ; macromolecular products derived from proteins ; preparation of glue or gelatine ; single cell proteins, enzymes ; genetic engineering processes for obtaining peptides ; compositions for measuring or testing processes involving enzymes ; investigation or analysis of biological material 4
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof 6

US Classification: 435/198.1 No data available

530/198.1 No data available

424/198.1 DRUG, BIO-AFFECTING AND BODY TREATING COMPOSITIONS
ANTIGEN, EPITOPE, OR OTHER IMMUNOSPECIFIC IMMUNOEFFECTOR (E.G., IMMUNOSPECIFIC VACCINE, IMMUNOSPECIFIC STIMULATOR OF CELL-MEDIATED IMMUNITY, IMMUNOSPECIFIC TOLEROGEN, IMMUNOSPECIFIC IMMUNOSUPPRESSOR, ETC.)
Hormone or other secreted growth regulatory factor, differentiation factor, intercellular mediator, neurotransmitter, or fragment thereof

424/85.6 DRUG, BIO-AFFECTING AND BODY TREATING COMPOSITIONS
LYMPHOKINE
Interferon
Beta or fibroblast

Database: US Patents

Compilation and indexing terms, ? 2006 LexisNexis Univentio B.V.
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