UY25790A1 - PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING. - Google Patents
PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING.Info
- Publication number
- UY25790A1 UY25790A1 UY25790A UY25790A UY25790A1 UY 25790 A1 UY25790 A1 UY 25790A1 UY 25790 A UY25790 A UY 25790A UY 25790 A UY25790 A UY 25790A UY 25790 A1 UY25790 A1 UY 25790A1
- Authority
- UY
- Uruguay
- Prior art keywords
- recombinant human
- humans
- stable
- room temperature
- formulations
- Prior art date
Links
- 241000282412 Homo Species 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 238000000034 method Methods 0.000 title 1
- 102000003951 Erythropoietin Human genes 0.000 abstract 3
- 108090000394 Erythropoietin Proteins 0.000 abstract 3
- 229940105423 erythropoietin Drugs 0.000 abstract 3
- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 abstract 3
- 101000987586 Homo sapiens Eosinophil peroxidase Proteins 0.000 abstract 2
- 101000920686 Homo sapiens Erythropoietin Proteins 0.000 abstract 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 2
- 102000044890 human EPO Human genes 0.000 abstract 2
- 102000008100 Human Serum Albumin Human genes 0.000 abstract 1
- 108091006905 Human Serum Albumin Proteins 0.000 abstract 1
- 208000007502 anemia Diseases 0.000 abstract 1
- 150000001720 carbohydrates Chemical class 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 235000019799 monosodium phosphate Nutrition 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 239000011780 sodium chloride Substances 0.000 abstract 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 abstract 1
- 229910000162 sodium phosphate Inorganic materials 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- 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
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/26—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
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
La peresente invención se refiere a formas farmacéuticas de Eritropoyetina (EPO) Humana Recombinante que se caracterizan porque: a) son estables a temperatura ambiente, b) son liofilizadas, c) son apropiadas para su uso en humanos y d) contienen un sacárido, NaCl, NaH2PO4, NaHPO4.12 H2O, albúmina humana, Eritropoyetina Humana Recombinante y agua. La EPO es una proteína que ha demostrado gran eficacia para el tratamiento de anemias. Las formulaciones reivindicadas contienen 1000 UI, 2000 UI, 4000 UI y 10000 UI de EPO con el agregado de excipientes específicos que aseguran la isotonicidad y estabilidad del producto.The permanent invention relates to pharmaceutical forms of Recombinant Human Erythropoietin (EPO) characterized in that: a) they are stable at room temperature, b) they are lyophilized, c) they are suitable for use in humans and d) they contain a saccharide, NaCl, NaH2PO4, NaHPO4.12 H2O, Human Albumin, Recombinant Human Erythropoietin and water. EPO is a protein that has shown great efficacy for the treatment of anemias. The claimed formulations contain 1000 IU, 2000 IU, 4000 IU and 10000 IU of EPO with the addition of specific excipients that ensure the isotonicity and stability of the product.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AR9805608 | 1998-11-06 | ||
| AR9900677 | 1999-02-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| UY25790A1 true UY25790A1 (en) | 2000-08-21 |
Family
ID=25590825
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| UY25790A UY25790A1 (en) | 1998-11-06 | 1999-11-05 | PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING. |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU1520800A (en) |
| UY (1) | UY25790A1 (en) |
| WO (1) | WO2000027419A1 (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR9905868A (en) | 1998-11-06 | 2001-01-23 | Bio Sidus S A | Mass culture procedure for mammalian cells to obtain recombinant human erythropoietin and recombinant human erythropoietin obtained with such procedure |
| BR9917606A (en) | 1998-11-06 | 2002-12-31 | Bio Sidus S A | Procedure for the purification of recombinant human erythropoietin from cell culture supernatants and recombinant human erythropoietin obtained with such procedure |
| US6777205B1 (en) | 1998-11-06 | 2004-08-17 | Sterrenbeld Biotechnologie North America, Inc. | Host cells expressing recombinant human erythropoietin |
| MXPA02011303A (en) | 2000-05-15 | 2003-04-25 | Hoffmann La Roche | Liquid pharmaceutical composition containing an erythropoietin derivate. |
| US7772182B2 (en) | 2004-08-05 | 2010-08-10 | Alza Corporation | Stable suspension formulations of erythropoietin receptor agonists |
| CN108606955B (en) * | 2016-12-09 | 2021-10-26 | 江苏豪森药业集团有限公司 | Medicinal composition of cultivated hippocampus japonicus peptide and preparation method thereof |
| WO2024064887A2 (en) * | 2022-09-23 | 2024-03-28 | Cal Poly Corporation | Development of solid-state storage of complex biochemical systems |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6197229A (en) * | 1984-10-18 | 1986-05-15 | Chugai Pharmaceut Co Ltd | Stable erythropoietin preparation |
| SE9300105D0 (en) * | 1993-01-15 | 1993-01-15 | Kabi Pharmacia Ab | STABLE PROTEIN SOLUTION |
| US5876992A (en) * | 1996-07-03 | 1999-03-02 | Molecular Biology Resources, Inc. | Method and formulation for stabilization of enzymes |
-
1999
- 1999-11-05 UY UY25790A patent/UY25790A1/en unknown
- 1999-11-08 AU AU15208/00A patent/AU1520800A/en not_active Abandoned
- 1999-11-08 WO PCT/US1999/026237 patent/WO2000027419A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| AU1520800A (en) | 2000-05-29 |
| WO2000027419A1 (en) | 2000-05-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| ABAN | Application deemed to be withdrawn (no publication fee paid) |
Effective date: 20090413 |