NO320171B1 - Fremgangsmate for fremstilling av krystaller av veksthormon eller funksjonelle derivater derav, krystaller fremstilt ved fremgangsmaten, anvendelse av kjemisk forbindelse for fremstilling av krystallene, suspensjon for injeksjon, torrformulering og depotformulering som omfatter krystallene, anvendelse av krystallene for fremstilling av medikament og fremgangsmate for rensing av veksthormon. - Google Patents

Fremgangsmate for fremstilling av krystaller av veksthormon eller funksjonelle derivater derav, krystaller fremstilt ved fremgangsmaten, anvendelse av kjemisk forbindelse for fremstilling av krystallene, suspensjon for injeksjon, torrformulering og depotformulering som omfatter krystallene, anvendelse av krystallene for fremstilling av medikament og fremgangsmate for rensing av veksthormon. Download PDF

Info

Publication number: NO320171B1
Authority: NO; Norway
Prior art keywords: crystals; growth hormone; preparation; phenyl; formulation
Prior art date: 1992-10-28

Application number

NO19951547A

Other languages

English (en)

Norwegian (no)

Other versions

NO951547D0 (no

NO951547L (no

Inventor

Ebba Florin-Robertsson

Elvy Hokby

Ronny Lundin

Sirkka Thome

Gertrud Westin-Sjodahl

Tomas Lundqvist

Original Assignee

Pfizer Health Ab

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

1992-10-28

Filing date

1995-04-24

Publication date

2005-11-07

1992-10-28 Priority claimed from SE9203175A external-priority patent/SE9203175D0/xx

1995-04-24 Application filed by Pfizer Health Ab filed Critical Pfizer Health Ab

1995-04-24 Publication of NO951547D0 publication Critical patent/NO951547D0/no

1995-04-24 Publication of NO951547L publication Critical patent/NO951547L/no

2005-11-07 Publication of NO320171B1 publication Critical patent/NO320171B1/no

Links

239000013078 crystal Substances 0.000 title claims abstract description 106
102000018997 Growth Hormone Human genes 0.000 title claims abstract description 62
108010051696 Growth Hormone Proteins 0.000 title claims abstract description 62
239000000122 growth hormone Substances 0.000 title claims abstract description 61
238000000034 method Methods 0.000 title claims abstract description 33
150000001875 compounds Chemical class 0.000 title claims abstract description 14
239000000203 mixture Substances 0.000 title claims description 22
238000009472 formulation Methods 0.000 title claims description 21
238000002347 injection Methods 0.000 title claims description 7
239000007924 injection Substances 0.000 title claims description 7
239000000725 suspension Substances 0.000 title claims description 6
238000002360 preparation method Methods 0.000 title description 10
239000000872 buffer Substances 0.000 claims abstract description 20
125000000217 alkyl group Chemical group 0.000 claims abstract description 13
238000004519 manufacturing process Methods 0.000 claims abstract description 13
125000001624 naphthyl group Chemical class 0.000 claims abstract description 10
125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims abstract description 10
239000007864 aqueous solution Substances 0.000 claims abstract description 5
238000002156 mixing Methods 0.000 claims abstract description 3
WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 27
238000002425 crystallisation Methods 0.000 claims description 13
235000019445 benzyl alcohol Nutrition 0.000 claims description 9
239000003814 drug Substances 0.000 claims description 5
229940079593 drug Drugs 0.000 claims description 5
XPNGNIFUDRPBFJ-UHFFFAOYSA-N (2-methylphenyl)methanol Chemical compound CC1=CC=CC=C1CO XPNGNIFUDRPBFJ-UHFFFAOYSA-N 0.000 claims description 4
WRMNZCZEMHIOCP-UHFFFAOYSA-N 2-phenylethanol Chemical compound OCCC1=CC=CC=C1 WRMNZCZEMHIOCP-UHFFFAOYSA-N 0.000 claims description 4
VAJVDSVGBWFCLW-UHFFFAOYSA-N 3-Phenyl-1-propanol Chemical compound OCCCC1=CC=CC=C1 VAJVDSVGBWFCLW-UHFFFAOYSA-N 0.000 claims description 4
CDRQOYRPWJULJN-UHFFFAOYSA-N 1-naphthalen-1-ylethanol Chemical compound C1=CC=C2C(C(O)C)=CC=CC2=C1 CDRQOYRPWJULJN-UHFFFAOYSA-N 0.000 claims description 3
238000011534 incubation Methods 0.000 claims description 3
238000002955 isolation Methods 0.000 claims description 3
WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims description 3
BDCFWIDZNLCTMF-UHFFFAOYSA-N 2-phenylpropan-2-ol Chemical compound CC(C)(O)C1=CC=CC=C1 BDCFWIDZNLCTMF-UHFFFAOYSA-N 0.000 claims description 2
DYUQAZSOFZSPHD-UHFFFAOYSA-N Phenylpropanol Chemical compound CCC(O)C1=CC=CC=C1 DYUQAZSOFZSPHD-UHFFFAOYSA-N 0.000 claims description 2
239000007853 buffer solution Substances 0.000 claims description 2
101001075374 Homo sapiens Gamma-glutamyl hydrolase Proteins 0.000 claims 4
101000664737 Homo sapiens Somatotropin Proteins 0.000 claims 4
108010000521 Human Growth Hormone Proteins 0.000 description 21
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239000000854 Human Growth Hormone Substances 0.000 description 21
239000000243 solution Substances 0.000 description 17
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 12
DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 12
230000008025 crystallization Effects 0.000 description 10
108090000623 proteins and genes Proteins 0.000 description 10
QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 9
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KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 6
FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 6
RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 6
239000004471 Glycine Substances 0.000 description 6
229930195725 Mannitol Natural products 0.000 description 6
241001465754 Metazoa Species 0.000 description 6
OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
241000700159 Rattus Species 0.000 description 6
239000000594 mannitol Substances 0.000 description 6
235000010355 mannitol Nutrition 0.000 description 6
239000000047 product Substances 0.000 description 6
238000000746 purification Methods 0.000 description 6
239000000523 sample Substances 0.000 description 6
238000004809 thin layer chromatography Methods 0.000 description 6
239000003795 chemical substances by application Substances 0.000 description 5
150000001413 amino acids Chemical class 0.000 description 4
238000004458 analytical method Methods 0.000 description 4
239000000463 material Substances 0.000 description 4
239000011734 sodium Substances 0.000 description 4
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
238000002965 ELISA Methods 0.000 description 3
XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 3
230000015572 biosynthetic process Effects 0.000 description 3
KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
238000002523 gelfiltration Methods 0.000 description 3
229940063135 genotropin Drugs 0.000 description 3
239000011521 glass Substances 0.000 description 3
230000012010 growth Effects 0.000 description 3
238000002844 melting Methods 0.000 description 3
230000008018 melting Effects 0.000 description 3
229920001184 polypeptide Polymers 0.000 description 3
102000004196 processed proteins & peptides Human genes 0.000 description 3
108090000765 processed proteins & peptides Proteins 0.000 description 3
239000001509 sodium citrate Substances 0.000 description 3
NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 3
239000007790 solid phase Substances 0.000 description 3
239000011701 zinc Substances 0.000 description 3
YBJHBAHKTGYVGT-ZKWXMUAHSA-N (+)-Biotin Chemical compound N1C(=O)N[C@@H]2[C@H](CCCCC(=O)O)SC[C@@H]21 YBJHBAHKTGYVGT-ZKWXMUAHSA-N 0.000 description 2
UAIUNKRWKOVEES-UHFFFAOYSA-N 3,3',5,5'-tetramethylbenzidine Chemical compound CC1=C(N)C(C)=CC(C=2C=C(C)C(N)=C(C)C=2)=C1 UAIUNKRWKOVEES-UHFFFAOYSA-N 0.000 description 2
241000251468 Actinopterygii Species 0.000 description 2
LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 2
101000868144 Sus scrofa Somatotropin Proteins 0.000 description 2
HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
239000003708 ampul Substances 0.000 description 2
238000003556 assay Methods 0.000 description 2
238000011953 bioanalysis Methods 0.000 description 2
229960002685 biotin Drugs 0.000 description 2
239000011616 biotin Substances 0.000 description 2
108010006025 bovine growth hormone Proteins 0.000 description 2
238000006243 chemical reaction Methods 0.000 description 2
239000003153 chemical reaction reagent Substances 0.000 description 2
238000004587 chromatography analysis Methods 0.000 description 2
238000001514 detection method Methods 0.000 description 2
238000000502 dialysis Methods 0.000 description 2
238000010790 dilution Methods 0.000 description 2
239000012895 dilution Substances 0.000 description 2
238000009826 distribution Methods 0.000 description 2
238000001035 drying Methods 0.000 description 2
239000012537 formulation buffer Substances 0.000 description 2
238000004108 freeze drying Methods 0.000 description 2
238000004128 high performance liquid chromatography Methods 0.000 description 2
230000007062 hydrolysis Effects 0.000 description 2
238000006460 hydrolysis reaction Methods 0.000 description 2
239000007943 implant Substances 0.000 description 2
238000000386 microscopy Methods 0.000 description 2
FEMOMIGRRWSMCU-UHFFFAOYSA-N ninhydrin Chemical compound C1=CC=C2C(=O)C(O)(O)C(=O)C2=C1 FEMOMIGRRWSMCU-UHFFFAOYSA-N 0.000 description 2
239000003960 organic solvent Substances 0.000 description 2
SQYNKIJPMDEDEG-UHFFFAOYSA-N paraldehyde Chemical compound CC1OC(C)OC(C)O1 SQYNKIJPMDEDEG-UHFFFAOYSA-N 0.000 description 2
229960003868 paraldehyde Drugs 0.000 description 2
239000008363 phosphate buffer Substances 0.000 description 2
238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 2
239000001488 sodium phosphate Substances 0.000 description 2
235000011008 sodium phosphates Nutrition 0.000 description 2
239000002904 solvent Substances 0.000 description 2
239000006228 supernatant Substances 0.000 description 2
230000001225 therapeutic effect Effects 0.000 description 2
RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 2
238000005406 washing Methods 0.000 description 2
230000004584 weight gain Effects 0.000 description 2
235000019786 weight gain Nutrition 0.000 description 2
229910052725 zinc Inorganic materials 0.000 description 2
-1 1% acetic acid Chemical class 0.000 description 1
208000020406 Creutzfeldt Jacob disease Diseases 0.000 description 1
208000003407 Creutzfeldt-Jakob Syndrome Diseases 0.000 description 1
208000010859 Creutzfeldt-Jakob disease Diseases 0.000 description 1
206010013883 Dwarfism Diseases 0.000 description 1
241000282412 Homo Species 0.000 description 1
101000642577 Homo sapiens Growth hormone variant Proteins 0.000 description 1
KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
239000004472 Lysine Substances 0.000 description 1
KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
239000007987 MES buffer Substances 0.000 description 1
108091005461 Nucleic proteins Proteins 0.000 description 1
241000283973 Oryctolagus cuniculus Species 0.000 description 1
102000006877 Pituitary Hormones Human genes 0.000 description 1
108010047386 Pituitary Hormones Proteins 0.000 description 1
229920001213 Polysorbate 20 Polymers 0.000 description 1
229920005654 Sephadex Polymers 0.000 description 1
239000012507 Sephadex™ Substances 0.000 description 1
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
239000012505 Superdex™ Substances 0.000 description 1
239000007983 Tris buffer Substances 0.000 description 1
208000026928 Turner syndrome Diseases 0.000 description 1
238000002835 absorbance Methods 0.000 description 1
239000002253 acid Substances 0.000 description 1
150000007513 acids Chemical class 0.000 description 1
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239000000427 antigen Substances 0.000 description 1
102000036639 antigens Human genes 0.000 description 1
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238000013459 approach Methods 0.000 description 1
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238000004166 bioassay Methods 0.000 description 1
235000020958 biotin Nutrition 0.000 description 1
229920001400 block copolymer Polymers 0.000 description 1
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239000000470 constituent Substances 0.000 description 1
RKTYLMNFRDHKIL-UHFFFAOYSA-N copper;5,10,15,20-tetraphenylporphyrin-22,24-diide Chemical compound [Cu+2].C1=CC(C(=C2C=CC([N-]2)=C(C=2C=CC=CC=2)C=2C=CC(N=2)=C(C=2C=CC=CC=2)C2=CC=C3[N-]2)C=2C=CC=CC=2)=NC1=C3C1=CC=CC=C1 RKTYLMNFRDHKIL-UHFFFAOYSA-N 0.000 description 1
230000001419 dependent effect Effects 0.000 description 1
ZOMNIUBKTOKEHS-UHFFFAOYSA-L dimercury dichloride Chemical compound Cl[Hg][Hg]Cl ZOMNIUBKTOKEHS-UHFFFAOYSA-L 0.000 description 1
238000006471 dimerization reaction Methods 0.000 description 1
LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
238000012377 drug delivery Methods 0.000 description 1
239000000428 dust Substances 0.000 description 1
238000001962 electrophoresis Methods 0.000 description 1
230000002124 endocrine Effects 0.000 description 1
238000011156 evaluation Methods 0.000 description 1
238000002474 experimental method Methods 0.000 description 1
239000013020 final formulation Substances 0.000 description 1
239000000499 gel Substances 0.000 description 1
238000001641 gel filtration chromatography Methods 0.000 description 1
208000037824 growth disorder Diseases 0.000 description 1
238000012835 hanging drop method Methods 0.000 description 1
238000003306 harvesting Methods 0.000 description 1
239000005556 hormone Substances 0.000 description 1
229940088597 hormone Drugs 0.000 description 1
239000000960 hypophysis hormone Substances 0.000 description 1
230000001900 immune effect Effects 0.000 description 1
239000003547 immunosorbent Substances 0.000 description 1
238000001727 in vivo Methods 0.000 description 1
239000012678 infectious agent Substances 0.000 description 1
229940102223 injectable solution Drugs 0.000 description 1
229910052500 inorganic mineral Inorganic materials 0.000 description 1
238000009413 insulation Methods 0.000 description 1
239000012931 lyophilized formulation Substances 0.000 description 1
230000004060 metabolic process Effects 0.000 description 1
125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 description 1
239000011707 mineral Substances 0.000 description 1
BDERNNFJNOPAEC-UHFFFAOYSA-N n-propyl alcohol Natural products CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 1
239000002736 nonionic surfactant Substances 0.000 description 1
102000039446 nucleic acids Human genes 0.000 description 1
108020004707 nucleic acids Proteins 0.000 description 1
150000007523 nucleic acids Chemical class 0.000 description 1
239000012053 oil suspension Substances 0.000 description 1
239000002245 particle Substances 0.000 description 1
239000012071 phase Substances 0.000 description 1
239000002953 phosphate buffered saline Substances 0.000 description 1
230000001817 pituitary effect Effects 0.000 description 1
210000002826 placenta Anatomy 0.000 description 1
229920002401 polyacrylamide Polymers 0.000 description 1
239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 description 1
229920000053 polysorbate 80 Polymers 0.000 description 1
229940068968 polysorbate 80 Drugs 0.000 description 1
239000012286 potassium permanganate Substances 0.000 description 1
239000000843 powder Substances 0.000 description 1
230000035935 pregnancy Effects 0.000 description 1
239000003755 preservative agent Substances 0.000 description 1
125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
230000002685 pulmonary effect Effects 0.000 description 1
238000000197 pyrolysis Methods 0.000 description 1
239000012925 reference material Substances 0.000 description 1
239000013074 reference sample Substances 0.000 description 1
238000011160 research Methods 0.000 description 1
150000003839 salts Chemical class 0.000 description 1
238000012216 screening Methods 0.000 description 1
238000000926 separation method Methods 0.000 description 1
210000002966 serum Anatomy 0.000 description 1
239000000741 silica gel Substances 0.000 description 1
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229910052709 silver Inorganic materials 0.000 description 1
239000004332 silver Substances 0.000 description 1
229910000162 sodium phosphate Inorganic materials 0.000 description 1
229960004532 somatropin Drugs 0.000 description 1
230000036435 stunted growth Effects 0.000 description 1
239000000126 substance Substances 0.000 description 1
239000000758 substrate Substances 0.000 description 1
238000013268 sustained release Methods 0.000 description 1
239000012730 sustained-release form Substances 0.000 description 1
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238000011179 visual inspection Methods 0.000 description 1
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Classifications

- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/61—Growth hormone [GH], i.e. somatotropin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Endocrinology (AREA)
Organic Chemistry (AREA)
Medicinal Chemistry (AREA)
General Health & Medical Sciences (AREA)
Biophysics (AREA)
Molecular Biology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Genetics & Genomics (AREA)
Biochemistry (AREA)
Gastroenterology & Hepatology (AREA)
Zoology (AREA)
Toxicology (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Bioinformatics & Cheminformatics (AREA)
Animal Behavior & Ethology (AREA)
Diabetes (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Engineering & Computer Science (AREA)
Public Health (AREA)
Chemical Kinetics & Catalysis (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Peptides Or Proteins (AREA)
Steroid Compounds (AREA)
Crystals, And After-Treatments Of Crystals (AREA)
Medicinal Preparation (AREA)
Preparation Of Compounds By Using Micro-Organisms (AREA)

NO19951547A 1992-10-28 1995-04-24 Fremgangsmate for fremstilling av krystaller av veksthormon eller funksjonelle derivater derav, krystaller fremstilt ved fremgangsmaten, anvendelse av kjemisk forbindelse for fremstilling av krystallene, suspensjon for injeksjon, torrformulering og depotformulering som omfatter krystallene, anvendelse av krystallene for fremstilling av medikament og fremgangsmate for rensing av veksthormon. NO320171B1 (no)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
SE9203175A SE9203175D0 (sv)	1992-10-28	1992-10-28	Growth hormone
SE19939302278A SE9302278D0 (sv)	1992-10-28	1993-07-02	Growth hormone
PCT/SE1993/000885 WO1994010192A1 (en)	1992-10-28	1993-10-27	Process for manufacturing crystals of growth hormone and crystals thereby obtained

Publications (3)

Publication Number	Publication Date
NO951547D0 NO951547D0 (no)	1995-04-24
NO951547L NO951547L (no)	1995-04-24
NO320171B1 true NO320171B1 (no)	2005-11-07

Family

ID=26661557

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
NO19951547A NO320171B1 (no)	1992-10-28	1995-04-24	Fremgangsmate for fremstilling av krystaller av veksthormon eller funksjonelle derivater derav, krystaller fremstilt ved fremgangsmaten, anvendelse av kjemisk forbindelse for fremstilling av krystallene, suspensjon for injeksjon, torrformulering og depotformulering som omfatter krystallene, anvendelse av krystallene for fremstilling av medikament og fremgangsmate for rensing av veksthormon.

Country Status (13)

Country	Link
US (1)	US5734026A (da)
EP (1)	EP0669934B1 (da)
JP (1)	JP3470135B2 (da)
AT (1)	ATE174602T1 (da)
AU (1)	AU679012B2 (da)
CA (1)	CA2147482C (da)
DE (1)	DE69322654T2 (da)
DK (1)	DK0669934T3 (da)
ES (1)	ES2126660T3 (da)
FI (1)	FI110609B (da)
NO (1)	NO320171B1 (da)
SE (1)	SE9302278D0 (da)
WO (1)	WO1994010192A1 (da)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
SE9302278D0 (sv) *	1992-10-28	1993-07-02	Kabi Pharmacia Ab	Growth hormone
US6500933B1 (en)	1997-09-05	2002-12-31	Altus Biologics Inc.	Methods of preparing carbohydrate crosslinked glycoprotein crystals
DK1009759T3 (da) *	1997-09-05	2008-08-04	Altus Pharmaceuticals Inc	Carbohydrat-tværbundne glycoproteinkrystaller
US6380357B2 (en)	1997-12-16	2002-04-30	Eli Lilly And Company	Glucagon-like peptide-1 crystals
US6541606B2 (en) *	1997-12-31	2003-04-01	Altus Biologics Inc.	Stabilized protein crystals formulations containing them and methods of making them
AU2003208945B2 (en) *	2002-02-20	2008-05-01	Emisphere Technologies, Inc	Method for administering GLP-1 molecules
SE0202719D0 (sv) *	2002-09-13	2002-09-13	Pharmacia Ab	Process for mfg crystals of growth hormone
DK1581251T3 (da)	2002-12-31	2016-06-27	Althea Tech Inc	Krystaller af humant væksthormon og fremgangsmåder til fremstilling deraf
US20060286129A1 (en) *	2003-12-19	2006-12-21	Emisphere Technologies, Inc.	Oral GLP-1 formulations
US7799273B2 (en)	2004-05-06	2010-09-21	Smp Logic Systems Llc	Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
US7444197B2 (en)	2004-05-06	2008-10-28	Smp Logic Systems Llc	Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes
EP1976551A4 (en) *	2005-12-23	2009-12-30	Altus Pharmaceuticals Inc	COMPOSITIONS COMPRISING COMPLEX PROTEIN CRYSTALS BY POLYCATIONS AND PROCESSING METHOD THEREOF

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
MY107450A (en) *	1990-06-04	1995-12-30	Schering Corp	Method for preparing interferon alpha-2 crystals.
IL98484A0 (en) *	1990-06-15	1992-07-15	Schering Corp	Crystalline interleukin-4
DK168790D0 (da) *	1990-07-13	1990-07-13	Novo Nordisk As
US5015627A (en) *	1990-07-20	1991-05-14	Smithkline Beecham Corporation	Stabilized somatotropin for parenteral administration
SE9302278D0 (sv) *	1992-10-28	1993-07-02	Kabi Pharmacia Ab	Growth hormone

1993
- 1993-07-02 SE SE19939302278A patent/SE9302278D0/xx unknown
- 1993-10-27 AT AT93924266T patent/ATE174602T1/de not_active IP Right Cessation
- 1993-10-27 EP EP93924266A patent/EP0669934B1/en not_active Expired - Lifetime
- 1993-10-27 ES ES93924266T patent/ES2126660T3/es not_active Expired - Lifetime
- 1993-10-27 WO PCT/SE1993/000885 patent/WO1994010192A1/en not_active Ceased
- 1993-10-27 DK DK93924266T patent/DK0669934T3/da active
- 1993-10-27 AU AU54011/94A patent/AU679012B2/en not_active Ceased
- 1993-10-27 JP JP51096494A patent/JP3470135B2/ja not_active Expired - Fee Related
- 1993-10-27 CA CA002147482A patent/CA2147482C/en not_active Expired - Fee Related
- 1993-10-27 DE DE69322654T patent/DE69322654T2/de not_active Expired - Fee Related
- 1993-10-27 US US08/424,450 patent/US5734026A/en not_active Expired - Fee Related
1995
- 1995-04-24 NO NO19951547A patent/NO320171B1/no unknown
- 1995-04-27 FI FI952021A patent/FI110609B/fi active

Also Published As

Publication number	Publication date
JP3470135B2 (ja)	2003-11-25
FI952021A0 (fi)	1995-04-27
AU5401194A (en)	1994-05-24
HK1013299A1 (en)	1999-08-20
CA2147482C (en)	2003-09-23
DK0669934T3 (da)	1999-08-23
FI110609B (fi)	2003-02-28
WO1994010192A1 (en)	1994-05-11
ATE174602T1 (de)	1999-01-15
EP0669934A1 (en)	1995-09-06
DE69322654D1 (de)	1999-01-28
EP0669934B1 (en)	1998-12-16
CA2147482A1 (en)	1994-05-11
ES2126660T3 (es)	1999-04-01
NO951547D0 (no)	1995-04-24
NO951547L (no)	1995-04-24
JPH08505127A (ja)	1996-06-04
DE69322654T2 (de)	1999-06-17
FI952021L (fi)	1995-04-27
AU679012B2 (en)	1997-06-19
US5734026A (en)	1998-03-31
SE9302278D0 (sv)	1993-07-02

Publication	Publication Date	Title
Brange et al.	1992	Chemical stability of insulin. 2. Formation of higher molecular weight transformation products during storage of pharmaceutical preparations
Brange et al.	1993	Insulin structure and stability
Brange et al.	1997	Toward understanding insulin fibrillation
TWI604850B (zh)	2017-11-11	藥學製劑
US5216004A (en)	1993-06-01	Method for preventing malaria
US6117984A (en)	2000-09-12	Growth hormone crystals and a process for production of these GH-crystals
AU679012B2 (en)	1997-06-19	Process for manufacturing crystals of growth hormone and crystals thereby obtained
Hofferer et al.	1993	Induction of ovulation and superovulation in mares using equine LH and FSH separated by hydrophobic interaction chromatography
Jetté et al.	2005	Human growth hormone-releasing factor (hGRF) 1–29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: Identification of CJC-1295 as a long-lasting GRF analog
KR100579872B1 (ko)	2006-05-12	단백질 제제
AU8761391A (en)	1992-04-15	Method for increasing red blood cell production by treatment with activin or activin-related peptides
AU638474B2 (en)	1993-07-01	Surfactant compositions and methods
HU206375B (en)	1992-10-28	Process for producing biologically active, stable somatotropins and pharmaceutical compositions comprising same as active ingredient
WO2024009205A1 (en)	2024-01-11	STABLE LIQUID FORMULATION OF AN ANTI-Α4ß7 ANTIBODY
US5876970A (en)	1999-03-02	Surfactant compositions and methods
WO1996033216A1 (en)	1996-10-24	Truncated igf-i
US5780599A (en)	1998-07-14	Growth hormone crystals and a process for production of growth hormone crystals
US5140010A (en)	1992-08-18	Stabilized aqueous formulations of thymopentin
HK1013299B (en)	2001-02-09	Process for manufacturing crystals of growth hormone and crystals thereby obtained
Xian et al.	1996	Production of a human epidermal growth factor fusion protein and its degradation in rat gastrointestinal flushings
WO2004024753A1 (en)	2004-03-25	Process for manufacturing crystals of growth hormone
TANAKA et al.	1982	The bioassay for human prolactin and human chorionic somatomammotropin in serum from pregnant women and in amniotic fluid
US20060116320A1 (en)	2006-06-01	Growth hormone crystals and a process for production of these GH-crystals
TWI322692B (en)	2010-04-01	Fsh and lh pharmaceutical formulations
MXPA03008545A (es)	2005-03-28	Composiciones farmaceuticas que contienen la hormona humana del crecimiento.