JPH10504531A - Hgh含有医薬組成物 - Google Patents
Hgh含有医薬組成物Info
- Publication number
- JPH10504531A JPH10504531A JP8501903A JP50190396A JPH10504531A JP H10504531 A JPH10504531 A JP H10504531A JP 8501903 A JP8501903 A JP 8501903A JP 50190396 A JP50190396 A JP 50190396A JP H10504531 A JPH10504531 A JP H10504531A
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- solution
- hgh
- composition according
- saccharose
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 26
- 239000000203 mixture Substances 0.000 claims abstract description 55
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 33
- 229930006000 Sucrose Natural products 0.000 claims abstract description 33
- 229960004793 sucrose Drugs 0.000 claims abstract description 33
- 235000013681 dietary sucrose Nutrition 0.000 claims abstract description 30
- 230000000087 stabilizing effect Effects 0.000 claims abstract description 4
- 239000000243 solution Substances 0.000 claims description 31
- 102000002265 Human Growth Hormone Human genes 0.000 claims description 29
- 108010000521 Human Growth Hormone Proteins 0.000 claims description 29
- 239000000854 Human Growth Hormone Substances 0.000 claims description 29
- 238000000034 method Methods 0.000 claims description 28
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims description 25
- 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 claims description 17
- 229930195725 Mannitol Natural products 0.000 claims description 17
- 239000000594 mannitol Substances 0.000 claims description 17
- 235000010355 mannitol Nutrition 0.000 claims description 17
- 239000002904 solvent Substances 0.000 claims description 11
- 239000008363 phosphate buffer Substances 0.000 claims description 10
- 238000003860 storage Methods 0.000 claims description 9
- 238000004108 freeze drying Methods 0.000 claims description 8
- 230000003385 bacteriostatic effect Effects 0.000 claims description 7
- 239000000872 buffer Substances 0.000 claims description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 7
- 239000008247 solid mixture Substances 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 6
- 239000008362 succinate buffer Substances 0.000 claims description 6
- 239000007864 aqueous solution Substances 0.000 claims description 4
- 239000007787 solid Substances 0.000 claims description 4
- 239000003381 stabilizer Substances 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 3
- 239000008351 acetate buffer Substances 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- 238000009472 formulation Methods 0.000 abstract description 32
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 description 24
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 16
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 12
- 238000004007 reversed phase HPLC Methods 0.000 description 11
- 238000011993 High Performance Size Exclusion Chromatography Methods 0.000 description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- 239000004471 Glycine Substances 0.000 description 8
- 235000019445 benzyl alcohol Nutrition 0.000 description 8
- 238000004458 analytical method Methods 0.000 description 7
- 230000000694 effects Effects 0.000 description 6
- 239000000122 growth hormone Substances 0.000 description 6
- 102000004169 proteins and genes Human genes 0.000 description 6
- 108090000623 proteins and genes Proteins 0.000 description 6
- 102000018997 Growth Hormone Human genes 0.000 description 5
- 108010051696 Growth Hormone Proteins 0.000 description 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 229910019142 PO4 Inorganic materials 0.000 description 3
- 108020004511 Recombinant DNA Proteins 0.000 description 3
- 239000007853 buffer solution Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 230000009467 reduction Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- 206010013883 Dwarfism Diseases 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 241000589516 Pseudomonas Species 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000013270 controlled release Methods 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 238000011081 inoculation Methods 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 230000035772 mutation Effects 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 238000012421 spiking Methods 0.000 description 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 239000004475 Arginine Substances 0.000 description 1
- 241000228212 Aspergillus Species 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 206010017788 Gastric haemorrhage Diseases 0.000 description 1
- 102000003886 Glycoproteins Human genes 0.000 description 1
- 108090000288 Glycoproteins Proteins 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 206010062767 Hypophysitis Diseases 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical group [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000005388 borosilicate glass Substances 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000007813 chromatographic assay Methods 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 230000006240 deamidation Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000000539 dimer Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 229960002449 glycine Drugs 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 239000007972 injectable composition Substances 0.000 description 1
- 229940102223 injectable solution Drugs 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 239000000644 isotonic solution Substances 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- -1 lactose and mannitol Chemical class 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012792 lyophilization process Methods 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229940100630 metacresol Drugs 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000004789 organ system Anatomy 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 230000001817 pituitary effect Effects 0.000 description 1
- 210000003635 pituitary gland Anatomy 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000003252 repetitive effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 1
- 210000002356 skeleton Anatomy 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 239000008227 sterile water for injection Substances 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000001384 succinic acid Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
- FYGDTMLNYKFZSV-BYLHFPJWSA-N β-1,4-galactotrioside Chemical group O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@H](CO)O[C@@H](O[C@@H]2[C@@H](O[C@@H](O)[C@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O FYGDTMLNYKFZSV-BYLHFPJWSA-N 0.000 description 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
- A61K38/22—Hormones
- A61K38/27—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
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- 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
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S930/00—Peptide or protein sequence
- Y10S930/01—Peptide or protein sequence
- Y10S930/12—Growth hormone, growth factor other than t-cell or b-cell growth factor, and growth hormone releasing factor; related peptides
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Diabetes (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Rheumatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Dermatology (AREA)
- Neurology (AREA)
- Obesity (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.ヒト成長ホルモン(hGH)及び安定化する量のサッカロースの固体の完全 な混合物を単独又は他の賦形剤と組み合わせて含むことを特徴とする医薬組成物 。 2.前記固体の完全な混合物が凍結乾燥物であることを特徴とする請求項1に 記載の医薬組成物。 3.前記hGHが組換え体であることを特徴とする請求項1に記載の医薬組成物 。 4.前記安定化剤がサッカロースのみであることを特徴とする請求項1〜3の いずれかに記載の医薬組成物。 5.前記安定化剤がマンニトールと組み合わせたサッカロースであることを特 徴とする請求項1〜4のいずれかに記載の医薬組成物。 6.5又は10mg/バイアルのhGHを含むことを特徴とする請求項1〜5のいず れかに記載の医薬組成物。 7.酢酸緩衝液、コハク酸緩衝液及びリン酸緩衝液から選択される緩衝液を含 むことを特徴とする請求項1〜6のいずれかに記載の医薬組成物。 8.前記緩衝液がリン酸緩衝液であることを特徴とする請求項1〜7のいずれ かに記載の医薬組成物。 9. 前記溶液のpHが6.0〜8.0の範囲内であることを特徴とする請求項1〜8 のいずれかに記載の医薬組成物。 10.前記溶液のpHが7.5であることを特徴とする請求項1〜9のいずれかに記 載の医薬組成物。 11.5もしくは10mg/バイアルのhGH,68.4mg/バイアルのサッカロース並び にpH7.5におけるリン酸緩衝液を含むことを特徴とす る請求項1〜10のいずれかに記載の医薬組成物。 12.前記構成物の水溶液の調製、容器内の分散及び該容器内の凍結乾燥を含む ことを特徴とする請求項1〜11のいずれかに記載の医薬組成物を調製するための 方法。 13.使用前の保存並びに注入可能物のための溶媒もしくは溶液内への前記混合 物の再構成のために適した容器内に滅菌条件において密閉された請求項1〜11の いずれかに記載の固体混合物を含む前記医薬組成物の提供形態。 14.注入可能物のための溶媒又は溶液において再構成されることを特徴とする 請求項13に記載の固体混合物を含む溶液。 15.前記溶媒が静菌溶媒であることを特徴とする請求項14に記載の溶液。 16.前記静菌溶媒がm−クレゾール 0.3%であることを特徴とする請求項15に 記載の溶液。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/IT1994/000086 WO1995035116A1 (en) | 1994-06-17 | 1994-06-17 | Hgh containing pharmaceutical compositions |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2005062441A Division JP4283776B2 (ja) | 2005-03-07 | 2005-03-07 | Hgh含有医薬組成物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH10504531A true JPH10504531A (ja) | 1998-05-06 |
JP3829991B2 JP3829991B2 (ja) | 2006-10-04 |
Family
ID=11332180
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP50190396A Expired - Lifetime JP3829991B2 (ja) | 1994-06-17 | 1994-06-17 | Hgh含有医薬組成物 |
Country Status (9)
Country | Link |
---|---|
US (1) | US5898030A (ja) |
EP (1) | EP0804223B1 (ja) |
JP (1) | JP3829991B2 (ja) |
AT (1) | ATE184798T1 (ja) |
DE (1) | DE69420872T2 (ja) |
DK (1) | DK0804223T3 (ja) |
ES (1) | ES2139081T3 (ja) |
GR (1) | GR3031687T3 (ja) |
WO (1) | WO1995035116A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1136068A2 (en) | 2000-03-21 | 2001-09-26 | Jcr Pharmaceuticals Co., Ltd. | Powder containing physiologically active peptide |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20070179096A1 (en) | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
EP1064934A1 (en) | 1999-06-30 | 2001-01-03 | Applied Research Systems ARS Holding N.V. | GRF-containing lyophilized pharmaceutical composition |
CA2418960A1 (en) | 2000-08-07 | 2002-02-14 | Inhale Therapeutic Systems, Inc. | Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation |
US7271150B2 (en) * | 2001-05-14 | 2007-09-18 | United States Of America, Represented By The Secretary, Department Of Health And Human Services | Modified growth hormone |
US7026354B2 (en) * | 2001-10-02 | 2006-04-11 | Kimberly-Clark Worldwide, Inc. | Aromatic compositions for the inhibition of exoprotein production from gram positive bacteria |
US7022333B2 (en) | 2001-10-02 | 2006-04-04 | Kimberly-Clark Worldwide, Inc. | Inhibition of exoprotein production in non-absorbent articles uisng aromatic compositions |
JP4949828B2 (ja) * | 2003-03-18 | 2012-06-13 | アレス トレーディング ソシエテ アノニム | 溶液中での成長ホルモンの安定化 |
FR2873695A1 (fr) * | 2004-07-30 | 2006-02-03 | Palumed Sa | Molecules hybrides qa ou q est une aminoquinoleine et a est un antibiotique ou un inhibiteur de resistance), leur synthese et leurs utilisations en tant qu'agent antibacterien |
US20060067990A1 (en) * | 2004-09-30 | 2006-03-30 | Kimberly-Clark Worldwide, Inc. | Absorbent articles for inhibiting the production of exoproteins |
US20060067991A1 (en) * | 2004-09-30 | 2006-03-30 | Kimberly-Clark Worldwide, Inc. | Non-absorbent articles for inhibiting the production of exoproteins |
KR101224781B1 (ko) * | 2004-12-22 | 2013-01-21 | 암브룩스, 인코포레이티드 | 비천연적으로 코딩된 아미노산을 포함하는 인간 성장호르몬의 조제물 |
CA2665902A1 (en) * | 2006-10-03 | 2008-04-10 | Wyeth | Lyophilization methods and apparatuses |
US8071544B2 (en) * | 2006-12-18 | 2011-12-06 | Althea Technologies, Inc. | Crystallized recombinant human growth factor formulations |
US20080260820A1 (en) * | 2007-04-19 | 2008-10-23 | Gilles Borrelly | Oral dosage formulations of protease-resistant polypeptides |
CA2811709C (en) * | 2010-09-21 | 2019-08-13 | Ferring B.V. | Improved process for production of recombinant human growth hormone |
RU2021103436A (ru) * | 2014-12-10 | 2021-02-25 | Опко Байолоджикс Лтд. | Способы производства ctp-модифицированных полипептидов гормона роста длительного действия |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4786501A (en) * | 1985-07-15 | 1988-11-22 | International Minerals & Chemical Corp. | Cylindrical implants for the controlled release of growth hormones |
ES2044941T5 (es) * | 1987-08-21 | 1999-02-16 | Mallinckrodt Group Inc | Estabilizador de hormonas promotoras del crecimiento. |
US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
US5122367A (en) * | 1989-03-31 | 1992-06-16 | Massachusetts Institute Of Technology | Polyanhydride bioerodible controlled release implants for administration of stabilized growth hormone |
DE69232847T2 (de) * | 1991-12-20 | 2003-09-11 | Novo Nordisk As | Stabilisierte pharmazeutische formulierung, die wachstumshormon und histidin enthält |
AU4278393A (en) * | 1992-04-07 | 1993-11-08 | Mallinckrodt Veterinary, Inc. | Lyophilized somatotropin formulations |
AU686567C (en) * | 1992-07-31 | 2002-08-08 | Genentech Inc. | Human growth hormone aqueous formulation |
EP1326439B1 (en) * | 2001-12-19 | 2009-07-29 | Alps Electric Co., Ltd. | Television tuner unit |
-
1994
- 1994-06-17 WO PCT/IT1994/000086 patent/WO1995035116A1/en active IP Right Grant
- 1994-06-17 AT AT94920573T patent/ATE184798T1/de active
- 1994-06-17 JP JP50190396A patent/JP3829991B2/ja not_active Expired - Lifetime
- 1994-06-17 EP EP94920573A patent/EP0804223B1/en not_active Expired - Lifetime
- 1994-06-17 DK DK94920573T patent/DK0804223T3/da active
- 1994-06-17 ES ES94920573T patent/ES2139081T3/es not_active Expired - Lifetime
- 1994-06-17 DE DE69420872T patent/DE69420872T2/de not_active Expired - Lifetime
- 1994-06-17 US US08/750,684 patent/US5898030A/en not_active Expired - Lifetime
-
1999
- 1999-10-29 GR GR990402777T patent/GR3031687T3/el unknown
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1136068A2 (en) | 2000-03-21 | 2001-09-26 | Jcr Pharmaceuticals Co., Ltd. | Powder containing physiologically active peptide |
US7235253B2 (en) | 2000-03-21 | 2007-06-26 | Jcr Pharmaceuticals Co., Ltd. | Powder containing physiologically active peptide |
Also Published As
Publication number | Publication date |
---|---|
EP0804223A1 (en) | 1997-11-05 |
JP3829991B2 (ja) | 2006-10-04 |
DK0804223T3 (da) | 2000-01-24 |
GR3031687T3 (en) | 2000-02-29 |
DE69420872T2 (de) | 2000-01-13 |
US5898030A (en) | 1999-04-27 |
ATE184798T1 (de) | 1999-10-15 |
WO1995035116A1 (en) | 1995-12-28 |
ES2139081T3 (es) | 2000-02-01 |
DE69420872D1 (de) | 1999-10-28 |
EP0804223B1 (en) | 1999-09-22 |
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