NO320069B1 - Stabile, vandige, farmasoytiske preparater av gamma-interferon, beholdere som inneholder slike, fremgangsmate for stabilisering av gamma-interferon i slike preparater, samt aerosolpartikler for anvendelse i terapi ved inhalasjon. - Google Patents
Stabile, vandige, farmasoytiske preparater av gamma-interferon, beholdere som inneholder slike, fremgangsmate for stabilisering av gamma-interferon i slike preparater, samt aerosolpartikler for anvendelse i terapi ved inhalasjon. Download PDFInfo
- Publication number
- NO320069B1 NO320069B1 NO19954544A NO954544A NO320069B1 NO 320069 B1 NO320069 B1 NO 320069B1 NO 19954544 A NO19954544 A NO 19954544A NO 954544 A NO954544 A NO 954544A NO 320069 B1 NO320069 B1 NO 320069B1
- Authority
- NO
- Norway
- Prior art keywords
- ifn
- preparation according
- preparation
- preparations
- phenol
- Prior art date
Links
- 108010074328 Interferon-gamma Proteins 0.000 title claims abstract description 67
- 238000002360 preparation method Methods 0.000 title claims description 48
- 239000000825 pharmaceutical preparation Substances 0.000 title claims description 23
- 239000000443 aerosol Substances 0.000 title claims description 8
- 238000000034 method Methods 0.000 title claims description 6
- 239000002245 particle Substances 0.000 title claims description 6
- 230000000087 stabilizing effect Effects 0.000 title claims description 4
- 102000008070 Interferon-gamma Human genes 0.000 title abstract description 8
- 229940044627 gamma-interferon Drugs 0.000 title abstract description 4
- 238000002664 inhalation therapy Methods 0.000 title 1
- 102100037850 Interferon gamma Human genes 0.000 claims description 59
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 42
- 239000003755 preservative agent Substances 0.000 claims description 24
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 19
- 230000000694 effects Effects 0.000 claims description 18
- 230000002335 preservative effect Effects 0.000 claims description 16
- 235000019445 benzyl alcohol Nutrition 0.000 claims description 14
- 101000599940 Homo sapiens Interferon gamma Proteins 0.000 claims description 13
- 239000008351 acetate buffer Substances 0.000 claims description 11
- 239000003599 detergent Substances 0.000 claims description 11
- -1 benzethonium halide Chemical class 0.000 claims description 10
- 229960003872 benzethonium Drugs 0.000 claims description 9
- 239000003795 chemical substances by application Substances 0.000 claims description 8
- 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 6
- 229930195725 Mannitol Natural products 0.000 claims description 6
- 239000000594 mannitol Substances 0.000 claims description 6
- 235000010355 mannitol Nutrition 0.000 claims description 6
- 239000003708 ampul Substances 0.000 claims description 5
- 238000004108 freeze drying Methods 0.000 claims description 5
- 150000005846 sugar alcohols Chemical class 0.000 claims description 5
- 210000004072 lung Anatomy 0.000 claims description 4
- 229920000136 polysorbate Polymers 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 238000002347 injection Methods 0.000 claims description 3
- 239000007924 injection Substances 0.000 claims description 3
- 238000002560 therapeutic procedure Methods 0.000 claims description 3
- 230000035515 penetration Effects 0.000 claims description 2
- 229950008882 polysorbate Drugs 0.000 claims description 2
- 125000001433 C-terminal amino-acid group Chemical group 0.000 claims 1
- 239000007788 liquid Substances 0.000 abstract description 23
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 230000004071 biological effect Effects 0.000 description 16
- 102000004169 proteins and genes Human genes 0.000 description 12
- 108090000623 proteins and genes Proteins 0.000 description 12
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 11
- 239000000243 solution Substances 0.000 description 9
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 description 8
- 229940099550 actimmune Drugs 0.000 description 7
- 108010042414 interferon gamma-1b Proteins 0.000 description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 230000015572 biosynthetic process Effects 0.000 description 6
- 208000015181 infectious disease Diseases 0.000 description 5
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 5
- 239000008362 succinate buffer Substances 0.000 description 5
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 description 4
- 108010050904 Interferons Proteins 0.000 description 4
- 102000014150 Interferons Human genes 0.000 description 4
- 150000001413 amino acids Chemical class 0.000 description 4
- 238000003556 assay Methods 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 4
- 238000006731 degradation reaction Methods 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 3
- 206010012438 Dermatitis atopic Diseases 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 230000002776 aggregation Effects 0.000 description 3
- 238000004220 aggregation Methods 0.000 description 3
- 230000000840 anti-viral effect Effects 0.000 description 3
- 201000008937 atopic dermatitis Diseases 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 230000001684 chronic effect Effects 0.000 description 3
- 230000006698 induction Effects 0.000 description 3
- 229940047124 interferons Drugs 0.000 description 3
- 239000000203 mixture Substances 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
- 239000011780 sodium chloride Substances 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- JIZRUFJGHPIYPS-SRVKXCTJSA-N Cys-Tyr-Cys Chemical compound C1=CC(=CC=C1C[C@@H](C(=O)N[C@@H](CS)C(=O)O)NC(=O)[C@H](CS)N)O JIZRUFJGHPIYPS-SRVKXCTJSA-N 0.000 description 2
- 241000710188 Encephalomyocarditis virus Species 0.000 description 2
- 241000588724 Escherichia coli Species 0.000 description 2
- 206010018691 Granuloma Diseases 0.000 description 2
- 208000031886 HIV Infections Diseases 0.000 description 2
- 208000037357 HIV infectious disease Diseases 0.000 description 2
- 208000000203 Hyaline Membrane Disease Diseases 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 208000032571 Infant acute respiratory distress syndrome Diseases 0.000 description 2
- 108010047761 Interferon-alpha Proteins 0.000 description 2
- 102000006992 Interferon-alpha Human genes 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 206010028974 Neonatal respiratory distress syndrome Diseases 0.000 description 2
- 208000001388 Opportunistic Infections Diseases 0.000 description 2
- 208000005384 Pneumocystis Pneumonia Diseases 0.000 description 2
- 206010073755 Pneumocystis jirovecii pneumonia Diseases 0.000 description 2
- 206010057469 Vascular stenosis Diseases 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000007815 allergy Effects 0.000 description 2
- 238000002399 angioplasty Methods 0.000 description 2
- 230000000259 anti-tumor effect Effects 0.000 description 2
- 239000004599 antimicrobial Substances 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 208000006673 asthma Diseases 0.000 description 2
- 238000004166 bioassay Methods 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 239000007857 degradation product Substances 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 208000033519 human immunodeficiency virus infectious disease Diseases 0.000 description 2
- 230000004957 immunoregulator effect Effects 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000005764 inhibitory process Effects 0.000 description 2
- 229960003130 interferon gamma Drugs 0.000 description 2
- 210000004698 lymphocyte Anatomy 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 2
- 230000002297 mitogenic effect Effects 0.000 description 2
- OHDXDNUPVVYWOV-UHFFFAOYSA-N n-methyl-1-(2-naphthalen-1-ylsulfanylphenyl)methanamine Chemical compound CNCC1=CC=CC=C1SC1=CC=CC2=CC=CC=C12 OHDXDNUPVVYWOV-UHFFFAOYSA-N 0.000 description 2
- 201000002652 newborn respiratory distress syndrome Diseases 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 201000000317 pneumocystosis Diseases 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000007631 vascular surgery Methods 0.000 description 2
- 230000029812 viral genome replication Effects 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 108700028369 Alleles Proteins 0.000 description 1
- 208000031729 Bacteremia Diseases 0.000 description 1
- 102100025621 Cytochrome b-245 heavy chain Human genes 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- HEBKCHPVOIAQTA-QWWZWVQMSA-N D-arabinitol Chemical compound OC[C@@H](O)C(O)[C@H](O)CO HEBKCHPVOIAQTA-QWWZWVQMSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- 239000004386 Erythritol Substances 0.000 description 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 description 1
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 description 1
- 102000018713 Histocompatibility Antigens Class II Human genes 0.000 description 1
- 108010027412 Histocompatibility Antigens Class II Proteins 0.000 description 1
- 102100026720 Interferon beta Human genes 0.000 description 1
- 108090000467 Interferon-beta Proteins 0.000 description 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 201000009906 Meningitis Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 206010036086 Polymenorrhoea Diseases 0.000 description 1
- 229920001213 Polysorbate 20 Polymers 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 108020004511 Recombinant DNA Proteins 0.000 description 1
- 208000006265 Renal cell carcinoma Diseases 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 1
- WJKJJGXZRHDNTN-UWVGGRQHSA-N Tyr-Cys Chemical compound SC[C@@H](C(O)=O)NC(=O)[C@@H](N)CC1=CC=C(O)C=C1 WJKJJGXZRHDNTN-UWVGGRQHSA-N 0.000 description 1
- 206010048038 Wound infection Diseases 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000009798 acute exacerbation Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 208000011341 adult acute respiratory distress syndrome Diseases 0.000 description 1
- 201000000028 adult respiratory distress syndrome Diseases 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 125000003275 alpha amino acid group Chemical group 0.000 description 1
- 125000000539 amino acid group Chemical group 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 230000001028 anti-proliverative effect Effects 0.000 description 1
- 239000003443 antiviral agent Substances 0.000 description 1
- 229960001950 benzethonium chloride Drugs 0.000 description 1
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 1
- 230000008512 biological response Effects 0.000 description 1
- 239000008366 buffered solution Substances 0.000 description 1
- 210000004899 c-terminal region Anatomy 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 208000016532 chronic granulomatous disease Diseases 0.000 description 1
- 239000002299 complementary DNA Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000006806 disease prevention Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 238000009510 drug design Methods 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000001516 effect on protein Effects 0.000 description 1
- 238000001962 electrophoresis Methods 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 235000019414 erythritol Nutrition 0.000 description 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 1
- 229940009714 erythritol Drugs 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 125000000524 functional group Chemical group 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 229940124622 immune-modulator drug Drugs 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 229940079322 interferon Drugs 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000004255 ion exchange chromatography Methods 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- 229940090046 jet injector Drugs 0.000 description 1
- 210000002414 leg Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 201000005296 lung carcinoma Diseases 0.000 description 1
- 210000001165 lymph node Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000003607 modifier Substances 0.000 description 1
- 239000006199 nebulizer Substances 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000002736 nonionic surfactant Substances 0.000 description 1
- 229940042443 other antivirals in atc Drugs 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 210000001539 phagocyte Anatomy 0.000 description 1
- 230000000144 pharmacologic effect Effects 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
- 229920001983 poloxamer Polymers 0.000 description 1
- 229920001993 poloxamer 188 Polymers 0.000 description 1
- 229940044519 poloxamer 188 Drugs 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 230000001323 posttranslational effect Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000017854 proteolysis Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 230000009257 reactivity Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000004007 reversed phase HPLC Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000009528 severe injury Effects 0.000 description 1
- 238000002741 site-directed mutagenesis Methods 0.000 description 1
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 1
- 238000001542 size-exclusion chromatography Methods 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 206010040882 skin lesion Diseases 0.000 description 1
- 231100000444 skin lesion Toxicity 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 229940074404 sodium succinate Drugs 0.000 description 1
- ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical compound [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000008227 sterile water for injection Substances 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 201000008827 tuberculosis Diseases 0.000 description 1
- 239000011123 type I (borosilicate glass) Substances 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/217—IFN-gamma
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US6032793A | 1993-05-12 | 1993-05-12 | |
| PCT/US1994/004928 WO1994026302A1 (en) | 1993-05-12 | 1994-05-04 | Stable liquid compositions of gamma interferon |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO954544D0 NO954544D0 (no) | 1995-11-10 |
| NO954544L NO954544L (no) | 1995-11-10 |
| NO320069B1 true NO320069B1 (no) | 2005-10-17 |
Family
ID=22028807
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19954544A NO320069B1 (no) | 1993-05-12 | 1995-11-10 | Stabile, vandige, farmasoytiske preparater av gamma-interferon, beholdere som inneholder slike, fremgangsmate for stabilisering av gamma-interferon i slike preparater, samt aerosolpartikler for anvendelse i terapi ved inhalasjon. |
Country Status (23)
| Country | Link |
|---|---|
| EP (1) | EP0697887B1 (cs) |
| JP (1) | JP4053586B2 (cs) |
| KR (1) | KR100330325B1 (cs) |
| CN (1) | CN1120724C (cs) |
| AT (1) | ATE173632T1 (cs) |
| AU (1) | AU683469B2 (cs) |
| CA (1) | CA2159602C (cs) |
| CZ (1) | CZ285389B6 (cs) |
| DE (1) | DE69414841T2 (cs) |
| DK (1) | DK0697887T3 (cs) |
| ES (1) | ES2126114T3 (cs) |
| FI (1) | FI111442B (cs) |
| GR (1) | GR3029286T3 (cs) |
| HK (1) | HK1008303A1 (cs) |
| HU (1) | HUT72980A (cs) |
| IL (1) | IL109350A (cs) |
| NO (1) | NO320069B1 (cs) |
| NZ (1) | NZ266354A (cs) |
| PL (1) | PL176079B1 (cs) |
| SK (1) | SK280958B6 (cs) |
| TW (1) | TW275585B (cs) |
| WO (1) | WO1994026302A1 (cs) |
| ZA (1) | ZA942955B (cs) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NO327844B1 (no) * | 1996-12-24 | 2009-10-05 | Biogen Idec Inc | Pakket sett for administrasjon av interferon beta, flytende sammensetning for slikt sett samt fremgangsmåte for fremstilling derav |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2758154B2 (ja) * | 1995-04-06 | 1998-05-28 | エフ・ホフマン−ラ ロシユ アーゲー | インターフェロンを含む液体製剤 |
| DK0862452T3 (da) * | 1995-11-07 | 2004-04-05 | Genentech Inc | Stabiliserende formulering af NGF |
| US6090781A (en) * | 1996-11-06 | 2000-07-18 | Genentech, Inc. | Stabilizing formulation for NGF |
| US6964947B1 (en) | 1995-11-07 | 2005-11-15 | Genentech, Inc. | Stabilizing formulation for NGF |
| JP3493866B2 (ja) * | 1995-12-27 | 2004-02-03 | ライオン株式会社 | 発泡性口腔用組成物 |
| PE63998A1 (es) * | 1996-04-19 | 1998-10-30 | Merck & Co Inc | Composiciones anti-fungosas |
| US6281212B1 (en) | 1996-07-12 | 2001-08-28 | Millennium Pharmaceuticals, Inc. | Chemokine receptor antagonists and methods of use therefor |
| US20030190307A1 (en) | 1996-12-24 | 2003-10-09 | Biogen, Inc. | Stable liquid interferon formulations |
| US6991790B1 (en) | 1997-06-13 | 2006-01-31 | Genentech, Inc. | Antibody formulation |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US7070799B1 (en) | 1998-02-10 | 2006-07-04 | Generex Pharmaceuticals, Inc. | Method for administering insulin to the buccal region |
| US6017545A (en) * | 1998-02-10 | 2000-01-25 | Modi; Pankaj | Mixed micellar delivery system and method of preparation |
| US6221378B1 (en) * | 1998-02-10 | 2001-04-24 | Generex Pharmaceuticals Incorporated | Mixed micellar delivery system and method of preparation |
| GB9803448D0 (en) * | 1998-02-18 | 1998-04-15 | Pharma Mar Sa | Pharmaceutical formulation |
| AU4445201A (en) * | 2000-03-30 | 2001-10-08 | Generex Pharmaceuticals Inc. | Method for administering insulin to the buccal region |
| AUPR381601A0 (en) * | 2001-03-19 | 2001-04-12 | Monash University | Method of treating respiratory conditions |
| EP1391209A4 (en) * | 2001-05-30 | 2009-12-16 | Chugai Pharmaceutical Co Ltd | PROTEIN PREPARATION |
| EP1516627A1 (en) * | 2003-09-17 | 2005-03-23 | CONARIS research institute AG | Interferon-Gamma for the treatment of diseases associated with the NOD2 gene |
| JP5137055B2 (ja) * | 2006-03-10 | 2013-02-06 | 塩野義製薬株式会社 | 安定化されたインターフェロン−γ組成物 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2032831T5 (es) * | 1986-08-19 | 2001-02-16 | Genentech Inc | Dispositivo y dispersion para suministro intrapulmonar de factores de crecimiento polipeptidos y citoquinas. |
| EP0308181A1 (en) * | 1987-09-14 | 1989-03-22 | Novo Nordisk A/S | Trans-mucosal delivery formulations and a method for preparation thereof |
| IL88233A (en) * | 1987-11-03 | 1993-08-18 | Genentech Inc | Gamma interferon formulation |
-
1994
- 1994-04-19 IL IL10935094A patent/IL109350A/en not_active IP Right Cessation
- 1994-04-28 ZA ZA942955A patent/ZA942955B/xx unknown
- 1994-05-04 ES ES94916004T patent/ES2126114T3/es not_active Expired - Lifetime
- 1994-05-04 SK SK1378-95A patent/SK280958B6/sk not_active IP Right Cessation
- 1994-05-04 NZ NZ266354A patent/NZ266354A/en not_active IP Right Cessation
- 1994-05-04 WO PCT/US1994/004928 patent/WO1994026302A1/en active IP Right Grant
- 1994-05-04 DK DK94916004T patent/DK0697887T3/da active
- 1994-05-04 CN CN94192046A patent/CN1120724C/zh not_active Expired - Lifetime
- 1994-05-04 PL PL94311639A patent/PL176079B1/pl unknown
- 1994-05-04 HU HU9503223A patent/HUT72980A/hu unknown
- 1994-05-04 JP JP52552294A patent/JP4053586B2/ja not_active Expired - Lifetime
- 1994-05-04 KR KR1019950705034A patent/KR100330325B1/ko not_active IP Right Cessation
- 1994-05-04 CA CA002159602A patent/CA2159602C/en not_active Expired - Lifetime
- 1994-05-04 AT AT94916004T patent/ATE173632T1/de active
- 1994-05-04 AU AU67822/94A patent/AU683469B2/en not_active Expired
- 1994-05-04 CZ CZ952955A patent/CZ285389B6/cs not_active IP Right Cessation
- 1994-05-04 DE DE69414841T patent/DE69414841T2/de not_active Expired - Lifetime
- 1994-05-04 EP EP94916004A patent/EP0697887B1/en not_active Expired - Lifetime
- 1994-05-06 TW TW083104134A patent/TW275585B/zh not_active IP Right Cessation
-
1995
- 1995-10-27 FI FI955136A patent/FI111442B/fi not_active IP Right Cessation
- 1995-11-10 NO NO19954544A patent/NO320069B1/no not_active IP Right Cessation
-
1998
- 1998-07-20 HK HK98109265A patent/HK1008303A1/xx not_active IP Right Cessation
-
1999
- 1999-02-03 GR GR990400366T patent/GR3029286T3/el unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NO327844B1 (no) * | 1996-12-24 | 2009-10-05 | Biogen Idec Inc | Pakket sett for administrasjon av interferon beta, flytende sammensetning for slikt sett samt fremgangsmåte for fremstilling derav |
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| NO320069B1 (no) | Stabile, vandige, farmasoytiske preparater av gamma-interferon, beholdere som inneholder slike, fremgangsmate for stabilisering av gamma-interferon i slike preparater, samt aerosolpartikler for anvendelse i terapi ved inhalasjon. | |
| ES2153385T5 (es) | Composicion acuosa a base de hormona del crecimiento humana. | |
| JP4988562B2 (ja) | 安定化したインターフェロン液体製剤 | |
| US9522174B2 (en) | Stable liquid interferon beta formulations | |
| BG65418B1 (bg) | Кит за парентерално приложение на стабилни течни интерферонови състави | |
| NO320604B1 (no) | Stabile, vandige alfa-interferonopplosningsformuleringer | |
| JP4870550B2 (ja) | Ｈｓａを含まない安定なインターフェロン液体製剤 | |
| CN101664378B (zh) | 一种重组人血清白蛋白与干扰素α融合蛋白的药物组合物 | |
| EP2585044B1 (en) | Long-term storage of non-glycosylated recombinant human g-csf |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK1K | Patent expired |