UA80095C2 - 2 methyl-thieno-benzodiazepine lyophilized formulation and method for the preparation thereof - Google Patents
2 methyl-thieno-benzodiazepine lyophilized formulation and method for the preparation thereof Download PDFInfo
- Publication number
- UA80095C2 UA80095C2 UA2004010428A UA2004010428A UA80095C2 UA 80095 C2 UA80095 C2 UA 80095C2 UA 2004010428 A UA2004010428 A UA 2004010428A UA 2004010428 A UA2004010428 A UA 2004010428A UA 80095 C2 UA80095 C2 UA 80095C2
- Authority
- UA
- Ukraine
- Prior art keywords
- olanzapine
- disorders
- composition
- composition according
- lactose
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims description 21
- 238000002360 preparation method Methods 0.000 title description 3
- 239000012931 lyophilized formulation Substances 0.000 title description 2
- KHXIELCFAHVRAL-UHFFFAOYSA-N 2-methylthieno[2,3-i][1,2]benzodiazepine Chemical compound C12=NN(C)C=CC=C2C=CC2=C1C=CS2 KHXIELCFAHVRAL-UHFFFAOYSA-N 0.000 title 1
- KVWDHTXUZHCGIO-UHFFFAOYSA-N olanzapine Chemical compound C1CN(C)CCN1C1=NC2=CC=CC=C2NC2=C1C=C(C)S2 KVWDHTXUZHCGIO-UHFFFAOYSA-N 0.000 claims abstract description 86
- 229960005017 olanzapine Drugs 0.000 claims abstract description 86
- 239000000203 mixture Substances 0.000 claims abstract description 85
- 208000019901 Anxiety disease Diseases 0.000 claims description 35
- 230000036506 anxiety Effects 0.000 claims description 33
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical group OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 28
- 239000000243 solution Substances 0.000 claims description 26
- 230000037007 arousal Effects 0.000 claims description 25
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 24
- 235000002906 tartaric acid Nutrition 0.000 claims description 24
- 239000011975 tartaric acid Substances 0.000 claims description 24
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 22
- 239000002904 solvent Substances 0.000 claims description 21
- 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 claims description 18
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 17
- 229960001375 lactose Drugs 0.000 claims description 17
- 239000008101 lactose Substances 0.000 claims description 17
- 229960001021 lactose monohydrate Drugs 0.000 claims description 17
- 238000004108 freeze drying Methods 0.000 claims description 15
- 239000003381 stabilizer Substances 0.000 claims description 11
- 208000028017 Psychotic disease Diseases 0.000 claims description 8
- 239000004480 active ingredient Substances 0.000 claims description 8
- 206010012289 Dementia Diseases 0.000 claims description 7
- 229940079593 drug Drugs 0.000 claims description 7
- 239000003814 drug Substances 0.000 claims description 7
- 208000015122 neurodegenerative disease Diseases 0.000 claims description 7
- 238000007911 parenteral administration Methods 0.000 claims description 7
- 201000000980 schizophrenia Diseases 0.000 claims description 7
- 206010026749 Mania Diseases 0.000 claims description 5
- 238000010255 intramuscular injection Methods 0.000 claims description 5
- 239000007927 intramuscular injection Substances 0.000 claims description 5
- 206010012218 Delirium Diseases 0.000 claims description 4
- 208000020401 Depressive disease Diseases 0.000 claims description 4
- 239000005022 packaging material Substances 0.000 claims description 4
- 208000020925 Bipolar disease Diseases 0.000 claims description 3
- 206010034719 Personality change Diseases 0.000 claims description 3
- 208000020114 Schizophrenia and other psychotic disease Diseases 0.000 claims description 3
- 208000012826 adjustment disease Diseases 0.000 claims description 3
- 230000003109 amnesic effect Effects 0.000 claims description 3
- 229940126601 medicinal product Drugs 0.000 claims description 3
- 230000003533 narcotic effect Effects 0.000 claims description 3
- 229940095064 tartrate Drugs 0.000 claims 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 claims description 2
- 208000010877 cognitive disease Diseases 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 208000020016 psychiatric disease Diseases 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 1
- 229960001367 tartaric acid Drugs 0.000 claims 1
- 238000009472 formulation Methods 0.000 abstract description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 23
- 238000002347 injection Methods 0.000 description 18
- 239000007924 injection Substances 0.000 description 18
- 208000035475 disorder Diseases 0.000 description 16
- 238000007918 intramuscular administration Methods 0.000 description 14
- 230000008569 process Effects 0.000 description 8
- 239000000047 product Substances 0.000 description 8
- 239000003125 aqueous solvent Substances 0.000 description 7
- 238000001816 cooling Methods 0.000 description 7
- 239000008194 pharmaceutical composition Substances 0.000 description 7
- 230000001755 vocal effect Effects 0.000 description 7
- 241000124008 Mammalia Species 0.000 description 6
- 238000013019 agitation Methods 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 239000008215 water for injection Substances 0.000 description 6
- 239000013543 active substance Substances 0.000 description 5
- 238000001035 drying Methods 0.000 description 5
- 239000000039 congener Substances 0.000 description 4
- 239000011521 glass Substances 0.000 description 4
- 238000010438 heat treatment Methods 0.000 description 4
- 230000003389 potentiating effect Effects 0.000 description 4
- NFEUHAIRXOEOTJ-LREBCSMRSA-N (2R,3R)-2,3-dihydroxybutanedioic acid 2-methyl-4-(4-methylpiperazin-1-yl)-10H-thieno[2,3-b][1,5]benzodiazepine Chemical compound O[C@H]([C@@H](O)C(O)=O)C(O)=O.CN1CCN(CC1)C1=Nc2ccccc2Nc2sc(C)cc12 NFEUHAIRXOEOTJ-LREBCSMRSA-N 0.000 description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 3
- 208000036626 Mental retardation Diseases 0.000 description 3
- 238000005481 NMR spectroscopy Methods 0.000 description 3
- 230000009471 action 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
- 238000009826 distribution Methods 0.000 description 3
- 238000001990 intravenous administration Methods 0.000 description 3
- 239000000523 sample Substances 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 238000000859 sublimation Methods 0.000 description 3
- 230000008022 sublimation Effects 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- 206010001540 Akathisia Diseases 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- 206010020400 Hostility Diseases 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 208000001431 Psychomotor Agitation Diseases 0.000 description 2
- 239000000164 antipsychotic agent Substances 0.000 description 2
- 229940005529 antipsychotics Drugs 0.000 description 2
- 230000006399 behavior Effects 0.000 description 2
- -1 but not limited to Chemical class 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 235000008504 concentrate Nutrition 0.000 description 2
- 239000012141 concentrate Substances 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000013480 data collection Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 230000007062 hydrolysis Effects 0.000 description 2
- 238000006460 hydrolysis reaction Methods 0.000 description 2
- 208000013403 hyperactivity Diseases 0.000 description 2
- 230000005032 impulse control Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 230000037023 motor activity Effects 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 230000003252 repetitive effect Effects 0.000 description 2
- 230000001624 sedative effect Effects 0.000 description 2
- 239000004065 semiconductor Substances 0.000 description 2
- QZAYGJVTTNCVMB-UHFFFAOYSA-N serotonin Chemical compound C1=C(O)C=C2C(CCN)=CNC2=C1 QZAYGJVTTNCVMB-UHFFFAOYSA-N 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000008223 sterile water Substances 0.000 description 2
- 239000008227 sterile water for injection Substances 0.000 description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- 238000001644 13C nuclear magnetic resonance spectroscopy Methods 0.000 description 1
- 102100036321 5-hydroxytryptamine receptor 2A Human genes 0.000 description 1
- 101710138091 5-hydroxytryptamine receptor 2A Proteins 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 241000283707 Capra Species 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 241000282693 Cercopithecidae Species 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000283086 Equidae Species 0.000 description 1
- 241000282326 Felis catus Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 101000743114 Homo sapiens WASH complex subunit 4 Proteins 0.000 description 1
- 206010049816 Muscle tightness Diseases 0.000 description 1
- 241001494479 Pecora Species 0.000 description 1
- 206010037180 Psychiatric symptoms Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 241000251539 Vertebrata <Metazoa> Species 0.000 description 1
- 102100038143 WASH complex subunit 4 Human genes 0.000 description 1
- 238000002441 X-ray diffraction Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000001800 adrenalinergic effect Effects 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000003693 atypical antipsychotic agent Substances 0.000 description 1
- 210000003403 autonomic nervous system Anatomy 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000003542 behavioural effect Effects 0.000 description 1
- 229940049706 benzodiazepine Drugs 0.000 description 1
- 208000028683 bipolar I disease Diseases 0.000 description 1
- 229920005549 butyl rubber Polymers 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 230000006652 catabolic pathway Effects 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000000739 chaotic effect Effects 0.000 description 1
- 230000001713 cholinergic effect Effects 0.000 description 1
- 230000003930 cognitive ability Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 239000013256 coordination polymer Substances 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000005388 cross polarization Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000003412 degenerative effect Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000000113 differential scanning calorimetry Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 230000009429 distress Effects 0.000 description 1
- 229960003638 dopamine Drugs 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 208000010118 dystonia Diseases 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- YUWFEBAXEOLKSG-UHFFFAOYSA-N hexamethylbenzene Chemical compound CC1=C(C)C(C)=C(C)C(C)=C1C YUWFEBAXEOLKSG-UHFFFAOYSA-N 0.000 description 1
- 229960001340 histamine Drugs 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 description 1
- 235000014666 liquid concentrate Nutrition 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 230000036997 mental performance Effects 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000003551 muscarinic effect Effects 0.000 description 1
- 239000003176 neuroleptic agent Substances 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 238000001050 pharmacotherapy Methods 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 230000010287 polarization Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000000634 powder X-ray diffraction Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 229940076279 serotonin Drugs 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000008247 solid mixture Substances 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 230000003595 spectral effect Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- SETMGIIITGNLAS-UHFFFAOYSA-N spizofurone Chemical compound O=C1C2=CC(C(=O)C)=CC=C2OC21CC2 SETMGIIITGNLAS-UHFFFAOYSA-N 0.000 description 1
- 229950001870 spizofurone Drugs 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000012086 standard solution Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 210000001364 upper extremity Anatomy 0.000 description 1
Classifications
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
-
- 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
- A61K47/26—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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Anesthesiology (AREA)
- Hospice & Palliative Care (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US30682901P | 2001-07-20 | 2001-07-20 | |
| US38647402P | 2002-06-07 | 2002-06-07 | |
| PCT/US2002/019799 WO2003007912A2 (en) | 2001-07-20 | 2002-07-05 | Lyophilized formulation comprising olanzapine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| UA80095C2 true UA80095C2 (en) | 2007-08-27 |
Family
ID=26975390
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| UA2004010428A UA80095C2 (en) | 2001-07-20 | 2002-05-07 | 2 methyl-thieno-benzodiazepine lyophilized formulation and method for the preparation thereof |
Country Status (33)
| Country | Link |
|---|---|
| US (1) | US20040176357A1 (de) |
| EP (1) | EP1423124B1 (de) |
| JP (1) | JP2004537546A (de) |
| KR (1) | KR20040017330A (de) |
| CN (1) | CN1537007A (de) |
| AR (1) | AR036180A1 (de) |
| AT (1) | ATE369137T1 (de) |
| AU (1) | AU2002320134B2 (de) |
| BR (1) | BR0211250A (de) |
| CA (1) | CA2448724A1 (de) |
| CO (1) | CO5540279A2 (de) |
| CY (1) | CY1107759T1 (de) |
| CZ (1) | CZ200484A3 (de) |
| DE (1) | DE60221674T2 (de) |
| DK (1) | DK1423124T3 (de) |
| EA (1) | EA006506B1 (de) |
| ES (1) | ES2289126T3 (de) |
| HK (1) | HK1066484A1 (de) |
| HR (1) | HRP20040037A2 (de) |
| HU (1) | HUP0401157A3 (de) |
| IL (1) | IL159098A0 (de) |
| MX (1) | MXPA04000541A (de) |
| MY (1) | MY135452A (de) |
| NZ (1) | NZ529667A (de) |
| PE (1) | PE20030281A1 (de) |
| PL (1) | PL366614A1 (de) |
| PT (1) | PT1423124E (de) |
| SI (1) | SI1423124T1 (de) |
| SK (1) | SK182004A3 (de) |
| SV (1) | SV2003001179A (de) |
| UA (1) | UA80095C2 (de) |
| WO (1) | WO2003007912A2 (de) |
| ZA (1) | ZA200400798B (de) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1575962A1 (de) * | 2002-12-24 | 2005-09-21 | Teva Pharmaceutical Industries Limited | Neue kristallformen von olanzapin, verfahren zu deren herstellung und verfahren zur herstellung bekannter kristallformen von olanzapin |
| HU226410B1 (en) | 2003-04-22 | 2008-11-28 | Egis Gyogyszergyar Nyilvanosan | Novel polymorphous forms of olanzapine hydrochlorides, process for producing them, use thereof and pharmaceutical compositions containing them |
| GB0314149D0 (en) * | 2003-06-18 | 2003-07-23 | Generics Uk Ltd | Novel amorphous forms |
| DE602005027308D1 (de) | 2004-01-27 | 2011-05-19 | Synthon Bv | Stabile salze von olanzapin |
| WO2006076124A2 (en) * | 2004-12-16 | 2006-07-20 | Nektar Therapeutics | Stable, non-crystalline formulation comprising olanzapine |
| US8158152B2 (en) * | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| WO2007134845A2 (en) * | 2006-05-18 | 2007-11-29 | Synthon B.V. | Olanzapine pharmaceutical composition |
| WO2019136308A1 (en) * | 2018-01-05 | 2019-07-11 | Impel Neuropharma, Inc. | Intranasal delivery of olanzapine by precision olfactory device |
| HUP2100259A1 (hu) | 2021-07-07 | 2023-01-28 | Richter Gedeon Nyrt | Cariprazine tartalmú szabályozott hatóanyag-leadású injekciós készítmények |
| CN115006406A (zh) * | 2021-12-28 | 2022-09-06 | 南京清普生物科技有限公司 | 一种稳定的奥氮平制剂 |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK0421297T3 (da) * | 1989-09-30 | 1994-01-17 | Eisai Co Ltd | Injicerbare præparater indeholdende cephalosporin som lægemiddel og anvendelse deraf |
| US5457101A (en) * | 1994-06-03 | 1995-10-10 | Eli Lilly And Company | Thieno[1,5]benzoidiazepine use |
-
2002
- 2002-05-07 UA UA2004010428A patent/UA80095C2/uk unknown
- 2002-07-05 WO PCT/US2002/019799 patent/WO2003007912A2/en active IP Right Grant
- 2002-07-05 PL PL02366614A patent/PL366614A1/xx not_active Application Discontinuation
- 2002-07-05 BR BR0211250-7A patent/BR0211250A/pt not_active IP Right Cessation
- 2002-07-05 AU AU2002320134A patent/AU2002320134B2/en not_active Expired
- 2002-07-05 SK SK18-2004A patent/SK182004A3/sk unknown
- 2002-07-05 PT PT02749634T patent/PT1423124E/pt unknown
- 2002-07-05 HU HU0401157A patent/HUP0401157A3/hu unknown
- 2002-07-05 EA EA200400211A patent/EA006506B1/ru not_active IP Right Cessation
- 2002-07-05 CN CNA028144473A patent/CN1537007A/zh active Pending
- 2002-07-05 IL IL15909802A patent/IL159098A0/xx unknown
- 2002-07-05 KR KR10-2004-7000829A patent/KR20040017330A/ko not_active Application Discontinuation
- 2002-07-05 JP JP2003513521A patent/JP2004537546A/ja active Pending
- 2002-07-05 SI SI200230629T patent/SI1423124T1/sl unknown
- 2002-07-05 NZ NZ529667A patent/NZ529667A/en not_active IP Right Cessation
- 2002-07-05 ES ES02749634T patent/ES2289126T3/es not_active Expired - Lifetime
- 2002-07-05 US US10/480,617 patent/US20040176357A1/en not_active Abandoned
- 2002-07-05 CZ CZ200484A patent/CZ200484A3/cs unknown
- 2002-07-05 CA CA002448724A patent/CA2448724A1/en not_active Abandoned
- 2002-07-05 MX MXPA04000541A patent/MXPA04000541A/es active IP Right Grant
- 2002-07-05 DK DK02749634T patent/DK1423124T3/da active
- 2002-07-05 AT AT02749634T patent/ATE369137T1/de active
- 2002-07-05 DE DE60221674T patent/DE60221674T2/de not_active Expired - Lifetime
- 2002-07-05 EP EP02749634A patent/EP1423124B1/de not_active Expired - Lifetime
- 2002-07-17 PE PE2002000636A patent/PE20030281A1/es active IP Right Grant
- 2002-07-18 MY MYPI20022723A patent/MY135452A/en unknown
- 2002-07-18 AR ARP020102700A patent/AR036180A1/es not_active Application Discontinuation
- 2002-07-19 SV SV2002001179A patent/SV2003001179A/es not_active Application Discontinuation
-
2003
- 2003-12-31 CO CO03113784A patent/CO5540279A2/es not_active Application Discontinuation
-
2004
- 2004-01-15 HR HR20040037A patent/HRP20040037A2/hr not_active Application Discontinuation
- 2004-01-30 ZA ZA2004/00798A patent/ZA200400798B/en unknown
- 2004-12-01 HK HK04109512A patent/HK1066484A1/xx not_active IP Right Cessation
-
2007
- 2007-10-11 CY CY20071101308T patent/CY1107759T1/el unknown
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP1523335B1 (de) | Injizierbare depotformulierung enthaltend iloperidonkrystalle | |
| KR100805651B1 (ko) | 안정한 고농축 멜록시캄 용액 | |
| US10493079B2 (en) | Stable carfilzomib formulations | |
| UA75879C2 (en) | Fulvestrant composition (variants) | |
| JP2008543789A (ja) | ドセタキセルの液体薬学的処方物 | |
| UA70357C2 (uk) | Фармацевтична композиція дигідроерготаміну (варіанти), спосіб лікування пацієнта з мігреневим головним болем (варіанти), терапевтична упаковка (варіанти) та спосіб її виготовлення (варіанти) | |
| UA80095C2 (en) | 2 methyl-thieno-benzodiazepine lyophilized formulation and method for the preparation thereof | |
| JP2017141307A (ja) | タキサン系活性成分含有液体組成物及び液体製剤 | |
| JP2023501902A (ja) | セトロレリクス酢酸塩の安定した非経口剤形 | |
| CN110464846B (zh) | 一种美洛昔康组合物、制剂及其制备方法与应用 | |
| AU2002320134A1 (en) | Lyophilized formulation comprising olanzapine | |
| BRPI0609794A2 (pt) | composição farmacêutica, produto de fármaco, método de fabricação de uma composição farmacêutica, método de diminuição dos nìveis de bilirrubina em um mamìfero e método para aumento da biodisponibilidade de estanosporfina após administração intramuscular em um paciente humano | |
| WO2014149939A1 (en) | Dye free liquid therapeutic solution | |
| JP2001316265A (ja) | オザグレルナトリウム含有注射液およびその安定化方法 | |
| CN102302495A (zh) | 一种供注射用盐酸托烷司琼药物组合物 | |
| AU2008250717A1 (en) | Aqueous pharmaceutical preparation | |
| RU2192855C1 (ru) | Способ получения лекарственного средства для инъекций на основе амиодарона | |
| WO2024062443A1 (en) | Pharmaceutical compositions | |
| EA023081B1 (ru) | Инъекционная лекарственная форма флупиртина |