TW426526B - Oral 2-methyl-thieno-benzodiazepine formulation - Google Patents
Oral 2-methyl-thieno-benzodiazepine formulation Download PDFInfo
- Publication number
- TW426526B TW426526B TW085103453A TW85103453A TW426526B TW 426526 B TW426526 B TW 426526B TW 085103453 A TW085103453 A TW 085103453A TW 85103453 A TW85103453 A TW 85103453A TW 426526 B TW426526 B TW 426526B
- Authority
- TW
- Taiwan
- Prior art keywords
- patent application
- formulation
- scope
- item
- cellulose
- Prior art date
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- 238000009472 formulation Methods 0.000 title claims 46
- 239000000203 mixture Substances 0.000 title claims 46
- 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
- 239000007787 solid Substances 0.000 claims 13
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 9
- 229920000609 methyl cellulose Polymers 0.000 claims 7
- 239000001923 methylcellulose Substances 0.000 claims 7
- 235000010981 methylcellulose Nutrition 0.000 claims 7
- 229920000642 polymer Polymers 0.000 claims 7
- -1 polyethylene Polymers 0.000 claims 6
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 5
- 239000001856 Ethyl cellulose Substances 0.000 claims 4
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 4
- 229920002678 cellulose Polymers 0.000 claims 4
- 239000001913 cellulose Substances 0.000 claims 4
- 235000010980 cellulose Nutrition 0.000 claims 4
- 230000002079 cooperative effect Effects 0.000 claims 4
- 229920001577 copolymer Polymers 0.000 claims 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical group OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 4
- 239000000126 substance Substances 0.000 claims 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 238000004458 analytical method Methods 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 238000000576 coating method Methods 0.000 claims 3
- 150000001875 compounds Chemical class 0.000 claims 3
- 235000019325 ethyl cellulose Nutrition 0.000 claims 3
- 229920001249 ethyl cellulose Polymers 0.000 claims 3
- 235000010944 ethyl methyl cellulose Nutrition 0.000 claims 3
- 239000000835 fiber Substances 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 3
- 239000000463 material Substances 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 229920003087 methylethyl cellulose Polymers 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- KVWDHTXUZHCGIO-UHFFFAOYSA-N olanzapine Chemical compound C1CN(C)CCN1C1=NC2=CC=CC=C2NC2=C1C=C(C)S2 KVWDHTXUZHCGIO-UHFFFAOYSA-N 0.000 claims 3
- 229960005017 olanzapine Drugs 0.000 claims 3
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 2
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 2
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 239000004698 Polyethylene Substances 0.000 claims 2
- 239000002202 Polyethylene glycol Substances 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 2
- 239000004067 bulking agent Substances 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 2
- 229960000913 crospovidone Drugs 0.000 claims 2
- 238000005384 cross polarization magic-angle spinning Methods 0.000 claims 2
- 239000002274 desiccant Substances 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000002706 dry binder Substances 0.000 claims 2
- 239000011521 glass Substances 0.000 claims 2
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 2
- 239000005022 packaging material Substances 0.000 claims 2
- 229920000573 polyethylene Polymers 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 2
- 239000000523 sample Substances 0.000 claims 2
- 239000011734 sodium Substances 0.000 claims 2
- 238000002411 thermogravimetry Methods 0.000 claims 2
- 239000011782 vitamin Substances 0.000 claims 2
- 229940088594 vitamin Drugs 0.000 claims 2
- 229930003231 vitamin Natural products 0.000 claims 2
- 235000013343 vitamin Nutrition 0.000 claims 2
- 150000003722 vitamin derivatives Chemical class 0.000 claims 2
- 238000005160 1H NMR spectroscopy Methods 0.000 claims 1
- ZVAPWJGRRUHKGP-UHFFFAOYSA-N 1h-1,5-benzodiazepine Chemical class N1C=CC=NC2=CC=CC=C12 ZVAPWJGRRUHKGP-UHFFFAOYSA-N 0.000 claims 1
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 claims 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 229910052693 Europium Inorganic materials 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 238000005481 NMR spectroscopy Methods 0.000 claims 1
- 208000012902 Nervous system disease Diseases 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- 239000000908 ammonium hydroxide Substances 0.000 claims 1
- 229910052799 carbon Inorganic materials 0.000 claims 1
- 239000004203 carnauba wax Substances 0.000 claims 1
- 229940082483 carnauba wax Drugs 0.000 claims 1
- 235000013869 carnauba wax Nutrition 0.000 claims 1
- 238000012512 characterization method Methods 0.000 claims 1
- 238000000113 differential scanning calorimetry Methods 0.000 claims 1
- 239000006185 dispersion Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 1
- OGPBJKLSAFTDLK-UHFFFAOYSA-N europium atom Chemical compound [Eu] OGPBJKLSAFTDLK-UHFFFAOYSA-N 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- YUWFEBAXEOLKSG-UHFFFAOYSA-N hexamethylbenzene Chemical compound CC1=C(C)C(C)=C(C)C(C)=C1C YUWFEBAXEOLKSG-UHFFFAOYSA-N 0.000 claims 1
- 229920001903 high density polyethylene Polymers 0.000 claims 1
- 239000004700 high-density polyethylene Substances 0.000 claims 1
- 229960003943 hypromellose Drugs 0.000 claims 1
- 239000007937 lozenge Substances 0.000 claims 1
- 239000011777 magnesium Substances 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims 1
- 230000010287 polarization Effects 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims 1
- 210000003296 saliva Anatomy 0.000 claims 1
- 235000015170 shellfish Nutrition 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 235000015424 sodium Nutrition 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 238000001228 spectrum Methods 0.000 claims 1
- 238000010561 standard procedure Methods 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 238000004448 titration Methods 0.000 claims 1
- 230000009466 transformation Effects 0.000 claims 1
- 238000000844 transformation Methods 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 abstract 6
- 108010024636 Glutathione Proteins 0.000 abstract 3
- 229960003180 glutathione Drugs 0.000 abstract 3
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 230000002708 enhancing effect Effects 0.000 abstract 2
- YTGJWQPHMWSCST-UHFFFAOYSA-N Tiopronin Chemical compound CC(S)C(=O)NCC(O)=O YTGJWQPHMWSCST-UHFFFAOYSA-N 0.000 abstract 1
- 108010058907 Tiopronin Proteins 0.000 abstract 1
- 230000037041 intracellular level Effects 0.000 abstract 1
- 208000002780 macular degeneration Diseases 0.000 abstract 1
- 231100000252 nontoxic Toxicity 0.000 abstract 1
- 230000003000 nontoxic effect Effects 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 229960004402 tiopronin Drugs 0.000 abstract 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
- 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
- A61P25/22—Anxiolytics
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Claims (1)
- 經濟部中央橾準局员工消費合作社印策 Η A8 B8 C8 D8 4 巧526 “ 第85103453號專利申請 中文申請專利範團修正本(89年12月） 六、申請專利範圍 1‘ 一種包含歐蘭雜苹（olanzapine)之固態口服調配物，其 中此調配物塗覆以一聚合物，其係選自幾丙甲基纖維 素、羥乙基纖維素、甲羥乙基纖維素、羧甲基纖維素 納’、輕丙基纖維素、聚乙缔外t洛咬酮、二甲胺乙基異丁 烯酸甲基丙烯酸酯共聚物、丙諦酸乙酷-異丁晞酸甲酯 共聚物、甲基纖維素及乙基纖維素，且其中該聚合物塗 覆料不含丙二醇及聚乙二醇。 2 .根據申請專利範圍第1項之調配物，其中該聚合物係為 羥丙甲基纖維素、羥丙基纖維素、甲基纖維素或乙基纖 維素。 3 -根據申請專利範圍第1項之調配物，其中該歐蘭雜苹實 質上呈形態11之多形性型態。 4.根據申請專利範圍第2項之調配物，其中該聚合物係為 禮丙甲基纖維素。 5根據申請專利範圍第1項之調配物’其中該膨脹劑係為 乳糖。 6 .根據申請專利範圍第1項之調配物’其中該枯合劑係為 羥丙基纖維素，及該崩解劑係為克羅斯普凡酮 (crospovidone) β 7. 根據申請專利範圍第1項之調配物，其中該調配物中之 乾燥粘合劑係為微晶纖維素/ 8. 根據申請專利範圍第1項之調配物’其中該調配物中之 潤滑劑係硬脂酸鎂。 9. 根據申請專利範園第4項之調配物’其中該超丙甲基纖 本紙诔尺度逋用中國囷家揉丰（CNS >八4洗格（210 X 297公羞） (請先Μ讀背面之注意事項再填寫本頁) ,1Τ Α8 Β8 C8'申請專利範圍 維素塗覆料再以含水分散薄膜覆料進一步塗覆。 10,根據申請專利範圍第9項之調配物，其中該固態調配物 係用可食墨料加以印跡。 11‘根據申請專利範圍第9項之調配物，其中該固態調配物 包括約1至約3〇/。w/w歐蘭雜苹；約69.5至約87.5% w/w乳 糖；約3.5至約4.5% w/w羥丙基纖維素；約4至約6% w/w 克羅斯普凡酮；約9至約11% w/w微晶纖維素；及約0.25 至約1%硬脂酸鎂- 12. 根據申請專利範圍第1項之調配物，其中該固態調配物 係銳劑。 13. 根據申請專利範圍第1 2項之調配物，其中各錠劑提供一 選自由1、2.5、5 ' 7.5、10、15或20毫克劑量之歐蘭雜 。 14. 根據申請專利範圍第1項之調配物，其中該固態調配物 係呈顆粒之形態。 (請先閱讀背面之注意事項再填寫本頁) ----訂_ 經濟部中央樣率局貝工消費合作社印SL 本紙浪尺度適用中國國家輮準（CNS ) A4此格（210X297公釐） 4 2 652 6 第85103453號專利申請案 中文說明書修正頁(89年12月） A7 B7 f月fi·曰 ~WK 經濟部中央標準局負工消費合作杜印裝 五、發明説明（8) 正丁醇 '丙二醇、氫氧化銨及FD&C藍。 固態調配物最好用羥丙甲基纖維素再塗覆、用有色覆料 塗覆及用可食墨料印跡。固態調配物如有須要可用標準方 法（如'巴西掠搞螺（carnaubawax)磨亮。 歐蘭雜苹在廣泛劑量範圍均有效，投與實際剩量视欲治 療病況而足。例如，成人治療，每用可用劑量約〇 2 5至5 〇 毫克’較佳為1至30毫克且最佳為1至20毫克。雖然可投與 已划为劑量但正常每天一劑即足夠。中柩神經系統病症之 治療’適當劑量每天1至30毫克，較佳1至20毫克。放射標 记形‘411 2·甲基-4_(4 -甲基-1_六氫tr比畊基）_1〇Η_β塞吩· [2,3-b][l，5]苯并二氮雜苹可在唾液中被傾測，因此可監 測病患體中該化合物以評估依順性。 本發明較佳之化合物係一固態口服調配物，包括約丨至約 20毫克歐蘭雜苹當作活性成份，其中此固態口服調配物塗 覆羥丙甲基纖維素。特別係口服調配物包括丨至2 〇毫克無 水形通11 I蘭雜苹當作有效量之活性成份，但此固態口服 調配物塗覆羥丙甲基纖維素β 更佳固fe 口服調配物含於包裝材料中，該材料保護調配 物免受潮及光照。例如合宜包裝材料包括琥珀色高密度聚 乙輝瓶、琥辑色玻璃瓶及以抑制光通過材料所製成之其它 容器。最佳包裝將包含一乾燥劑包。可用鋁泊泡狀罩密封 容器以提供所欲保護並維持產品穩定性。 在嚴苛、4 0 C / 7 5 %相對濕度條件下，貯存於琥珀色瓶 (有乾燥劑）中之羥丙甲基纖維再次塗覆錠劑，經研究6個 -11 - -------1T (請先閱讀r面之汰意事項再填寫本頁) 本紙張尺度適用中國國家標準（CNS ) A4規格（210 X 297公釐） 經濟部中央橾準局員工消費合作社印製 魏: A7 B7 426526 第851〇3453號專利申請案 中文說明書修正頁(89年12月） 五、發明説明（9) 月，顯示在全部有關物質上，其醫藥上可接受之穩定性增 加0.4 %至約1.2 %。 可購買或以精藝者熟知不同程序製備本發明之物質。可 以全文併入文中參考之Chakrabarti所述美國專利 5,229,382( 382)號製備歐蘭雜苹。最想要製備含實質純晶狀 形態11之快速溶解調配物。此實質純晶狀形態丨丨歐蘭雜苹 可以下文製法章節所述技術製備。 化合物特徵化方法包括如x射線粉狀圖式分析、熱重量分 析（TGA) '差式掃描式量熱法（DSC)、水之滴定分析及溶劑 量之1H-NMR分析。 使用13C交錯極化法/魔角旋轉（cp/MAs)NMR研究調配物 以確認形態II多形物係實質純的。在1〇〇 577 MHz碳頻率且 配有完整固體附件與Varian 5mm或7 mm VT CP/MAS探針 操作Varian單一 400 MHz分光計得到光譜。歐蘭雜苹形態π 最佳之測試條件如下：9〇。質子r.f·脈衝4.5 ms，接觸時間1.1 ms ’脈衝重覆時間5 s，MAS頻率7.0 KHz，光柵寬50 KHz，取數時間50 ms。化學位移係以樣本置換參照六甲基 苯之CH3(d=l7.3 ppm)。決定實質純形態Π多形物自始至終 留存在文中所請調配物過程。因此，本發明之調配物提供 實質純形態II歐蘭雜苹多形物，其呈醫藥上美觀調配物且 沒有產生不欲之多形性轉換。 下列實例係描述本發明之目的而非限制本發明所請的範。 製法1 工業級歐蘭雜苹 -12- 本紙張尺度適用中國國家標準（CNS > M规格（210X297公釐） 請 先 閱 讀 背. 面 之 汰 意 事 項 再 填1 本衣 頁 訂 經濟部中央橾準局员工消費合作社印策 Η A8 B8 C8 D8 4 巧526 “ 第85103453號專利申請 中文申請專利範團修正本(89年12月） 六、申請專利範圍 1‘ 一種包含歐蘭雜苹（olanzapine)之固態口服調配物，其 中此調配物塗覆以一聚合物，其係選自幾丙甲基纖維 素、羥乙基纖維素、甲羥乙基纖維素、羧甲基纖維素 納’、輕丙基纖維素、聚乙缔外t洛咬酮、二甲胺乙基異丁 烯酸甲基丙烯酸酯共聚物、丙諦酸乙酷-異丁晞酸甲酯 共聚物、甲基纖維素及乙基纖維素，且其中該聚合物塗 覆料不含丙二醇及聚乙二醇。 2 .根據申請專利範圍第1項之調配物，其中該聚合物係為 羥丙甲基纖維素、羥丙基纖維素、甲基纖維素或乙基纖 維素。 3 -根據申請專利範圍第1項之調配物，其中該歐蘭雜苹實 質上呈形態11之多形性型態。 4.根據申請專利範圍第2項之調配物，其中該聚合物係為 禮丙甲基纖維素。 5根據申請專利範圍第1項之調配物’其中該膨脹劑係為 乳糖。 6 .根據申請專利範圍第1項之調配物’其中該枯合劑係為 羥丙基纖維素，及該崩解劑係為克羅斯普凡酮 (crospovidone) β 7. 根據申請專利範圍第1項之調配物，其中該調配物中之 乾燥粘合劑係為微晶纖維素/ 8. 根據申請專利範圍第1項之調配物’其中該調配物中之 潤滑劑係硬脂酸鎂。 9. 根據申請專利範園第4項之調配物’其中該超丙甲基纖 本紙诔尺度逋用中國囷家揉丰（CNS >八4洗格（210 X 297公羞） (請先Μ讀背面之注意事項再填寫本頁) ,1Τ
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| ZA922777B (en) * | 1991-04-29 | 1993-10-15 | Lilly Co Eli | Pharmaceutical formulation containing dirithromycin |
| JPH05194225A (ja) * | 1991-11-07 | 1993-08-03 | Yoshitomi Pharmaceut Ind Ltd | 安定化された抗潰瘍剤含有製剤 |
| DE69329887T2 (de) * | 1992-05-29 | 2001-05-23 | Lilly Co Eli | Thienobenzodiazepinderivate zur Behandlung von Störungen des Zentralnervensystems |
| SE9302395D0 (sv) * | 1993-07-09 | 1993-07-09 | Ab Astra | New pharmaceutical formulation |
| US5457101A (en) * | 1994-06-03 | 1995-10-10 | Eli Lilly And Company | Thieno[1,5]benzoidiazepine use |
| CR5278A (es) * | 1995-03-24 | 1996-07-04 | Lilly Co Eli | Formulacion oral de 2-metil-tieno-benzodiacepina |
| US5696115A (en) * | 1995-04-21 | 1997-12-09 | Eli Lilly And Company | Method for treating nicotine withdrawal |
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1996
- 1996-03-12 CR CR5278A patent/CR5278A/es not_active Application Discontinuation
- 1996-03-21 EG EG25196A patent/EG24077A/xx active
- 1996-03-22 CO CO96014566A patent/CO4700474A1/es unknown
- 1996-03-22 EP EP96301997A patent/EP0733367B1/en not_active Expired - Lifetime
- 1996-03-22 CZ CZ19973001A patent/CZ296007B6/cs not_active IP Right Cessation
- 1996-03-22 PT PT96301997T patent/PT733367E/pt unknown
- 1996-03-22 DE DE19681287T patent/DE19681287T1/de not_active Ceased
- 1996-03-22 DE DE69634053T patent/DE69634053T2/de not_active Expired - Lifetime
- 1996-03-22 SI SI9620041A patent/SI9620041A/sl unknown
- 1996-03-22 EP EP00204708A patent/EP1093815B1/en not_active Expired - Lifetime
- 1996-03-22 AP APAP/P/1997/001064A patent/AP679A/en active
- 1996-03-22 TW TW085103453A patent/TW426526B/zh not_active IP Right Cessation
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- 1996-03-22 DE DE69615887T patent/DE69615887T2/de not_active Expired - Lifetime
- 1996-03-22 RO RO97-01776A patent/RO118370B1/ro unknown
- 1996-03-22 HU HU9800410A patent/HU225269B1/hu unknown
- 1996-03-22 AT AT0902296A patent/AT405606B/de not_active IP Right Cessation
- 1996-03-22 JP JP8529533A patent/JPH11502848A/ja active Pending
- 1996-03-22 KR KR1019970706592A patent/KR100408172B1/ko not_active IP Right Cessation
- 1996-03-22 ES ES96301997T patent/ES2164837T3/es not_active Expired - Lifetime
- 1996-03-22 PL PL96322579A patent/PL188316B1/pl unknown
- 1996-03-22 DK DK96301997T patent/DK0733367T3/da active
- 1996-03-22 IL IL11761196A patent/IL117611A/en unknown
- 1996-03-22 EA EA199700260A patent/EA000938B1/ru not_active IP Right Cessation
- 1996-03-22 EE EE9700328A patent/EE03551B1/xx unknown
- 1996-03-22 PT PT00204708T patent/PT1093815E/pt unknown
- 1996-03-22 DK DK00204708T patent/DK1093815T3/da active
- 1996-03-22 BR BR9607791A patent/BR9607791A/pt not_active IP Right Cessation
- 1996-03-22 CN CNB96192778XA patent/CN1178662C/zh not_active Expired - Fee Related
- 1996-03-22 AT AT96301997T patent/ATE206924T1/de active
- 1996-03-22 SI SI9630707T patent/SI1093815T1/xx unknown
- 1996-03-22 AR AR33587496A patent/AR001405A1/es not_active Application Discontinuation
- 1996-03-22 ES ES00204708T patent/ES2232379T3/es not_active Expired - Lifetime
- 1996-03-22 CA CA002216372A patent/CA2216372C/en not_active Expired - Lifetime
- 1996-03-22 PE PE1996000204A patent/PE44997A1/es not_active IP Right Cessation
- 1996-03-22 GB GB9719817A patent/GB2313783B/en not_active Revoked
- 1996-03-22 WO PCT/US1996/003918 patent/WO1996029995A1/en active IP Right Grant
- 1996-03-22 UA UA97094738A patent/UA44766C2/uk unknown
- 1996-03-22 CH CH02246/97A patent/CH691217A5/de not_active IP Right Cessation
- 1996-03-22 AT AT00204708T patent/ATE284695T1/de active
- 1996-03-22 NZ NZ306111A patent/NZ306111A/xx not_active IP Right Cessation
- 1996-03-22 MY MYPI96001086A patent/MY113440A/en unknown
- 1996-03-22 SK SK1282-97A patent/SK283745B6/sk not_active IP Right Cessation
- 1996-03-22 AU AU54280/96A patent/AU696601B2/en not_active Ceased
- 1996-03-22 AR ARP960101877A patent/AR002720A1/es not_active Application Discontinuation
- 1996-03-22 ZA ZA9602338A patent/ZA962338B/xx unknown
- 1996-09-20 US US08/716,922 patent/US5919485A/en not_active Expired - Lifetime
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1997
- 1997-07-30 LU LU90115A patent/LU90115B1/fr active
- 1997-09-05 SE SE9703206A patent/SE9703206D0/xx not_active Application Discontinuation
- 1997-09-16 LT LT97-149A patent/LT4350B/lt not_active IP Right Cessation
- 1997-09-22 IS IS4565A patent/IS1903B/is unknown
- 1997-09-22 FI FI973749A patent/FI973749A/fi unknown
- 1997-09-22 BG BG101901A patent/BG62594B1/bg unknown
- 1997-09-22 NO NO19974363A patent/NO320388B1/no not_active IP Right Cessation
- 1997-09-23 DK DK199701090A patent/DK173323B1/da not_active IP Right Cessation
- 1997-09-24 OA OA70083A patent/OA10511A/en unknown
- 1997-10-14 LV LVP-97-199A patent/LV11983B/en unknown
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1998
- 1998-08-31 US US09/144,188 patent/US6190698B1/en not_active Expired - Lifetime
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2001
- 2001-01-19 US US09/766,218 patent/US6780433B2/en not_active Expired - Fee Related
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2004
- 2004-07-08 US US10/887,017 patent/US7229643B2/en not_active Expired - Fee Related
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