KR930702959A - 수-분산성 정제 - Google Patents
수-분산성 정제Info
- Publication number
- KR930702959A KR930702959A KR1019930702233A KR930702233A KR930702959A KR 930702959 A KR930702959 A KR 930702959A KR 1019930702233 A KR1019930702233 A KR 1019930702233A KR 930702233 A KR930702233 A KR 930702233A KR 930702959 A KR930702959 A KR 930702959A
- Authority
- KR
- South Korea
- Prior art keywords
- tablet
- water
- expandable clay
- granules
- lamotrigine
- Prior art date
Links
- 239000004565 water dispersible tablet Substances 0.000 title claims abstract 8
- 239000003826 tablet Substances 0.000 claims abstract 38
- 239000004927 clay Substances 0.000 claims abstract 16
- 239000008187 granular material Substances 0.000 claims abstract 12
- 150000001875 compounds Chemical class 0.000 claims abstract 11
- PYZRQGJRPPTADH-UHFFFAOYSA-N lamotrigine Chemical compound NC1=NC(N)=NN=C1C1=CC=CC(Cl)=C1Cl PYZRQGJRPPTADH-UHFFFAOYSA-N 0.000 claims abstract 10
- 229960001848 lamotrigine Drugs 0.000 claims abstract 10
- 239000000440 bentonite Substances 0.000 claims abstract 8
- 229910000278 bentonite Inorganic materials 0.000 claims abstract 8
- SVPXDRXYRYOSEX-UHFFFAOYSA-N bentoquatam Chemical compound O.O=[Si]=O.O=[Al]O[Al]=O SVPXDRXYRYOSEX-UHFFFAOYSA-N 0.000 claims abstract 8
- 239000006185 dispersion Substances 0.000 claims abstract 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract 8
- 229960004150 aciclovir Drugs 0.000 claims abstract 7
- MKUXAQIIEYXACX-UHFFFAOYSA-N aciclovir Chemical compound N1C(N)=NC(=O)C2=C1N(COCCO)C=N2 MKUXAQIIEYXACX-UHFFFAOYSA-N 0.000 claims abstract 7
- 239000002270 dispersing agent Substances 0.000 claims abstract 4
- 229910021647 smectite Inorganic materials 0.000 claims abstract 3
- 239000002245 particle Substances 0.000 claims 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 8
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 6
- OFCNXPDARWKPPY-UHFFFAOYSA-N allopurinol Chemical compound OC1=NC=NC2=C1C=NN2 OFCNXPDARWKPPY-UHFFFAOYSA-N 0.000 claims 6
- 229960003459 allopurinol Drugs 0.000 claims 6
- 239000002131 composite material Substances 0.000 claims 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims 6
- 229940079832 sodium starch glycolate Drugs 0.000 claims 6
- 239000008109 sodium starch glycolate Substances 0.000 claims 6
- 229920003109 sodium starch glycolate Polymers 0.000 claims 6
- 150000003920 1,2,4-triazines Chemical class 0.000 claims 5
- 229930192627 Naphthoquinone Natural products 0.000 claims 5
- 239000004353 Polyethylene glycol 8000 Substances 0.000 claims 5
- 230000000202 analgesic effect Effects 0.000 claims 5
- 230000002082 anti-convulsion Effects 0.000 claims 5
- 230000000840 anti-viral effect Effects 0.000 claims 5
- 229940111131 antiinflammatory and antirheumatic product propionic acid derivative Drugs 0.000 claims 5
- 229940049706 benzodiazepine Drugs 0.000 claims 5
- 150000001557 benzodiazepines Chemical class 0.000 claims 5
- 238000000034 method Methods 0.000 claims 5
- 239000000203 mixture Substances 0.000 claims 5
- 150000002791 naphthoquinones Chemical class 0.000 claims 5
- 150000003833 nucleoside derivatives Chemical class 0.000 claims 5
- 229940085678 polyethylene glycol 8000 Drugs 0.000 claims 5
- 235000019446 polyethylene glycol 8000 Nutrition 0.000 claims 5
- 239000006041 probiotic Substances 0.000 claims 5
- 230000000529 probiotic effect Effects 0.000 claims 5
- 235000018291 probiotics Nutrition 0.000 claims 5
- 150000005599 propionic acid derivatives Chemical class 0.000 claims 5
- -1 β-D-arabinofuranosyl Chemical group 0.000 claims 5
- 235000019359 magnesium stearate Nutrition 0.000 claims 4
- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical compound COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 claims 4
- 229960001082 trimethoprim Drugs 0.000 claims 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- 229920002472 Starch Polymers 0.000 claims 3
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 3
- 229940069328 povidone Drugs 0.000 claims 3
- 229920003133 pregelled starch Polymers 0.000 claims 3
- 229940032147 starch Drugs 0.000 claims 3
- 239000008107 starch Substances 0.000 claims 3
- 235000019698 starch Nutrition 0.000 claims 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 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 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 claims 2
- 229920003081 Povidone K 30 Polymers 0.000 claims 2
- GUJOJGAPFQRJSV-UHFFFAOYSA-N dialuminum;dioxosilane;oxygen(2-);hydrate Chemical group O.[O-2].[O-2].[O-2].[Al+3].[Al+3].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O GUJOJGAPFQRJSV-UHFFFAOYSA-N 0.000 claims 2
- 239000007919 dispersible tablet Substances 0.000 claims 2
- 238000009826 distribution Methods 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000007941 film coated tablet Substances 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 238000002156 mixing Methods 0.000 claims 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 2
- APSBXTVYXVQYAB-UHFFFAOYSA-M sodium docusate Chemical compound [Na+].CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC APSBXTVYXVQYAB-UHFFFAOYSA-M 0.000 claims 2
- BSJMWHQBCZFXBR-UHFFFAOYSA-N 3-[4-(p-chlorophenyl)cyclohexyl]-4-hydroxy-1,2-naphthoquinone Chemical compound O=C1C(=O)C2=CC=CC=C2C(O)=C1C(CC1)CCC1C1=CC=C(Cl)C=C1 BSJMWHQBCZFXBR-UHFFFAOYSA-N 0.000 claims 1
- WKVDSZYIGHLONN-RRKCRQDMSA-N 5-chloro-1-[(2r,4s,5r)-4-fluoro-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione Chemical compound C1[C@H](F)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(Cl)=C1 WKVDSZYIGHLONN-RRKCRQDMSA-N 0.000 claims 1
- POYNHVFBISCPAG-DJLDLDEBSA-N 5-ethynyl-1-[(2r,4s,5r)-4-fluoro-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione Chemical compound C1[C@H](F)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(C#C)=C1 POYNHVFBISCPAG-DJLDLDEBSA-N 0.000 claims 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims 1
- QCDFBFJGMNKBDO-UHFFFAOYSA-N Clioquinol Chemical compound C1=CN=C2C(O)=C(I)C=C(Cl)C2=C1 QCDFBFJGMNKBDO-UHFFFAOYSA-N 0.000 claims 1
- MKXZASYAUGDDCJ-SZMVWBNQSA-N LSM-2525 Chemical compound C1CCC[C@H]2[C@@]3([H])N(C)CC[C@]21C1=CC(OC)=CC=C1C3 MKXZASYAUGDDCJ-SZMVWBNQSA-N 0.000 claims 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 239000004698 Polyethylene Substances 0.000 claims 1
- GCQYYIHYQMVWLT-HQNLTJAPSA-N Sorivudine Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(\C=C\Br)=C1 GCQYYIHYQMVWLT-HQNLTJAPSA-N 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 235000010323 ascorbic acid Nutrition 0.000 claims 1
- 229960005070 ascorbic acid Drugs 0.000 claims 1
- 239000011668 ascorbic acid Substances 0.000 claims 1
- 229960000892 attapulgite Drugs 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 229910052792 caesium Inorganic materials 0.000 claims 1
- TVFDJXOCXUVLDH-UHFFFAOYSA-N caesium atom Chemical compound [Cs] TVFDJXOCXUVLDH-UHFFFAOYSA-N 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003086 colorant Substances 0.000 claims 1
- 229960001985 dextromethorphan Drugs 0.000 claims 1
- AAOVKJBEBIDNHE-UHFFFAOYSA-N diazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 AAOVKJBEBIDNHE-UHFFFAOYSA-N 0.000 claims 1
- 229960003529 diazepam Drugs 0.000 claims 1
- RBOXVHNMENFORY-DNJOTXNNSA-N dihydrocodeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC RBOXVHNMENFORY-DNJOTXNNSA-N 0.000 claims 1
- 229960000920 dihydrocodeine Drugs 0.000 claims 1
- XYYVYLMBEZUESM-UHFFFAOYSA-N dihydrocodeine Natural products C1C(N(CCC234)C)C2C=CC(=O)C3OC2=C4C1=CC=C2OC XYYVYLMBEZUESM-UHFFFAOYSA-N 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 229960004396 famciclovir Drugs 0.000 claims 1
- GGXKWVWZWMLJEH-UHFFFAOYSA-N famcyclovir Chemical compound N1=C(N)N=C2N(CCC(COC(=O)C)COC(C)=O)C=NC2=C1 GGXKWVWZWMLJEH-UHFFFAOYSA-N 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 1
- 239000007788 liquid 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
- 229910052901 montmorillonite Inorganic materials 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 125000004043 oxo group Chemical group O=* 0.000 claims 1
- 229910052625 palygorskite Inorganic materials 0.000 claims 1
- 229960005489 paracetamol Drugs 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 229920000573 polyethylene Polymers 0.000 claims 1
- 229910000027 potassium carbonate Inorganic materials 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 229960005404 sulfamethoxazole Drugs 0.000 claims 1
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- CBEQULMOCCWAQT-WOJGMQOQSA-N triprolidine Chemical compound C1=CC(C)=CC=C1C(\C=1N=CC=CC=1)=C/CN1CCCC1 CBEQULMOCCWAQT-WOJGMQOQSA-N 0.000 claims 1
- 229960001128 triprolidine Drugs 0.000 claims 1
- 229940035893 uracil Drugs 0.000 claims 1
- 239000000080 wetting agent Substances 0.000 claims 1
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 claims 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
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
-
- 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
- A61P31/12—Antivirals
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Virology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cosmetics (AREA)
- General Preparation And Processing Of Foods (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Glanulating (AREA)
Abstract
본 발명은 아사이클로비르 또는 라모트리긴과 같은 활성 화합물 및 분산제를 포함하는 수-분산성 정제에 관한 것이다. 상기 분산제는 스멕타이트, 예컨대, 비굼 F 또는 벤토나이트와 같은 팽창성 점토이며, 3분이내에 물에 분산될 수 있는 정제를 제공하는 정제의 과립에 대개 존재하여 710㎛체에 통과될 수 있는 분산액을 제공한다. 상기 정제는 분산 시간이 5분 미만인 경우, 임의로 필름코팅될 수 있다.
Description
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
Claims (30)
- 진통성 프로피온산 유도체, 신경안정성 벤조디아제핀, 항바이러스성 뉴클레오시드 유도체, 항원생동물성 나프토퀴논, 알로푸리놀, 옥소푸리놀, 항경련성 1,2,4-트리아진 유도체 및 트리메토프림(설파메톡스아졸과 조합될 수 있음)으로 구성된 군으로부터 선택된 치료학적 활성 화학물 및 3분이내에 물에 분산될 수 있는 정제를 제공하는 유효량의 약학적으로 허용가능한 팽창성 점토를 포함하여 문헌[British Pharmacopoeia, 1988, VolumeⅡ, 895페이지]에서 정의된 분산성 정제 테스트에 따라서 710㎛의 메쉬 구경을 갖는 체 스크린에 통과시킬 수 있는 분산액을 제공하는 수-분산성 정제.
- 진통성 프로피온산 유도체, 신경안정성 벤조디아제핀, 항바이러스성 뉴클레오시드 유도체, 항원생동물성 나프토퀴논, 알로푸리놀, 옥소푸리놀, 항경련성 1,2,4-트리아진 유도체 및 트리메토프림(설파메톡스아졸과 조합될 수 있음)으로 구성된 군으로부터 선택된 치료학적 활성 화합물 및, 5분이내에 물에 분산될 수 있는 필름 코팅된 정제를 제공하는 유효량의 약학적으로 허용가능한 팽창성 점토를 포함하여 문헌[British Pharmacopoeia, 1988, VolumeⅡ, 895페이지]에서 정의된 분산성 정제 테스트에 따라서 710㎛의 메쉬 구경을 갖는 체 스크린에 통과시킬 수 있는 분산액을 제공하는 수-분산성 필름 코팅된 정제.
- 제1항 또는 제2항에 있어서, 2분 이내에 물에 분산될 수 있는 정제.
- 제1항 내지 3항중 어느 한항에 있어서, 상기 분산액의 입자 크기 분포가 100%의 입자는 710㎛미만, 50%이상의 입자는 310㎛미만인 입자를 함유하는 정제.
- 제4항에 있어서, 상기 분산액의 입자 크기 분포가 100%의 입자는 710㎛미만, 70%이상의 입자는 310㎛미만, 50%이상의 입자는 200㎛미만인 입자를 함유하는 정제.
- 제1항 내지 제5항중 어느 한항에 있어서, 상기 활성 화합물이 아사이클로비르, 라모트리긴, 디아제팜, 파라세타몰, 1-(β-D-아라비노푸라노실)-5-프로피-1-이닐-우라실, 2-[4-(4-클로로페닐)시클로헥실]-3-히드록시-1,4-나프토퀴논, 알로푸리놀, 3'-아지도-3'-데옥시티미딘), 5-프로프-1-(5-트리메틸아세틸-β-D-아라비노푸라노실)우라실, 2-(2-아미노-1,6-디히드로-6-옥소-9H(푸린-9-일)메톡시)-에틸-발리네이트, 2',3'-디데옥시-5-에티닐-3'-플루오로우리딘, 5-클로로-1-(2,3-디데옥시-3-플루오르-β-에리트로펜토푸라노실)우라실, 펜시클로비르, 팜시클로비르, E-5-(2-브로모비닐)-1-β-아라비노푸라노실 우라실, 덱스트로메토르판, 슈도페드린, 아크리베스틴, 트리프롤리딘, 구아페네신, 디히드로코데인, 코테인 인산염 및 아스코르브산으로 구성된 군에서 선택되는 정제.
- 제1항내지 제6항중 어느 한항에 있어서, 상기 팽창성 점토가 스멕타이트 도는 아타풀가이트를 포함하는 정제.
- 제7항에 있어서, 상기 스멕타이트가 몬트모릴로나이트 군에서 선택되는 정제.
- 제8항에 있어서, 상기 몬트모릴로나이트가 비굼 F 또는 벤토나이트인 정제.
- 제1항내지 제9항중 어느 한항에 있어서, 상기 팽창성 점토가 0.25% 내지 60% w/w 의 함량으로 정제의 과립에 존재하는 정제.
- 제10항에 있어서, 상기 팽창성 점토가 0.25%내지 40% w/w의 함량으로 정제의 과립에 존재하는 정제.
- 제11항에 있어서, 상기 팽창성 점토가 1%내지 10% w/w의 함량으로 정제의 과립에 존재하는 정제.
- 제1항 내지 제12항중 어느 한항에 있어서, 5내지 90% w/w의 함량으로 상기 활성 성분을 함유하는 정제.
- 제1항 내지 제13항중 어느 한항에 있어서, 5내지 90% w/w의 활성 화합물, 0.25내지 60%w/w의 팽창성 점토, 0내지 25%w/w의 결합제, 0내지 20%w/w의 붕해제, 0내지 95%w/w의 수용성 충전제, 0내지 95%w/w의 불수용성 충전제, 0내지 5%w/w의 습윤제, 0.1 내지 5%w/w의 윤활제, 착색제, 향미제, 0내지 10%w/w의 감미제의 통상 배합을 갖는 정제.
- 제1항 내지 제14항중 어느 한항에 있어서, 상기 활성 화합물이 아사이클로비르인 정제.
- 제15항에 있어서, 상기 아사이클로비르가 50 내지 95%w/w의 함량으로 존재하고, 상기 팽창성 점토가 0.5 내지 40%w/w의 함량으로 정제의 과립에 존재하는 정제.
- 제16항에 있어서, 상기 정제가 200 내지 800mg의 아사이클로비르를 포함하며, 70내지 90%w/w의 아사이클로비르, 0.25내지 5%w/w의 포비된 또는 예비겔화된 전분, 0.5 내지 30%w/w의 비굼 F 또는 벤토나이트, 5내지 25%w/w의 미정질 셀룰로스 또는 LHPC-LH11, 0내지 8%w/w의 나트륨 전분 글리콜레이트, 0.25내지 2%w/w스테아르산 마그세슘, 및 부가로 0.1 내지 2%w/w의 오파드라이, 0.1 내지 0.5w/w의 폴리에틸렌 글리콜 8000으로 필름 코팅된 복합물질의 배합을 갖는 정제.
- 제17항에 있어서, 상기 배합이 75내지 85%w/w의 아사이클로비르, 0.5내지 2%w/w의 포비돈 또는 예비켈화된 전분, 0.5내지 10%w/w의 비굼 F 또는 벤토나이트, 5내지 15%w/w의 미정질 셀룰로스 또는 LHPC-LH11, 0내지 5% w/w나트륨 전분 글리콜레이트, 0.25내지 2.0%w/w스테아르산 마그세슘, 및 부가로 0.25 내지 1.0%w/w의 오파드라이, 0.1 내지 0.2w/w의 폴리에틸렌 글리콜 8000으로 필름 코팅된 복합물질의 배합을 갖는 정제.
- 제1항 내지 제14항에 있어서, 상기 활성 화합물이 라모트리긴인 정제.
- 제19항에 있어서, 상기 라모트리긴이 2내지 90%w/w의 함량으로 존재하고, 상기 팽창성 점토가 0.25내지 40%w/w의 함량으로 정제의 과립에 존재하는 정제.
- 제20항에 있어서, 상기 정제가 25내지 200mg의 라모트리긴을 포함하며, 30내지 50%w/w의 라모트리긴, 26내지 46% w/w의 탄산 칼슘, 5내지 30%w/w의 미정질 셀룰로스 또는 LHPC-LH11. 0.25 내지 30%w/w의 비굼 F 또는 벤토나이트, 1.0 내지 8.0w/w의 포비돈 또는 예비겔화된 전분, 0내지 8%w/w의 나트륨 전분 글리콜레이트, 0.25 내지 2%w/w스테아르산 마그네슘, 및 부가로 0.1 내지 2%w/w의 오파드라이및 0.1 내지 0.5%w/w의 폴리에틸렌 글리콜 8000으로 필름 코팅된 복합물질의 배합을 갖는 정제.
- 제21항에 있어서, 상기 배합이 35내지 45%w/w의 라모트리긴, 31내지 41% w/w의 탄산 칼륨, 5내지 15%w/w의 미정질 셀룰로스 또는 LHPC-LH11. 0.25 내지 10%w/w의 비굼 F 또는 벤토나이트, 2 내지 5%w/w의 포비돈 또는 예비겔화된 전분, 0내지 5%w/w의 나트륨 전분 글리콜레이트, 0.25 내지 1%w/w스테아르산 마그네슘, 및 부가로 0.25 내지 1%w/w의 오파드라이및 0.1 내지 0.2%w/w의 폴리에틸렌 글리콜 8000으로 필름 코팅된 복합물질의 배합을 갖는 정제.
- 제20항에 있어서, 상기 정제가 5mg 내지 50mg의 라모트리긴을 포함하며, 3내지 13%w/w의 라모트리긴, 50내지 60% w/w의 락토스 또는 탄산 칼슘, 20내지 35%w/w의 미정질 셀룰로스 또는 LHPC-LH11, 0내지 8%w/w의 나트륨 전분 글리콜레이트, 0.25 내지 30%w/w의 비굼 F 또는 벤토나이트, 1.0 내지 8.0%w/w의 포비돈 K30 또는 예비겔화된 전분, 0내지 0.5%w/w의 나트륨 도큐세이트, 0내지 3%w/w의 사카린 나트륨, 0.25 내지 2%w/w스테아르산 마그네슘, 및 부가로 0.1 내지 2.0%w/w의 오파드라이, 및 0.1 내지 0.5%w/w의 폴리에틸렌 글리콜 8000으로 필름 코팅된 복합물질의 배합을 갖는 정제.
- 제23항에 있어서, 상기 배합이 5내지 11%w/w의 라모트리긴, 53내지 59% w/w의 락토스 또는 탄산 클슘, 24내지 30%w/w의 미정질 셀룰로스 또는 LHPC-LH11, 0내지 5%w/w의 나트륨 전분 글리콜레이트, 0.25 내지 10%w/w의 비굼 F 또는 벤토나이트, 2 내지 5%w/w의 포비돈 K30 또는 예비겔화된 전분, 0.5내지 0.15%w/w의 나트륨 도큐세이트, 0.5내지 2%w/w의 사카린 나트륨, 0.25 내지 1%w/w스테아르산 마그네슘, 및 부가로 0.25 내지 1%w/w의 오파드라이, 및 0.1 내지 2%w/w의 폴리에틸렌 글리콜 8000으로 필름 코팅된 복합물질의 배합을 갖는 정제.
- 진통성 프로피온산 유도체, 신경안정성 벤조디아제핀, 항바이러스성 뉴클레오시드 유도체, 항원생동물성 나프토퀴논, 알로푸리놀, 옥소푸리놀, 항경련성 1,2,4-트리아진 유도체 및 트리메토프림(설파메톡스아졸과 조합될 수 있음)으로 구성된 군으로부터 선택된 치료학적 활성 화합물 및, 3분이내에 물에 분산될 수 있는 수-분산성 정제를 제공하는 유효량의 약학적으로 허용가능한 팽창성 점토와 함께 상기 활성 화합물을 포함하는 상기 팽창성 점토를 포함하여, 문헌[British Pharmacopoeia, 1988, VolumeⅡ, 895페이지]에서 정의된 분산성 정제 테스트에 따라서 710㎛의 메쉬 구경을 갖는 체 스크린에 통과시킬 수 있는 분산액을 제공하는 수-분산성 정제의 제조 방법.
- 제25항에 있어서, 항기 a)-e)단계를 포함하는 제조 방법 : a)진통성 프로피온산 유도체, 신경안정성 벤조디아제핀, 항바이러스성 뉴클레오시드 유도체, 항원생동물성 나프토퀴논, 알로푸리놀, 옥소푸리놀, 항경련성 1,2,4-트리아진 유도체 및 트리메토프림(설파메톡스아졸과 조합될 수 있음)으로 구성된 군으로부터 선택된 활성 화합물을 유효량의 약학적으로 허용가능한 팽창성 점토, 부가로 하나이상의 다른 약학적 담체 또는 부형제와 함께 무수 미분 형태로 혼합하는 단계, b)무수 혼합물을 습윤시키기에 충분한 다량의 약학적으로 허용가능한 액체를 첨가하는 단계, c)상기 생성된 습윤 환합물을 과립화시켜 과립을 형성하는 단계, d)상기 과립을 건조시키고, 부과로, 윤활제, 글라이던트, 향미제 및 붕해제와 같은 담체 또는 부형제로 상기 과립을 혼합시키는 단계, 및 (e)상기 과립을 압축시켜 문헌[British Pharmacopoeia]에서 상기 정의된 분산성 정제 테스트에 따라서 710㎛의 메쉬 구경을 갖는 체 스크린에 통과시킬 수 있는 분산액을 제공하는, 3분이내에 물에 분산될 수 있는 정제를 형성시키는 단계.
- 진통성 프로피온산 유도체, 신경안정성 벤조디아제핀, 항바이러스성 뉴클레오시드 유도체, 항원생동물성 나프토퀴논, 알로푸리놀, 옥소푸리놀, 항경련성 1,2,4-트리아진 유도체 및 트리메토프림(설파메톡스아졸과 조합될 수 있음)으로 구성된 군으로부터 선택된 치료학적 활성 화합물 및, 유효량의 약학적으로 허용가능한 팽창성 점토를 포함하는 제1항 내지 제24항 중 어느 한항에 따른 수-분산성 정제용 과립.
- 제1항 내지 제24항중 어느 한항에 따른 수-분산성 정제의 제조시에 제27항에서 정의된 바와 같은 과립을 사용하는 방법.
- 제1항 내지 제24항중 어느 한항에 따른 수-분산성 정제의 제조시에 분산제로서 약학적으로 허용가능한 팽창성 점토를 사용하는 방법.
- 수-분산성 정제용 분산제로 사용하기 위한 약학적으로 허용가능한 팽창성 점토.※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB919102019A GB9102019D0 (en) | 1991-01-30 | 1991-01-30 | Pharmaceutical formulations |
| GB9102019.8 | 1991-01-30 | ||
| GB9124807.0 | 1991-11-22 | ||
| GB919124803A GB9124803D0 (en) | 1991-11-22 | 1991-11-22 | Pharmaceutical formulations |
| GB919124807A GB9124807D0 (en) | 1991-11-22 | 1991-11-22 | Pharmaceutical formulations |
| GB9124803.9 | 1991-11-22 | ||
| GB9125005.0 | 1991-11-25 | ||
| GB919125005A GB9125005D0 (en) | 1991-11-25 | 1991-11-25 | Pharmaceutical formulations |
| PCT/GB1992/000163 WO1992013527A1 (en) | 1991-01-30 | 1992-01-29 | Water-dispersible tablets |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR930702959A true KR930702959A (ko) | 1993-11-29 |
| KR100190254B1 KR100190254B1 (ko) | 1999-06-01 |
Family
ID=27450613
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1019930702233A KR100190254B1 (ko) | 1991-01-30 | 1992-01-29 | 수-분산성 정제 |
Country Status (37)
| Country | Link |
|---|---|
| US (2) | US5556639A (ko) |
| EP (1) | EP0522128B1 (ko) |
| JP (2) | JP3118255B2 (ko) |
| KR (1) | KR100190254B1 (ko) |
| AT (1) | ATE133068T1 (ko) |
| AU (2) | AU653203B2 (ko) |
| BE (1) | BE1004461A5 (ko) |
| BG (1) | BG61665B2 (ko) |
| CA (1) | CA2098108C (ko) |
| CH (1) | CH685978A5 (ko) |
| CY (1) | CY2007A (ko) |
| CZ (1) | CZ286723B6 (ko) |
| DE (2) | DE69207656T2 (ko) |
| DK (2) | DK0522128T3 (ko) |
| ES (2) | ES2080641B1 (ko) |
| FI (2) | FI111605B (ko) |
| FR (1) | FR2671970B1 (ko) |
| GB (1) | GB2257363B (ko) |
| GR (1) | GR3019545T3 (ko) |
| HK (1) | HK78597A (ko) |
| HU (2) | HU221677B1 (ko) |
| IE (1) | IE77165B1 (ko) |
| IL (1) | IL100796A (ko) |
| IT (1) | IT1257473B (ko) |
| LU (1) | LU88323A1 (ko) |
| MX (1) | MX9200412A (ko) |
| MY (2) | MY110880A (ko) |
| NL (1) | NL9220009A (ko) |
| NO (1) | NO306697B1 (ko) |
| PA (1) | PA7695401A1 (ko) |
| PL (1) | PL169106B1 (ko) |
| RU (1) | RU2106861C1 (ko) |
| SA (1) | SA92120365B1 (ko) |
| SE (1) | SE9302363L (ko) |
| SK (2) | SK282071B6 (ko) |
| UA (1) | UA37214C2 (ko) |
| WO (1) | WO1992013527A1 (ko) |
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- 1992-01-29 PL PL92300134A patent/PL169106B1/pl unknown
- 1992-01-29 KR KR1019930702233A patent/KR100190254B1/ko not_active IP Right Cessation
- 1992-01-29 US US08/090,111 patent/US5556639A/en not_active Expired - Lifetime
- 1992-01-29 DK DK92903508.7T patent/DK0522128T3/da active
- 1992-01-29 DE DE69207656T patent/DE69207656T2/de not_active Expired - Lifetime
- 1992-01-29 UA UA93002090A patent/UA37214C2/uk unknown
- 1992-01-29 IL IL10079692A patent/IL100796A/en not_active IP Right Cessation
- 1992-01-29 FR FR9200938A patent/FR2671970B1/fr not_active Expired - Fee Related
- 1992-01-29 SK SK817-93A patent/SK282071B6/sk unknown
- 1992-01-29 HU HU9302212A patent/HU221677B1/hu unknown
- 1992-01-29 JP JP04503284A patent/JP3118255B2/ja not_active Expired - Lifetime
- 1992-01-29 CZ CZ19931082A patent/CZ286723B6/cs not_active IP Right Cessation
- 1992-01-29 CA CA002098108A patent/CA2098108C/en not_active Expired - Lifetime
- 1992-01-29 AT AT92903508T patent/ATE133068T1/de not_active IP Right Cessation
- 1992-01-29 NL NL9220009A patent/NL9220009A/nl active Search and Examination
- 1992-01-29 ES ES09250043A patent/ES2080641B1/es not_active Expired - Fee Related
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- 1992-01-29 SK SK1655-2000A patent/SK282072B6/sk unknown
- 1992-01-29 DE DE4290300T patent/DE4290300T1/de not_active Withdrawn
- 1992-01-29 WO PCT/GB1992/000163 patent/WO1992013527A1/en not_active IP Right Cessation
- 1992-01-29 CH CH309292A patent/CH685978A5/fr not_active IP Right Cessation
- 1992-01-29 ES ES92903508T patent/ES2089498T3/es not_active Expired - Lifetime
- 1992-01-29 BE BE9200088A patent/BE1004461A5/fr not_active IP Right Cessation
- 1992-01-29 EP EP92903508A patent/EP0522128B1/en not_active Expired - Lifetime
- 1992-01-29 RU RU93051524A patent/RU2106861C1/ru active
- 1992-01-29 MY MYPI92000143A patent/MY110880A/en unknown
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- 1992-01-30 IT ITRM920069A patent/IT1257473B/it active IP Right Grant
- 1992-02-02 SA SA92120365A patent/SA92120365B1/ar unknown
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1993
- 1993-06-22 LU LU88323A patent/LU88323A1/fr unknown
- 1993-07-02 NO NO932422A patent/NO306697B1/no not_active IP Right Cessation
- 1993-07-08 SE SE9302363A patent/SE9302363L/xx not_active Application Discontinuation
- 1993-07-27 DK DK087893A patent/DK87893A/da not_active Application Discontinuation
- 1993-07-29 FI FI933401A patent/FI111605B/fi active
- 1993-08-26 BG BG98071A patent/BG61665B2/bg unknown
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1994
- 1994-07-13 AU AU67454/94A patent/AU659581B2/en not_active Expired
- 1994-10-03 US US08/317,300 patent/US5660860A/en not_active Expired - Lifetime
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1995
- 1995-06-28 HU HU95P/P00506P patent/HU211161A9/hu unknown
- 1995-08-24 PA PA19957695401A patent/PA7695401A1/es unknown
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1996
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1997
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1998
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2000
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2002
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