LV11983B - Iekšķīgi lietojams 2-metil-tieno-benzodiazepīna zāļu preparāts - Google Patents
Iekšķīgi lietojams 2-metil-tieno-benzodiazepīna zāļu preparāts Download PDFInfo
- Publication number
- LV11983B LV11983B LVP-97-199A LV970199A LV11983B LV 11983 B LV11983 B LV 11983B LV 970199 A LV970199 A LV 970199A LV 11983 B LV11983 B LV 11983B
- Authority
- LV
- Latvia
- Prior art keywords
- olanzapine
- pharmaceutical preparation
- preparation according
- formulation
- methylcellulose
- Prior art date
Links
- 229940049706 benzodiazepine Drugs 0.000 title description 2
- 239000003814 drug Substances 0.000 title description 2
- 239000000203 mixture Substances 0.000 claims description 77
- 238000009472 formulation Methods 0.000 claims description 59
- KVWDHTXUZHCGIO-UHFFFAOYSA-N olanzapine Chemical compound C1CN(C)CCN1C1=NC2=CC=CC=C2NC2=C1C=C(C)S2 KVWDHTXUZHCGIO-UHFFFAOYSA-N 0.000 claims description 50
- 229960005017 olanzapine Drugs 0.000 claims description 49
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 26
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 25
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 25
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound 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 description 25
- 239000007787 solid Substances 0.000 claims description 24
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 20
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 20
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 20
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 19
- 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 description 16
- 229920000609 methyl cellulose Polymers 0.000 claims description 16
- 239000001923 methylcellulose Substances 0.000 claims description 16
- 235000010981 methylcellulose Nutrition 0.000 claims description 16
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- 239000011248 coating agent Substances 0.000 claims description 15
- 238000000576 coating method Methods 0.000 claims description 15
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 13
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- 239000008101 lactose Substances 0.000 claims description 13
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- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 13
- 239000004480 active ingredient Substances 0.000 claims description 11
- 239000001856 Ethyl cellulose Substances 0.000 claims description 10
- 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 description 10
- -1 dimethylaminoethyl methacrylamylmethylacrylate Chemical compound 0.000 claims description 10
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 10
- 229920001249 ethyl cellulose Polymers 0.000 claims description 10
- 235000019359 magnesium stearate Nutrition 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 9
- 239000011230 binding agent Substances 0.000 claims description 9
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 8
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 8
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 8
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 8
- 229920001479 Hydroxyethyl methyl cellulose Polymers 0.000 claims description 7
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 7
- 239000002253 acid Substances 0.000 claims description 7
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 7
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 7
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 7
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 6
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 6
- 239000007884 disintegrant Substances 0.000 claims description 6
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 6
- 239000000314 lubricant Substances 0.000 claims description 6
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 6
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- 239000000825 pharmaceutical preparation Substances 0.000 claims 12
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
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- 239000001993 wax Substances 0.000 description 4
- 238000005550 wet granulation Methods 0.000 description 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical group CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
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- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
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- PVOAHINGSUIXLS-UHFFFAOYSA-N 1-Methylpiperazine Chemical compound CN1CCNCC1 PVOAHINGSUIXLS-UHFFFAOYSA-N 0.000 description 1
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- 244000202285 Acrocomia mexicana Species 0.000 description 1
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- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 1
- 101100114828 Drosophila melanogaster Orai gene Proteins 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 238000005004 MAS NMR spectroscopy Methods 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
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- 241000206607 Porphyra umbilicalis Species 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
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- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
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- 239000012080 ambient air Substances 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
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- YUWFEBAXEOLKSG-UHFFFAOYSA-N hexamethylbenzene Chemical compound CC1=C(C)C(C)=C(C)C(C)=C1C YUWFEBAXEOLKSG-UHFFFAOYSA-N 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
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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
Claims (17)
- LV 11983 IZGUDROJUMA FORMULA 1. Ciets orāls zāļu preparāts, kas satur olanzapinu kā aktīvo sastāvdaļu, cieši sajauktu ar aizpildītājvielu, saistītājvielu, irdinātājvielu, sauso aizpildītāju, lai garantētu adekvātu irdenumu, un smērvielu; kurā šāds ciets zāļu preparāts ir noklāts ar polimēru, kas ir izvēlēts no grupas, kura sastāv no hidroksipropilmetilcelulozes, hidroksietilcelulozes, metilhidroksietilcelulozes, nātrija karboksimetilcelulozes, hidroksipropilcelulozes, polivinilpirolidona, dimetilaminoetil-metakrilatametilakrilata un skābes estera kopolimēra, etilakrilat-metilmetakrilata kopolimēra, metilcellulozes un etilcelulozes.
- 2. Zāļu preparāts saskaņā ar 1. punktu, kurā polimēra pārklājums ir izvēlēts no grupas, kura sastāv no hidroksipropil -metilcelulozes, hidroksipropilcelulozes, metilcellulozes un etilcelulozes.
- 3. Zāļu preparāts saskaņā ar 2. punktu, kurā polimēra pārklājums ir hidroksipropilmetilceluloze.
- 4. Zāļu preparāts saskaņā ar jebkuru no 1. līdz 3. punktam, kurā polimēra pārklājums nesatur propilēnglikolu.
- 5. Zāļu preparāts saskaņā ar 4. punktu, kurā aizpildītājviela ir laktoze.
- 6. Zāļu preparāts saskaņā ar 4. punktu, kurā saistītājviela ir hidroksipropilceluloze, un irdinātājviela ir krospovidons.
- 7. Zāļu preparāts saskaņā ar 1. punktu, kurā sausais aizpildītājs ir mikrokristāliskā celuloze.
- 8. Zāļu preparāts saskaņā ar 1. punktu, kurā smērviela ir magnija stearāts.
- 9. Zāļu preparāts saskaņā ar 1. punktu, kurā hidroksipropil -metilceluloze ir apakškārta, kura tālāk tiek noklāta ar ūdens dispersijas plēves kārtu.
- 10. Zāļu preparāts saskaņā ar 9. punktu, kuram informatīvi uzraksti ir iespiesti izmantojot ēdamu tinti.
- 11. Zāļu preparāts saskaņā ar 9. punktu, kas satur no aptuveni 1 līdz aptuveni 3 svara % olanzapinu; no aptuveni 69.5 līdz aptuveni 87.5 svara % laktozi; no aptuveni 3.5 līdz aptuveni 4.5 svara % hidroksipropilcelulozi; no aptuveni 4 līdz aptuveni 6 svara % krospovidonu; no aptuveni 9 līdz aptuveni 11 svara % mikrokristālisko celulozi; un no aptuveni 0.25 līdz aptuveni 1 svara % magnija stearātu.
- 12. Zaļu preparāts saskaņā ar 1. punktu, kurā preparāts ir tabletes formā.
- 13. Zāļu preparāts saskaņā ar 12. punktu, kurā katra tablete nodrošina olanzapina dozu, kas izvēlēta no grupas, kura sastāv no 1, 2.5, 5, 7.5, 10, 15 un 20 mg.
- 14. Zāļu preparāts saskaņā ar 1. punktu, kurā olanzapins ir būtībā tīra II Formas kristāliskā forma, kuras tipiska rentgenstaru difrakcijas aina ir attēlota ar sekojošiem atomu plakņu savstarpējiem attālumiem: d (Ā) 10.2689 8.577 7.4721 7.125 6.1459 6.071 5.4849 5.2181 5.1251 4.9874 4.7665 4.7158 4.4787 4.3307 4.2294 4.141 3.9873 3.7206 LV 11983 3.5645 3.5366 3.3828 3.2516 3.134 3.0848 3.0638 3.0111 2.8739 2.8102 2.7217 2.6432 2.6007
- 15. Process stabila farmaceitiski eleganta cieta orālā zāļu preparāta pagatavošanai, kas satur olanzapinu kā aktīvo sastāvdaļu un ir noklāts ar polimēru, kas ir izvēlēts no grupas, kura sastāv no hidroksipropilmetilcelulozes, hidroksietil-celulozes, metilhidroksietilcelulozes, nātrija karboksimetilcelulozes, hidroksipropilcelulozes, polivinilpirolidona, dimetilaminoetilmetakrilatametilakrilata un skābes estera kopolimēra, etilakrilat-metilmetakrilata kopolimēra, metilcellulozes un etilcelulozes, kas ietver augstas smalkuma pakāpes mitru granulu veidošanu, kuras žāvē pseidosašķidrinātajā slānī.
- 16. Process saskaņā ar 15. punktu, kurā olanzapins ir būtībā tīra II Formas kristāliskā forma, kuras tipiska rentgenstaru difrakcijas aina ir attēlota ar sekojošiem atomu plakņu savstarpējiem attālumiem: d (A) 10.2689 8.577 7.4721 7.125 6.1459 6.071 5.4849 5.2181 5.1251 4.9874 4.7665 4.7158 4.4787 4.3307 4.2294 4.141 3.9873 3.7206 3.5645 3.5366 3.3828 3.2516 3.134 3.0848 3.0638 3.0111 2.8739 2.8102 2.7217 2.6432 2.6007
- 17. Ciets orāls zāļu preparāts saskaņā ar 1. punktu izmantošanai, lai ārstētu tādus stāvokļus, kā psihoze, šizofrēnija, šizofrēnijas veida slimības, viegls nemiers, kuņģa un zarnu slimības, un akūtā mānija.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US41046595A | 1995-03-24 | 1995-03-24 | |
| PCT/US1996/003918 WO1996029995A1 (en) | 1995-03-24 | 1996-03-22 | Oral 2-methyl-thieno-benzodiazepine formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| LV11983A LV11983A (lv) | 1998-03-20 |
| LV11983B true LV11983B (lv) | 1998-07-20 |
Family
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| LVP-97-199A LV11983B (lv) | 1995-03-24 | 1997-10-14 | Iekšķīgi lietojams 2-metil-tieno-benzodiazepīna zāļu preparāts |
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1996
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