FI111605B - Förfarande för framställning av i vatten dispergerbara tabletter - Google Patents
Förfarande för framställning av i vatten dispergerbara tabletter Download PDFInfo
- Publication number
- FI111605B FI111605B FI933401A FI933401A FI111605B FI 111605 B FI111605 B FI 111605B FI 933401 A FI933401 A FI 933401A FI 933401 A FI933401 A FI 933401A FI 111605 B FI111605 B FI 111605B
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- FI
- Finland
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- weight
- tablet
- tablets
- granules
- veegum
- Prior art date
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- 239000004565 water dispersible tablet Substances 0.000 title claims abstract description 12
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Classifications
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- 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
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- 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
Claims (22)
1. Förfarande för framställning av en sadan i vat-ten dispergerbar tablett, som omfattar en aktiv ingredi- 5 ens, som valts ur en grupp som bestär av 2 - 90 vikt-% la-motrigin eller ett farmaceutiskt godtagbart sait därav ooh 50 - 95 vikt-% aciklovir eller ett farmaceutiskt godtagbart sait därav tillsammans med 0,25 - 40 vikt-% av farmaceutiskt godtagbar svällbar lera, kännetecknat 10 av att nämnda aktiva ingrediens bringas i kontakt med nämnda svällbara lera för att bilda granulat och därefter komprimeras granulaten sä att en i vatten dispergerande tablett bildas som kan dispergeras i vatten inom en tids-period av 3 minuter sä att en dispersion ästadkoms vilken 15 kan gä genom ett silnät med en masköppning av 710 pm i en-lighet med testet för dispergerbara tabletter vilket defi-nierats i publikationen British Pharmacopoeia, 1998, Volume II, sid 895.
2. Förfarande enligt patentkrav 1, kanne-20 tecknat av att omfattar steg där a) den i en torr, finfördelad form förefintliga aktiva ingrediensen blandas med svällbar lera, eventuellt under tillsättning av en eller flera andra farmaceutiska v bärare eller fyllningsmedel, 25 b) en tillräcklig mängd granuleringsvätska till- sätts för att fukta den torra blandningen, c) den sälunda erhällna fuktiga blandningen granu-leras för att bilda granulat, d) granulaten torkas och eventuellt blandas granu-30 laten med andra eventuella bärare eller fyllningsmedel, säsom smörjmedel, glidmedel, smak- eller arommedel och e) granulaten komprimeras sä att en tablett bildas som kan dispergeras i vatten inom en tidsperiod av 3 minuter sä att en dispersion ästadkoms vilken kan gä genom ett 35 silnät med en masköppning av 710 pm i enlighet med testet 111605 för dispergerbara tabletter vilket definierats i ovan nämnda British Pharmacopoeia.
3. Förfarande enligt patentkrav 1 eller 2, k ä n-netecknat av att man bildar en f ilmöverdragen 5 tablett, som kan dispergera i vatten inom en tidsperiod av 5 minuter sä att en dispersion ästadkoms vilken kan gä genom ett silnät med en masköppning av 710 pm i enlighet med testet för dispergerbara tabletter vilket definierats i publikationen British Pharmacopoeia, 1998, Volume II, 10 sid 895.
4. Förfarande enligt nägot av patentkraven 1-3, kännetecknat av att man framställer en tablett, som kan dispergeras i vatten inom en tidsperiod av 2 minuter. 15
5. Förfarande enligt nägot av patentkraven 1 - 4, kännetecknat av att dispersionen innehäller partiklar med en sadan partikelstorleksfördelning att 100 % tili storleken är mindre än 710 pm och mer än 50 %' är mindre än 300 pm. 20
6. Förfarande enligt patentkrav 5, känne tecknat av att dispersionen innehäller partiklar med en sädan partikelstorleksfördelning att 100 % tili storleken är mindre än 710 pm, mer än 70 % är mindre än 300 pm och mer än 50 % är mindre än 200 pm. *. 25
7. Förfarande enligt nägot av patentkraven 1-3, kännetecknat av att den svällbara leran omfattar smektit eller attapulgit.
8. Förfarande enligt patentkrav 7, kännetecknat av att smektit väljs ur montmorillo-30 nitgruppen.
• · .. 9. Förfarande enligt patentkrav 8, känne tecknat av att montmorilloniten är Veegum F eller bentonit. 111605
10. Förfarande enligt nägot av patentkraven 1-3, kännetecknat av att den svällbara leran är närvarande i tablettgranulaten i en mängd av 1-40 vikt-%. 5
11. Förfarande enligt patentkrav 10, känne tecknat av att den svällbara leran är närvarande i en mängd av 1 - 10 vikt-%.
12. Förfarande enligt patentkrav 11, kännetecknat av att den svällbara leran är närvarande i 10 en mängd av 5 - 10 vikt-%.
13. Förfarande enligt nägot av patentkraven 1-3, kännetecknat av att man framställer en tablett, som dessutom omfattar ett sönderdelande medel.
14. Förfarande enligt nägot av de föregäende 15 patentkraven, kännetecknat av att den aktiva ingrediensen är aciklovir.
15. Förfarande enligt patentkrav 14, kännetecknat av att aciklovir är närvarande i en mängd av 60 - 95 vikt-%. 20
16. Förfarande enligt patentkrav 15, känne tecknat av att man framställer en tablett, som omfattar 200 - 800 mg aciklovir och har följande formel: 70 - 90 vikt-% aciklovir, 0,25 - 5 vikt-% povidon eller förgelad stärkelse, 0,5 - 30 vikt-% Veegum F eller 25 bentonit, 5-25 vikt-% mikrokristallin cellulosa eller LHPC-LH11, 0-8 vikt-% natriumstärkelseglykolat, 0,25 - 2 vikt-% magnesiumstearat och eventuellt 0,1-2 vikt-% . Opadry-filmöverdragssammansättning eller 0,1 - 0,5 vikt-% polyetenglykol 8000-filmöverdragssammansättning. 30
17. Förfarande enligt patentkrav 16, k ä n n e - '> * * t e c k n a t av att man framställer en tablett, som har följande formel: 75 - 85 vikt-% aciklovir, 0,5-2 vikt-% povidon eller förgelad stärkelse, 0,5 - 10 vikt-% Veegum F eller bentonit, 5-15 vikt-% mikrokristallin cellulosa 35 eller LHPC-LH11, 0-5 vikt-% natriumstärkelseglykolat, 0,25 - 2 vikt-% magnesium-stearat och eventuellt 0,1 - 111605 1,0 vikt-% Opadry-filmöverdragssammansättning eller 0,1 -0,2 vikt-% polyetenglykol 8000-filmöverdragssammansätt- ' rung.
18. Förfarande enligt nägot av patentkraven 1-3, 5 kännetecknat av att den'aktiva ingrediensen är lamotrigin.
19. Förfarande enligt patentkrav 18, kännetecknat av att man framställer en tablett, som omfattar 25 - 200 mg lamotrigin och har följande formel: 10 30 - 50 vikt-% lamotrigin, 26 - 46 vikt-% kalciumkarbonat, 5-30 vikt-% LHPC-LH11 eller mikrokristallin cellulosa, 0,25 - 30 vikt-% Veegum F eller bentonit, 1-8 vikt-% povidon eller förgelad stärkelse, 0-8 vikt-% natrium-stärkelseglykolat, 0,25 - 2 vikt-% magnesiumstearat och 15 eventuellt 0,1-2 vikt-% Opadry-filmöverdragssamman- sättning eller 0,1 - 0,5 vikt-% polyetenglykol 8000-film-överdragssammansättning.
20. Förfarande enligt patentkrav 19, kännetecknat av att man framställer en tablett, som har 20 följande formel: 35 - 45 vikt-% lamotrigin, 31 - 41 vikt-% kalciumkarbonat, 5-15 vikt-% LHPC-LHll eller mikrokristallin cellulosa, 0,25 - 10 vikt-% Veegum F eller bentonit, 2-5 vikt-% povidon eller förgelad stärkelse, 0-5 vikt-% natriumstärkelseglykolat, 0,25 - 1 vikt-% V 25 magnesiumstearat och eventuellt 0,25 - 1 vikt-% Opadry- filmöverdragssammansättning eller 0,1 - 0,2 vikt-% polyetenglykol· 8000-filmöverdragssammansättning.
21. Förfarande enligt patentkrav 18, kännetecknat av att man framställer en tablett, som om- 30 fattar 5 - 50 mg lamotrigin och har följande formel: 3 - » · · ,.. 13 vikt-% lamotrigin, 50 - 60 vikt-% laktos eller kalcium karbonat, 20 - 35 vikt-% mikrokristallin cellulosa eller LHPC-LHll, 0-8 vikt-% natriumstärkelseglykolat, 0,25 -30 vikt-% Veegum F, 1,0-8,0 vikt-% povidon K30 eller 35 förgelad stärkelse, 0-0,5 vikt-% natriumdokusat, 0-3 vikt-% natriumsackarin, 0,25 - 2 vikt-% magnesium- 111605 stearat och eventuellt 0,1 - 2,0 vikt-% Opadry-film-överdragssammansättning eller 0,1 - 0,5 vikt-% polyeten-glykol 8000-filmöverdragssammansättning.
22. Förfarande enligt patentkrav 21, kanne-5 tecknat av att man framställer en tablett, som har följande formel: 5-11 vikt-% lamotrigin, 53 - 59 vikt-% laktos eller kalciumkarbonat, 24 - 30 vikt-% mikrokris- tallin cellulosa eller LHPC-LHll, 0-5 vikt-% natriumstärkelseglykolat, 0,25 - 10 vikt-% Veegum F, 2 - 5 10 vikt-% povidon K30 eller förgelad stärkelse, 0,5 - 0,15 vikt-% natriumdokusat, 0,5-2 vikt-% natriumsackarin, 0,25 -1 vikt-% magnesiumstearat och eventuellt 0,1-1 vikt-% Opadry-filmöverdragssammansättning eller 0,1 - 0,2 vikt-% polyetenglykol 8000-filmöverdragssammansättning. t < 1 I I • · <
Applications Claiming Priority (10)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB919102019A GB9102019D0 (en) | 1991-01-30 | 1991-01-30 | Pharmaceutical formulations |
| GB9102019 | 1991-01-30 | ||
| GB9124807 | 1991-11-22 | ||
| GB919124807A GB9124807D0 (en) | 1991-11-22 | 1991-11-22 | Pharmaceutical formulations |
| GB9124803 | 1991-11-22 | ||
| GB919124803A GB9124803D0 (en) | 1991-11-22 | 1991-11-22 | Pharmaceutical formulations |
| GB9125005 | 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 |
| GB9200163 | 1992-01-29 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| FI933401A FI933401A (fi) | 1993-07-29 |
| FI933401A0 FI933401A0 (fi) | 1993-07-29 |
| FI111605B true FI111605B (sv) | 2003-08-29 |
Family
ID=27450613
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FI933401A FI111605B (sv) | 1991-01-30 | 1993-07-29 | Förfarande för framställning av i vatten dispergerbara tabletter |
| FI20021701A FI20021701A (sv) | 1991-01-30 | 2002-09-24 | I vatten dispergerbara tabletter |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FI20021701A FI20021701A (sv) | 1991-01-30 | 2002-09-24 | I vatten dispergerbara tabletter |
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| EP (1) | EP0522128B1 (sv) |
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| GR (1) | GR3019545T3 (sv) |
| HK (1) | HK78597A (sv) |
| HU (2) | HU221677B1 (sv) |
| IE (1) | IE77165B1 (sv) |
| IL (1) | IL100796A (sv) |
| IT (1) | IT1257473B (sv) |
| LU (1) | LU88323A1 (sv) |
| MX (1) | MX9200412A (sv) |
| MY (2) | MY110880A (sv) |
| NL (1) | NL9220009A (sv) |
| NO (1) | NO306697B1 (sv) |
| PA (1) | PA7695401A1 (sv) |
| PL (1) | PL169106B1 (sv) |
| RU (1) | RU2106861C1 (sv) |
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| SK (2) | SK282071B6 (sv) |
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| KR960001372B1 (ko) * | 1986-09-24 | 1996-01-26 | 예일 유니버시티 | 레트로비루스로 감염된 환자의 치료에 사용되는 2',3'-디디옥시사이티딘-2'-엔(2',3'-디디옥시-2',3'-디디하이드로사이티딘)의 항생물질 |
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| US4771077A (en) * | 1986-10-21 | 1988-09-13 | American Home Products Corporation (Del.) | Spray dried acetaminophen |
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-
1992
- 1992-01-29 SK SK817-93A patent/SK282071B6/sk unknown
- 1992-01-29 HU HU9302212A patent/HU221677B1/hu unknown
- 1992-01-29 DK DK92903508.7T patent/DK0522128T3/da active
- 1992-01-29 FR FR9200938A patent/FR2671970B1/fr not_active Expired - Fee Related
- 1992-01-29 CH CH309292A patent/CH685978A5/fr not_active IP Right Cessation
- 1992-01-29 BE BE9200088A patent/BE1004461A5/fr not_active IP Right Cessation
- 1992-01-29 IL IL10079692A patent/IL100796A/en not_active IP Right Cessation
- 1992-01-29 PL PL92300134A patent/PL169106B1/pl unknown
- 1992-01-29 EP EP92903508A patent/EP0522128B1/en not_active Expired - Lifetime
- 1992-01-29 IE IE920284A patent/IE77165B1/en not_active IP Right Cessation
- 1992-01-29 AT AT92903508T patent/ATE133068T1/de not_active IP Right Cessation
- 1992-01-29 US US08/090,111 patent/US5556639A/en not_active Expired - Lifetime
- 1992-01-29 JP JP04503284A patent/JP3118255B2/ja not_active Expired - Lifetime
- 1992-01-29 WO PCT/GB1992/000163 patent/WO1992013527A1/en not_active IP Right Cessation
- 1992-01-29 ES ES09250043A patent/ES2080641B1/es not_active Expired - Fee Related
- 1992-01-29 DE DE69207656T patent/DE69207656T2/de not_active Expired - Lifetime
- 1992-01-29 NL NL9220009A patent/NL9220009A/nl active Search and Examination
- 1992-01-29 AU AU11863/92A patent/AU653203B2/en not_active Expired
- 1992-01-29 GB GB9218097A patent/GB2257363B/en not_active Revoked
- 1992-01-29 CA CA002098108A patent/CA2098108C/en not_active Expired - Lifetime
- 1992-01-29 UA UA93002090A patent/UA37214C2/uk unknown
- 1992-01-29 KR KR1019930702233A patent/KR100190254B1/ko not_active IP Right Cessation
- 1992-01-29 ES ES92903508T patent/ES2089498T3/es not_active Expired - Lifetime
- 1992-01-29 MY MYPI92000143A patent/MY110880A/en unknown
- 1992-01-29 SK SK1655-2000A patent/SK282072B6/sk unknown
- 1992-01-29 DE DE4290300T patent/DE4290300T1/de not_active Withdrawn
- 1992-01-29 RU RU93051524A patent/RU2106861C1/ru active
- 1992-01-29 CZ CZ19931082A patent/CZ286723B6/cs not_active IP Right Cessation
- 1992-01-30 IT ITRM920069A patent/IT1257473B/it active IP Right Grant
- 1992-01-30 MX MX9200412A patent/MX9200412A/es unknown
- 1992-02-02 SA SA92120365A patent/SA92120365B1/ar unknown
-
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 SE19939302363A patent/SE9302363D0/sv not_active Application Discontinuation
- 1993-07-27 DK DK93878A patent/DK87893D0/da not_active Application Discontinuation
- 1993-07-29 FI FI933401A patent/FI111605B/sv active
- 1993-08-26 BG BG98071A patent/BG61665B2/bg unknown
-
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
-
1995
- 1995-06-28 HU HU95P/P00506P patent/HU211161A9/hu unknown
- 1995-08-24 PA PA19957695401A patent/PA7695401A1/es unknown
-
1996
- 1996-04-03 GR GR960400936T patent/GR3019545T3/el unknown
-
1997
- 1997-06-12 HK HK78597A patent/HK78597A/xx not_active IP Right Cessation
-
1998
- 1998-02-20 CY CY200798A patent/CY2007A/xx unknown
- 1998-02-27 MY MYPI98000866A patent/MY120025A/en unknown
-
2000
- 2000-03-14 JP JP2000070675A patent/JP3483515B2/ja not_active Expired - Lifetime
-
2002
- 2002-09-24 FI FI20021701A patent/FI20021701A/sv unknown
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190343906A1 (en) * | 2017-04-10 | 2019-11-14 | Zhejiang Shouxiangu Pharmaceutical Company, Ltd. | Tablet of sporoderm-removed ganoderma lucidum spore and preparation method thereof |
| US11931389B2 (en) * | 2017-04-10 | 2024-03-19 | Zhejiang Shouxiangu Pharmaceutical Company, Ltd. | Tablet of sporoderm-removed ganoderma lucidum spore and preparation method thereof |
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