DE1027037T1 - Arzneimittel, das clodronat als wirkstoff und mit siliciumdioxid behandelte mikrokristalline cellulose als füllsstoff enhält - Google Patents
Arzneimittel, das clodronat als wirkstoff und mit siliciumdioxid behandelte mikrokristalline cellulose als füllsstoff enhältInfo
- Publication number
- DE1027037T1 DE1027037T1 DE1027037T DE98945336T DE1027037T1 DE 1027037 T1 DE1027037 T1 DE 1027037T1 DE 1027037 T DE1027037 T DE 1027037T DE 98945336 T DE98945336 T DE 98945336T DE 1027037 T1 DE1027037 T1 DE 1027037T1
- Authority
- DE
- Germany
- Prior art keywords
- microcrystalline cellulose
- medicament according
- product containing
- medicinal product
- silicified microcrystalline
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- ACSIXWWBWUQEHA-UHFFFAOYSA-N clodronic acid Chemical compound OP(O)(=O)C(Cl)(Cl)P(O)(O)=O ACSIXWWBWUQEHA-UHFFFAOYSA-N 0.000 title claims abstract 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 title claims 4
- 229940126601 medicinal product Drugs 0.000 title claims 3
- 239000000377 silicon dioxide Substances 0.000 title claims 2
- 235000012239 silicon dioxide Nutrition 0.000 title claims 2
- 229960002286 clodronic acid Drugs 0.000 title abstract 2
- 239000013543 active substance Substances 0.000 title 1
- 239000001913 cellulose Substances 0.000 title 1
- 229920002678 cellulose Polymers 0.000 title 1
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 claims abstract 6
- 150000003839 salts Chemical class 0.000 claims abstract 4
- 238000004519 manufacturing process Methods 0.000 claims abstract 2
- 239000008184 oral solid dosage form Substances 0.000 claims abstract 2
- 239000003814 drug Substances 0.000 claims 7
- 238000000034 method Methods 0.000 claims 5
- 239000004480 active ingredient Substances 0.000 claims 2
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical class [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- HJKBJIYDJLVSAO-UHFFFAOYSA-L clodronic acid disodium salt Chemical compound [Na+].[Na+].OP([O-])(=O)C(Cl)(Cl)P(O)([O-])=O HJKBJIYDJLVSAO-UHFFFAOYSA-L 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 238000007908 dry granulation Methods 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 238000005550 wet granulation Methods 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract 1
- 230000001184 hypocalcaemic effect Effects 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000006186 oral dosage form Substances 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
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
-
- 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
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Physical Education & Sports Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Inorganic Chemistry (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Silicates, Zeolites, And Molecular Sieves (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (10)
1. Arzneimittel, das als Wirkstoff ein pharmakologisch verträgliches Salz von Dichlormethylenbisphosphonsäure
enthält, dadurch gekennzeichnet, dass es eine ora-Ie feste Dosierungsform ist, die silicifizierte mikrokristalline Cellulose umfasst.
2. Arzneimittel nach Anspruch 1, dadurch gekennzeichnet, dass es 5 - 25 Gew.-%
silicifizierte mikrokristalline Cellulose umfasst.
3. Arzneimittel nach Anspruch 1, dadurch gekennzeichnet, dass es umfasst:
a) etwa 60 bis 80 Gew.-% wasserfreies Dinatriumclodronat;
b) etwa 8 bis 20 Gew.-% silicifizierte mikrokristalline Cellulose; und
c) etwa 0,5 bis 10 Gew.-% Gleitmittel und/oder Sprengmittel.
4. Arzneimittel nach einem der vorstehenden Ansprüche, in dem Siliciumdioxid in
der silicifizierten mikrokristallinen Cellulose in einer Menge von etwa 0,1 bis 20
Gew.-%, bezogen auf das Gewicht der mikrokristallinen Cellulose, vorhanden ist.
5. Arzneimittel nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet,
dass es entweder eine Tablette oder eine Kapsel ist.
6. Arzneimittel nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet,
dass das Salz von Dichlormethylenbisphosphonsäure das Dinatriumsalz ist.
7. Verfahren zur Herstellung eines Arzneimittels nach Anspruch 1, dadurch gekennzeichnet,
dass ein Nassgranulierverfahren verwendet wird.
8. Verfahren zur Herstellung eines Arzneimittels nach Anspruch 1, dadurch gekennzeichnet,
dass ein Trockengranulierverfahren verwendet wird.
9. Verfahren zur Herstellung eines Arzneimittels nach Anspruch 1, dadurch gekennzeichnet,
dass ein direktes Komprimierverfahren verwendet wird.
10. Verwendung von silicifizierter mikrokristalliner Cellulose zur Herstellung eines
Arzneimittels, das als Wirkstoff ein pharmakologisch verträgliches Salz von Dichlormethylenbisphosphonsäure enthält.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FI973733A FI109088B (fi) | 1997-09-19 | 1997-09-19 | Tabletti ja menetelmä sen valmistamiseksi |
| PCT/FI1998/000735 WO1999015155A1 (en) | 1997-09-19 | 1998-09-18 | Pharmaceutical preparation comprising clodronate as active ingredient and silicified microcrystalline cellulose as excipient |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE1027037T1 true DE1027037T1 (de) | 2002-11-28 |
Family
ID=8549561
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE1027037T Pending DE1027037T1 (de) | 1997-09-19 | 1998-09-18 | Arzneimittel, das clodronat als wirkstoff und mit siliciumdioxid behandelte mikrokristalline cellulose als füllsstoff enhält |
| DE69820287T Expired - Lifetime DE69820287T2 (de) | 1997-09-19 | 1998-09-18 | Pharmazeutische Zubereitung, die Chlodronat als Wirkstoff und silicifizierte mikrokristalline Cellulose als Exipienten umfasst |
| DE29824938U Expired - Lifetime DE29824938U1 (de) | 1997-09-19 | 1998-09-18 | Pharmazeutische Zubereitung, die Clodronat als Wirkstoff und silifizierte mikrokristalline Cellulose als Exzipienten umfasst |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE69820287T Expired - Lifetime DE69820287T2 (de) | 1997-09-19 | 1998-09-18 | Pharmazeutische Zubereitung, die Chlodronat als Wirkstoff und silicifizierte mikrokristalline Cellulose als Exipienten umfasst |
| DE29824938U Expired - Lifetime DE29824938U1 (de) | 1997-09-19 | 1998-09-18 | Pharmazeutische Zubereitung, die Clodronat als Wirkstoff und silifizierte mikrokristalline Cellulose als Exzipienten umfasst |
Country Status (31)
| Country | Link |
|---|---|
| EP (1) | EP1027037B1 (de) |
| JP (1) | JP3589977B2 (de) |
| KR (1) | KR20010024184A (de) |
| CN (1) | CN1124130C (de) |
| AT (1) | ATE255410T1 (de) |
| AU (1) | AU737738B2 (de) |
| BG (1) | BG64886B1 (de) |
| BR (1) | BR9812480A (de) |
| CA (1) | CA2301185C (de) |
| CZ (1) | CZ298675B6 (de) |
| DE (3) | DE1027037T1 (de) |
| DK (1) | DK1027037T3 (de) |
| EA (1) | EA002331B1 (de) |
| EE (1) | EE04218B1 (de) |
| ES (1) | ES2212341T3 (de) |
| FI (1) | FI109088B (de) |
| HK (1) | HK1031325A1 (de) |
| HR (1) | HRP20000142B1 (de) |
| HU (1) | HU226118B1 (de) |
| ID (1) | ID24423A (de) |
| IL (1) | IL135130A (de) |
| IS (1) | IS5404A (de) |
| NO (1) | NO327728B1 (de) |
| NZ (1) | NZ503766A (de) |
| PL (1) | PL191166B1 (de) |
| PT (1) | PT1027037E (de) |
| SI (1) | SI1027037T1 (de) |
| SK (1) | SK284088B6 (de) |
| TR (1) | TR200000722T2 (de) |
| UA (1) | UA73078C2 (de) |
| WO (1) | WO1999015155A1 (de) |
Families Citing this family (86)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6395303B1 (en) | 1996-06-10 | 2002-05-28 | Edward Mendell Co., Inc. | Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose |
| SE9901272D0 (sv) * | 1999-04-09 | 1999-04-09 | Astra Ab | New improved formulation |
| SE9903345D0 (sv) | 1999-09-17 | 1999-09-17 | Astra Pharma Prod | Novel process |
| DE10006125C2 (de) * | 2000-02-11 | 2003-08-28 | Kallies Feinchemie Ag | Modifizierte Mikrocellulose |
| US6399101B1 (en) | 2000-03-30 | 2002-06-04 | Mova Pharmaceutical Corp. | Stable thyroid hormone preparations and method of making same |
| US8052987B2 (en) * | 2000-06-20 | 2011-11-08 | Novartis Pharmaceuticals Corporation | Method of administering bisphosphonates |
| EP1591122B1 (de) * | 2000-06-20 | 2012-09-26 | Novartis AG | Methode zur Verabreichung von Biphosphonaten |
| US6753017B2 (en) | 2001-11-07 | 2004-06-22 | Jrs Pharma Lp | Process for preparing dry extracts |
| EP1509204A4 (de) * | 2001-11-29 | 2005-07-13 | Rettenmaier & Soehne Gmbh & Co | Agglomerierte teilchen mit einem wirkstoff, der zusammen mit verkieselter mikrokristalliner cellulose aufbereitet wird |
| GB0209265D0 (en) | 2002-04-23 | 2002-06-05 | Novartis Ag | Organic compounds |
| US20040109889A1 (en) | 2002-12-04 | 2004-06-10 | Bunick Frank J. | Surface treatment composition for soft substrates |
| US7862552B2 (en) | 2005-05-09 | 2011-01-04 | Boston Scientific Scimed, Inc. | Medical devices for treating urological and uterine conditions |
| DK2279731T3 (da) * | 2008-04-23 | 2013-03-18 | Farmasierra Mfg S L | Forbedret farmaceutisk sammensætning, som indeholder ibuprofen og codein |
| US8603527B2 (en) * | 2010-10-25 | 2013-12-10 | Signal Pharmaceuticals, Llc | Pharmaceutical formulations of a substituted diaminopurine |
| EP2811994A4 (de) * | 2012-02-07 | 2016-01-13 | Biogen Ma Inc | Pharmazeutische zusammensetzungen mit dimethylfumarat |
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| CN102671203B (zh) * | 2012-05-29 | 2013-07-10 | 安吉东来药用辅料有限责任公司 | 裙带菜多糖片剂赋形剂、药物片剂及药物片剂的制备方法 |
| CN102671205B (zh) * | 2012-05-29 | 2013-07-10 | 安吉东来药用辅料有限责任公司 | 紫菜多糖片剂赋形剂、药物片剂及药物片剂的制备方法 |
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| CN102671200B (zh) * | 2012-05-29 | 2013-07-10 | 安吉东来药用辅料有限责任公司 | 低聚异麦芽糖片剂赋形剂、药物片剂及制备方法 |
| US9127069B1 (en) | 2014-06-11 | 2015-09-08 | Antecip Bioventures LLC | Compositions comprising rank/rankl antagonists and related compounds for treating pain |
| SG10202009598VA (en) | 2014-10-06 | 2020-10-29 | Signal Pharm Llc | Substituted aminopurine compounds, compositions thereof, and methods of treatment therewith |
| CN104771761A (zh) * | 2015-03-19 | 2015-07-15 | 深圳国源国药有限公司 | 一种创新药用辅料硅化微晶纤维素及其制备方法 |
| MX2018011970A (es) | 2016-04-01 | 2019-05-20 | Signal Pharm Llc | Formas sólidas de (1s,4s)-4-(2-(((3s,4r)-3-fluorotetrahidro-2h-pir an-4-il)amino)-8-((2,4,6-triclorofenilo)amino)-9h-purin-9-il)-1-m etilciclohexano-1-carboxamida y métodos para utilizarlas. |
| EA039392B1 (ru) | 2016-04-01 | 2022-01-21 | СИГНАЛ ФАРМАСЬЮТИКАЛЗ, ЭлЭлСи | Способ лечения рака с применением замещенного аминопуринового соединения |
| KR20200061363A (ko) | 2017-10-04 | 2020-06-02 | 셀진 코포레이션 | 시스-4-[2-｛[(3ｓ,4ｒ)-3-플루오로옥산-4-일]아미노｝-8-(2,4,6-트리클로로아닐리노)-9ｈ-퓨린-9-일]-1-메틸사이클로헥산-1-카르복스아미드의 제조 공정 |
| BR122022005778B1 (pt) | 2017-10-04 | 2024-01-09 | Celgene Corporation | Cápsula compreendendo cis-4-[2-{[(3s,4r)-3-fluoro-oxan-4-il]amino}-8-(2,4,6-tricloroanilino)-9h-purin-9-il]-1-metilciclohexano-1-carboxamida |
| CN110787140A (zh) * | 2018-08-01 | 2020-02-14 | 北京万全德众医药生物技术有限公司 | 比拉斯汀片剂及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3767998D1 (de) * | 1986-12-20 | 1991-03-14 | Boehringer Mannheim Gmbh | Clodronat-haltige arzneimittel und verfahren zur herstellung derselben. |
| SK281193B6 (sk) * | 1993-05-15 | 2001-01-18 | Roche Diagnostics Gmbh | Tableta so zlepšenou biodostupnosťou účinnej látky, kyseliny klodrónovej, spôsob jej výroby a použitie mikrokryštalickej celulózy |
| FI94926C (fi) * | 1993-11-12 | 1995-11-27 | Leiras Oy | Menetelmä klodronaattivalmisteen valmistamiseksi |
| US5585115A (en) * | 1995-01-09 | 1996-12-17 | Edward H. Mendell Co., Inc. | Pharmaceutical excipient having improved compressability |
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1997
- 1997-09-19 FI FI973733A patent/FI109088B/fi not_active IP Right Cessation
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1998
- 1998-09-18 EA EA200000317A patent/EA002331B1/ru not_active IP Right Cessation
- 1998-09-18 DK DK98945336T patent/DK1027037T3/da active
- 1998-09-18 UA UA2000042105A patent/UA73078C2/uk unknown
- 1998-09-18 CZ CZ20000787A patent/CZ298675B6/cs not_active IP Right Cessation
- 1998-09-18 SI SI9830599T patent/SI1027037T1/xx unknown
- 1998-09-18 ES ES98945336T patent/ES2212341T3/es not_active Expired - Lifetime
- 1998-09-18 DE DE1027037T patent/DE1027037T1/de active Pending
- 1998-09-18 NZ NZ503766A patent/NZ503766A/en not_active IP Right Cessation
- 1998-09-18 DE DE69820287T patent/DE69820287T2/de not_active Expired - Lifetime
- 1998-09-18 SK SK393-2000A patent/SK284088B6/sk not_active IP Right Cessation
- 1998-09-18 EE EEP200000096A patent/EE04218B1/xx unknown
- 1998-09-18 PT PT98945336T patent/PT1027037E/pt unknown
- 1998-09-18 AT AT98945336T patent/ATE255410T1/de active
- 1998-09-18 KR KR1020007002955A patent/KR20010024184A/ko active Search and Examination
- 1998-09-18 CA CA002301185A patent/CA2301185C/en not_active Expired - Lifetime
- 1998-09-18 AU AU92685/98A patent/AU737738B2/en not_active Expired
- 1998-09-18 BR BR9812480-3A patent/BR9812480A/pt not_active Application Discontinuation
- 1998-09-18 PL PL339290A patent/PL191166B1/pl unknown
- 1998-09-18 ID IDW20000735A patent/ID24423A/id unknown
- 1998-09-18 DE DE29824938U patent/DE29824938U1/de not_active Expired - Lifetime
- 1998-09-18 EP EP98945336A patent/EP1027037B1/de not_active Expired - Lifetime
- 1998-09-18 TR TR2000/00722T patent/TR200000722T2/xx unknown
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