CA2127352A1 - Pharmaceutical preparation in the form of an effervescent and/or disintegrating tablet or an instant granulate, and process for producing it - Google Patents
Pharmaceutical preparation in the form of an effervescent and/or disintegrating tablet or an instant granulate, and process for producing itInfo
- Publication number
- CA2127352A1 CA2127352A1 CA002127352A CA2127352A CA2127352A1 CA 2127352 A1 CA2127352 A1 CA 2127352A1 CA 002127352 A CA002127352 A CA 002127352A CA 2127352 A CA2127352 A CA 2127352A CA 2127352 A1 CA2127352 A1 CA 2127352A1
- Authority
- CA
- Canada
- Prior art keywords
- agent
- matrix
- effervescent
- granulate
- pharmaceutical preparation
- 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.)
- Granted
Links
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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
Abstract
The pharmaceutical preparation in the form of an effervescent and/or disintegrating tablet or an instant granulate contains at least one taste irritating agent and at least one matrix delaying the release of the agent which is intimately mixed with the agent particles or envelops them and is applied to a substrate. The preparation in aqueous solution at room temperature releases at most 65 and preferably at most 50 % of the agent within some 2 minutes, but in 0.1n HCl at 38°C releases over 70 and preferably 80 %
of the agent within at most 20 and preferably at most 15 minutes. The matrix preferably contains at least one fatty acid ester and/or a wax, preferably with a melting point between 30 and 45, especially between 32 and 35°C, and/or at least one cellulose derivative and/or at least one polymethacrylate acid ester. The quantity of the agent is under 60 and preferably under 10 mg, that of the matrix 1 to 10, preferably 3 to 5 times that of the agent per tablet or dose of granulate. For the treatment of diarrhoea by means of loperamide, the matrix also contains a mixture and quantity of alkaline and/or alkaline earth salts, preferably organic salts, and chlorides which compensate for the loss of electrolyte in the body.
of the agent within at most 20 and preferably at most 15 minutes. The matrix preferably contains at least one fatty acid ester and/or a wax, preferably with a melting point between 30 and 45, especially between 32 and 35°C, and/or at least one cellulose derivative and/or at least one polymethacrylate acid ester. The quantity of the agent is under 60 and preferably under 10 mg, that of the matrix 1 to 10, preferably 3 to 5 times that of the agent per tablet or dose of granulate. For the treatment of diarrhoea by means of loperamide, the matrix also contains a mixture and quantity of alkaline and/or alkaline earth salts, preferably organic salts, and chlorides which compensate for the loss of electrolyte in the body.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP92100441 | 1992-01-13 | ||
| EP92100441.2 | 1992-01-13 | ||
| PCT/EP1993/000055 WO1993013760A1 (en) | 1992-01-13 | 1993-01-12 | Pharmaceutical preparation in the form of an effervescent and/or disintegrating tablet or an instant granulate, and process for producing it |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2127352A1 true CA2127352A1 (en) | 1993-07-22 |
| CA2127352C CA2127352C (en) | 2005-05-31 |
Family
ID=8209237
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002127352A Expired - Fee Related CA2127352C (en) | 1992-01-13 | 1993-01-12 | Pharmaceutical preparation in the form of an effervescent and/or disintegrating tablet or an instant granulate, and process for producing it |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US5587179A (en) |
| EP (1) | EP0620731B1 (en) |
| JP (1) | JPH07506336A (en) |
| AT (1) | ATE128028T1 (en) |
| AU (1) | AU668375B2 (en) |
| CA (1) | CA2127352C (en) |
| CZ (1) | CZ283351B6 (en) |
| DE (1) | DE59300632D1 (en) |
| DK (1) | DK0620731T3 (en) |
| ES (1) | ES2068800T3 (en) |
| FI (1) | FI110353B (en) |
| GR (2) | GR950300005T1 (en) |
| MX (1) | MX9300110A (en) |
| PL (1) | PL173676B1 (en) |
| WO (1) | WO1993013760A1 (en) |
| ZA (1) | ZA93215B (en) |
Families Citing this family (41)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5395627A (en) * | 1992-09-04 | 1995-03-07 | Akzo N.V. | Pharmaceutical granulate |
| DE4403943A1 (en) * | 1994-02-08 | 1995-08-10 | Hexal Pharma Gmbh | Oral preparation of the preparation with diclofenac sodium |
| TW466119B (en) * | 1994-02-28 | 2001-12-01 | Janssen Pharmaceutica Nv | Film coated tablet of paracetamol and domperidone |
| GB9421836D0 (en) * | 1994-10-28 | 1994-12-14 | Scherer Corp R P | Process for preparing solid pharmaceutical dosage forms of hydrophobic substances |
| US5837287A (en) * | 1994-10-28 | 1998-11-17 | R P Scherer Corporation | Process for preparing solid pharmaceutical dosage forms |
| US5807577A (en) * | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
| US6974595B1 (en) * | 1996-05-17 | 2005-12-13 | Proethic Pharmaceuticals, Inc. | Pharmaceutical compositions based on Diclofenae |
| GB9710767D0 (en) * | 1996-06-26 | 1997-07-23 | On Ninh | Analgesic and anti-inflamatory compositions comprising domperidone and methods of using same |
| BE1011045A3 (en) * | 1997-03-14 | 1999-04-06 | Ucb Sa | Pharmaceutical composition for controlled release of active substances. |
| US5843477A (en) * | 1997-09-30 | 1998-12-01 | Bayer Corporation | Lubricants for use in tabletting |
| US5904937A (en) * | 1997-10-03 | 1999-05-18 | Fmc Corporation | Taste masked pharmaceutical compositions |
| DE19814256A1 (en) * | 1998-03-31 | 1999-10-07 | Asta Medica Ag | Solid, fast-breaking cetirizine formulations |
| DE19814257A1 (en) * | 1998-03-31 | 1999-10-07 | Asta Medica Ag | effervescent formulations |
| DE19822036A1 (en) * | 1998-05-15 | 1999-11-18 | Bayer Ag | Effervescent pharmaceutical composition with improved stability |
| GB9816899D0 (en) | 1998-08-05 | 1998-09-30 | Boots Co Plc | Therapeutic agents |
| US7001612B2 (en) | 1998-08-26 | 2006-02-21 | All Sun Hsf Company Limited | Composition for the relief of heat stress |
| US6235322B1 (en) * | 1999-03-09 | 2001-05-22 | Mintech, Inc. | Highly soluble and stable mineral supplements containing calcium and magnesium |
| US6284270B1 (en) * | 1999-08-04 | 2001-09-04 | Drugtech Corporation | Means for creating a mass having structural integrity |
| AU5060499A (en) * | 1999-08-04 | 2001-03-05 | Ranbaxy Laboratories Limited | Hydrodynamically balanced oral drug delivery system |
| AU2001234005B2 (en) * | 2000-02-28 | 2006-01-19 | Pharmakodex Limited | Improvements in or relating to the delivery of oral drugs |
| WO2001091730A1 (en) | 2000-05-31 | 2001-12-06 | Drugtech Corporation | Mineral supplement |
| GB0222612D0 (en) * | 2002-09-30 | 2002-11-06 | Univ Gent | Controlled delivery system for bioactive substances |
| EP1560569A4 (en) * | 2002-10-11 | 2006-03-22 | Depomed Dev Ltd | Gastro-retentive levodopa delivery form |
| JP4601271B2 (en) * | 2003-08-01 | 2010-12-22 | 大洋薬品工業株式会社 | COMPRESSION MOLDING AND METHOD FOR PRODUCING THE SAME |
| US20050089502A1 (en) * | 2003-08-21 | 2005-04-28 | Todd Schansberg | Effervescent delivery system |
| US8216610B2 (en) * | 2004-05-28 | 2012-07-10 | Imaginot Pty Ltd. | Oral paracetamol formulations |
| JO3352B1 (en) * | 2005-06-17 | 2019-03-13 | Apr Applied Pharma Res Sa | Diclofenac formulations and methods of use |
| US7811604B1 (en) | 2005-11-14 | 2010-10-12 | Barr Laboratories, Inc. | Non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising clozapine and methods of making and using the same |
| EP1954298A4 (en) | 2005-11-28 | 2012-10-31 | Imaginot Pty Ltd | Oral therapeutic compound delivery system |
| EP1902708A1 (en) * | 2006-09-25 | 2008-03-26 | Losan Pharma GmbH | Drug comprising stabilized pharmaceutical solid compositions and processes for their preparation |
| CN101084881B (en) * | 2007-06-23 | 2012-08-29 | 淮北辉克药业有限公司 | Targeted quick-releasing effervescence preparation and preparation method thereof |
| US20090110716A1 (en) * | 2007-10-31 | 2009-04-30 | Frank Bunick | Orally disintegrative dosage form |
| US8313768B2 (en) | 2009-09-24 | 2012-11-20 | Mcneil-Ppc, Inc. | Manufacture of tablet having immediate release region and sustained release region |
| US8784781B2 (en) | 2009-09-24 | 2014-07-22 | Mcneil-Ppc, Inc. | Manufacture of chewing gum product with radiofrequency |
| US8858210B2 (en) | 2009-09-24 | 2014-10-14 | Mcneil-Ppc, Inc. | Manufacture of variable density dosage forms utilizing radiofrequency energy |
| US9445971B2 (en) | 2012-05-01 | 2016-09-20 | Johnson & Johnson Consumer Inc. | Method of manufacturing solid dosage form |
| US9511028B2 (en) | 2012-05-01 | 2016-12-06 | Johnson & Johnson Consumer Inc. | Orally disintegrating tablet |
| PL2953617T3 (en) | 2013-02-06 | 2020-05-18 | Hermes Arzneimittel Gmbh | Pharmaceutical compositions incorporating low-dose drugs |
| ES2750323T3 (en) | 2014-01-10 | 2020-03-25 | Johnson & Johnson Consumer Inc | Method for manufacturing a tablet using radio frequency and loss coated particles |
| PL3157506T3 (en) | 2014-06-20 | 2021-03-08 | Hermes Arzneimittel Gmbh | Taste-masked oral pharmaceutical composition |
| US10493026B2 (en) | 2017-03-20 | 2019-12-03 | Johnson & Johnson Consumer Inc. | Process for making tablet using radiofrequency and lossy coated particles |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4289751A (en) * | 1979-06-29 | 1981-09-15 | Merck & Co., Inc. | Effervescent enteric-coated formulation of soluble form of erythromycin and therapeutic use thereof |
| US4704284A (en) * | 1982-08-12 | 1987-11-03 | Pfizer Inc. | Long-acting matrix tablet formulations |
| US4539198A (en) * | 1983-07-07 | 1985-09-03 | Rowell Laboratories, Inc. | Solid pharmaceutical formulations for slow, zero order release via controlled surface erosion: expanded range |
| HU198844B (en) * | 1984-06-14 | 1989-12-28 | Sandoz Ag | Process for producing new galenic pharmaceutical composition ensuring retarded release of active ingredient |
| DE3440288A1 (en) * | 1984-11-05 | 1986-05-07 | Gergely, Gerhard, Dr.-Ing., Wien | PHARMACEUTICAL PREPARATION WITH A CONTENT OF AT LEAST ONE Mucous-irritating SUBSTANCE OR THE LIKE, PARTICULARLY PROFESSIONALS, AND METHOD FOR THE PRODUCTION THEREOF |
| DE3524003A1 (en) * | 1985-07-04 | 1987-01-08 | Heumann Ludwig & Co Gmbh | MEDICINE GRANULES WITH DELAYED ACTIVE SUBSTANCE RELEASE AND METHOD FOR THE PRODUCTION THEREOF |
| WO1987001936A1 (en) * | 1985-09-25 | 1987-04-09 | Gerhard Gergely | Desintegration tablet and process for its manufacture |
| US4753800A (en) * | 1985-10-04 | 1988-06-28 | Warner-Lambert Company | Medicament adsorbates and their preparation |
| NZ231281A (en) * | 1988-11-08 | 1991-01-29 | Takeda Chemical Industries Ltd | Sustained release pharmaceutical preparations comprising the active agent dispersed in a solid matrix of a fatty acid ester of a polyglycerol |
| GB8908361D0 (en) * | 1989-04-13 | 1989-06-01 | Beecham Group Plc | Composition |
-
1993
- 1993-01-11 MX MX9300110A patent/MX9300110A/en not_active IP Right Cessation
- 1993-01-12 WO PCT/EP1993/000055 patent/WO1993013760A1/en active IP Right Grant
- 1993-01-12 AU AU33492/93A patent/AU668375B2/en not_active Ceased
- 1993-01-12 JP JP5512137A patent/JPH07506336A/en active Pending
- 1993-01-12 CA CA002127352A patent/CA2127352C/en not_active Expired - Fee Related
- 1993-01-12 US US08/256,503 patent/US5587179A/en not_active Expired - Lifetime
- 1993-01-12 EP EP93902180A patent/EP0620731B1/en not_active Expired - Lifetime
- 1993-01-12 CZ CZ941605A patent/CZ283351B6/en not_active IP Right Cessation
- 1993-01-12 AT AT93902180T patent/ATE128028T1/en active
- 1993-01-12 PL PL93304677A patent/PL173676B1/en not_active IP Right Cessation
- 1993-01-12 DE DE59300632T patent/DE59300632D1/en not_active Expired - Lifetime
- 1993-01-12 DK DK93902180.4T patent/DK0620731T3/en active
- 1993-01-12 ES ES93902180T patent/ES2068800T3/en not_active Expired - Lifetime
- 1993-01-13 ZA ZA93215A patent/ZA93215B/en unknown
-
1994
- 1994-07-12 FI FI943315A patent/FI110353B/en active
-
1995
- 1995-02-28 GR GR950300005T patent/GR950300005T1/en unknown
- 1995-10-18 GR GR950402909T patent/GR3017806T3/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| FI943315A (en) | 1994-07-12 |
| EP0620731A1 (en) | 1994-10-26 |
| GR3017806T3 (en) | 1996-01-31 |
| FI110353B (en) | 2002-12-31 |
| ES2068800T1 (en) | 1995-05-01 |
| FI943315A0 (en) | 1994-07-12 |
| ZA93215B (en) | 1993-08-19 |
| GR950300005T1 (en) | 1995-02-28 |
| DE59300632D1 (en) | 1995-10-26 |
| AU668375B2 (en) | 1996-05-02 |
| CZ160594A3 (en) | 1994-12-15 |
| ATE128028T1 (en) | 1995-10-15 |
| ES2068800T3 (en) | 1995-12-16 |
| CA2127352C (en) | 2005-05-31 |
| DK0620731T3 (en) | 1996-04-09 |
| US5587179A (en) | 1996-12-24 |
| MX9300110A (en) | 1994-07-29 |
| AU3349293A (en) | 1993-08-03 |
| PL173676B1 (en) | 1998-04-30 |
| JPH07506336A (en) | 1995-07-13 |
| WO1993013760A1 (en) | 1993-07-22 |
| EP0620731B1 (en) | 1995-09-20 |
| CZ283351B6 (en) | 1998-03-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |