WO2000056266A2 - Taste masking coating compositions - Google Patents
Taste masking coating compositions Download PDFInfo
- Publication number
- WO2000056266A2 WO2000056266A2 PCT/IB1999/001735 IB9901735W WO0056266A2 WO 2000056266 A2 WO2000056266 A2 WO 2000056266A2 IB 9901735 W IB9901735 W IB 9901735W WO 0056266 A2 WO0056266 A2 WO 0056266A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composition
- dry weight
- film forming
- present
- polymers
- Prior art date
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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
Definitions
- drugs are administered orally as tablets or capsules.
- drugs can be provided either as chewable or dispersible tablets or, as liquid dosage forms such as solutions, emulsions and suspensions. These dosage forms permit perceptible exposure of the active drug to the taste buds.
- Some drugs are extremely bitter and therefore unpalatable when given in these dosage forms. As a consequence, measures need to be taken to mask the taste of these drugs in order to enhance patient compliance.
- US 4,865,851 describes a taste masked formulation of cefuroxime axetil where the drug particles are provided with integral coatings of a lipid or mixtures of lipids which are insoluble in water and which serve to mask the bitter taste of cefuroxime axetil upon oral administration.
- This coating however, results in a significant reduction in the dissolution and consequently the bioavailability of cefuroxime axetil suspension is significantly low as compared to tablet dosage form.
- the coating composition also contains lubricants which function as anti- sticking agents (e.g. talc, colloidal silica and magnesium stearate) and pharmaceutically acceptable plasticisers (e.g. triethyl citrate, polyethylene glycol, glyceryl monostearate, giyceryl triacetate, acetyl triethylcitrate, triethylcitrate, dibutyl phthalate and dibutyl sebacate).
- the lubricant quantity may be upto 200% of the dry weight of film-forming polymer, and more preferably, upto 100% of the dry weight of the film-forming polymer.
- the plasticiser quantity may be upto 40% the dry weight of the film forming polymer.
- the coated formulations may optionally be cured at elevated temperatures.
- a total polymer content in the coating of upto 30% by weight of pharmaceutical cores or, more preferably, 10% by weight of pharmaceutical cores is sufficient to mask the taste of bitter tasting, highly water soluble drugs.
- the total polymer content of the applied coat was 12.0% by weight of the core while the total solids applied was 26% by weight of the core.
- a total polymer coating of only 12% was sufficient to mask the bitter taste of Norfloxacin while giving optimum dissolution required for immediate release formulations. (Table 1.3).
- the total polymer content of the applied coat was 11.90% by weight of the core while the total solids application was 27% by weight of the core.
- the bitter taste of ciprofloxacin was masked with the applied coat without affecting dissolution, as shown in Table 5.3
- aqueous talc dispersion (30% w/w) was added to a 1% carbopol dispersion in water under stirring for 30 minutes.
- the carbopol - talc dispersion was finally added into plasticized (with triethyl citrate) ethyl cellulose dispersion with stirring for 30-40 minutes.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP99949283A EP1235556A4 (en) | 1999-03-19 | 1999-10-26 | Taste masking coating compositions |
AU62246/99A AU6224699A (en) | 1999-03-19 | 1999-10-26 | Taste masking coating compositions |
BR9917219-4A BR9917219A (en) | 1999-03-19 | 1999-10-26 | Coating compositions for flavor masking |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IN454DE1999 IN191482B (en) | 1999-03-19 | 1999-03-19 | |
IN454/DEL/99 | 1999-03-19 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2000056266A2 true WO2000056266A2 (en) | 2000-09-28 |
WO2000056266A3 WO2000056266A3 (en) | 2002-07-04 |
Family
ID=11089863
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB1999/001735 WO2000056266A2 (en) | 1999-03-19 | 1999-10-26 | Taste masking coating compositions |
Country Status (7)
Country | Link |
---|---|
EP (1) | EP1235556A4 (en) |
CN (1) | CN1615121A (en) |
AU (1) | AU6224699A (en) |
BR (1) | BR9917219A (en) |
IN (1) | IN191482B (en) |
WO (1) | WO2000056266A2 (en) |
ZA (1) | ZA200007724B (en) |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1110544A2 (en) * | 1999-12-20 | 2001-06-27 | Basf Aktiengesellschaft | Use of a film coating as taste masking coating for oral dosage forms |
US6565877B1 (en) | 1999-06-11 | 2003-05-20 | Ranbaxy Laboratories Limited | Taste masked compositions |
EP1411899A2 (en) * | 2001-08-01 | 2004-04-28 | Bristol-Myers Squibb Company | Taste masking composition |
US20060233873A1 (en) * | 2003-01-24 | 2006-10-19 | Julien Meissonnier | Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same |
US20090142378A1 (en) | 2002-02-21 | 2009-06-04 | Biovail Laboratories International S.R.L. | Controlled release dosage forms |
US7780987B2 (en) | 2002-02-21 | 2010-08-24 | Biovail Laboratories International Srl | Controlled release dosage forms |
US8889184B2 (en) * | 2006-09-07 | 2014-11-18 | Losan Pharma Gmbh | Particulate form of a pharmaceutical composition which is easy to swallow |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5958459A (en) * | 1991-12-24 | 1999-09-28 | Purdue Pharma L.P. | Opioid formulations having extended controlled released |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4321253A (en) * | 1980-08-22 | 1982-03-23 | Beatty Morgan L | Suspension of microencapsulated bacampicillin acid addition salt for oral, especially pediatric, administration |
CH666405A5 (en) * | 1985-06-24 | 1988-07-29 | Ciba Geigy Ag | SOLID, DURABLE PHARMACEUTICAL FORMS WITH ELASTIC FILM COVER. |
US4851226A (en) * | 1987-11-16 | 1989-07-25 | Mcneil Consumer Products Company | Chewable medicament tablet containing means for taste masking |
IT1227899B (en) * | 1988-12-23 | 1991-05-14 | Poli Ind Chimica Spa | TOTAL OR PARTIAL COATING OF PHARMACEUTICAL ACTIVE SUBSTANCES AND RELATED COMPOSITIONS |
US5527545A (en) * | 1989-09-18 | 1996-06-18 | Recordati S.A. Chemical And Pharmaceutical Company | Liquid-suspension controlled-release pharmaceutical composition |
IE65964B1 (en) * | 1990-07-20 | 1996-01-24 | Slagel David | Products and processes for the treatment of the alimentary canal |
IT1250421B (en) * | 1991-05-30 | 1995-04-07 | Recordati Chem Pharm | CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION WITH BIO-ADHESIVE PROPERTIES. |
WO1993024109A1 (en) * | 1992-06-04 | 1993-12-09 | Smithkline Beecham Corporation | Palatable pharmaceutical compositions |
DE19709532A1 (en) * | 1997-03-10 | 1998-09-17 | Basf Ag | Use of redispersible polymer powders or polymer granules for coating pharmaceutical or agrochemical dosage forms |
-
1999
- 1999-03-19 IN IN454DE1999 patent/IN191482B/en unknown
- 1999-10-26 BR BR9917219-4A patent/BR9917219A/en not_active Application Discontinuation
- 1999-10-26 WO PCT/IB1999/001735 patent/WO2000056266A2/en not_active Application Discontinuation
- 1999-10-26 AU AU62246/99A patent/AU6224699A/en not_active Abandoned
- 1999-10-26 EP EP99949283A patent/EP1235556A4/en not_active Withdrawn
- 1999-10-26 CN CNA998165883A patent/CN1615121A/en active Pending
-
2001
- 2001-09-19 ZA ZA200007724A patent/ZA200007724B/en unknown
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5958459A (en) * | 1991-12-24 | 1999-09-28 | Purdue Pharma L.P. | Opioid formulations having extended controlled released |
Non-Patent Citations (1)
Title |
---|
See also references of EP1235556A2 * |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6565877B1 (en) | 1999-06-11 | 2003-05-20 | Ranbaxy Laboratories Limited | Taste masked compositions |
EP1110544A2 (en) * | 1999-12-20 | 2001-06-27 | Basf Aktiengesellschaft | Use of a film coating as taste masking coating for oral dosage forms |
EP1110544A3 (en) * | 1999-12-20 | 2003-01-22 | Basf Aktiengesellschaft | Use of a film coating as taste masking coating for oral dosage forms |
EP1411899A2 (en) * | 2001-08-01 | 2004-04-28 | Bristol-Myers Squibb Company | Taste masking composition |
EP1411899A4 (en) * | 2001-08-01 | 2006-06-07 | Novartis Ag | Taste masking composition |
US20090142378A1 (en) | 2002-02-21 | 2009-06-04 | Biovail Laboratories International S.R.L. | Controlled release dosage forms |
US7780987B2 (en) | 2002-02-21 | 2010-08-24 | Biovail Laboratories International Srl | Controlled release dosage forms |
US8323692B2 (en) | 2002-02-21 | 2012-12-04 | Valeant International Bermuda | Controlled release dosage forms |
US20060233873A1 (en) * | 2003-01-24 | 2006-10-19 | Julien Meissonnier | Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same |
US8889184B2 (en) * | 2006-09-07 | 2014-11-18 | Losan Pharma Gmbh | Particulate form of a pharmaceutical composition which is easy to swallow |
Also Published As
Publication number | Publication date |
---|---|
CN1615121A (en) | 2005-05-11 |
BR9917219A (en) | 2002-04-23 |
AU6224699A (en) | 2000-10-09 |
EP1235556A4 (en) | 2003-07-16 |
IN191482B (en) | 2003-12-06 |
WO2000056266A3 (en) | 2002-07-04 |
EP1235556A2 (en) | 2002-09-04 |
ZA200007724B (en) | 2002-06-12 |
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