USRE42096E1 - Oral pulsed dose drug delivery system - Google Patents
Oral pulsed dose drug delivery system Download PDFInfo
- Publication number
- USRE42096E1 USRE42096E1 US11/091,011 US9101105A USRE42096E US RE42096 E1 USRE42096 E1 US RE42096E1 US 9101105 A US9101105 A US 9101105A US RE42096 E USRE42096 E US RE42096E
- Authority
- US
- United States
- Prior art keywords
- pharmaceutically active
- enteric
- release coating
- amphetamine salts
- coating
- 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.)
- Expired - Lifetime
Links
Images
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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K9/5073—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
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Abstract
Description
-
- (a) one or more pharmaceutically active amphetamine salts that are covered with an immediate release coating, and
- (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the at least one pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating.
TABLE 1 | |||
Ingredients | Amount (%) | ||
Nonpareil seed | 88.00 | ||
mixed amphetamine salts | 11.40 | ||
METHOCEL ® E5 Premium | 0.60 | ||
Water | * | ||
*removed during processing |
TABLE 2 | |||
Ingredients | Amount (%) | ||
MASL pellets | 40.0070.00 | ||
EUDRAGIT ® L 30D-55 | 24.88 | ||
Triethyl citrate | 2.52 | ||
Talc | 2.60 | ||
Water | * | ||
*removed during processing |
TABLE 3 | |||
Ingredients | Amount (%) | ||
MASL pellets | 70.00 | ||
EUDRAGIT ® 4110D | 26.24 | ||
Triethyl citrate | 0.76 | ||
Talc | 3.00 | ||
Water | * | ||
*removed during processing |
TABLE 4 | |||
Ingredients | Amount, kg (%) | ||
Enteric coated MASL pellets | 90.00 | ||
SURLEASE ® | 8.00 | ||
OPADRY ® white | 2.00 | ||
Water | * | ||
*removed during processing |
Claims (25)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/091,011 USRE42096E1 (en) | 1998-10-21 | 2005-03-24 | Oral pulsed dose drug delivery system |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/176,542 US6322819B1 (en) | 1998-10-21 | 1998-10-21 | Oral pulsed dose drug delivery system |
US11/091,011 USRE42096E1 (en) | 1998-10-21 | 2005-03-24 | Oral pulsed dose drug delivery system |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/176,542 Reissue US6322819B1 (en) | 1998-10-21 | 1998-10-21 | Oral pulsed dose drug delivery system |
Publications (1)
Publication Number | Publication Date |
---|---|
USRE42096E1 true USRE42096E1 (en) | 2011-02-01 |
Family
ID=22644775
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/176,542 Granted US20010055613A1 (en) | 1998-10-21 | 1998-10-21 | Oral pulsed dose drug delivery system |
US09/176,542 Ceased US6322819B1 (en) | 1998-10-21 | 1998-10-21 | Oral pulsed dose drug delivery system |
US09/807,462 Ceased US6605300B1 (en) | 1998-10-21 | 1999-10-20 | Oral pulsed dose drug delivery system |
US11/091,010 Expired - Lifetime USRE41148E1 (en) | 1998-10-21 | 1999-10-20 | Oral pulsed dose drug delivery system |
US10/172,705 Abandoned US20030124188A1 (en) | 1998-10-21 | 2002-06-14 | Oral pulsed dose drug delivery system |
US10/758,417 Abandoned US20040219213A1 (en) | 1998-10-21 | 2004-01-16 | Oral pulsed dose drug delivery system |
US11/091,011 Expired - Lifetime USRE42096E1 (en) | 1998-10-21 | 2005-03-24 | Oral pulsed dose drug delivery system |
Family Applications Before (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/176,542 Granted US20010055613A1 (en) | 1998-10-21 | 1998-10-21 | Oral pulsed dose drug delivery system |
US09/176,542 Ceased US6322819B1 (en) | 1998-10-21 | 1998-10-21 | Oral pulsed dose drug delivery system |
US09/807,462 Ceased US6605300B1 (en) | 1998-10-21 | 1999-10-20 | Oral pulsed dose drug delivery system |
US11/091,010 Expired - Lifetime USRE41148E1 (en) | 1998-10-21 | 1999-10-20 | Oral pulsed dose drug delivery system |
US10/172,705 Abandoned US20030124188A1 (en) | 1998-10-21 | 2002-06-14 | Oral pulsed dose drug delivery system |
US10/758,417 Abandoned US20040219213A1 (en) | 1998-10-21 | 2004-01-16 | Oral pulsed dose drug delivery system |
Country Status (10)
Country | Link |
---|---|
US (7) | US20010055613A1 (en) |
EP (2) | EP1977736A1 (en) |
JP (2) | JP2002527468A (en) |
AT (1) | ATE427101T1 (en) |
AU (1) | AU1214500A (en) |
CA (1) | CA2348090C (en) |
DE (1) | DE69940673D1 (en) |
ES (1) | ES2323910T3 (en) |
HK (1) | HK1038701A1 (en) |
WO (1) | WO2000023055A1 (en) |
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US9675703B2 (en) | 2006-03-16 | 2017-06-13 | Tris Pharma, Inc | Modified release formulations containing drug - ion exchange resin complexes |
US9974752B2 (en) | 2014-10-31 | 2018-05-22 | Purdue Pharma | Methods and compositions particularly for treatment of attention deficit disorder |
US10722473B2 (en) | 2018-11-19 | 2020-07-28 | Purdue Pharma L.P. | Methods and compositions particularly for treatment of attention deficit disorder |
US11590081B1 (en) | 2017-09-24 | 2023-02-28 | Tris Pharma, Inc | Extended release amphetamine tablets |
US11590228B1 (en) | 2015-09-08 | 2023-02-28 | Tris Pharma, Inc | Extended release amphetamine compositions |
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US20010055613A1 (en) | 1998-10-21 | 2001-12-27 | Beth A. Burnside | Oral pulsed dose drug delivery system |
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EP1123087A1 (en) | 2001-08-16 |
US20040219213A1 (en) | 2004-11-04 |
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EP1977736A1 (en) | 2008-10-08 |
WO2000023055A9 (en) | 2000-08-31 |
CA2348090C (en) | 2004-04-13 |
ES2323910T3 (en) | 2009-07-27 |
ATE427101T1 (en) | 2009-04-15 |
EP1123087B1 (en) | 2009-04-01 |
WO2000023055A1 (en) | 2000-04-27 |
JP2008303223A (en) | 2008-12-18 |
US20030124188A1 (en) | 2003-07-03 |
US6605300B1 (en) | 2003-08-12 |
DE69940673D1 (en) | 2009-05-14 |
USRE41148E1 (en) | 2010-02-23 |
JP2002527468A (en) | 2002-08-27 |
HK1038701A1 (en) | 2002-03-28 |
AU1214500A (en) | 2000-05-08 |
CA2348090A1 (en) | 2000-04-27 |
US20010055613A1 (en) | 2001-12-27 |
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