Directly compressible high load acetaminophen formulations

Number of patents in Portfolio can not be more than 2000

United States of America Patent

PATENT NO 5965166
SERIAL NO

08964917

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ATTORNEY / AGENT: (SPONSORED)

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Abstract

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Direct compressed solid pharmaceutical dosage forms containing: a) from about 40 to about 95% by weight acetaminophen; b) from about 1 to about 60% by weight of a direct compression vehicle comprising microcrystalline cellulose; and c) from about 0.01 to about 4.0% by weight of a pharmaceutically-acceptable lubricant are disclosed. The acetaminophen and direct compression vehicle are combined under high shear conditions which are sufficient to transform acetaminophen and direct compression vehicle into a homogenous granulate without degradation. In preferred aspects of the invention, the lubricant is also combined with the acetaminophen and direct compression vehicle under high shear conditions. Methods of preparing the directly compressed solid pharmaceutical dosage forms and methods of treatment with the dosage forms are also disclosed. The methods are particularly well suited for preparing directly compressed dosage forms containing high load (i.e., up to 80% or greater) amounts of acetaminophen based on the weight of the total tablet.

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First Claim

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Patent Owner(s)

Patent OwnerAddressTotal Patents
J. Rettenmaier & Soehne GmbH + Co. KGROSENBERG11

International Classification(s)

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  • [Patents Count]

Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Hunter, Edward A Glenham, NY 32 911
Sherwood, Bob E Amenia, NY 35 978
Zeleznik, Joseph A New Paltz, NY 12 174

Cited Art Landscape

Patent Info (Count) # Cites Year
 
Other [Check patent profile for assignment information] (1)
* H1229 Stabilizing agent for dry mix food products 29 1990
 
BASF CORPORATION (1)
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TOSHIBA CORPORATION (1)
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ALZA CORPORATION (1)
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BRISTOL-MYERS SQUIBB COMPANY (1)
* 4664915 Compressed and formed alkaline component suitable for use in buffered aspirin product 62 1986
 
TEVA GYOGYSZERGYAR RESZVENYTARSASAG (1)
* 5322698 Process for the preparation of a tablet or dragee composition containing a heat-, light- and moisture-sensitive active ingredient having monoclinic crystal structure 25 1992
 
RHODIA INC. (1)
* 4439453 Directly compressible acetaminophen granulation 53 1982
 
NIRO HOLDING A/S (1)
* 5030400 Process and an apparatus for agglomeration of a powdery material 91 1990
 
MALLINCKRODT SPECIALTY CHEMICALS COMPANY, A DE CORP. (1)
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CP KELCO U.S., INC. (1)
* 4911946 Carbohydrate cream substitute 85 1988
 
PURDUE PHARMA L.P. (1)
* 5472712 Controlled-release formulations coated with aqueous dispersions of ethylcellulose 275 1993
 
BUCKEYE TECHNOLOGIES INC. (1)
* 5026569 Cotton fiber particles for use in baked goods 19 1989
 
Winters Canning Co. (1)
* 4814195 Reduced calorie peanut butter product 62 1987
 
KRAFT FOODS HOLDINGS, INC. (1)
* 5011701 Low calorie food products having smooth, creamy, organoleptic characteristics 74 1989
 
CULTOR LTD. (1)
* 5158798 Low-calorie fat substitute 41 1991
 
FMC CORPORATION (10)
* 4744987 Coprocessed microcrystalline cellulose and calcium carbonate composition and its preparation 114 1987
* 4980193 Microcrystalline cellulose-based stabilizer system for dry mix instant chocolate drink 50 1989
* 5075115 Process for polymerizing poly(lactic acid) 126 1990
* 5192569 Fat-like bulking agent for aqueous foods comprising microcrystalline cellulose and a galactomannan gum 71 1991
* 5338562 Low fat spread and process for making same 23 1992
* 5366742 Colloidal microcrystalline cellulose and barrier dispersant composition and method for manufacture 41 1993
* 5441753 Coprocessed particulate bulking and formulating AIDS: their composition, production, and use 45 1994
* 5462761 Microcrystalline cellulose and glucomannan aggregates 32 1994
* 5429830 Marshmallow-type confections 39 1994
* 5505982 Chocolate confection 73 1995
 
Lipton, division of Conopco, Inc. (1)
* 5209942 Low fat/no fat salad dressing having mimetic functional properties fat and a process therefor 38 1991
 
THE J.M. SMUCKER COMPANY (1)
* 5132128 Reduced calorie dessert topping 22 1991
 
J. Rettenmaier & Soehne GmbH + Co. KG (1)
* 5585115 Pharmaceutical excipient having improved compressability 100 1995
 
TEVA WOMEN'S HEALTH, INC. (1)
* 5370878 Method for preparing a direct compression granulated acetaminophen composition 17 1993
 
MERCK PATENT GMBH (1)
* 5560926 Process for the production of an S-ibuprofen-containing tablet 23 1994
 
TCF NATIONAL BANK (1)
* 5126145 Controlled release tablet containing water soluble medicament 138 1990
 
NEXUS APS, A CORP OF DENMARK (1)
* 4748027 Powder product and a method for its preparation 32 1985
* Cited By Examiner

Patent Citation Ranking

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Patent Info (Count) # Cites Year
 
Other [Check patent profile for assignment information] (1)
* 2005/0100,600 Pharmaceutical superdisintegrant 0 2003
 
Pemix Sleep, Inc. (1)
9463181 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders 0 2012
 
PERNIX SLEEP, INC. (3)
9107898 Methods of using low-dose doxepin for the improvement of sleep 0 2012
9572814 Methods of improving the pharmacokinetics of doxepin 0 2012
9532971 Low-dose doxepin formulations and methods of making and using the same 0 2013
 
SYMRISE GMBH & CO. KG (1)
* 2005/0169,987 Compacted menthol 12 2004
 
EDWARD MENDELL & CO. (1)
6660303 Pharmaceutical superdisintegrant 8 2000
 
SOMAXON PHARMACEUTICALS, INC. (4)
* 2008/0182,890 METHODS OF USING LOW-DOSE DOXEPIN FOR THE IMPROVEMENT OF SLEEP 7 2007
* 2010/0105,614 ULTRA LOW DOSE DOXEPIN AND METHODS OF USING THE SAME TO TREAT SLEEP DISORDERS 7 2007
* 2009/0074,862 LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME 7 2008
* 2011/0166,215 METHODS OF IMPROVING THE PHARMACOKINETICS OF DOXEPIN 7 2011
 
PROCOM ONE, INC. (4)
8513299 Methods of using low-dose doxepin for the improvement of sleep 0 2007
* 2007/0281,990 Methods of using low-dose doxepin for the improvement of sleep 6 2007
9498462 Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders 0 2012
9486437 Methods of using low-dose doxepin for the improvement of sleep 0 2015
 
SCHERING CORPORATION (2)
* 6335032 Orally administrable solid dosage form 2 2000
* 6337090 Orally administrable solid ribavirin dosage forms and process for making them 3 2000
 
JRS Pharma LP (1)
6753017 Process for preparing dry extracts 6 2001
 
J. Rettenmaier & Soehne GmbH + Co. KG (11)
* 6217907 Directly compressible high load acetaminophen formulations 26 1999
* 6391337 Directly compressible high load acetaminophen formulations 12 2001
* 2003/0086,982 Process for preparing dry extracts 0 2001
6866867 Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose 12 2001
* 2002/0182,259 Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose 0 2001
6852336 Directly compressible high load acetaminophen formulations 21 2002
7179488 Process for co-spray drying liquid herbal extracts with dry silicified MCC 8 2002
* 2003/0206,978 Agglomerated particles including an active agent coprocessed with silicified microcrystalline cellulose 25 2002
* 2003/0203,050 Process for co-spray drying liquid herbal extracts with dry silicified MCC 2 2002
* 2003/0104,076 Process for preparing dry extracts 20 2002
* 2005/0196,439 Process for co-spray drying agents with dry silicified MCC 7 2004
* Cited By Examiner