Patents Assigned to Aptalis Pharmatech, Inc.
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Patent number: 9089490Abstract: A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of rapidly dispersing microgranules prepared by granulating a sugar alcohol or a saccharide or a mixture thereof having an average particle size less than about 30 microns and a disintegrant, and a taste-masked microcapsule containing at least one drug, the microcapsule being prepared by granulating a pharmaceutically acceptable formulation comprising at least one drug in a therapeutically effective amount and at least one polymeric binder that improves resilience of the microgranules, wet milling the granulated mass, and microencapsulating the milled granules to provide microcapsules.Type: GrantFiled: August 23, 2013Date of Patent: July 28, 2015Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi M Venkatesh, Ken Kangyi Qian, Shyam Vangala, James M Clevenger, Donald Guenther
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Patent number: 9040086Abstract: A unit dosage form, such as a capsule or the like for delivering drugs into the body in a circadian release fashion, is comprising of one or more populations of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a pre-designed rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release cardiovascular drug delivery system is designed to provide a plasma concentration-time profile, which varies according to physiological need during the day, i.e., mimicking the circadian rhythm and severity/manifestation of a cardiovascular disease, predicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.Type: GrantFiled: August 9, 2006Date of Patent: May 26, 2015Assignee: Aptalis Pharmatech, Inc.Inventors: Phillip J. Percel, Krishna S. Vishnupad, Gopi M. Venkatesh
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Patent number: 8962022Abstract: The present invention is directed to compositions of taste-masked microparticles comprising a substituted benzhydrylpiperazine coated and a taste-masking layer comprising a water-insoluble polymer and a gastrosoluble polymer, and methods of making such taste-masked microparticles. The present invention is also directed to stable orally disintegrating compositions comprising taste-masked microparticles of a substituted benzhydrylpiperazine and rapidly dispersing granules, and methods of making such orally disintegrating compositions.Type: GrantFiled: March 27, 2008Date of Patent: February 24, 2015Assignee: Aptalis Pharmatech, Inc.Inventor: Gopi Venkatesh
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Patent number: 8877245Abstract: A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once—daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.Type: GrantFiled: August 9, 2012Date of Patent: November 4, 2014Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi Venkatesh, James M. Clevenger
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Publication number: 20140287051Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.Type: ApplicationFiled: June 3, 2014Publication date: September 25, 2014Applicant: APTALIS PHARMATECH, INC.Inventors: Stephen PERRETT, Fredric Jay COHEN, Gopi VENKATESH
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Patent number: 8840925Abstract: The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.Type: GrantFiled: April 25, 2012Date of Patent: September 23, 2014Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, Nehal H. Vyas, Michael Gosselin, Jin-Wang Lai
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Publication number: 20140220144Abstract: The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.Type: ApplicationFiled: February 5, 2014Publication date: August 7, 2014Applicant: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, Nehal H. Vyas, Michael Gosselin, Jin-Wang Lai
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Patent number: 8771729Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.Type: GrantFiled: October 1, 2010Date of Patent: July 8, 2014Assignee: Aptalis Pharmatech, Inc.Inventors: Stephen Perrett, Fredric Jay Cohen, Gopi Venkatesh
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Patent number: 8747895Abstract: A coated multi-particulate pharmaceutical dosage form such as an orally disintegrating tablet (ODT) presentation for delivering atomoxetine or a pharmaceutically acceptable salt thereof, a selective norepinephrine reuptake inhibitor indicated for the treatment of ADHD, into the body to maintain a therapeutically effective amount of atomoxetine in the plasm. The dosage form may comprise one or more populations of coated atomoxetine-containing particles (beads, pellets, granules etc.) providing a pre-designed rapid release profile after a predesigned lag-time of about 0 to 6 hours following oral administration.Type: GrantFiled: September 9, 2005Date of Patent: June 10, 2014Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, Troy M. Harmon, John Taylor
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Publication number: 20140134246Abstract: Disclosed herein are pharmaceutically acceptable rapid dissolve vaginal tablet compositions comprising one or more active pharmaceutical ingredients suitable for therapy via topical action or systemic absorption, and methods of making and using such compositions.Type: ApplicationFiled: November 1, 2013Publication date: May 15, 2014Applicant: Aptalis Pharmatech, Inc.Inventors: Gopi VENKATESH, Vijaya SWAMINATHAN, Jin-Wang LAI
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Patent number: 8647656Abstract: The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.Type: GrantFiled: December 1, 2009Date of Patent: February 11, 2014Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, Nehal H. Vyas, Michael Gosselin, Jin-Wang Lai
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Publication number: 20130108703Abstract: The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.Type: ApplicationFiled: April 25, 2012Publication date: May 2, 2013Applicant: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, Nehal H. Vyas, Michael Gosselin, Jin-Wang Lai
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Patent number: 8367111Abstract: A unit dosage form, such as a capsule or the like for delivering drugs into the body in a sustained release fashion similar to that produced by INDERAL® LA indicated for the treatment of cardiovascular diseases, comprises two populations of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a pre-designed rapid release profile (i.e., substantially complete release within 60 minutes) or sustained release profile over a period of 24 hours. Such a cardiovascular drug delivery system is designed by combining immediate release (IR) beads and sustained release (SR) beads. SR beads may be obtained by membrane coating IR beads with a water-insoluble polymer such as ethylcellulose or a mixture of a water insoluble polymer and a water-soluble polymer such as hydroxypropylcellulose at a ratio of from about 65/35 to 95/5.Type: GrantFiled: December 31, 2002Date of Patent: February 5, 2013Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, Krishna S. Vishnupad, Phillip J. Percel
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Publication number: 20120282335Abstract: This invention relates to rapidly dispersing microgranules comprising at least one sugar alcohol or saccharide, at least one super disintegrant, and a pharmaceutically acceptable additive with multi-functionality (e.g., starch acting as a binder, disintegrant, diluent/filler, glidant, etc) at a low level, which can be formed by not only eliminating a wet milling step but also avoiding an extensive dry milling step.Type: ApplicationFiled: December 2, 2011Publication date: November 8, 2012Applicant: Aptalis Pharmatech Inc.Inventors: Gopi M. Venkatesh, Vijaya Swaminathan, Jin-Wang Lai, James M. Clevenger
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Publication number: 20120196028Abstract: The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.Type: ApplicationFiled: February 13, 2012Publication date: August 2, 2012Applicant: Aptalis Pharmatech, Inc.Inventors: Gopi M. VENKATESH, James M. Clevenger, Timothy Grinstead
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Publication number: 20120128764Abstract: The present invention relates to pharmaceutical compositions, and methods of preparing such compositions, comprising one or more populations of controlled-release particles comprising one or more proton pump inhibitors. The present invention also relates to pharmaceutical dosage forms, including orally disintegrating tablets, tablets, capsules, and methods for their preparation.Type: ApplicationFiled: February 23, 2010Publication date: May 24, 2012Applicant: Aptalis Pharmatech, Inc.Inventors: Gopi Venkatesh, Michael Gosselin, Jin-Wang Lai, Christian Stollberg, Flavio Fabiani
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Patent number: 8137734Abstract: The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.Type: GrantFiled: June 18, 2009Date of Patent: March 20, 2012Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi M. Venkatesh, James M. Clevenger, Timothy Grinstead
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Patent number: 8133506Abstract: The present invention is directed to pharmaceutical compositions, and methods of making such compositions, wherein the compositions comprise a plurality of TPR and RR particles, wherein: the TPR particles each comprise a core coated with a TPR layer; the core comprises a weakly basic, poorly soluble drug and a pharmaceutically acceptable organic acid separated from each other by an SR layer; the RR particles each comprise the weakly basic, poorly soluble drug, and release at least about 80 wt. % of the weakly basic, poorly soluble drug in about 5 minutes when dissolution tested using United States Pharmacopoeia (USP) dissolution methodology (Apparatus 2—paddles@50 RPM and a two-stage dissolution medium at 37° C. (first 2 hours in 0.1N HCl followed by testing in a buffer at pH 6.8).Type: GrantFiled: September 12, 2008Date of Patent: March 13, 2012Assignee: Aptalis Pharmatech, Inc.Inventors: Gopi Venkatesh, Jin-Wang Lai, Nehal H. Vyas, Vivek Purohit