Patents Assigned to Roxane Laboratories, Inc.
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Patent number: 9060951Abstract: The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.Type: GrantFiled: September 16, 2013Date of Patent: June 23, 2015Assignee: Roxane Laboratories, Inc.Inventors: Julie Economou, Shehla Uraizee
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Publication number: 20140010869Abstract: The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.Type: ApplicationFiled: September 16, 2013Publication date: January 9, 2014Applicant: Roxane Laboratories, Inc.Inventors: Julie Economou, Shehla Uraizee
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Patent number: 8563032Abstract: The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.Type: GrantFiled: December 5, 2006Date of Patent: October 22, 2013Assignee: Roxane Laboratories, Inc.Inventors: Julie Economou, Shehla Uraizee
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Patent number: 8501764Abstract: The present invention relates to a pharmaceutical formulation and process for preparing the same comprising an oral dosage formulation, such as a capsule formulation, of a macrolide compound, such as tacrolimus, wherein the capsule formulation contains both a solid dispersion of the macrolide along with a non-dispersed form of the macrolide. The pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product according to a bioavailability study conducted in humans.Type: GrantFiled: June 13, 2012Date of Patent: August 6, 2013Assignee: Roxane Laboratories, Inc.Inventors: Greg A. Brubaker, Thomas D. Mahon
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Publication number: 20120258143Abstract: The present invention relates to a pharmaceutical formulation and process for preparing the same comprising an oral dosage formulation, such as a capsule formulation, of a macrolide compound, such as tacrolimus, wherein the capsule formulation contains both a solid dispersion of the macrolide along with a non-dispersed form of the macrolide. The pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product according to a bioavailability study conducted in humans.Type: ApplicationFiled: June 13, 2012Publication date: October 11, 2012Applicant: ROXANE LABORATORIES, INC.Inventors: Greg A. Brubaker, Thomas D. Mahon
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Patent number: 8222272Abstract: The present invention relates to a pharmaceutical formulation and process for preparing the same comprising an oral dosage formulation, such as a capsule formulation, of a macrolide compound, such as tacrolimus, wherein the capsule formulation contains both a solid dispersion of the macrolide along with a non-dispersed form of the macrolide. The pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product according to a bioavailability study conducted in humans.Type: GrantFiled: April 11, 2008Date of Patent: July 17, 2012Assignee: Roxane Laboratories, Inc.Inventors: Greg A. Brubaker, Thomas D. Mahon
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Publication number: 20120003314Abstract: A timed or delayed release oral composition delivery system for the treatment of colonic disorders and diseases is provided. According to one aspect, a delayed release oral pharmaceutical composition includes an active core comprising a therapeutically effective amount of 5-amino salicylic acid (i.e., mesalamine); a primary coating composition disposed around the active core, wherein the primary coating composition includes an enteric polymer; and a secondary coating composition disposed around the primary coating composition, wherein the secondary coating composition includes a ratio mixture of ethyl cellulose and hydroxypropyl methylcellulose.Type: ApplicationFiled: September 15, 2011Publication date: January 5, 2012Applicant: ROXANE LABORATORIES, INC.Inventors: Vinay H. SHUKLA, Eric M. SPILLER
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Publication number: 20090258895Abstract: The present invention relates to a pharmaceutical formulation and process for preparing the same comprising an oral dosage formulation, such as a capsule formulation, of a macrolide compound, such as tacrolimus, wherein the capsule formulation contains both a solid dispersion of the macrolide along with a non-dispersed form of the macrolide. The pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product according to a bioavailability study conducted in humans.Type: ApplicationFiled: April 11, 2008Publication date: October 15, 2009Applicant: ROXANE LABORATORIES, INC.Inventors: Greg A. BRUBAKER, Thomas D. MAHON
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Publication number: 20090169622Abstract: A timed or delayed release oral composition delivery system for the treatment of colonic disorders and diseases is provided. According to one aspect, a delayed release oral pharmaceutical composition includes an active core comprising a therapeutically effective amount of 5-amino salicylic acid (i.e., mesalamine); a primary coating composition disposed around the active core, wherein the primary coating composition includes an enteric polymer; and a secondary coating composition disposed around the primary coating composition, wherein the secondary coating composition includes a ratio mixture of ethyl cellulose and hydroxypropyl methylcellulose.Type: ApplicationFiled: December 27, 2007Publication date: July 2, 2009Applicant: ROXANE LABORATORIES, INC.Inventors: Vinay H. SHUKLA, Eric M. Spiller
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Publication number: 20080145422Abstract: The present invention relates to a direct compression tablet formulation comprising, as the active ingredient, galantamine, and more specifically, galantamine hydrobromide along with a process of making the same. The tablet formulation is a direct compression tablet and has excellent content uniformity and dissolution properties.Type: ApplicationFiled: February 10, 2005Publication date: June 19, 2008Applicant: Roxane Laboratories, Inc.Inventors: Yunlong Zhou, Andrea McPhillips, Julie Economou
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Publication number: 20070248564Abstract: This invention relates to a stable, sorbitol free suspension formulation of sodium polystyrene sulfonate.Type: ApplicationFiled: April 25, 2007Publication date: October 25, 2007Applicant: ROXANE LABORATORIES, INC.Inventors: Randall S. Wilson, Andrea M. McPhillips
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Publication number: 20070128271Abstract: The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.Type: ApplicationFiled: December 5, 2006Publication date: June 7, 2007Applicant: ROXANE LABORATORIES, INC.Inventors: Julie Economou, Shehla Uraizee
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Publication number: 20060263431Abstract: A solid, oral, controlled release dosage form comprising a therapeutically effective amount of an opioid compound, or a salt thereof, a matrix-forming polymer and an ionic exchange resin.Type: ApplicationFiled: August 3, 2006Publication date: November 23, 2006Applicant: Roxane Laboratories, Inc.Inventor: Ann Maloney
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Publication number: 20050163856Abstract: A method for reducing the abuse potential of an oral dosage form of an opioid extractable by commonly available household solvents said method comprising combining a therapeutically effective amount of the opioid compound, or a salt thereof, a matrix-forming polymer and an ionic exchange resin.Type: ApplicationFiled: March 23, 2005Publication date: July 28, 2005Applicant: Roxane Laboratories, Inc.Inventors: Ann Maloney, Debra Murwin, Michael Schobelock
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Publication number: 20040062812Abstract: A solid, oral, controlled release dosage form comprising a therapeutically effective amount of an opioid compound, or a salt thereof, a matrix-forming polymer and an ionic exchange resin.Type: ApplicationFiled: September 5, 2003Publication date: April 1, 2004Applicant: Roxane Laboratories, Inc.Inventor: Ann M. Maloney
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Publication number: 20030118641Abstract: A method for reducing the abuse potential of an oral dosage form of an opioid extractable by commonly available household solvents said method comprising combining a therapeutically effective amount of the opioid compound, or a salt thereof, a matrix-forming polymer and an ionic exchange resin.Type: ApplicationFiled: October 3, 2002Publication date: June 26, 2003Applicant: Roxane Laboratories, Inc.Inventors: Ann Maloney, Debra Marie Murwin, Michael Jay Schobelock