Patents by Inventor John J. Koleng
John J. Koleng has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Patent number: 9364445Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.Type: GrantFiled: October 17, 2014Date of Patent: June 14, 2016Assignee: Auxilium US Holdings, LLCInventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Publication number: 20160082026Abstract: A transmucosal formulation comprising a ganglioside and a mucosal absorption enhancer, as well as a method of treating or preventing Parkinson's disease in a human patient in need thereof comprising parenterally administering such a transmucosal formulation to said patient.Type: ApplicationFiled: June 1, 2015Publication date: March 24, 2016Inventors: Jay S. Schneider, John J. Koleng, Robert Florentine, David W. Anderson
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Publication number: 20150320722Abstract: Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.Type: ApplicationFiled: July 21, 2015Publication date: November 12, 2015Inventors: Nicholas S. BODOR, John J. Koleng, David Angulo
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Publication number: 20150283158Abstract: A transmucosal formulation comprising a ganglioside and a mucosal absorption enhancer, as well as a method of treating or preventing Parkinson's disease in a human patient in need thereof comprising parenterally administering such a transmucosal formulation to said patient.Type: ApplicationFiled: October 21, 2014Publication date: October 8, 2015Inventors: John J. Koleng, Robert Florentine, David W. Anderson, David W. Anderson
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Publication number: 20150259283Abstract: Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.Type: ApplicationFiled: May 22, 2014Publication date: September 17, 2015Applicant: BRICKELL BIOTECH, INC.Inventors: John J. Koleng, David Angulo
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Publication number: 20150057259Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.Type: ApplicationFiled: October 17, 2014Publication date: February 26, 2015Applicant: Auxilium US Holdings, LLCInventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Patent number: 8883187Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.Type: GrantFiled: May 3, 2012Date of Patent: November 11, 2014Assignee: Auxilium US Holdings, LLCInventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Publication number: 20130259920Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.Type: ApplicationFiled: May 28, 2013Publication date: October 3, 2013Inventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Patent number: 8465759Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.Type: GrantFiled: March 22, 2007Date of Patent: June 18, 2013Assignee: Auxilium US Holdings, LLCInventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Publication number: 20130072532Abstract: Analgesic topical formulations of dexmedetomidine and methods of use thereof in the treatment and management of pain and other conditions.Type: ApplicationFiled: January 7, 2011Publication date: March 21, 2013Applicant: Recro Pharma, Inc.Inventors: Geraldine A. Henwood, Randall J. Mack, Christopher T. Sharr, John J. Koleng, JR.
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Patent number: 8394434Abstract: A supercritical fluid (SCF) extract of a cardiac glycoside-containing plant mass is provided. The extract can be included in a pharmaceutical composition containing an extract-solubilizing amount of solubilizer. Oleandrin is included within the extract when a cardiac glycoside-containing plant, such as Nerium oleander, is extracted by SCF extraction. The extract can also contain one or more other SCF extractable pharmacologically active agents. The composition can be used to treat a wide range of disorders that are therapeutically responsive to a cardiac glycoside.Type: GrantFiled: March 12, 2012Date of Patent: March 12, 2013Assignee: Phoenix Biotechnology, Inc.Inventors: Otis Crandell Addington, Feng Zhang, John J. Koleng
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Publication number: 20120220544Abstract: A transmucosal formulation comprising a ganglioside and a mucosal absorption enhancer, as well as a method of treating or preventing Parkinson's disease in a human patient in need thereof comprising parenterally administering such a transmucosal formulation to said patient.Type: ApplicationFiled: February 28, 2012Publication date: August 30, 2012Inventors: Jay S. Schneider, John J. Koleng, Robert Florentine, David W. Anderson
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Publication number: 20120219620Abstract: A supercritical fluid (SCF) extract of a cardiac glycoside-containing plant mass is provided. The extract can be included in a pharmaceutical composition containing an extract-solubilizing amount of solubilizer. Oleandrin is included within the extract when a cardiac glycoside-containing plant, such as Nerium oleander, is extracted by SCF extraction. The extract can also contain one or more other SCF extractable pharmacologically active agents. The composition can be used to treat a wide range of disorders that are therapeutically responsive to a cardiac glycoside.Type: ApplicationFiled: March 12, 2012Publication date: August 30, 2012Applicant: Phoenix Biotechnology, Inc.Inventors: O.Cradell Addington, Feng Zhang, John J. Koleng
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Publication number: 20120214777Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.Type: ApplicationFiled: May 3, 2012Publication date: August 23, 2012Applicant: Auxilium U.S. Holdings, LLCInventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Patent number: 8173152Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.Type: GrantFiled: March 22, 2007Date of Patent: May 8, 2012Assignee: Auxilium US Holdings, LLCInventors: Michael W. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Publication number: 20100137357Abstract: The present disclosure relates, according to some embodiments, to compositions, systems, and methods for ameliorating, preventing, and/or treating (collectively “treating”) hyperhidrosis and/or excessive perspiration (collectively “hyperhidrosis”). For example, a method for treating hyperhidrosis may comprise administering (e.g., topically administering) a composition comprising an anticholinergic compound (e.g., an ipratropium compound) to a mammal. A composition (e.g., a topical composition) for treating hyperhidrosis may comprise an anticholinergic compound (e.g., an ipratropium compound) and a vehicle (e.g., a physiologically acceptable vehicle). In some embodiments, administering a composition comprising an anticholinergic compound may comprise contacting the subject with a medicated article comprising the composition.Type: ApplicationFiled: November 24, 2009Publication date: June 3, 2010Inventors: John J. Koleng, Josef Rossart
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Publication number: 20090264385Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.Type: ApplicationFiled: March 22, 2007Publication date: October 22, 2009Inventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Publication number: 20090136555Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.Type: ApplicationFiled: March 22, 2007Publication date: May 28, 2009Inventors: Michael M. Crowley, Justin M. Keen, John J. Koleng, Feng Zhang
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Publication number: 20080131504Abstract: The present invention is directed to a novel short term slow release drug delivery system, preferably for solid oral dosage forms of water-soluble, alkaline salts of alkali metals and alkaline earth metals comprising polyvinylpyrrolidone and CPAA and preferably a wax component.Type: ApplicationFiled: December 1, 2006Publication date: June 5, 2008Applicant: Mission Pharmacal Co.Inventors: Neill B. Walsdorf, Sr., Jon C. Taylor, Feng Zhang, Francis K. Sherwood, John J. Koleng
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Publication number: 20030124190Abstract: Compositions useful for long-lasting pain relief from mucosal damage, such as mucosal inflamation, abrasions, ulcerations, lesions, trauma and incisions, without significant systemic absorption. The compositions of the invention are particularly suitable for application to the mucous membrane of the nasal cavity and buccal cavity. To relieve pain, the compositions or the invention are topically applied directly to the affected area.Type: ApplicationFiled: January 21, 2003Publication date: July 3, 2003Applicant: EpiCept, Inc.Inventors: Robert O. Williams, Feng Zhang, John J. Koleng, Gavril W. Pasternak, Yuri A. Kolesnikov