Patents by Inventor Alison Fleming
Alison Fleming 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: 10668060Abstract: Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.Type: GrantFiled: May 15, 2019Date of Patent: June 2, 2020Assignee: Collegium Pharmaceutical, Inc.Inventors: Roman V. Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
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Patent number: 10525052Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.Type: GrantFiled: August 21, 2017Date of Patent: January 7, 2020Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane Hirsh, Alison Fleming, Roman Rariy, Alexander Klibanov
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Publication number: 20190167662Abstract: Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.Type: ApplicationFiled: June 25, 2018Publication date: June 6, 2019Inventors: Roman Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
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Publication number: 20180369236Abstract: Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.Type: ApplicationFiled: June 25, 2018Publication date: December 27, 2018Inventors: Roman V. Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
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Patent number: 10004729Abstract: Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.Type: GrantFiled: May 26, 2017Date of Patent: June 26, 2018Assignee: COLLEGIUM PHARMACEUTICAL, INC.Inventors: Roman V. Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
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Publication number: 20170360710Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicty by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.Type: ApplicationFiled: August 21, 2017Publication date: December 21, 2017Inventors: Jane HIRSH, Alison Fleming, Roman Rariy, Alexander Klibanov
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Patent number: 9763883Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.Type: GrantFiled: January 3, 2014Date of Patent: September 19, 2017Assignee: COLLEGIUM PHARMACEUTICAL, INC.Inventors: Jane Hirsh, Alison Fleming, Roman Rariy, Alexander Klibanov
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Patent number: 9682075Abstract: Tamper-resistance pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.Type: GrantFiled: June 30, 2014Date of Patent: June 20, 2017Assignee: COLLEGIUM PHARMACEUTICAL, INC.Inventors: Roman Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
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Patent number: 9044398Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.Type: GrantFiled: July 17, 2012Date of Patent: June 2, 2015Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane Hirsh, Alexander M. Klibanov, Timothy M. Swager, Stephen L. Buchwald, Whe Yong Lo, Alison Fleming, Roman V. Rariy
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Publication number: 20150004244Abstract: Tamper-resistance pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.Type: ApplicationFiled: June 30, 2014Publication date: January 1, 2015Inventors: Roman RARIY, Alison Fleming, Jane C. Hirsh, Said SAIM, Ravi K. Varanasi
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Patent number: 8758813Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In one embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.Type: GrantFiled: April 25, 2013Date of Patent: June 24, 2014Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane Hirsh, Alison Fleming, Roman Rariy, Alexander M. Klibanov
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Publication number: 20140121232Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.Type: ApplicationFiled: January 3, 2014Publication date: May 1, 2014Applicant: Collegium Pharmaceutical, Inc.Inventors: Jane C. HIRSH, Alison Fleming, Roman Rariy, Alexander Klibanov
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Publication number: 20130310413Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In one embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.Type: ApplicationFiled: April 25, 2013Publication date: November 21, 2013Applicant: Collegium Pharmaceutical, Inc.Inventors: Jane Hirsh, Alison Fleming, Roman Rariy, Alexander Kilbanov
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Patent number: 8449909Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.Type: GrantFiled: June 25, 2010Date of Patent: May 28, 2013Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane Hirsh, Alison Fleming, Roman Rariy, Alexander Kilbanov
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Publication number: 20130045960Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.Type: ApplicationFiled: July 17, 2012Publication date: February 21, 2013Applicant: Collegium Pharmaceuticals, Inc.Inventors: Jane Hirsh, Alexander M. Klibanov, Timothy M. Swager, Stephen L. Buchwald, Whe Yong Lo, Alison Fleming, Roman V. Rariy
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Publication number: 20080199530Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble, but enzymatically degradable by enzymes present in the human gastrointestinal tract. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed.Type: ApplicationFiled: April 30, 2008Publication date: August 21, 2008Inventors: Jane Hirsh, Alison Fleming, Roman V. Rariy
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Publication number: 20070036843Abstract: An improved controlled release composition for non-parenteral administration of active agents and other therapeutics, particularly for oral or topical administration, has been developed. The composition is made by dispersing a complex formed of an active agent bound to an ion-exchange resin or to another form of resin or carrier, in a non-ionic non-aqueous (“NINA”) vehicle. The complexes are optionally coated with one or more layers of coating material to provide a controlled pattern of release of active agent from the carrier. Replacing the usual aqueous vehicle with a NINA vehicle, such as an oil or an ointment, allows the active agent-carrier complexes, with or without coatings, to be both orally and topically administered.Type: ApplicationFiled: January 27, 2006Publication date: February 15, 2007Inventors: Jane Hirsh, Roman Rariy, Mark Trumbore, Alison Fleming, Mark Hirsh
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Publication number: 20050281748Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.Type: ApplicationFiled: June 10, 2005Publication date: December 22, 2005Inventors: Jane Hirsh, Alison Fleming, Roman Rariy, Alexander Klibanov
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Publication number: 20050181050Abstract: A multiparticulate, modified release composition for oral administration has been developed. The formulation is made by complexing a drug with an ion-exchange resin in the form of small particles, typically less than 150 microns. The present invention provides novel extended release coated ion exchange particles comprising drug-resin complexes, produced by binding the salt form of the drug, that do not require impregnating agents to insure the integrity of the extended release coat. To prepare a modified release formulation, one or more of the following types of particles are formulated into a final dosage form: (a) Immediate release particles, (b) Enteric coated particles, (c) Extended release particles, (d) Enteric coated-extended release particles; and (e) Delayed release particles.Type: ApplicationFiled: January 28, 2005Publication date: August 18, 2005Inventors: Jane Hirsh, Alison Fleming, Roman Rariy
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Publication number: 20040143213Abstract: The systems and methods described herein include, inter alia, drug delivery devices that can provide doses of medicaments over a defined region of skin. Such systems and methods described herein may employ a hollow perforator that can receive a volume of drug and an actuator that can drive the perforator through a stroke cycle that accelerates the perforator and the volume of drug distally and then decelerates the perforator so that the volume of fluid is ejected out of the perforator.Type: ApplicationFiled: November 12, 2003Publication date: July 22, 2004Applicant: Collegium Pharmaceutical, Inc.Inventors: Ian Warwick Hunter, Jane Hirsh, Alison Fleming