Patents Assigned to Collegium Pharmaceuticals, Inc.
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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: 8557291Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In a preferred embodiment, a drug is modified to increase its lipophilicity. In some embodiments the modified drug is homogeneously dispersed within spherical 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/or organic solvent insoluble. 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 passes through the GI tract.Type: GrantFiled: May 27, 2009Date of Patent: October 15, 2013Assignee: Collegium Pharmaceutical, Inc.Inventors: Roman V. Rariy, Alison B. Fleming, Jane Hirsh, Alexander M. Klibanov
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Patent number: 8512751Abstract: Pharmaceutical compositions are provided for the pharmacological treatment of breathing disorders and, more specifically, to compositions containing agents having serotonin receptor modulating activity for the alleviation of sleep apnea (central and obstructive) and other sleep-related breathing disorders wherein the active ingredients are released such as to extend effective blood plasma concentrations across the period of sleep.Type: GrantFiled: December 20, 2005Date of Patent: August 20, 2013Assignee: Collegium Pharmaceutical, Inc.Inventors: Roman V. Rariy, Michael Heffernan
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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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Patent number: 8021687Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.Type: GrantFiled: April 7, 2010Date of Patent: September 20, 2011Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane C. Hirsh, Roman V. Rariy, Shubha Chungi, Srinivas G. Rao, Michael T. Heffernan
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Publication number: 20110212035Abstract: Described herein are emulsions and compositions for the treatment of various dermatoses. The emulsions may be formulated as aerosol compositions. The aerosol propellant may be a hydrofluoroalkane propellant. Also described are methods of treating dermatoses, comprising the step of applying to an affected area of a subject in need thereof a therapeutically-effective amount of an inventive emulsion or aerosol composition. The dermatosis may be atopic dermatitis, allergic contact dermatitis, or radiation dermatitis.Type: ApplicationFiled: February 26, 2010Publication date: September 1, 2011Applicant: Collegium Pharmaceutical, Inc.Inventors: Ronald M. Gurge, Mark W. Trumbore, Wendy Schilling, Lisa Chin
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Publication number: 20110142943Abstract: 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: December 10, 2010Publication date: June 16, 2011Applicant: Collegium Pharmaceutical, Inc.Inventors: Roman V. Rariy, Alison B. Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
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Publication number: 20110052506Abstract: Described herein are compositions useful in the treatment of atopic dermatitis and other skin conditions, which compositions exhibit enhanced stability. The compositions contain a hypochlorite salt, useful for its antimicrobial properties, and are non-irritating when applied to the skin. The compositions also provide enhanced moisturizing properties. The compositions can be formulated into a topical aerosol foam with inert, non-flammable propellants, such as hydrofluoroalkanes, and may be used in cosmetics or pharmaceuticals.Type: ApplicationFiled: August 31, 2010Publication date: March 3, 2011Applicant: Collegium Pharmaceutical, Inc.Inventors: Douglas Abel, Ronald M. Gurge, Mark W. Trumbore
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Patent number: 7771707Abstract: 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 10, 2005Date of Patent: August 10, 2010Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane C. Hirsh, Alison B. Fleming, Roman V. Rariy, Alexander M. Klibanov
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Publication number: 20100196472Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.Type: ApplicationFiled: April 7, 2010Publication date: August 5, 2010Applicant: Collegium Pharmaceutical, Inc.Inventors: Jane C. HIRSH, Roman V. Rariy, Shubha Chungi, Srinivas G. Rao, Michael T. Heffernan
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Patent number: 7704527Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.Type: GrantFiled: September 16, 2008Date of Patent: April 27, 2010Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane C. Hirsh, Roman V. Rariy, Shubha Chungi, Srinivas G. Rao, Michael T. Heffernan
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Publication number: 20090232743Abstract: Described are ethanol-free foamable microemulsions for topical application, and method of making them. The propellants used in the compositions may be environmentally-friendly hydrofluoroalkanes. The foam compositions may also comprise one or more of a variety of active ingredients, including anti-inflammatory agents, anesthetics, and keratolytic agents.Type: ApplicationFiled: February 13, 2009Publication date: September 17, 2009Applicant: Collegium Pharmaceutical, Inc.Inventors: Ravi K. Varanasi, Roman V. Rariy
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Patent number: 7585520Abstract: Compositions containing both a sedative compound and a non-sedative antihistamine are provided. More particularly, compositions for administration at bedtime containing a sedating antihistamine or other sedating compound in immediate release form and a non-sedating antihistamine in delayed-release form are described. Alternatively, a composition, for administrating upon awakening, containing a non-sedating antihistamine in immediate release form, and a sedating antihistamine or other sedative in delayed-release form is described. Methods of inhibiting the release of histamines by administration of the compositions to a mammalian subject are also provided. The dosage forms may comprise other medications, such as leukotriene receptor antagonists, to enhance the suppression of histamine symptoms.Type: GrantFiled: September 17, 2004Date of Patent: September 8, 2009Assignee: Collegium Pharmaceutical, Inc.Inventors: Mark Hirsh, Jane Hirsh, Whe-Yong Lo
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Publication number: 20090018203Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.Type: ApplicationFiled: September 16, 2008Publication date: January 15, 2009Applicant: Collegium Pharmaceutical, Inc.Inventors: Jane C. HIRSH, Roman V. RARIY, Shubha CHUNGI, Srinivas G. RAO, Michael T. HEFFERNAN
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Publication number: 20080200508Abstract: Pharmaceutical compositions are provided for the pharmacological treatment of breathing disorders and, more specifically, to compositions containing agents having serotonin receptor modulating activity for the alleviation of sleep apnea (central and obstructive) and other sleep-related breathing disorders wherein the active ingredients are released such as to extend effective blood plasma concentrations across the period of sleep.Type: ApplicationFiled: December 20, 2005Publication date: August 21, 2008Applicant: COLLEGIUM PHARMACEUTICAL, INC.Inventors: Roman V. Rariy, Michael Heffernan
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Patent number: 7399488Abstract: 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: GrantFiled: July 7, 2003Date of Patent: July 15, 2008Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane Hirsh, Alexander M. Kibanov, Timothy M. Swager, Stephen L. Buchwald, Whe Yong Lo, Alison B. Fleming, Roman V. Rariy
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Patent number: 7387792Abstract: New pharmaceutical compositions in unit dosage form are disclosed for both intraoral and oral administration to a patient, said unit dosage form configured to be placed intraorally of said patient, which comprises: (a) as a first portion, at least one discrete molded triturate tablet comprising a therapeutically effective amount of at least one pharmaceutically active ingredient capable of intraoral administration; and (b) as a second portion located around the said first portion, a therapeutically effective amount of at least one pharmaceutically active ingredient capable of oral administration and which is releasable and orally ingestible by the patient after the molded triturate tablet has disintegrated or has dissolved intraorally.Type: GrantFiled: January 24, 2005Date of Patent: June 17, 2008Assignee: Collegium Pharmaceutical, Inc.Inventors: Jane C. Hirsh, Kamal K. Midha, Mark Hirsh, Whe-Yong Lo
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Patent number: 7309799Abstract: One aspect of the present invention relates to methods for synthesizing milnacipran or congeners thereof. Another aspect of the present invention relates to asymmetric methods for synthesizing enantiomerically enriched milnacipran or congeners thereof. The present invention also relates to methods for synthesizing intermediates useful in the non-asymmetric or asymmetric methods for synthesizing enantiomerically enriched milnacipran or congeners thereof.Type: GrantFiled: April 1, 2005Date of Patent: December 18, 2007Assignee: Collegium Pharmaceutical, Inc.Inventors: Stephen L. Buchwald, Timothy M. Swager, Roman V. Rariy
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Patent number: 7038085Abstract: The present invention relates generally to the enantiomers of para-hydroxy-milnacipran or congeners thereof. Biological assays revealed that racemic para-hydroxy-milnacipran is approximately equipotent in inhibiting serotonin and norepinephrine uptake (IC50=28.6 nM for norepinephrine, IC50=21.7 nM for serotonin). Interestingly, (+)-para-hydroxy-milnacipran is a more potent inhibitor of norepinephrine uptake than serotonin uptake (IC50=10.3 nM for norepinephrine, IC50=22 nM for serotonin). In contrast, (?)-para-hydroxy-milnacipran is a more potent inhibitor of serotonin uptake compared to norepinephrin uptake (IC50=88.5 nM for norepinephrine, IC50=40.3 nM for serotonin). The invention also relates to salts and prodrug forms of the aforementioned compounds. In certain embodiments, the compounds of the present invention and a pharmaceutically acceptable excipient are combined to prepare a formulation for administration to a patient.Type: GrantFiled: October 22, 2003Date of Patent: May 2, 2006Assignee: Collegium Pharmaceutical, Inc.Inventors: Roman V. Rariy, Michael Heffernan, Stephen L. Buchwald, Timothy M. Swager