Patents by Inventor David A. Czekai
David A. Czekai 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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Publication number: 20230405021Abstract: This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.Type: ApplicationFiled: August 28, 2023Publication date: December 21, 2023Inventors: David CZEKAI, Maciej GASIOR, Lorianne MASUOKA, Julia TSAI, Joseph HULIHAN, Alex AIMETTI
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Publication number: 20230390305Abstract: This disclosure relates to a solid pharmaceutical formulation comprising an amorphous neurosteroid dispersed in a polymer matrix that is suitable for oral administration. The disclosure also relates to methods for effectively treating an epileptic disorder, central nervous system disorder, or a neurological disorder. The methods disclosed herein comprise orally administering to a subject in need thereof a therapeutically effective amount of the solid pharmaceutical formulation disclosed herein comprising an amorphous neurosteroid, preferably ganaxolone dispersed in a polymer matrix.Type: ApplicationFiled: July 20, 2023Publication date: December 7, 2023Inventors: David CZEKAI, Vinod TULIANI, Michael SAPORITO
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Patent number: 11679117Abstract: This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.Type: GrantFiled: April 26, 2022Date of Patent: June 20, 2023Assignee: Marinus Pharmaceuticals, Inc.Inventors: David Czekai, Maciej Gasior, Lorianne Masuoka, Julia Tsai, Joseph Hulihan, Alex Aimetti
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Publication number: 20230181600Abstract: The disclosure provides an injectable neurosteroid nanoparticle formulation comprising nanoparticles having a D50 of less than 2000 nm the nanoparticles comprising a neurosteroid of Formula I, where the variables R1-R9 and X are defined herein and at least one surface stabilizer. The surface stabilizer can be a polymeric surface stabilizer such as hydroxyethyl starch, dextran, or povidone. The injectable neurosteroid nanoparticle formulation can be an intravenous formulation. The disclosure also provides a lyophilized powder of the injectable neurosteroid nanoparticle formulation that can be reconstituted in an aqueous solution prior to administration. The disclosure provides injectable neurosteroid nanoparticle formulations and dry powders of such formulations that have been sterilized by ebeam irradiation.Type: ApplicationFiled: February 10, 2023Publication date: June 15, 2023Inventors: Mingbao ZHANG, Raymond C. GLOWAKY, David CZEKAI
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Publication number: 20220265680Abstract: This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.Type: ApplicationFiled: April 26, 2022Publication date: August 25, 2022Inventors: David CZEKAI, Maciej GASIOR, Lorianne MASUOKA, Julia TSAI, Joseph HULIHAN, Alex AIMETTI
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Publication number: 20220202831Abstract: This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.Type: ApplicationFiled: August 4, 2021Publication date: June 30, 2022Inventors: David CZEKAI, Maciej GASIOR, Lorianne MASUOKA, Julia TSAI, Joseph HULIHAN, Alex AIMETTI
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Patent number: 11110100Abstract: This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.Type: GrantFiled: February 26, 2021Date of Patent: September 7, 2021Assignee: Marinus Pharmaceuticals, Inc.Inventors: David Czekai, Maciej Gasior, Lorianne Masuoka, Julia Tsai, Joseph Hulihan, Alex Aimetti
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Publication number: 20210186987Abstract: This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.Type: ApplicationFiled: February 26, 2021Publication date: June 24, 2021Inventors: David CZEKAI, Maciej GASIOR, Lorianne MASUOKA, Julia TSAI, Joseph HULIHAN, Alex AIMETTI
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Patent number: 11000531Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurosteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.Type: GrantFiled: March 25, 2020Date of Patent: May 11, 2021Assignee: Marinus Pharmaceuticals, Inc.Inventors: Christopher Cashman, Jaakko Lappalainen, David A. Czekai
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Publication number: 20210128583Abstract: The disclosure provides an injectable neurosteroid nanoparticle formulation comprising nanoparticles having a D50 of less than 2000 nm the nanoparticles comprising a neurosteroid of Formula I, where the variables R1-R9 and X are defined herein and at least one surface stabilizer,. The surface stabilizer can be a polymeric surface stabilizer such as hydroxyethyl starch, dextran, or povidone. The injectable neurosteroid nanoparticle formulation can be an intravenous formulation. The disclosure also provides a lyophilized powder of the injectable neurosteroid nanoparticle formulation that can be reconstituted in an aqueous solution prior to administration. The disclosure provides injectable neurosteroid nanoparticle formulations and dry powders of such formulations that have been sterilized by ebeam irradiation.Type: ApplicationFiled: August 13, 2020Publication date: May 6, 2021Inventors: Mingbao Zhang, Raymond C. Glowaky, David Czekai
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Patent number: 10780099Abstract: The disclosure provides an injectable neurosteroid nanoparticle formulation comprising nanoparticles having a D50 of less than 2000 nm the nanoparticles comprising a neurosteroid of Formula I, where the variables R1-R9 and X are defined herein and at least one surface stabilizer. The surface stabilizer can be a polymeric surface stabilizer such as hydroxyethyl starch, dextran, or povidone. The injectable neurosteroid nanoparticle formulation can be an intravenous formulation. The disclosure also provides a lyophilized powder of the injectable neurosteroid nanoparticle formulation that can be reconstituted in an aqueous solution prior to administration. The disclosure provides injectable neurosteroid nanoparticle formulations and dry powders of such formulations that have been sterilized by ebeam irradiation.Type: GrantFiled: October 14, 2016Date of Patent: September 22, 2020Assignee: MARINUS PHARMACEUTICALS, INC.Inventors: Mingbao Zhang, Raymond C. Glowaky, David Czekai
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Publication number: 20200289530Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurossteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.Type: ApplicationFiled: March 25, 2020Publication date: September 17, 2020Inventors: Christopher Cashman, Jaakko Lappalainen, David A. Czekai
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Patent number: 10639317Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurosteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.Type: GrantFiled: October 3, 2018Date of Patent: May 5, 2020Assignee: MARINUS PHARMACEUTICALS INC.Inventors: Christopher Cashman, Jaakko Lappalainen, David A Czekai
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Publication number: 20190321375Abstract: The disclosure provides a method of eliciting electroencephalographic burst suppression or electroencephalographic suppression in a patient. the method includes administering to the patient a formulation comprising neurosteroid nanoparticles having a D50 of less than 2 microns and a polymeric surface stabilizer chosen from hydroxyethyl starch, dextran, and povidone and 0.1 to 50 mg of the neurosteroid per 1 kg of the patient's body weight The neurosteroid may be administered intravenously, intramuscularly, subcutaneously, or orally. Continuous intravenous administration and intravenously, intramuscularly, subcutaneously, or orally administering sequential bolus doses comprising 0.5 mg of ganaxolone per 1 kg of body weight in a human patient, with an interval of less than 30 minutes between two consecutive doses are included in the disclosure.Type: ApplicationFiled: October 13, 2017Publication date: October 24, 2019Inventors: Michael SAPORITO, Albena PATRONEVA, David CZEKAI
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Patent number: 10391105Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurossteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.Type: GrantFiled: September 11, 2017Date of Patent: August 27, 2019Assignee: MARINUS PHARMACEUTICALS INC.Inventors: Christopher Cashman, Jaakko Lappalainen, David A Czekai
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Publication number: 20190167698Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurosteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.Type: ApplicationFiled: October 3, 2018Publication date: June 6, 2019Inventors: Christopher Cashman, Jaakko Lappalainen, David A. Czekai
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Publication number: 20180296487Abstract: The disclosure provides a sustained release injectable neurosteroid formulation comprising neurosteroid particles having a D50 of less than 10 microns, the neurosteroid particles comprising a neurosteroid of Formula I: or a pharmaceutically acceptable salt thereof, wherein: is a double or single bond and the variables, e.g., R1, R2, R3, R4, R4a, R5, R6, R7, R8, R9, R10, and R10a are described herein. The formulation comprises neurosteroid particles comprising the neurosteroid and a polymeric surface stabilizer and provides an effective plasma concentration of the neurosteroid at steady state for at least 48 hours, and in some embodiments for at least 4 weeks. The sustained release injectable neurosteroid formulation can formulated for intramuscular or subcutaneous administration.Type: ApplicationFiled: April 18, 2018Publication date: October 18, 2018Inventors: Michael Saporito, Mingbao Zhang, Raymond C. Glowaky, David Czekai
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Publication number: 20180071315Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurossteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.Type: ApplicationFiled: September 11, 2017Publication date: March 15, 2018Inventors: Christopher Cashman, Jaakko Lappalainen, David A. Czekai
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Publication number: 20170258812Abstract: The disclosure provides an injectable neurosteroid nanoparticle formulation comprising nanoparticles having a D50 of less than 2000 nm the nanoparticles comprising a neurosteroid of Formula I, where the variables R1-R9 and X are defined herein and at least one surface stabilizer. The surface stabilizer can be a polymeric surface stabilizer such as hydroxyethyl starch, dextran, or povidone. The injectable neurosteroid nanoparticle formulation can be an intravenous formulation. The disclosure also provides a lyophilized powder of the injectable neurosteroid nanoparticle formulation that can be reconstituted in an aqueous solution prior to administration. The disclosure provides injectable neurosteroid nanoparticle formulations and dry powders of such formulations that have been sterilized by ebeam irradiation.Type: ApplicationFiled: October 14, 2016Publication date: September 14, 2017Inventors: Mingbao Zhang, Raymond C. Glowaky, David Czekai
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Publication number: 20150343453Abstract: A system for wet milling or dry milling at least one material. The system includes a milling apparatus and at least one milling medium. The milling apparatus includes a chamber, at least one inlet, at least one outlet and a fluid pump. The fluid pump facilitates concomitant flow of the milling medium and material to be milled within the milling chamber to effect milling of the material.Type: ApplicationFiled: May 25, 2015Publication date: December 3, 2015Applicant: NanoCentrix L.L.C.Inventor: David A. Czekai