Patents by Inventor Rekha Nayak
Rekha Nayak 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: 20200289439Abstract: A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient is provided. The oxidation susceptible active pharmaceutical ingredient is mixed with excipients and deoxygenated water to prepare a non-sterile drug solution. The non-sterile drug solution is filled into a moist heat sterilizable flexible infusion bag. The flexible infusion bag with the non-sterile drug solution is terminally moist heat sterilized at a preset air overpressure between about 0.2 bar to about 1.2 bar to obtain a parenteral drug product. The highest degradation product in the parenteral drug product is less than 0.5% by weight of a labeled amount of the oxidation susceptible active pharmaceutical ingredient in the parenteral drug product.Type: ApplicationFiled: May 28, 2020Publication date: September 17, 2020Applicant: InnoPharma Licensing, LLCInventors: Tushar Hingorani, Kumaresh Soppimath, Rekha Nayak
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Patent number: 9801859Abstract: A lyophilized bendamustine composition consisting of bendamustine hydrochloride, an aqueous solvent, and optionally an excipient, and a method of preparation thereof for treating a condition in a subject are provided. The aqueous solvent includes, for example, water, an acid, a base, or a salt, etc. The excipient includes at least one cryoprotectant, for example, sucrose, trehalose, mannitol, etc. A pre-lyophilization bendamustine composition is lyophilized, for example, by freezing, primary drying, annealing, secondary drying, condensed cooling and evacuation at preset temperatures to obtain the lyophilized bendamustine composition as a cake, a powder, or a solid concentrate. The lyophilized bendamustine composition is free of a non-aqueous solvent. Reconstitution is performed by mixing the lyophilized bendamustine composition with an aqueous solvent for about 30 seconds to 300 seconds. The reconstituted bendamustine product containing about 0.2 wt % to about 2.Type: GrantFiled: September 18, 2013Date of Patent: October 31, 2017Assignee: InnoPharma Licensing, LLCInventors: Udaya Toti, Kumaresh Soppimath, Rekha Nayak, Satish Pejaver, Navneet Puri
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Publication number: 20150005376Abstract: A concentrate esmolol formulation is provided that is safer than current concentrate (e.g., 250 mg/ml) esmolol compositions. The concentrate esmolol formulation can include from about 40-60 mg/ml of esmolol hydrochloride. The concentrate esmolol composition allows a practitioner the flexibility of choosing a bolus volume for direct injection to a patient or, optionally, to use the composition to make a customized, diluted composition of esmolol. Methods of the present invention provide for the reduction of potential adverse health consequences resulting in the improper dosing of prior art concentrate compositions of esmolol. Also, a medical product is provided that includes a concentrate esmolol housed in a container, and a package housing the container and instructions.Type: ApplicationFiled: September 12, 2014Publication date: January 1, 2015Applicants: BAXTER INTERNATIONAL INC., BAXTER HEALTHCARE SAInventors: Deepak Tiwari, George Owoo, Rekha Nayak, Kenneth E. Burhop
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Publication number: 20140303254Abstract: A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient is provided. The oxidation susceptible active pharmaceutical ingredient is mixed with excipients and deoxygenated water to prepare a non-sterile drug solution. The non-sterile drug solution is filled into a moist heat sterilizable flexible infusion bag. The flexible infusion bag with the non-sterile drug solution is terminally moist heat sterilized at a preset air overpressure between about 0.2 bar to about 1.2 bar to obtain a parenteral drug product. The highest degradation product in the parenteral drug product is less than 0.5% by weight of a labeled amount of the oxidation susceptible active pharmaceutical ingredient in the parenteral drug product.Type: ApplicationFiled: April 5, 2014Publication date: October 9, 2014Inventors: Tushar Hingorani, Kumaresh Soppimath, Rekha Nayak, Tushar Malkan, Satish Pejaver, Navneet Puri
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Patent number: 8722736Abstract: Disclosed are concentrate esmolol injection essentially free from other related esters of esmolol and diluted esmolol compositions. The concentrate esmolol formulation includes from about 25-1000 mg/ml of esmolol and about 1-25% w/v of benzyl alcohol and the combination thereof. The compositions can also be used as multi-dose compositions. The present invention also discloses diluted, ready-to-use compositions of esmolol prepared by dilution of the present invention concentrates. Also disclosed are methods of making and using the ready-to-use compositions of the present invention.Type: GrantFiled: May 22, 2007Date of Patent: May 13, 2014Assignees: Baxter International Inc., Baxter Healthcare SAInventors: Deepak Tiwari, George Owoo, Rekha Nayak, Kenneth E. Burhop
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Publication number: 20140080880Abstract: A lyophilized bendamustine composition consisting of bendamustine hydrochloride, an aqueous solvent, and optionally an excipient, and a method of preparation thereof for treating a condition in a subject are provided. The aqueous solvent includes, for example, water, an acid, a base, or a salt, etc. The excipient includes at least one cryoprotectant, for example, sucrose, trehalose, mannitol, etc. A pre-lyophilization bendamustine composition is lyophilized, for example, by freezing, primary drying, annealing, secondary drying, condensed cooling and evacuation at preset temperatures to obtain the lyophilized bendamustine composition as a cake, a powder, or a solid concentrate. The lyophilized bendamustine composition is free of a non-aqueous solvent. Reconstitution is performed by mixing the lyophilized bendamustine composition with an aqueous solvent for about 30 seconds to 300 seconds. The reconstituted bendamustine product containing about 0.2 wt % to about 2.Type: ApplicationFiled: September 18, 2013Publication date: March 20, 2014Applicant: InnoPharma, Inc.Inventors: Udaya Toti, Kumaresh Soppimath, Rekha Nayak, Satish Pejaver, Navneet Puri
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Patent number: 8426467Abstract: A concentrated esmolol formulation is provided that is distinguishable from a diluted form of the concentrated esmolol formulation.Type: GrantFiled: May 22, 2007Date of Patent: April 23, 2013Assignees: Baxter International Inc., Baxter Healthcare SAInventors: Deepak Tiwari, George Owoo, Rekha Nayak, Kenneth E. Burhop
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Publication number: 20080292558Abstract: A concentrated esmolol formulation is provided that is distinguishable from a diluted form of the concentrated esmolol formulation. In one embodiment, the concentrated esmolol formulation allows identification of the concentrate even after transfer of the concentrate out of a labeled primary container. The concentrated esmolol formulation can include from about 25 to about 1000 mg/ml of esmolol hydrochloride, a buffering agent and a color additive. Any number of color additives may be included such as indocyanine green, phenopheylene, hemoglobin, cyanocobalamine, patent blue, and indigo carmine vitamin B2 and naturally occurring vitamins and minerals. The amount included in the formulation is highly dependent on the color additive selected. The color additive should be included in an amount sufficient to easily distinguish the concentrated esmolol formulation from at least about a 1:4 dilution of the concentrate.Type: ApplicationFiled: May 22, 2007Publication date: November 27, 2008Inventors: Deepak Tiwari, George Owoo, Rekha Nayak, Kenneth E. Burhop
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Publication number: 20080293814Abstract: A concentrate esmolol formulation is provided that is safer than current concentrate (e.g., 250 mg/ml) esmolol compositions. The concentrate esmolol formulation can include from about 40-60 mg/ml of esmolol hydrochloride. The concentrate esmolol composition allows a practitioner the flexibility of choosing a bolus volume for direct injection to a patient or, optionally, to use the composition to make a customized, diluted composition of esmolol. Methods of the present invention provide for the reduction of potential adverse health consequences resulting in the improper dosing of prior art concentrate compositions of esmolol. Also, a medical product is provided that includes a concentrate esmolol housed in a container, and a package housing the container and instructions.Type: ApplicationFiled: May 22, 2007Publication date: November 27, 2008Inventors: Deepak Tiwari, George Owoo, Rekha Nayak, Kenneth E. Burhop
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Publication number: 20080293810Abstract: Disclosed are concentrate esmolol injection essentially free from other related esters of esmolol and diluted esmolol compositions. The concentrate esmolol formulation includes from about 25-1000 mg/ml of esmolol and about 1-25% w/v of benzyl alcohol and the combination thereof. The compositions can also be used as multi-dose compositions. The present invention also discloses diluted, ready-to-use compositions of esmolol prepared by dilution of the present invention concentrates. Also disclosed are methods of making and using the ready-to-use compositions of the present invention.Type: ApplicationFiled: May 22, 2007Publication date: November 27, 2008Inventors: Deepak Tiwari, George Owoo, Rekha nayak, kenneth E. Burhop