Patents by Inventor Navnit H. Shah
Navnit H. Shah 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: 20220249377Abstract: The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced Cmax, a Cmin:Cmax ratio of ?0.4, Fluctuation Index of ?1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.Type: ApplicationFiled: September 23, 2021Publication date: August 11, 2022Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
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Publication number: 20220241184Abstract: The present disclosure provides self-regulating, oral, osmotic, floating gastroretentive CD/LD compositions that are suitable for once- or twice-daily administration. The compositions provide extended release with enhanced pharmacokinetic attributes of LD, e.g., reduced lag time, avoidance of low trough levels, and reduced peak-to-trough ratios (Cmax/Cmin) compared to marketed CD/LD products. The compositions provide extended release of CD/LD for about 8 to about 14 hours, without losing gastroretentive attributes of the system (GRS attributes), and collapse/squeeze after at least about 80% of the drug (CD/LD) is released from the system.Type: ApplicationFiled: June 17, 2020Publication date: August 4, 2022Inventors: Kanji MEGHPARA, Jaydeep VAGHASHIYA, Dipen DESAI, Wantanee PHUAPRADIT, Navnit H. SHAH
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Publication number: 20220218604Abstract: The present disclosure is directed to floating gastroretentive dosage forms with prolonged gastric residence time. The disclosure also provides rapidly expanding sustained release or combined immediate release and sustained release formulations comprising drugs that require targeted release in the proximal gastrointestinal tract for maximum therapeutic benefit. The rapidly expanding floating gastroretentive dosage forms comprise a permeable elastic membrane providing desired characteristics for drug release and mechanical strength to maintain tablet integrity.Type: ApplicationFiled: March 24, 2022Publication date: July 14, 2022Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
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Publication number: 20220192977Abstract: The present disclosure provides floating gastroretentive compositions comprising a multilayer core comprising 1) a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, and a gas-generating agent; and 2) a push layer. Each of the pull layer and the push layer comprises a swellable water-soluble hydrophilic polymer. The composition further comprises a permeable elastic membrane covering at least a portion of the multilayer core and containing at least one orifice in fluid communication with the pull layer. The permeable elastic membrane comprises a copolymer of ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride. The composition provides sustained release of liothyronine or a pharmaceutically acceptable salt thereof.Type: ApplicationFiled: June 9, 2021Publication date: June 23, 2022Applicant: Amneal Complex Products Rearch LLCInventors: Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah
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Publication number: 20220133635Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed extended release of a therapeutically acceptable amount of methylphenidate hydrochloride. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm that matches the circadian rhythm of an individual being treated to optimize therapeutic outcome and minimize side effects.Type: ApplicationFiled: March 5, 2020Publication date: May 5, 2022Applicant: KASHIV BIOSCIENCES, LLCInventors: Siva Ram Kiran Vaka, Atsawin Thongsukmak, Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah, Wantanee Phuapradit, Paras Jariwala
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Patent number: 11318091Abstract: The present disclosure is directed to floating gastroretentive dosage forms with prolonged gastric residence time. The disclosure also provides rapidly expanding sustained release or combined immediate release and sustained release formulations comprising drugs that require targeted release in the proximal gastrointestinal tract for maximum therapeutic benefit. The rapidly expanding floating gastroretentive dosage forms comprise a permeable elastic membrane providing desired characteristics for drug release and mechanical strength to maintain tablet integrity.Type: GrantFiled: April 19, 2021Date of Patent: May 3, 2022Assignee: Amneal Complex Products Research LLCInventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
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Publication number: 20220096386Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.Type: ApplicationFiled: December 14, 2021Publication date: March 31, 2022Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah, Namdev B. Shelke
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Publication number: 20220096366Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. In certain embodiments, the programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The programmable osmotic-controlled oral compositions of the disclosure comprise a multilayer core comprising a drug for controlled release, wherein the core is coated with a semipermeable membrane comprising an orifice and, optionally, an immediate release coating, comprising a drug for immediate release, over the semipermeable membrane. The multilayered core comprises a pull layer containing the drug and a push layer.Type: ApplicationFiled: October 7, 2021Publication date: March 31, 2022Applicant: Amneal Complex Products Research LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
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Publication number: 20220079896Abstract: The present disclosure provides oral compositions providing delayed release of armodafinil/modafinil. The compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired lag time, and release drug at a rhythm that matches the human circadian rhythm regulating sleep-wake cycle to optimize therapeutic outcome and minimize side effects.Type: ApplicationFiled: September 9, 2021Publication date: March 17, 2022Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Kanji Meghpara, Siva Ram Kiran Vaka, Dipen Desai, Navnit H. Shah
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Publication number: 20220040114Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed extended release of a therapeutically acceptable amount of methylphenidate hydrochloride. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm that matches the circadian rhythm of an individual being treated to optimize therapeutic outcome and minimize side effects.Type: ApplicationFiled: October 22, 2021Publication date: February 10, 2022Applicant: Amneal Complex Products Research LLCInventors: Siva Ram Kiran Vaka, Atsawin Thongsukmak, Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah, Wantanee Phuapradit, Paras Jariwala, Gaurang Patel
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Publication number: 20220031604Abstract: Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as, optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane.Type: ApplicationFiled: October 18, 2021Publication date: February 3, 2022Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
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Patent number: 11229606Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.Type: GrantFiled: June 18, 2019Date of Patent: January 25, 2022Assignee: Amneal Complex Products Research LLCInventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
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Publication number: 20210393512Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.Type: ApplicationFiled: September 3, 2021Publication date: December 23, 2021Applicant: Amneal Complex Products Research LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
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Patent number: 11179320Abstract: Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as, optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane.Type: GrantFiled: January 19, 2021Date of Patent: November 23, 2021Assignee: Amneal Complex Products Research LLCInventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
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Patent number: 11166906Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. In certain embodiments, the programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The programmable osmotic-controlled oral compositions of the disclosure comprise a multilayer core comprising a drug for controlled release, wherein the core is coated with a semipermeable membrane comprising an orifice and, optionally, an immediate release coating, comprising a drug for immediate release, over the semipermeable membrane. The multilayered core comprises a pull layer containing the drug and a push layer.Type: GrantFiled: April 5, 2021Date of Patent: November 9, 2021Assignee: Amneal Complex Products Research LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
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Publication number: 20210330657Abstract: The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising organic acid that is coated with at least one drug layer comprising trihexyphenidyl hydrochloride, and a functional coat over the drug-layered core. The extended release compositions of the disclosure provide extended release of trihexyphenidyl hydrochloride, with reduced Cmax, and a Cmin:Cmax ratio of ?0.4, while maintaining a therapeutically effective concentration for a period of at least about 16 hours. The compositions of the disclosure improve solubility of trihexyphenidyl hydrochloride, at a pH of greater than or equal to 5, to maintain its minimum effective concentration at such pH.Type: ApplicationFiled: September 19, 2019Publication date: October 28, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
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Patent number: 11154494Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.Type: GrantFiled: March 11, 2021Date of Patent: October 26, 2021Assignee: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
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Patent number: 11154505Abstract: The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced Cmax, a Cmin:Cmax ratio of ?0.4, Fluctuation Index of ?1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.Type: GrantFiled: February 3, 2021Date of Patent: October 26, 2021Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
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Publication number: 20210236421Abstract: The present disclosure is directed to floating gastroretentive dosage forms with prolonged gastric residence time. The disclosure also provides rapidly expanding sustained release or combined immediate release and sustained release formulations comprising drugs that require targeted release in the proximal gastrointestinal tract for maximum therapeutic benefit. The rapidly expanding floating gastroretentive dosage forms comprise a permeable elastic membrane providing desired characteristics for drug release and mechanical strength to maintain tablet integrity.Type: ApplicationFiled: April 19, 2021Publication date: August 5, 2021Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
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Publication number: 20210236429Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.Type: ApplicationFiled: January 20, 2021Publication date: August 5, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah