Patents by Inventor JAYDEEP VAGHASHIYA
JAYDEEP VAGHASHIYA 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: 11964048Abstract: 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: GrantFiled: June 9, 2021Date of Patent: April 23, 2024Inventors: Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah, Wantanee Phuapradit, Kanji Meghpara
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Publication number: 20240000701Abstract: 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: September 14, 2023Publication date: January 4, 2024Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLCInventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
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Patent number: 11793747Abstract: 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: October 18, 2021Date of Patent: October 24, 2023Inventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
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Publication number: 20230330006Abstract: 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 facing 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 20, 2023Publication date: October 19, 2023Applicant: Amneal Complex Products Rearch LLCInventors: Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah, Prajakta Bagul, Wantanee Phuapradit, Kanji Meghpara
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Publication number: 20230023032Abstract: The present disclosure provides osmotic, floating gastroretentive compositions comprising a multilayer core comprising a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, a gas-generating agent, a first osmogen, and at least one water-soluble hydrophilic polymer; and a push layer comprising a polyethylene oxide polymer with an average molecular weight of at least 900,000 Da, and a second osmogen. 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 composition provides sustained release, while maintaining plasma concentration of from 0.5 ng/ml to 3 ng/ml, of liothyronine or a pharmaceutically acceptable salt, for at least 6 hours.Type: ApplicationFiled: December 16, 2020Publication date: January 26, 2023Applicant: Amneal Complex Products Research LLCInventors: Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah
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Patent number: 11547670Abstract: 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: GrantFiled: March 5, 2020Date of Patent: January 10, 2023Assignee: Amneal Complex Products Research LLCInventors: Siva Ram Kiran Vaka, Atsawin Thongsukmak, Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah, Wantanee Phuapradit, Paras Jariwala
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Publication number: 20220370343Abstract: 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: August 1, 2022Publication date: November 24, 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: 20220347089Abstract: 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: July 12, 2022Publication date: November 3, 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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Patent number: 11439585Abstract: 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: September 3, 2021Date of Patent: September 13, 2022Assignee: 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: 11419813Abstract: 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: October 7, 2021Date of Patent: August 23, 2022Inventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
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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: 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: 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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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