Patents Assigned to KASHIV SPECIALTY PHARMACEUTICALS, LLC
-
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
-
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
-
Publication number: 20210205207Abstract: 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: March 11, 2021Publication date: July 8, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Patent number: 11045420Abstract: 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 reduced Cmax, a Cmin:Cmax ratio of ?0.4, and extended release, while maintaining therapeutically effective concentration, of trihexyphenidyl for 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: GrantFiled: October 9, 2020Date of Patent: June 29, 2021Assignee: Kashiv Specialty Pharmaceuticals, LLCInventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
-
Patent number: 11040014Abstract: 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 reduced Cmax, a Cmin:Cmax ratio of ?0.4, and extended release, while maintaining therapeutically effective concentration, of trihexyphenidyl for 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: GrantFiled: October 30, 2020Date of Patent: June 22, 2021Assignee: Kashiv Specialty Pharmaceuticals, LLCInventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
-
Patent number: 11007145Abstract: 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: October 7, 2020Date of Patent: May 18, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
-
Publication number: 20210137827Abstract: 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: January 19, 2021Publication date: May 13, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
-
Patent number: 11000471Abstract: 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: March 5, 2019Date of Patent: May 11, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Patent number: 10987311Abstract: 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: April 27, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Patent number: 10980738Abstract: 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 15, 2020Date of Patent: April 20, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Patent number: 10952957Abstract: 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 29, 2020Date of Patent: March 23, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
-
Publication number: 20210052487Abstract: 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 29, 2020Publication date: February 25, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Jaydeep Vaghashiya, Kanji Meghpara
-
Patent number: 10925833Abstract: 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: August 26, 2020Date of Patent: February 23, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Patent number: 10918597Abstract: 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: June 18, 2018Date of Patent: February 16, 2021Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Kanji Meghpara, Harpreet Kaur Sandhu, Ashish Chatterji, Navnit H. Shah, Wantanee Phuapradit, Dipen Desai, Jaydeep Vaghashiya
-
Publication number: 20210038523Abstract: 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 reduced Cmax, a Cmin:Cmax ratio of ?0.4, and extended release, while maintaining therapeutically effective concentration, of trihexyphenidyl for 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: October 9, 2020Publication date: February 11, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
-
Publication number: 20210038524Abstract: 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 reduced Cmax, a Cmin:Cmax ratio of ?0.4, and extended release, while maintaining therapeutically effective concentration, of trihexyphenidyl for 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: October 30, 2020Publication date: February 11, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
-
Publication number: 20210030685Abstract: 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: March 5, 2019Publication date: February 4, 2021Applicant: KASHiV SPECIALTY PHARMACEUTICALS, LLCInventors: Siva Ram Kiran Vaka, Paras Jariwaia, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Publication number: 20210022999Abstract: 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: October 7, 2020Publication date: January 28, 2021Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
-
Publication number: 20200405626Abstract: 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 15, 2020Publication date: December 31, 2020Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Siva Ram Kiran Vaka, Paras Jariwala, Jaydeep Vaghashiya, Atsawin Thongsukmak, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
-
Publication number: 20200383923Abstract: 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: August 26, 2020Publication date: December 10, 2020Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLCInventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah