Patents by Inventor Namdev B. Shelke

Namdev B. Shelke 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).

  • Patent number: 11154505
    Abstract: 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: Grant
    Filed: February 3, 2021
    Date of Patent: October 26, 2021
    Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Publication number: 20210236421
    Abstract: 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: Application
    Filed: April 19, 2021
    Publication date: August 5, 2021
    Applicant: AMNEAL COMPLEX PRODUCTS RESEARCH LLC
    Inventors: 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: 20210236429
    Abstract: 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: Application
    Filed: January 20, 2021
    Publication date: August 5, 2021
    Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Patent number: 11045420
    Abstract: 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: Grant
    Filed: October 9, 2020
    Date of Patent: June 29, 2021
    Assignee: Kashiv Specialty Pharmaceuticals, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Patent number: 11040014
    Abstract: 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: Grant
    Filed: October 30, 2020
    Date of Patent: June 22, 2021
    Assignee: Kashiv Specialty Pharmaceuticals, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Patent number: 11007145
    Abstract: 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: Grant
    Filed: October 7, 2020
    Date of Patent: May 18, 2021
    Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
  • Patent number: 10987311
    Abstract: 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: Grant
    Filed: June 18, 2019
    Date of Patent: April 27, 2021
    Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Publication number: 20210069117
    Abstract: 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: Application
    Filed: June 18, 2019
    Publication date: March 11, 2021
    Applicant: KASHIV BIOSCIENCES, LLC
    Inventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Patent number: 10925833
    Abstract: 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: Grant
    Filed: August 26, 2020
    Date of Patent: February 23, 2021
    Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Publication number: 20210038523
    Abstract: 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: Application
    Filed: October 9, 2020
    Publication date: February 11, 2021
    Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Publication number: 20210038524
    Abstract: 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: Application
    Filed: October 30, 2020
    Publication date: February 11, 2021
    Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Publication number: 20210022999
    Abstract: 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: Application
    Filed: October 7, 2020
    Publication date: January 28, 2021
    Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Kanji Meghpara, Jaydeep Vaghashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
  • Patent number: 10881617
    Abstract: 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: Grant
    Filed: June 23, 2020
    Date of Patent: January 5, 2021
    Assignee: KASHIV BIOSCIENCES, LLC
    Inventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Patent number: 10869839
    Abstract: 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: Grant
    Filed: May 1, 2020
    Date of Patent: December 22, 2020
    Assignee: KASHIV BIOSCIENCES, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Publication number: 20200383923
    Abstract: 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: Application
    Filed: August 26, 2020
    Publication date: December 10, 2020
    Applicant: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Patent number: 10857098
    Abstract: 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: Grant
    Filed: May 6, 2020
    Date of Patent: December 8, 2020
    Assignee: KASHIV SPECIALTY PHARMACEUTICALS, LLC
    Inventors: 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: 20200261359
    Abstract: 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: Application
    Filed: May 6, 2020
    Publication date: August 20, 2020
    Applicant: KASHIV BIOSCIENCES, LLC
    Inventors: 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: 20200261372
    Abstract: 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: Application
    Filed: May 1, 2020
    Publication date: August 20, 2020
    Applicant: KASHIV BIOSCIENCES, LLC
    Inventors: Namdev B. Shelke, Siva Ram Kiran- Vaka, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit
  • Patent number: 10744093
    Abstract: 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: Grant
    Filed: January 28, 2020
    Date of Patent: August 18, 2020
    Assignee: KASHIV BIOSCIENCES, LLC
    Inventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
  • Publication number: 20200163889
    Abstract: 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: Application
    Filed: January 28, 2020
    Publication date: May 28, 2020
    Applicant: KASHIV BIOSCIENCES, LLC
    Inventors: Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah