公开(公告)号：US10925833B2

公开(公告)日：2021-02-23

申请号：US17003323

申请日：2020-08-26

申请人： KASHIV SPECIALTY PHARMACEUTICALS, LLC

发明人： Namdev B. Shelke ,  Siva Ram Kiran Vaka ,  Dipen Desai ,  Wantanee Phuapradit ,  Navnit H. Shah

IPC分类号： A61K9/20 ,  A61K31/4425 ,  A61K9/28

摘要： 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.

公开(公告)号：US10987311B2

公开(公告)日：2021-04-27

申请号：US16445110

申请日：2019-06-18

申请人： Kashiv BioSciences, LLC

发明人： Siva Ram Kiran Vaka ,  Namdev B. Shelke ,  Dipen Desai ,  Wantanee Phuapradit ,  Navnit H. Shah

IPC分类号： A61K9/20 ,  A61K31/4425 ,  A61K9/28

摘要： 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.

公开(公告)号：US10980738B2

公开(公告)日：2021-04-20

申请号：US17021124

申请日：2020-09-15

申请人： KASHIV SPECIALTY PHARMACEUTICALS, LLC

发明人： Siva Ram Kiran Vaka ,  Paras Jariwala ,  Jaydeep Vaghashiya ,  Atsawin Thongsukmak ,  Dipen Desai ,  Wantanee Phuapradit ,  Navnit H. Shah

IPC分类号： A61K9/00 ,  A61K9/20 ,  A61K31/138 ,  A61K31/155 ,  A61K31/165 ,  A61K31/4045 ,  A61K31/4178 ,  A61K31/4458 ,  A61K31/573 ,  A61K45/06

摘要： 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.

公开(公告)号：US10918597B2

公开(公告)日：2021-02-16

申请号：US16319086

申请日：2018-06-18

申请人： KASHIV PHARMA LLC

发明人： Kanji Meghpara ,  Harpreet Kaur Sandhu ,  Ashish Chatterji ,  Navnit H. Shah ,  Wantanee Phuapradit ,  Dipen Desai ,  Jaydeep Vaghashiya

IPC分类号： A61K9/00 ,  A61K9/28 ,  A61K47/32 ,  A61K47/34 ,  A61K47/38 ,  A61K31/195 ,  A61K31/403 ,  A61K31/421 ,  A61K31/4412 ,  A61K31/198 ,  A61K31/404 ,  A61K31/4166 ,  A61K31/4425 ,  A61K9/46

摘要： 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.

公开(公告)号：US11000471B2

公开(公告)日：2021-05-11

申请号：US16975493

申请日：2019-03-05

申请人： KASHIV SPECIALTY PHARMACEUTICALS, LLC

发明人： Siva Ram Kiran Vaka ,  Paras Jariwala ,  Jaydeep Vaghashiya ,  Atsawin Thongsukmak ,  Dipen Desai ,  Wantanee Phuapradit ,  Navnit H. Shah

IPC分类号： A61K9/00 ,  A61K9/20 ,  A61K31/138 ,  A61K31/155 ,  A61K31/165 ,  A61K31/4045 ,  A61K31/4178 ,  A61K31/4458 ,  A61K31/573 ,  A61K45/06

摘要： 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. The pull layer comprises at least two layers: a placebo layer for providing a desired lag time for the drug release; and an active layer containing the drug and providing a delayed controlled release of the drug. 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.