Patents Assigned to VELOXIS PHARMACEUTICALS INC.
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Patent number: 11957666Abstract: The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.Type: GrantFiled: September 14, 2021Date of Patent: April 16, 2024Assignee: VELOXIS PHARMACEUTICALS, INC.Inventor: William J. Polvino
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Patent number: 11419823Abstract: The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.Type: GrantFiled: November 13, 2018Date of Patent: August 23, 2022Assignee: VELOXIS PHARMACEUTICALS, INC.Inventors: Nikolaj Skak, Per Holm
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Patent number: 11141408Abstract: The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.Type: GrantFiled: November 8, 2019Date of Patent: October 12, 2021Assignee: VELOXIS PHARMACEUTICALS INC.Inventor: William J. Polvino
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Patent number: 11129815Abstract: A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.Type: GrantFiled: October 18, 2019Date of Patent: September 28, 2021Assignee: VELOXIS PHARMACEUTICALS INC.Inventor: Per Holm
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Patent number: 11123331Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.Type: GrantFiled: October 30, 2020Date of Patent: September 21, 2021Assignee: VELOXIS PHARMACEUTICALS, INC.Inventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Patent number: 11110081Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.Type: GrantFiled: October 30, 2020Date of Patent: September 7, 2021Assignee: VELOXIS PHARMACEUTICALS, INC.Inventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Patent number: 11077096Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.Type: GrantFiled: August 15, 2017Date of Patent: August 3, 2021Assignee: VELOXIS PHARMACEUTICALS INC.Inventors: Per Holm, Tomas Norling