Patents Assigned to Veloxis Pharmaceuticals A/S
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Patent number: 8664239Abstract: 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: June 23, 2011Date of Patent: March 4, 2014Assignee: Veloxis Pharmaceuticals A/SInventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Patent number: 8623411Abstract: 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: June 23, 2011Date of Patent: January 7, 2014Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Patent number: 8623410Abstract: 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: June 23, 2011Date of Patent: January 7, 2014Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Patent number: 8617599Abstract: 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: June 23, 2011Date of Patent: December 31, 2013Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Patent number: 8591946Abstract: 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 30, 2004Date of Patent: November 26, 2013Assignee: Veloxis Pharmaceuticals A/SInventor: Per Holm
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Patent number: 8586084Abstract: 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: June 23, 2011Date of Patent: November 19, 2013Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Publication number: 20130303612Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in a non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.Type: ApplicationFiled: February 25, 2013Publication date: November 14, 2013Applicant: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Patent number: 8535799Abstract: A process for the preparation of a particulate material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5° C. or more which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or the carrier composition and ii) mixing or others means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material.Type: GrantFiled: February 27, 2007Date of Patent: September 17, 2013Assignee: Veloxis Pharmaceuticals A/SInventors: Anders Burr, Michiel Ringkjøbing-Elema, Jannie Egeskov Holm, Per Holm, Birgitte Møllgaard, Kirsten Schultz
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Publication number: 20130189318Abstract: 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: ApplicationFiled: December 20, 2012Publication date: July 25, 2013Applicant: Veloxis Pharmaceuticals A/SInventor: Veloxis Pharmaceuticals A/S
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Patent number: 8486993Abstract: 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: July 7, 2011Date of Patent: July 16, 2013Assignee: Veloxis Pharmaceuticals A/SInventor: Per Holm
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Patent number: 8481078Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.Type: GrantFiled: December 8, 2011Date of Patent: July 9, 2013Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Publication number: 20120195965Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.Type: ApplicationFiled: December 8, 2011Publication date: August 2, 2012Applicant: Veloxis Pharmaceuticals A/SInventors: Per HOLM, Tomas NORLING
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Patent number: 8124125Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.Type: GrantFiled: December 18, 2009Date of Patent: February 28, 2012Assignee: Veloxis Pharmaceuticals A/SInventors: Per Holm, Tomas Norling
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Publication number: 20110263632Abstract: 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: ApplicationFiled: July 7, 2011Publication date: October 27, 2011Applicant: Veloxis Pharmaceuticals A/SInventors: Per HOLM, Tomas Norling