Patents Assigned to LifeCycle Pharma A/S
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Publication number: 20140038998Abstract: 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: ApplicationFiled: February 17, 2011Publication date: February 6, 2014Applicant: LifeCycle Pharma A/SInventors: Nikolaj Skak, Per Holm
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Publication number: 20120029009Abstract: 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: ApplicationFiled: June 23, 2011Publication date: February 2, 2012Applicant: LifeCycle Pharma A/SInventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Publication number: 20110275659Abstract: 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: ApplicationFiled: June 23, 2011Publication date: November 10, 2011Applicant: LifeCycle Pharma A/SInventors: Robert D. GORDON, Per HOLM, Anne-Marie LADEMANN, Tomas NORLING
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Publication number: 20110256190Abstract: 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: ApplicationFiled: June 23, 2011Publication date: October 20, 2011Applicant: LifeCycle Pharma A/SInventors: Per HOLM, Tomas Norling
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Publication number: 20110251232Abstract: 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: ApplicationFiled: June 23, 2011Publication date: October 13, 2011Applicant: LifeCycle Pharma A/SInventors: Per HOLM, Tomas NORLING
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Publication number: 20110250277Abstract: 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: ApplicationFiled: June 23, 2011Publication date: October 13, 2011Applicant: LifeCycle Pharma A/SInventors: Per Holm, Tomas Norling
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Publication number: 20110251231Abstract: 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: ApplicationFiled: June 23, 2011Publication date: October 13, 2011Applicant: LifeCycle Pharma A/SInventors: Per HOLM, Tomas NORLING
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Publication number: 20110244031Abstract: A tablet composition, which in an easy, flexible and reproducible manner can be loaded with a relatively high amount of a pharmaceutically acceptable oily substance, may be produced in large-scale batches and stored until use; and tablets loaded with a pharmaceutically acceptable oily substance as well as a method for the preparation thereof. The tablet composition comprises a release enhancing agent and provides high and/or consistent release of the pharmaceutically acceptable oily substance, in particular release of a pharmaceutically acceptable, but substantially water-insoluble, oily substance.Type: ApplicationFiled: March 31, 2011Publication date: October 6, 2011Applicant: LifeCycle Pharma A/SInventors: Nikolaj SKAK, Bent HOJGAARD
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Publication number: 20110201639Abstract: 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: ApplicationFiled: February 17, 2011Publication date: August 18, 2011Applicant: LifeCycle Pharma A/SInventors: Nikolaj Skak, Liselotte Hansen
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Patent number: 7994214Abstract: 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: August 30, 2004Date of Patent: August 9, 2011Assignee: Lifecycle Pharma A/SInventor: Per Holm
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Publication number: 20100323008Abstract: 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 18, 2009Publication date: December 23, 2010Applicant: LIFECYCLE PHARMA A/SInventors: Per Holm, Tomas Norling
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Patent number: 7772273Abstract: A stable pharmaceutical composition for oral administration comprising atorvastatin and an amount of a pharmaceutically acceptable organic alkalizing compound capable of establishing a microenvironment for atorvastatin having a pH of at least about 5, for example 2-amino-2-(hydroxymethyl)-1,3-propanediol (trometamol).Type: GrantFiled: February 9, 2007Date of Patent: August 10, 2010Assignee: LifeCycle Pharma A/SInventor: Per Holm
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Publication number: 20100105717Abstract: 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: ApplicationFiled: July 7, 2009Publication date: April 29, 2010Applicant: LifeCycle Pharma A/SInventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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Patent number: 7658944Abstract: 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: October 1, 2004Date of Patent: February 9, 2010Assignee: LifeCycle Pharma A/SInventors: Per Holm, Tomas Norling
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Publication number: 20090186081Abstract: A disintegrating loadable tablet product in compressed form comprising i) at least 60% w/w of a sorbent material having a specific surface area (BET surface area) of at least 50 m2/g as measured by gas adsorption or mixtures of such sorbent materials, and ii) a disintegrant or a mixture of disintegrants wherein the tablet in compressed form has a) a porosity of 45% v/v or more, b) a hardness of at least 20 Newton, and c) a loading capacity of at least 30% of a liquid. The tablet is suitable for the preparation of a tablet containing an active substance by e.g. immersing the tablet in a liquid containing the active substance. The invention thus provides a safe and reproducible new method of preparing pharmaceutical tablets.Type: ApplicationFiled: January 5, 2007Publication date: July 23, 2009Applicant: LifeCycle Pharma A/SInventors: Per Holm, Lillian Slot
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Publication number: 20090011013Abstract: The present invention relates to a pharmaceutical composition comprising tacrolimus or an analogue thereof and a substance being a substrate for CYP3A4 and/or P-glycoprotein, oral solid dosage forms comprising the pharmaceutical composition such as tablets, methods for preparing the pharmaceutical composition and oral dosage forms and use of the pharmaceutical composition for preparing a medicament. The substance being a substrate for CYP3A4 and/or P-glycoprotein is preferably cyclosporine A. The invention further relates to treatment of a patient in need thereof by coadministration of the combination according to the invention. In a further aspect, the invention relates to the above combination further comprising a CYP3A4 inhibitor compound, preferably a compound naturally occurring in citrus juice, for example grapefruit juice, preferably a spiro ortho ester compound.Type: ApplicationFiled: October 9, 2006Publication date: January 8, 2009Applicant: LIFECYCLE PHARMA A/SInventors: Lisbet Bonlokke Ranklove, Jan Moller Mikkelsen
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Publication number: 20070275074Abstract: 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: ApplicationFiled: February 27, 2007Publication date: November 29, 2007Applicant: LifeCycle Pharma A/SInventors: Per Holm, Anders Burr, Michiel Elema, Birgitte Mollgaard, Jannie Holm, Kirsten Schultz
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Patent number: 7252247Abstract: A self-cleaning spray nozzle, and in particular a self-cleaning spray nozzle for use in an apparatus for the preparation of a particulate material by a controlled agglomeration method, for example a method for controlled growth of particle size. The apparatus 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.Type: GrantFiled: December 22, 2003Date of Patent: August 7, 2007Assignee: LifeCycle Pharma A/SInventors: Per Holm, Elo Nielsen
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Patent number: 7217431Abstract: 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: July 5, 2002Date of Patent: May 15, 2007Assignee: LifeCycle Pharma A/SInventors: Per Holm, Anders Buur, Michiel Onne Elema, Birgitte Møllgaard, Jannie Egeskov Holm, Kirsten Schultz
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Publication number: 20070026062Abstract: Stable tablets and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved or dispersed in an non-aqueous vehicle with improved bioavailability, thereby eliminating the food effect so that the tablet or composition can be administered to a patient irrespective of being in fed or fasted state.Type: ApplicationFiled: June 9, 2006Publication date: February 1, 2007Applicant: LIFECYCLE PHARMA A/SInventors: Per Holm, Tomas Norling