Patents by Inventor Rok Grahek
Rok Grahek 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).
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Patent number: 10702477Abstract: The present invention refers to a process for preparing granules or particles comprising afatinib dimaleate, comprising the steps of providing afatinib dimaleate and at least one pharmaceutically acceptable excipient, and preparing granules or particles involving the use of at least one solvent selected from organic solvent and water, wherein all pharmaceutically acceptable excipients used in the process for preparing granules or particles have neutral or acidic properties, and wherein afatinib dimaleate has a solubility of at least 5 mg/ml in said at least one solvent. The present invention further refers to granules or particles comprising afatinib dimaleate that are prepared according to this process. Additionally, the present invention refers to a process for preparing a pharmaceutical composition comprising afatinib dimaleate, as well as to an adsorbate comprising afatinib dimaleate.Type: GrantFiled: October 11, 2016Date of Patent: July 7, 2020Inventors: Jan Pelipenko, Katja Kristan, Marko Oblak, Miha Homar, Rok Grahek
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Publication number: 20200163882Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a solid pharmaceutical composition comprising androgen receptor antagonists, e.g. Enzalutamide or ARN-509, as well as to processes for preparing the same. The solid pharmaceutical compositions are useful in the treatment of prostate cancer.Type: ApplicationFiled: January 24, 2020Publication date: May 28, 2020Applicant: Lek Pharmaceuticals d.d.Inventors: Rok Grahek, Andrija Lebar, Petra Draksler, Bostjan Petek, Jerneja Opara, Klemen Naversnik, Petra Bozic
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Publication number: 20190175543Abstract: The present invention belongs to the field of pharmaceutical industry and relates to an amorphous solid dispersion comprising at least one polymer and dapagliflozin, to a pharmaceutical composition comprising said solid dispersion, to a process for the preparation thereof, and to the solid dispersion and pharmaceutical composition respectively obtainable by said process. Further, the present invention refers to an adsorbate comprising dapagliflozin and to a pharmaceutical composition comprising said adsorbate, as well as to a process for the preparation thereof. Finally, the present invention relates to the solid dispersion, the adsorbate or the pharmaceutical composition for use in the treatment of diseases related to hypoglycemia.Type: ApplicationFiled: January 24, 2019Publication date: June 13, 2019Applicant: Sandoz AGInventors: Rok Staric, Sandra Berglez, Jernej GRMAS, Tijana Stanic Ljubin, Rok Grahek, Luka Peternel
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Publication number: 20190029962Abstract: The present invention refers to a process for preparing granules or particles comprising afatinib dimaleate, comprising the steps of providing afatinib dimaleate and at least one pharmaceutically acceptable excipient, and preparing granules or particles involving the use of at least one solvent selected from organic solvent and water, wherein all pharmaceutically acceptable excipients used in the process for preparing granules or particles have neutral or acidic properties, and wherein afatinib dimaleate has a solubility of at least 5 mg/ml in said at least one solvent. The present invention further refers to granules or particles comprising afatinib dimaleate that are prepared according to this process. Additionally, the present invention refers to a process for preparing a pharmaceutical composition comprising afatinib dimaleate, as well as to an adsorbate comprising afatinib dimaleate.Type: ApplicationFiled: October 11, 2016Publication date: January 31, 2019Applicant: Sandoz AGInventors: Jan Pelipenko, Katja Kristan, Marko Oblak, Miha Homar, Rok Grahek
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Patent number: 9907757Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.Type: GrantFiled: September 10, 2015Date of Patent: March 6, 2018Assignee: Lek Pharmaceuticals d.d.Inventors: Vlasta Humar, Mateja Burjak, Rok Grahek, Mateja Salobir, Janez Kerc, Klemen Kocevar
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Publication number: 20170258761Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a dry pharmaceutical composition comprising Canagliflozin, as well as to a process for preparing the same. Such dry pharmaceutical composition is useful as a medicament, especially for the normalization of plasma glucose levels.Type: ApplicationFiled: August 28, 2015Publication date: September 14, 2017Applicant: Sandoz AGInventors: Mateja Burjak, Tanja Rozman Peterka, Bostjan Petek, Bostjan Markun, Katja Berginc, Miha Tomaz Jaklic, Rok Grahek, Zoran Ham
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Publication number: 20160346207Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a solid pharmaceutical composition comprising androgen receptor antagonists, e.g. Enzalutamide or ARN-509, as well as to processes for preparing the same. The solid pharmaceutical compositions are useful in the treatment of prostate cancer.Type: ApplicationFiled: February 4, 2015Publication date: December 1, 2016Applicant: Lek Pharmaceuticals d.d.Inventors: Rok Grahek, Andrija Lebar, Petra Draksler, Bostjan Petek, Jerneja Opara, Klemen Naversnik, Petra Bozic
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Patent number: 9453030Abstract: The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.Type: GrantFiled: December 18, 2014Date of Patent: September 27, 2016Assignee: Lek Pharmaceuticals d.d.Inventors: Rok Grahek, Darko Kocjan, Andrej Bastarda, Andrej Kocijan, Matjaz Kracun
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Publication number: 20160256433Abstract: The present invention belongs to the field of pharmaceutical industry and relates to an amorphous solid dispersion comprising at least one polymer and dapagliflozin, to a pharmaceutical composition comprising said solid dispersion, to a process for the preparation thereof, and to the solid dispersion and pharmaceutical composition respectively obtainable by said process. Further, the present invention refers to an adsorbate comprising dapagliflozin and to a pharmaceutical composition comprising said adsorbate, as well as to a process for the preparation thereof. Finally, the present invention relates to the solid dispersion, the adsorbate or the pharmaceutical composition for use in the treatment of diseases related to hypoglycemia.Type: ApplicationFiled: July 22, 2014Publication date: September 8, 2016Applicant: Sandoz AGInventors: Rok Staric, Sandra Berglez, Jernej GRMAS, Tijana Stanic Ljubin, Rok Grahek, Luka Peternel
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Publication number: 20160128946Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.Type: ApplicationFiled: September 10, 2015Publication date: May 12, 2016Applicant: LEK PHARMACEUTICALS D.D.Inventors: Vlasta Humar, Mateja Burjak, Rok Grahek, Mateja Salobir, Janez Kerc, Klemen Kocevar
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Patent number: 9149460Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.Type: GrantFiled: September 27, 2007Date of Patent: October 6, 2015Assignee: Lek Pharmaceuticals d.d.Inventors: Vlasta Humar, Mateja Burjak, Rok Grahek, Mateja Salobir, Janez Kerc, Klemen Kocevar
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Publication number: 20150105551Abstract: The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.Type: ApplicationFiled: December 18, 2014Publication date: April 16, 2015Inventors: Rok GRAHEK, Darko KOCJAN, Andrej BASTARDA, Andrej KOCIJAN, Matjaz KRACUN
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Patent number: 8435938Abstract: The new pure vancomycin hydrochloride substantially free of impurities known in commercially available products is described. The term “substantially free of impurities” designates a purity of vancomycin hydrochloride between about 97% and about 99%, particularly between about 98% and about 99%, preferably about 99%, as determined by HPLC analytical method as directed in U.S.P., NF 27th revision, 22 (2004). The new pure vancomycin hydrochloride (vancomycin B hydrochloride) contains less than 0.7% of total impurities, namely, only one impurity exceeds 0.3%. The new process for the purification of crude vancomycin by displacement chromatography is described by which the desired pure antibiotic according to the present invention is produced, based on the finding that high purity of the vancomycin hydrochloride is obtained using low selected pH values of the mobile phase between 3.9 and 4.2.Type: GrantFiled: December 5, 2005Date of Patent: May 7, 2013Assignee: Lek Pharmaceuticals d.d.Inventors: Rok Grahek, Andrej Bastarda
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Patent number: 8309719Abstract: Process for the preparation of enantiomerically pure methyl ester of rosuvastatin has been developed, wherein the crude methyl ester ester is first purified by preparative chromatography, followed by crystallization.Type: GrantFiled: August 1, 2008Date of Patent: November 13, 2012Assignee: LEK Pharmaceuticals D.D.Inventors: Andrej Bastarda, Rok Grahek, Martin Crnugelj
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Publication number: 20120088774Abstract: The present invention belongs to the field of pharmaceutical industry and relates to dosage forms comprising active pharmaceutical ingredients (API) such as tadalafil, simvastatin, fenofibrate and lovastatin that are practically insoluble in water, adsorbed on a carrier. Furthermore it relates to an adsorbate comprising API being practically insoluble in water and to a process for the preparation of said adsorbate with non-polar solvent (s) such as chlorinated hydrocarbon, diisopropylethes and hexane. Furthermore the invention relates to a process for the preparation of the dosage form, as well as to the use of the adsorbate for the preparation of the dosage form. Moreover it relates to the dosage form for use in the treatment of erectile dysfunction, human immunodeficiency virus (HIV) infections and/or Acquired Immune Deficiency Syndrome (AIDS).Type: ApplicationFiled: April 6, 2010Publication date: April 12, 2012Applicant: LEK PHARMACEUTICALS D.D.Inventors: Rok Grahek, Andrej Bastarda, Miha T. Jaklic, Klemen Kocevar, Samo Pirc
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Patent number: 8044086Abstract: The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.Type: GrantFiled: July 15, 2005Date of Patent: October 25, 2011Assignee: Lek Pharmaceuticals D.D.Inventors: Rok Grahek, Darko Kocjan, Andrej Bastarda, Andrej Kocijan, Matjaz Kracun
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Publication number: 20110184172Abstract: Process for the preparation of enantiomerically pure methyl ester of rosuvastatin has been developed, wherein the crude methyl ester ester is first purified by preparative chromatography, followed by crystallization.Type: ApplicationFiled: August 1, 2008Publication date: July 28, 2011Applicant: LEK PHARMACEUTICALS D.D.Inventors: Andrej Bastarda, Rok Grahek, Martin Crnugelj
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Publication number: 20110112165Abstract: A new compound in which atorvastatin and aliskiren are covalently bound, salts of this compound, pharmaceutical compositions thereof, as well the use of this compound as a medicament and as an impurity standard are provided. Furthermore, a 0 process for the preparation of a compound in which atorvastatin and aliskiren are covalently bound, a method for analyzing a sample of atorvastatin and/or aliskiren, and a method for determining the retention time on a chromatographic system for atorvastatin and/or aliskiren are provided.Type: ApplicationFiled: January 13, 2009Publication date: May 12, 2011Inventors: Andrej Kocijan, Matjaz Kracun, Andrej Bastarda, Rok Grahek, Darko Kocjan
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Publication number: 20100305087Abstract: A combination preparation comprising an active pharmaceutical ingredient (API) and a pharmaceutically acceptable solid support, wherein said solid support is in a water-insoluble particulate form and comprises a material selected from silicic acid, aluminum hydroxide and titanium hydroxide is disclosed. The API is a compound having both, at least one hydrophobic structural moiety causing the API to have a low solubility in water or in an aqueous solution, and multiple hydrophilic groups arranged to form multiple intermolecular interactions to the solid support involving polar or ionic or hydrogen bonding. The hydrophilic groups of the API are independently equal or different and comprise at least one of the groups consisting of OH- and halogen-groups. The API is bound to the solid support by adsorption, and a major proportion of said API is in an amorphous state. Related pharmaceuticals and methods of preparation also are disclosed.Type: ApplicationFiled: December 18, 2008Publication date: December 2, 2010Applicant: Lek Pharmaceuticals d.d.Inventors: Rok Grahek, Aleksander Resman, Andrej Bastarda, Martin Crnugelj
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Publication number: 20100219063Abstract: The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.Type: ApplicationFiled: April 30, 2010Publication date: September 2, 2010Applicant: Lek Pharmaceuticals D.D.Inventors: Rok GRAHEK, Darko Kocjan, Andrej Bastarda, Andrej Kocijan, Matjaz Kracun