RU2007141518A - COMBINATIONS FOR TREATING PROSTATIVE HYPERPLASIA OF THE PROSTATE - Google Patents

COMBINATIONS FOR TREATING PROSTATIVE HYPERPLASIA OF THE PROSTATE Download PDF

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RU2007141518A
RU2007141518A RU2007141518/15A RU2007141518A RU2007141518A RU 2007141518 A RU2007141518 A RU 2007141518A RU 2007141518/15 A RU2007141518/15 A RU 2007141518/15A RU 2007141518 A RU2007141518 A RU 2007141518A RU 2007141518 A RU2007141518 A RU 2007141518A
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inhibitor
pde
dosage form
controlled release
form according
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RU2007141518/15A
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Russian (ru)
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Хельмут ХАНИНГ (DE)
Хельмут Ханинг
Петер СЕРНО (DE)
Петер СЕРНО
Эрвин БИШОФФ (DE)
Эрвин БИШОФФ
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Байер ХельсКер АГ (DE)
Байер ХельсКер АГ
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Abstract

1. Лекарственная форма или комбинированная упаковка для лечения доброкачественной гиперплазии предстательной железы, содержащая, по меньшей мере, один антагонист α-1 адренорецепторов в препаративной форме с контролируемым высвобождением и по меньшей мере один ингибитор PDE 5 в препаративной форме с контролируемым высвобождением или по меньшей мере один ингибитор PDE 5 с длительным периодом полураспада. ! 2. Лекарственная форма по п.1, содержащая препаративную форму с контролируемым высвобождением тамсулозина, альфузозина, доксазосина или теразосина и препаративную форму с контролируемым высвобождением варденафила или сильденафила. ! 3. Лекарственная форма по п.1, содержащая препаративную форму с контролируемым высвобождением тамсулозина, альфузозина, доксазосина или теразосина и тадалафила. ! 4. Лекарственная форма или комбинированная упаковка для лечения доброкачественной гиперплазии предстательной железы, содержащая, по меньшей мере, один ингибитор 5-α редуктазы и по меньшей мере один ингибитор PDE 5 в препаративной форме с контролируемым высвобождением или по меньшей мере один ингибитор PDE 5 с длительным периодом полураспада. ! 5. Лекарственная форма по п.4, содержащая финастерид или дутастерид и варденафил или сильденафил в препаративной форме с контролируемым высвобождением. ! 6. Лекарственная форма по п.4, содержащая финастерид или дутастерид и тадалафил. ! 7. Лекарственная форма или комбинированная упаковка для лечения доброкачественной гиперплазии предстательной железы, содержащая, по меньшей мере, один антагонист α-1 адренорецепторов в препаративной форме с контролируемым высвобождением, по меньшей мер�1. A dosage form or combination package for treating benign prostatic hyperplasia, comprising at least one α-1 adrenergic antagonist in a controlled release formulation and at least one PDE 5 inhibitor in a controlled release or at least one PDE 5 inhibitor with a long half-life. ! 2. A dosage form according to claim 1, comprising a controlled release formulation of tamsulosin, alfuzosin, doxazosin or terazosin and a controlled release formulation of vardenafil or sildenafil. ! 3. The dosage form according to claim 1, containing a formulation with controlled release of tamsulosin, alfuzosin, doxazosin or terazosin and tadalafil. ! 4. A dosage form or combination package for the treatment of benign prostatic hyperplasia, comprising at least one 5-α reductase inhibitor and at least one PDE 5 inhibitor in a controlled release formulation or at least one long-acting PDE 5 inhibitor half-life. ! 5. The dosage form according to claim 4, containing finasteride or dutasteride and vardenafil or sildenafil in a controlled release formulation. ! 6. The dosage form according to claim 4, containing finasteride or dutasteride and tadalafil. ! 7. Dosage form or combination package for the treatment of benign prostatic hyperplasia, containing at least one α-1 adrenergic receptor antagonist in a controlled release formulation, at least

Claims (21)

1. Лекарственная форма или комбинированная упаковка для лечения доброкачественной гиперплазии предстательной железы, содержащая, по меньшей мере, один антагонист α-1 адренорецепторов в препаративной форме с контролируемым высвобождением и по меньшей мере один ингибитор PDE 5 в препаративной форме с контролируемым высвобождением или по меньшей мере один ингибитор PDE 5 с длительным периодом полураспада.1. A dosage form or combination package for treating benign prostatic hyperplasia, comprising at least one α-1 adrenergic antagonist in a controlled release formulation and at least one PDE 5 inhibitor in a controlled release or at least one PDE 5 inhibitor with a long half-life. 2. Лекарственная форма по п.1, содержащая препаративную форму с контролируемым высвобождением тамсулозина, альфузозина, доксазосина или теразосина и препаративную форму с контролируемым высвобождением варденафила или сильденафила.2. The dosage form according to claim 1, containing a controlled release formulation of tamsulosin, alfuzosin, doxazosin or terazosin and a controlled release formulation of vardenafil or sildenafil. 3. Лекарственная форма по п.1, содержащая препаративную форму с контролируемым высвобождением тамсулозина, альфузозина, доксазосина или теразосина и тадалафила.3. The dosage form according to claim 1, containing a formulation with controlled release of tamsulosin, alfuzosin, doxazosin or terazosin and tadalafil. 4. Лекарственная форма или комбинированная упаковка для лечения доброкачественной гиперплазии предстательной железы, содержащая, по меньшей мере, один ингибитор 5-α редуктазы и по меньшей мере один ингибитор PDE 5 в препаративной форме с контролируемым высвобождением или по меньшей мере один ингибитор PDE 5 с длительным периодом полураспада.4. A dosage form or combination package for the treatment of benign prostatic hyperplasia, comprising at least one 5-α reductase inhibitor and at least one PDE 5 inhibitor in a controlled release formulation or at least one long-acting PDE 5 inhibitor half-life. 5. Лекарственная форма по п.4, содержащая финастерид или дутастерид и варденафил или сильденафил в препаративной форме с контролируемым высвобождением.5. The dosage form according to claim 4, containing finasteride or dutasteride and vardenafil or sildenafil in a controlled release formulation. 6. Лекарственная форма по п.4, содержащая финастерид или дутастерид и тадалафил.6. The dosage form according to claim 4, containing finasteride or dutasteride and tadalafil. 7. Лекарственная форма или комбинированная упаковка для лечения доброкачественной гиперплазии предстательной железы, содержащая, по меньшей мере, один антагонист α-1 адренорецепторов в препаративной форме с контролируемым высвобождением, по меньшей мере один ингибитор PDE 5 в препаративной форме с контролируемым высвобождением или по меньшей мере один ингибитор PDE 5 с длительным периодом полураспада и по меньшей мере один ингибитор 5-α редуктазы.7. A dosage form or combination package for the treatment of benign prostatic hyperplasia, containing at least one α-1 adrenergic antagonist in a controlled release formulation, at least one PDE 5 inhibitor in a controlled release or at least one long half-life PDE 5 inhibitor and at least one 5-α reductase inhibitor. 8. Лекарственная форма по п.1, отличающаяся тем, что она8. The dosage form according to claim 1, characterized in that it представляет капсулу, которая содержит:represents a capsule that contains: антагонист α-1 адренорецепторов в форме гранул, гранулята или таблетки (таблеток), которые покрыты мембраной для контролируемой диффузии,α-1 adrenergic antagonist in the form of granules, granules or tablets (tablets), which are coated with a membrane for controlled diffusion, иand ингибитор PDE 5 в форме гранул, гранулята или таблетки (таблеток), которые покрыты мембраной для контролируемой диффузии.a PDE 5 inhibitor in the form of granules, granules or tablets (tablets), which are coated with a membrane for controlled diffusion. 9. Лекарственная форма по п.1, отличающаяся тем, что она представляет капсулу, которая содержит:9. The dosage form according to claim 1, characterized in that it is a capsule that contains: антагонист α-1 адренорецепторов в виде матричной таблетки с контролируемым высвобождением действующего веществаα-1 adrenergic antagonist in the form of a matrix tablet with controlled release of the active substance иand ингибитор PDE 5 в виде матричной таблетки с контролируемым высвобождением действующего вещества.PDE 5 inhibitor in the form of a matrix tablet with controlled release of the active substance. 10. Лекарственная форма по п.1, отличающаяся тем, что она представляет двухслойную таблетку, которая содержит:10. The dosage form according to claim 1, characterized in that it is a two-layer tablet, which contains: слой с антагонистом α-1 адренорецепторов в форме матричной препаративной формы с контролируемым высвобождениемα-1 adrenergic antagonist layer in the form of a controlled release matrix formulation иand слой с ингибитором PDE 5 в форме матричной препаративной формы с контролируемым высвобождением.layer with a PDE 5 inhibitor in the form of a controlled-release matrix formulation. 11. Лекарственная форма по п.1, отличающаяся тем, что она представляет капсулу, которая содержит:11. The dosage form according to claim 1, characterized in that it is a capsule that contains: антагонист α-1 адренорецепторов в форме гранул, гранулята или таблетки (таблеток), которые покрыты мембраной для контролируемой диффузии,α-1 adrenergic antagonist in the form of granules, granules or tablets (tablets), which are coated with a membrane for controlled diffusion, иand ингибитор PDE 5 с длительным периодом полураспада.PDE 5 inhibitor with a long half-life. 12. Лекарственная форма по п.1, отличающаяся тем, что она представляет капсулу, которая содержит:12. The dosage form according to claim 1, characterized in that it is a capsule that contains: антагонист α-1 адренорецепторов в виде матричной таблетки с контролируемым высвобождением действующего веществаα-1 adrenergic antagonist in the form of a matrix tablet with controlled release of the active substance иand ингибитор PDE 5 с длительным периодом полураспада.PDE 5 inhibitor with a long half-life. 13. Лекарственная форма по п.1, отличающаяся тем, что она представляет двухслойную таблетку, которая содержит:13. The dosage form according to claim 1, characterized in that it is a two-layer tablet, which contains: слой с антагонистом α-1 адренорецепторов в форме матричной препаративной формы с контролируемым высвобождениемα-1 adrenergic receptor antagonist layer in the form of a controlled release matrix formulation иand слой с ингибитором PDE 5 с длительным периодом полураспада.a long half-life PDE 5 inhibitor layer. 14. Лекарственная форма по п.1, отличающаяся тем, что она представляет однослойную таблетку, которая содержит:14. The dosage form according to claim 1, characterized in that it is a single-layer tablet, which contains: слой с антагонистом α-1 адренорецепторов в форме гранул, гранулята или таблетки (таблеток), которые покрыты мембраной для контролируемой диффузии,a layer with an α-1 adrenergic antagonist in the form of granules, granules or tablets (tablets), which are coated with a membrane for controlled diffusion, иand слой с ингибитором PDE 5 с длительным периодом полураспада.a long half-life PDE 5 inhibitor layer. 15. Лекарственная форма по п.1, отличающаяся тем, что она представляет осмотическую систему высвобождения лекарственного средства, которая содержит антагонист α-1 адренорецепторов и ингибитор PDE 5.15. The dosage form according to claim 1, characterized in that it represents an osmotic drug release system that contains an α-1 adrenergic antagonist and a PDE 5 inhibitor. 16. Лекарственная форма по п.2, отличающаяся тем, что она представляет капсулу, которая содержит:16. The dosage form according to claim 2, characterized in that it is a capsule that contains: ингибитор 5-α редуктазы и5-α reductase inhibitor and ингибитор PDE 5 в форме гранул, гранулята или таблетки (таблеток), покрытых мембраной для контролируемой диффузии.a PDE 5 inhibitor in the form of granules, granules or tablets (tablets) coated with a membrane for controlled diffusion. 17. Лекарственная форма по п.2, отличающаяся тем, что она представляет капсулу, которая содержит:17. The dosage form according to claim 2, characterized in that it is a capsule that contains: ингибитор 5-α редуктазы и5-α reductase inhibitor and ингибитор PDE 5 в виде матричной таблетки с контролируемым высвобождением действующего вещества.PDE 5 inhibitor in the form of a matrix tablet with controlled release of the active substance. 18. Лекарственная форма по п.2, отличающаяся тем, что она представляет двухслойную таблетку, которая содержит:18. The dosage form according to claim 2, characterized in that it is a two-layer tablet, which contains: слой с ингибитором 5-α редуктазы5-α reductase inhibitor layer иand слой с ингибитором PDE 5 в форме матричной препаративной формы с контролируемым высвобождением.layer with a PDE 5 inhibitor in the form of a controlled-release matrix formulation. 19. Лекарственная форма по п.2, отличающаяся тем, что она представляет однослойную таблетку, которая содержит:19. The dosage form according to claim 2, characterized in that it is a single-layer tablet, which contains: слой с ингибитором PDE 5 в форме гранул, гранулята или таблетки (таблеток), покрытых мембраной для контролируемой диффузии,a layer with a PDE 5 inhibitor in the form of granules, granules or tablets (tablets) coated with a membrane for controlled diffusion, иand слой с ингибитором 5-α редуктазы.layer with a 5-α reductase inhibitor. 20. Лекарственная форма по п.2, отличающаяся тем, что она представляет осмотическую систему высвобождения лекарственного средства, которая содержит ингибитор 5-α редуктазы и ингибитор PDE 5.20. The dosage form according to claim 2, characterized in that it represents an osmotic drug release system that contains a 5-α reductase inhibitor and a PDE 5 inhibitor. 21. Препаративная форма лекарственных средств по п.2, отличающаяся тем, что она содержит ингибитор PDE 5 с длительным периодом полураспада и ингибитор 5-α редуктазы.21. The drug formulation according to claim 2, characterized in that it contains a PDE 5 inhibitor with a long half-life and a 5-α reductase inhibitor.
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