HRP20140900T1 - Farmaceutski sastav koji sadrži pimobendan - Google Patents
Farmaceutski sastav koji sadrži pimobendan Download PDFInfo
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- HRP20140900T1 HRP20140900T1 HRP20140900TT HRP20140900T HRP20140900T1 HR P20140900 T1 HRP20140900 T1 HR P20140900T1 HR P20140900T T HRP20140900T T HR P20140900TT HR P20140900 T HRP20140900 T HR P20140900T HR P20140900 T1 HRP20140900 T1 HR P20140900T1
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- Croatia
- Prior art keywords
- solid preparation
- starch
- mixture
- preparation according
- pimobendan
- Prior art date
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- 229960002164 pimobendan Drugs 0.000 title claims 10
- GLBJJMFZWDBELO-UHFFFAOYSA-N pimobendane Chemical compound C1=CC(OC)=CC=C1C1=NC2=CC=C(C=3C(CC(=O)NN=3)C)C=C2N1 GLBJJMFZWDBELO-UHFFFAOYSA-N 0.000 title claims 10
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000007787 solid Substances 0.000 claims 26
- 239000000203 mixture Substances 0.000 claims 15
- 229920002472 Starch Polymers 0.000 claims 13
- 239000008107 starch Substances 0.000 claims 13
- 229940032147 starch Drugs 0.000 claims 13
- 235000019698 starch Nutrition 0.000 claims 13
- 239000008187 granular material Substances 0.000 claims 10
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 9
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 8
- 239000000796 flavoring agent Substances 0.000 claims 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 7
- 235000019634 flavors Nutrition 0.000 claims 6
- 239000008101 lactose Substances 0.000 claims 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 6
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 6
- 239000000314 lubricant Substances 0.000 claims 5
- WQNHWIYLCRZRLR-UHFFFAOYSA-N 2-(3-hydroxy-2,5-dioxooxolan-3-yl)acetic acid Chemical compound OC(=O)CC1(O)CC(=O)OC1=O WQNHWIYLCRZRLR-UHFFFAOYSA-N 0.000 claims 4
- 239000011230 binding agent Substances 0.000 claims 4
- 235000013355 food flavoring agent Nutrition 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 239000000377 silicon dioxide Substances 0.000 claims 4
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 claims 3
- 229920002261 Corn starch Polymers 0.000 claims 3
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 3
- 239000007864 aqueous solution Substances 0.000 claims 3
- 239000012752 auxiliary agent Substances 0.000 claims 3
- 235000015278 beef Nutrition 0.000 claims 3
- 239000000969 carrier Substances 0.000 claims 3
- 239000008120 corn starch Substances 0.000 claims 3
- 229960001681 croscarmellose sodium Drugs 0.000 claims 3
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 3
- 239000007884 disintegrant Substances 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 3
- 230000003179 granulation Effects 0.000 claims 3
- 235000019359 magnesium stearate Nutrition 0.000 claims 3
- 230000002265 prevention Effects 0.000 claims 3
- 241000282326 Felis catus Species 0.000 claims 2
- 208000010496 Heart Arrest Diseases 0.000 claims 2
- 241000124008 Mammalia Species 0.000 claims 2
- 229920000881 Modified starch Polymers 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 241000009328 Perro Species 0.000 claims 2
- 241000283984 Rodentia Species 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 229920000609 methyl cellulose Polymers 0.000 claims 2
- 239000001923 methylcellulose Substances 0.000 claims 2
- 235000010981 methylcellulose Nutrition 0.000 claims 2
- 229940069328 povidone Drugs 0.000 claims 2
- 239000000454 talc Substances 0.000 claims 2
- 229910052623 talc Inorganic materials 0.000 claims 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 1
- PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 claims 1
- 241000287828 Gallus gallus Species 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 241001465754 Metazoa Species 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 239000004368 Modified starch Substances 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 150000008064 anhydrides Chemical class 0.000 claims 1
- 239000000378 calcium silicate Substances 0.000 claims 1
- 229910052918 calcium silicate Inorganic materials 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 239000008116 calcium stearate Substances 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims 1
- 235000015165 citric acid Nutrition 0.000 claims 1
- 239000011362 coarse particle Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- -1 flow regulators Substances 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 229940014259 gelatin Drugs 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 229940049654 glyceryl behenate Drugs 0.000 claims 1
- 239000007970 homogeneous dispersion Substances 0.000 claims 1
- 235000012907 honey Nutrition 0.000 claims 1
- 229920003063 hydroxymethyl cellulose Polymers 0.000 claims 1
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims 1
- 229940040511 liver extract Drugs 0.000 claims 1
- 239000000391 magnesium silicate Substances 0.000 claims 1
- 229910052919 magnesium silicate Inorganic materials 0.000 claims 1
- 235000019792 magnesium silicate Nutrition 0.000 claims 1
- ZADYMNAVLSWLEQ-UHFFFAOYSA-N magnesium;oxygen(2-);silicon(4+) Chemical compound [O-2].[O-2].[O-2].[Mg+2].[Si+4] ZADYMNAVLSWLEQ-UHFFFAOYSA-N 0.000 claims 1
- 235000013372 meat Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 235000019426 modified starch Nutrition 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000015277 pork Nutrition 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 239000008247 solid mixture Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
Classifications
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- 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
- A61K31/50—Pyridazines; Hydrogenated pyridazines
- A61K31/501—Pyridazines; Hydrogenated pyridazines not condensed and containing further 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
- A61K31/33—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
- A61K31/50—Pyridazines; Hydrogenated pyridazines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2009—Inorganic compounds
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- 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
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- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
Claims (20)
1. Kruti pripravak, naznačen time, da obuhvaća homogenu disperziju pimobendana ili njegovu farmaceutski prihvatljivu sol u limunskoj kiselini ili njezinom anhidridu i dodatak za okus prihvatljiv za male životinje, pri čemu se kruti pripravak može dobiti pomoću granulacijskog postupka na fluidiziranom sloju, koji obuhvaća sljedeće korake:
a) vodena otopina pimobendana i veziva se raspršuje na kruti nosač koji sadrži jedno ili nekoliko pomoćnih sredstava, dodatak za okus i anhidrid limunske kiseline; i
b) smjesa iz koraka a) se suši; i
c) smjesa iz koraka b) se prosijava i deaglomerira; i
d) u smjesu iz koraka c) se dodaje regulator protoka; i
e) u smjesu iz koraka d) se dodaje lubrikant; i
f) smjesa iz koraka e) se miješa za postizanje jednolikosti granula za dobivanje konačnih granula; i/ili
g) gotove granule iz koraka f) se stlačuju u tablete.
2. Kruti pripravak prema zahtjevu 1, naznačen time, da je jedno ili su nekoliko pomoćnih sredstava odabrani iz skupine koju čine razrjeđivači, dezintegranti, nosači, veziva, regulatori protoka, lubrikanti i otapala.
3. Kruti pripravak prema zahtjevu 1 ili 2, naznačen time, da je vezivo odabrano iz skupine koju čine polividon/povidon, metilceluloza, hidroksipropilmetilceluloza (HPMC), hidroksimetilceluloza, škrob i želatina.
4. Kruti pripravak prema zahtjevu 2 ili 3, naznačen time, da je dezintegrant/nosač odabran iz skupine koju čine laktoza, škrob, celuloza, mikrokristalna celuloza i metilceluloza, a poželjno je naznačen time, da nosači su škrob i laktoza.
5. Kruti pripravak prema zahtjevu 4, naznačen time, da se laktoza sastoji od grubih čestica većih od 200 μm.
6. Kruti pripravak prema bilo kojem od zahtjeva 2 do 5, naznačen time, da su škrob ili razne vrste škroba odabrane iz skupine koju čine čisti izvorni škrob, želatinizirani škrob, djelomično želatinizirani škrob, škrob u prahu, škrob u granulama, kemijski modificirani škrob, fizikalno modificirani škrob koji može nabubriti, poželjno naznačen time, da škrob je kukuruzni škrob.
7. Kruti pripravak prema bilo kojem od zahtjeva 2 do 6, naznačen time, da je dezintegrant odabran iz skupine koju čine kroskarmeloza-natrij, natrijev škrobni glikolat, predželatinizirani škrob i križno povezani polivinilpirolidon.
8. Kruti pripravak prema bilo kojem od zahtjeva 2 do 7, naznačen time, da je regulator protoka odabran iz skupine koju čine silika, poželjno koloidna anhidridna silika, kalcijev silikat, magnezijev silikat i talk.
9. Kruti pripravak prema bilo kojem od zahtjeva 2 do 8, naznačen time, da je lubrikant odabran iz skupine koju čine magnezijev stearat, kalcijev stearat, gliceril behenat, polietilen glikol, stearinska kiselina i talk.
10. Kruti pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time, da je dodatak za okus odabran iz skupine koju čine umjetni okusi govedine, umjetni okusi piletine, ekstrakt svinjske jetre, umjetni mesni okus i okus meda.
11. Kruti pripravak prema bilo kojem od zahtjeva 1 do 10, naznačen time, da obuhvaća pimobendan od 0,5 do 20 mg, poželjno pimobendan od 1 do 10 mg, još bolje od 1,25 mg do 2,5 mg, 5 mg ili 10 mg pimobendna.
12. Kruti pripravak prema bilo kojem od zahtjeva 1 do 11, naznačen time, da je sadržaj pimobendana u odnosu na sadržaj anhidrida limunske kiseline u omjeru 1:10 do 1:40, poželjno 1:20.
13. Kruti pripravak prema bilo kojem od zahtjeva 1 do 12, naznačen time, da je masa krutog pripravka u rasponu od 250 mg do 3000 mg, poželjno od 500 do 2000 mg, još bolje masa je 500 mg, 1000 mg ili 2000 mg.
14. Kruti pripravak prema bilo kojem od zahtjeva 1 do 13, naznačen time, da je kruti pripravak tableta ili granula.
15. Kruti pripravak prema bilo kojem od zahtjeva 1 do 14, naznačen time, da je kruti pripravak tableta koja se sastoji od 1,25 mg, 2,5 mg, 5 mg ili 10 mg pimobendana, i dodatno se sastoji od laktoze, kukuruznog škroba, kroskarmeloze-natrij, limunske kiseline, umjetnog okusa govedine, polividona, koloidne anhidridne silike i magnezijevog stearata.
16. Kruti pripravak prema bilo kojem od zahtjeva 1 do 15, naznačen time, da je kruti pripravak tableta koja se sastoji od 1,25 mg, 2,5 mg, 5 mg ili 10 mg pimobendana, i dodatno se sastoji od 35 do 50% (masa/masa) laktoze, 25 do 50% (masa/masa) kukuruznog škroba, 1 do 5% (masa/masa) kroskarmeloze-natrij, 2,5 do 10% (masa/masa) limunske kiseline, 5 do 30% (masa/masa) umjetnog okusa govedine, 1 do 5% (masa/masa) polividona, 0,1 do 1% (masa/masa) koloidne anhidridne silike i 0,25 do 1,5% (masa/masa) magnezijevog stearata.
17. Postupak granulacije na fluidiziranom sloju, naznačen time, da obuhvaća sljedeće korake:
a) vodena otopina pimobendana i veziva se raspršuje na kruti nosač koji sadrži jedan ili nekoliko nosača, jedno ili nekoliko pomoćnih sredstava, dodatak za okus i anhidrid limunske kiseline; i
b) smjesa iz koraka a) se suši; i
c) smjesa iz koraka b) se prosijava i deaglomerira; i
d) u smjesu iz koraka c) se dodaje regulator protoka; i
e) u smjesu iz koraka d) se dodaje lubrikant; i
f) smjesa iz koraka e) se miješa za postizanje jednolikosti granula za dobivanje konačnih granula; i/ili
g) gotove granule iz koraka f) se stlačuju u tablete.
18. Postupak granulacije na fluidiziranom sloju prema zahtjevu 17, naznačen time, da obuhvaća sljedeće korake:
a) vodena otopina pimobendana i povidona se raspršuje na kruti nosač koji sadrži laktozu, škrob, dodatak za okus i anhidrid limunske kiseline; i
b) smjesa iz koraka a) se suši; i
c) smjesa iz koraka b) se prosijava i deaglomerira; i
d) u smjesu iz koraka c) se dodaje regulator protoka; i
e) u smjesu iz koraka d) se dodaje lubrikant; i
f) smjesa iz koraka e) se miješa za postizanje jednolikosti granula za dobivanje konačnih granula; i/ili
g) gotove granule iz koraka f) se stlačuju u tablete.
19. Kruti pripravak prema bilo kojem od zahtjeva 1 do 16, naznačen time, da se upotrebljava u postupku prevencije i/ili liječenja kongestivnog srčanog zastoja kod sisavca, posebno kod psa, mačke ili glodavca.
20. Garnitura, naznačena time, da obuhvaća kruti pripravak prema bilo kojem od zahtjeva 1 do 16 i pakirani listić ili uputstvo za korisnika, koji sadrži informaciju da se kruti pripravak treba upotrebljavati za prevenciju i/ili liječenje kongestivnog srčanog zastoja kod sisavca, poželjno kod psa, mačke ili glodavca, kojima treba takva prevencija ili liječenje.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102004011512.5A DE102004011512B4 (de) | 2004-03-08 | 2004-03-08 | Pharmazeutische Zubereitung enthaltend Pimobendan |
| PCT/EP2005/002133 WO2005084647A1 (en) | 2004-03-08 | 2005-03-01 | Pharmaceutical composition comprising pimobendan |
Publications (1)
| Publication Number | Publication Date |
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| HRP20140900T1 true HRP20140900T1 (hr) | 2014-11-07 |
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| HRP20140900TT HRP20140900T1 (hr) | 2004-03-08 | 2014-09-22 | Farmaceutski sastav koji sadrži pimobendan |
| HRP20191360 HRP20191360T1 (hr) | 2004-03-08 | 2019-07-26 | Farmaceutski pripravak koji sadržava pimobendan |
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| HRP20191360 HRP20191360T1 (hr) | 2004-03-08 | 2019-07-26 | Farmaceutski pripravak koji sadržava pimobendan |
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| EP (2) | EP1725218B1 (hr) |
| JP (2) | JP4757253B2 (hr) |
| KR (2) | KR20070014143A (hr) |
| CN (1) | CN100546568C (hr) |
| AR (2) | AR047993A1 (hr) |
| AU (1) | AU2005218912C1 (hr) |
| BR (1) | BRPI0508557B1 (hr) |
| CA (1) | CA2557161C (hr) |
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| ES (2) | ES2736022T3 (hr) |
| HR (2) | HRP20140900T1 (hr) |
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| NZ (1) | NZ549630A (hr) |
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| PT (2) | PT1725218E (hr) |
| SI (2) | SI1725218T1 (hr) |
| TW (1) | TWI355947B (hr) |
| WO (1) | WO2005084647A1 (hr) |
| ZA (1) | ZA200606154B (hr) |
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| DE102004011512B4 (de) | 2004-03-08 | 2022-01-13 | Boehringer Ingelheim Vetmedica Gmbh | Pharmazeutische Zubereitung enthaltend Pimobendan |
| US8980894B2 (en) | 2004-03-25 | 2015-03-17 | Boehringer Ingelheim Vetmedica Gmbh | Use of PDE III inhibitors for the treatment of asymptomatic (occult) heart failure |
| EP1579862A1 (en) | 2004-03-25 | 2005-09-28 | Boehringer Ingelheim Vetmedica Gmbh | Use of PDE III inhibitors for the reduction of heart size in mammals suffering from heart failure |
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| JP2006028130A (ja) * | 2004-07-21 | 2006-02-02 | Toa Eiyo Ltd | ピモベンダン経口投与製剤 |
| JP4572296B2 (ja) * | 2004-07-21 | 2010-11-04 | トーアエイヨー株式会社 | ピモベンダン経口投与製剤 |
| JP4572300B2 (ja) * | 2006-01-19 | 2010-11-04 | トーアエイヨー株式会社 | ピモベンダン経口投与製剤 |
| EP1920785A1 (en) | 2006-11-07 | 2008-05-14 | Boehringer Ingelheim Vetmedica Gmbh | Liquid preparation comprising a complex of pimobendan and cyclodextrin |
| GB0818473D0 (en) | 2008-10-08 | 2008-11-12 | Probio Nutraceuticals As | Composition |
| WO2010055119A2 (en) * | 2008-11-17 | 2010-05-20 | Novartis Ag | Pharmaceutical composition comprising pimobendan |
| KR20110089851A (ko) | 2008-11-25 | 2011-08-09 | 베링거잉겔하임베트메디카게엠베하 | 비대 심근병증의 치료를 위한 포스포디에스테라제 타입 Ⅲ（ＰＤＥ Ⅲ） 억제제 또는 Ｃａ２＋―감작제 |
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| KR102455648B1 (ko) | 2013-07-19 | 2022-10-19 | 베링거잉겔하임베트메디카게엠베하 | 보존된 에테르화된 사이클로덱스트린 유도체 함유 액체 수성 약제학적 조성물 |
| BR112016011111B1 (pt) * | 2013-12-04 | 2022-11-16 | Boehringer Ingelheim Vetmedica Gmbh | Composições farmacêuticas aprimoradas de pimobendan |
| US11246867B2 (en) | 2015-12-17 | 2022-02-15 | Ceva Sante Animale | Pharmaceutical composition comprising pimobendan |
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| CN106729723A (zh) * | 2016-11-21 | 2017-05-31 | 青岛农业大学 | 一种含匹莫苯丹的药物组合物及其制备方法 |
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- 2005-03-04 AR ARP050100830A patent/AR047993A1/es active Pending
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2011
- 2011-02-03 JP JP2011021706A patent/JP5875231B2/ja active Active
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2012
- 2012-02-22 US US13/402,292 patent/US8846680B2/en active Active
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2013
- 2013-03-14 US US13/802,989 patent/US8859554B2/en active Active
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2014
- 2014-08-21 US US14/465,273 patent/US20140363510A1/en not_active Abandoned
- 2014-09-03 CY CY20141100704T patent/CY1115526T1/el unknown
- 2014-09-22 HR HRP20140900TT patent/HRP20140900T1/hr unknown
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2016
- 2016-11-30 AR ARP160103652A patent/AR106850A2/es not_active Application Discontinuation
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2017
- 2017-09-05 US US15/695,334 patent/US20170368062A1/en not_active Abandoned
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2019
- 2019-07-26 HR HRP20191360 patent/HRP20191360T1/hr unknown
- 2019-08-08 CY CY20191100849T patent/CY1121877T1/el unknown
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