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1 Patentni zahtevki 1. Tabletna oblika, ki ima strukturo, ki vsebuje stisnjene granulate; pri čemer granulati vsebujejo β-laktamski antibiotik skupaj z intragranulamim dezintegrantom; pri čemer so granulati stisnjeni skupaj v obliko tablete skupaj z ekstragranulamim dezintegrantom in po izbiri tudi skupaj z ekstragranularnim mazivom, pod pogojem, da če je prisotno mazivo, je količina maziva manj kot 0,5 mas.% celotne tablete.CLAIMS 1. A tablet form having a structure comprising compressed granules; wherein the granulates contain a β-lactam antibiotic together with an intragranulum disintegrant; the granules being compressed together into the tablet form together with the extragranulum disintegrant and optionally also with the extragranular lubricant, provided that if the lubricant is present, the amount of lubricant is less than 0.5% by weight of the total tablet.2. Tabletna oblika po zahtevku 1, označena s tem, da je β-Iaktamski antibiotik v kombinaciji z β-laktamaznim inhibitorjem.Tablet form according to claim 1, characterized in that the β-Ictam antibiotic is in combination with a β-lactamase inhibitor.3. Tabletna oblika po zahtevku 2, označena s tem, da je antibiotik amoksicilin, v kombinaciji s klavulansko kislino ali njeno soljo v masnem razmerju, ekvivalentnem amoksicilinu : klavulanski kislini v območju 12:1 do 1:1.The tablet form according to claim 2, wherein the antibiotic is amoxicillin in combination with clavulanic acid or a salt thereof in a weight ratio equivalent to amoxycillin: clavulanic acid in the range of 12: 1 to 1: 1.4. Tabletna oblika po zahtevku 1, označena s tem, da intragranulami dezintegrant izberemo iz skupine, v kateri so koruzni škrob, rižev škrob, premrežen N-vinil-2-pirolidon ("CLPVP"), natrijev škrobni glikolat, natrijeva kroskarmeloza, formaldehid-kazein in njihove kombinacije.The tablet form according to claim 1, characterized in that the intragranulum disintegrant is selected from the group consisting of corn starch, rice starch, cross-linked N-vinyl-2-pyrrolidone (" CLPVP "), sodium starch glycolate, sodium croscarmellose, formaldehyde casein and combinations thereof.5. Tabletna oblika po zahtevku 1, označena s tem, da je delež intragranularnega dezintegranta 0,1 do 10 mas.% mase granulata.The tablet form according to claim 1, characterized in that the proportion of the intragranular disintegrant is 0.1 to 10% by weight of the weight of the granulate.6. Tabletna oblika po zahtevku 1, označena s tem, da granulat vsebuje zdravilo, ki je amoksicilin ali amoksicilin+klavulanska kislina ali njena sol v kombinaciji, intragranulami dezintegrant, ki je CLPVP ali natrijev škrobni glikolat, in po izbiri eno ali več razredčil v deležu 70 do 99 mas.% zdravila, 1 do 5 mas.% dezintegranta in do 30 mas.% razredčila. 2The tablet form according to claim 1, characterized in that the granulate contains a medicament which is amoxicillin or amoxicillin + clavulanic acid or a salt thereof in combination, a disintegrant intragranulum which is CLPVP or sodium starch glycolate, and optionally one or more diluents in a proportion of 70 to 99% by weight of the drug, 1 to 5% by weight of disintegrant and up to 30% by weight of a diluent. 27. Tabletna oblika po zahtevku 1, označena s tem, da granulat vsebuje 70 mas.% ali več mase tablete.Tablet form according to claim 1, characterized in that the granulate contains 70% or more of the weight of the tablet.8. Tabletna oblika po zahtevku 1, označena s tem, da ekstragranularni dezintegrant izberemo iz skupine, v kateri so koruzni škrob, rižev škrob, CLPVP, natrijev škrobni glikolat, natrijeva kroskarmeloza, mikrokristalna ali mikrollna celuloza, nabrekljive ionske izmenjevalne smole, formaldehid-kazein in alginati.A tablet form according to claim 1, characterized in that the extragranular disintegrant is selected from the group consisting of maize starch, rice starch, CLPVP, sodium starch glycolate, sodium croscarmellose, microcrystalline or microroll cellulose, swellable ion exchange resins, formaldehyde casein and alginates.9. Tabletna oblika po zahtevku 1, označena s tem, da je delež ekstragranularnega dezintegranta v tableti med 0,1 do 25 mas.% celotne mase tablete.A tablet form according to claim 1, characterized in that the proportion of the extragranular disintegrant in the tablet is between 0.1 and 25% by weight of the total weight of the tablet.10. Tabletna oblika po zahtevku 1, označena s tem, da vsebuje 0 do 0,35 mas.% maziva.A tablet form according to claim 1, characterized in that it contains 0 to 0.35% by weight of the lubricant.11. Farmacevtska granulatna oblika, označena s tem, da vsebuje zdravilo, ki je β-laktamski antibiotik, skupaj v kombinaciji z β-laktamaznim inhibitorjem; pod pogojem, da če je prisotno mazivo, je v količini manj kot 0,5 mas.% zmesi.Pharmaceutical granulate form, characterized in that it comprises a medicament which is a β-lactam antibiotic, in combination with a β-lactamase inhibitor; provided that if a lubricant is present, it is in an amount of less than 0.5% by weight of the mixture.12. Oblika po zahtevku 11, označena s tem, da je zdravilo amoksicilin v kombinaciji s klavulansko kislino ali njeno soljo v masnem razmerju, ekvivalentnem amoksicilinu : klavulanski kislini v območju 12:1 do 1:1.Form according to claim 11, characterized in that the amoxicillin in combination with clavulanic acid or a salt thereof is in weight ratio equivalent to amoxycillin: clavulanic acid in the range of 12: 1 to 1: 1.13. Oblika po zahtevku 11, označena s tem, da oblika dodatno vključuje intragranularni dezintegrant.A formulation according to claim 11, characterized in that the form further comprises an intragranular disintegrant.14. Oblika po zahtevku 13, označena s tem, da dezintegrant izberemo iz skupine, v kateri so koruzni škrob, CLPVP, natrijev škrobni glikolat, natrijeva kroskarmeloza, formaldehid-kazein in njihove kombinacije. 3A formulation according to claim 13, characterized in that the disintegrant is selected from the group consisting of corn starch, CLPVP, sodium starch glycolate, sodium croscarmellose, formaldehyde casein and combinations thereof. 315. Oblika po zahtevku 13, označena s tem, da je delež intragranularnega dezintegranta 0,1 do 10 mas.% oblike.Form according to claim 13, characterized in that the proportion of intragranular disintegrant is 0.1 to 10% by weight of the form.16. Oblika po zahtevku 11, označena s tem, da granulat obsega zdravilo, ki je amoksicilin+klavulanska kislina ali njena sol v kombinaciji, intragranularni dezintegrant, ki je CLPVP ali natrijev škrobni glikolat, in po izbiri enega ali več razredčil v deležu 70 do 99 mas.% zdravila, 1 do 5 mas.% dezintegranta in do 30 mas.% razredčila.A formulation according to claim 11, characterized in that the granulate comprises a medicament that is amoxicillin + clavulanic acid or a salt thereof in combination, an intragranular disintegrant, which is CLPVP or sodium starch glycolate, and optionally one or more diluents in a proportion of 70 to 99% by weight of the drug, 1 to 5% by weight of disintegrant and up to 30% by weight of the diluent.17. Oblika po zahtevku 1 ali granulat, kot je definiran v zahtevku L ali granulat, kot je definiran v zahtevku l, kadar je vkapsuliran v farmacevtsko kapsulo.A form according to claim 1 or a granulate as defined in claim L or a granulate as defined in claim 1 when enclosed in a pharmaceutical capsule.18. Postopek za izdelavo farmacevtske tablete, označen s tem, da granulate, ki vsebujejo β-laktamski antibiotik, skupaj z intragranulamim dezintegrantom pomešamo z ekstragranulamim dezintegrantom in po izbiri z ekstragranularnim mazivom in ekscipienti, pod pogojem, da če je prisotno mazivo, je v količini manj kot 0,5 mas.% zmesi, in zmes stisnemo v tablete.A process for the manufacture of a pharmaceutical tablet, characterized in that the granules containing the β-lactam antibiotic together with the intragranulamine disintegrant are mixed with the extragranulamine disintegrant and optionally with an extragranular lubricant and excipients, provided that if a lubricant is present, amount less than 0.5% by weight of the mixture, and the mixture is compressed into tablets.19. Postopek za izdelavo farmacevtskega granulata, označen s tem, da zdravilo, ki je β-laktamski antibiotik, skupaj v kombinaciji z β-laktamaznim inhibitorjem stisnemo pod tlakom skupaj z intragranulamim dezintegrantom; in pod pogojem, da če je prisotno mazivo, je v količini manj kot 0,5 mas.% zmesi.A process for the production of a pharmaceutical granulate, characterized in that the medicament, which is a β-lactam antibiotic, in combination with the β-lactamase inhibitor is pressurized together with the intragranulum disintegrant; and provided that if a lubricant is present, it is in an amount of less than 0.5% by weight of the mixture.20. Postopek po zahtevku 19, označen s tem, da stisnjenje izvedemo ob uporabi stiskanja v bobnasti stiskalnici.A method according to claim 19, characterized in that the compression is performed using a pressing in a drum press.21. Farmacevtska oblika po zahtevku 1 za uporabo kot aktivna terapevtska snov.The pharmaceutical formulation according to claim 1 for use as an active therapeutic substance.
Pharmaceutical preparations in the form of tablets or coated tablets containing light, heat and moisture sensitive active compounds, and having a monocoinic crystal structure