SI21259A - Farmacevtski pripravki z antibiotičnim delovanjem - Google Patents

Farmacevtski pripravki z antibiotičnim delovanjem Download PDF

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SI21259A
SI21259A SI200300194A SI200300194A SI21259A SI 21259 A SI21259 A SI 21259A SI 200300194 A SI200300194 A SI 200300194A SI 200300194 A SI200300194 A SI 200300194A SI 21259 A SI21259 A SI 21259A
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sodium
potassium
citrate
tribasic
arginine
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Luca Rampoldi
Luca Pirrone
Sarah Faccin
Alessandro Grassano
Giovanni Gurrieri
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Zambon Group S.P.A.
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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Abstract

Opisana je uporaba določenih soli in amino kislin kot stabilizatorja antibiotika Fosfomicin Trometamola in farmacevtski pripravki, ki jih vsebujejo.ŕ

Description

Sedanja iznajdba obravnava uporabo določenih soli in amino kislin kot stabilizatorjev antibiotika Fosfomicin Trometamol in farmacevtskih pripravkov, kijih vsebujejo.
Fosfomicin Trometamol (spodaj FT) (Indeks Merck-a XIII izdaja, št. 4277, stran 755) je znani antibiotik, ki se uporablja za zdravljenje infekcij is sečil in je aktivna sestavina, na primer, zdravila z imenom MONURIL®.
FT je relativno nestabilna spojina, ker vsebuje reaktivno funkcionalno skupino in lahko zaradi temperature in vlažnosti hitro razpade. To otežuje shranjevanje surovin, izdelavo in pripravo farmacevtskih spojin (danes izključno v obliki vodotopnega granulata) in shranjevanje gotovih zavitkov.
2o Pri uporabi se granulat raztopi v vodi in popije. Tudi kislost želodca lahko povzroči obsežen pojav razpadanja, ki praktično zniža količino aktivne sestavine za absorpcijo.
Sedaj smo presenetljivo odkrili, da so nekatere snovi, kadar se uporabijo v mešanici s FT, sposobne stabilizirati antibiotik in s tem olajšajo njegovo uporabo v postopkih farmacevtske tehnologije in za daljši čas stabilizirajo gotove zavitke.
Nadalje se razpad FT pri pH želodčnega soka zmanjša, kadar je FT povezan s temi snovmi. Zato je predmet sedanje iznajdbe uporaba snovi, izbrane izmed naslednjih spojin:
tribazni natrijev ali kalijev citrat monokislinski natrijev ali kalijev citrat
- tribazni natrijev ali kalijev fosfat monokislinski natrijev ali kalijev fosfat natrijev ali kalijev karbonat natrijev ali kalijev bikarbonat natrijev ali kalijev tartrat
- arginin lizin ali njihove mešanice, za stabiliziranje Fosfomicin Trometamola.
Drugi predmet sedanje iznajdbe so farmacevtski pripravki, ki vsebujejo
Fosfomicin Trometamol, spojino izbrano izmed naslednjih: tribazni natrijev ati kalijev citrat monokislinski natrijev ali kalijev citrat tribazni natrijev ali kalijev fosfat
- monokislinski natrijev ali kalijev fosfat
- natrijev ali kalijev karbonat
- natrijev ali kalijev bikarbonat
- natrijev ali kalijev tartrat
- arginin
- lizin ali njihove mešanice, in pomožne snovi, primerne za farmacevtsko uporabo.
Spodaj bodo snovi, čigar uporaba je predmet iznajdbe, skupno 10 imenovane kot stabilizator, kar bo pomenilo tudi mešanice iz dveh ali večih snovi. Količina stabilizatorja za uporabo je med 10% in 100% v molih glede na FT, po možnosti med 30% in 70% in še bolje okoli 50%. Med zgoraj naštetimi stabilizatorji so sedaj najbolj zaželeni tribazni natrijev citrat, natrijev ali kalijev karbonat ali bikarbonat in arginin.
Farmacevtski pripravki, ki so predmet iznajdbe, so pripravljeni iz FT in stabilizatorja z dodajanjem pomožnih snovi za farmacevtsko uporabo.
Sedaj najbolj zaželena farmacevtska oblika FT je oblika vodotopnih granul, ker je zaradi relativno velike količine FT za vnos glede na trenutno dovoljeno količino (5,631 g) raztopina, pridobljena z raztapljanjem granul v vodi, najprimernejša in jo pacienti dobro sprejemajo.
Z novimi pripravki te iznajdbe je možno pridobiti oblike v granulah, možno pa je tudi pripraviti vodotopne pripravke, pridobljene s preprostim primešanjem FT, stabilizatorja in drugih pomožnih snovi, če so potrebne.
Primerne pomožne snovi za pripravo vodotopnih pripravkov vsebujejo FT in stabilizator so, na primer, naravna kot tudi umetna sladila ali arome.
Možno je celo dodati nadaljne pomožne snovi, uporabne na primer za postopek granulacije, vendar njihova uporaba ni nujna. Izdelava pripravkov te iznajdbe lahko ustrezno poteka na različne načine. Možno je, na primer, pripraviti polizdelani granulat FT, ki se mu postopno primeša stabilizator, aromo in sladilo in se v končni fazi celoten izdelek razpošlje v vrečkah.
Po drugem načinu se vse sestavine izdelka lahko direktno zmeša skupaj.
Za boljšo ponazoritev sedanje iznajdbe so podani naslednji primeri.
Primer 1
Stabilizacija FT z izbranimi stabilizatorji se je ocenila eksperimentalno s is tehnologijo DSC. Mehansko mešanico FT (0,02 mola) z vsakim izmed stabilizatorjev (0,01 mola) se je zmešalo z 0,05% vode glede na FT. Tehnologija DSC, uporabljena za vsako mešanico (skeniranje 10°C/min.), omogoča merjenje reakcijske toplote, ki se razvije po talilnem vrhu FT zaradi reakcije razpadanja. Znižana količina razvite toplote kaže na višjo stabilizacijo, če je količina FT enaka.
Dobili smo naslednje vrednosti:
FT (posamezna snov) = 271,03 ± 16,73 (J/g)
FT + natrijev citrat tribazni (dihidrat) = 119,19 ± 7,47 (J/g)
FT + natrijev bikarbonat = 143,32 ±4,92 (J/g)
FT + natrijev karbonat = 115,84 ±9,89 (J/g)
FT + arginin = 175,25 ±9,41 (J/g)
Dobljeni podatki prikazujejo, da se je FT učinkovito stabiliziral z s dodajanjem zgoraj omenjenih snovi. Toplota rekcije razpadanja pri enaki količini FT seje znižala v procentih med okoli 35 in 70%.
Primer 2
Stabilizacijo FT v simuliranem želodčnem soku se je ocenilo s io posnemanjem pogojev pacienta: 5,631 g FT se je dodalo 0,01 mola izbranega stabilizatorja in se oboje raztopilo v vodi (180 ml). Raztopino se je zlilo v simulirani želodčni sok (100 ml, pH 1) in se razpadanje izmerilo kot procent obnove aktivne sestavine v določenem času. Že po 30 minutah je obnova FT brez stabilizatorja znašala 82%, med tem ko je is obnova s stabilizatorjem znašala 90%.
Primer 3
Naslednje farmacevtske pripravke se je pripravilo s preprostim primešanjem sestavin.
Pripravek 1
Fosfomicin Trometamol 5,631 g natrijev citrat dihidrat
1,125 g
aspartam 0,100 g
aroma mandarine 0,100 g
aroma pomaranče 0,100 g
Pripravek 2
Fosfomicin Trometamol 5,631 g
natrijev citrat dihidrat 0,500 g
natrijev bikarbonat 0,840 g
aspartam 0,100 g
aroma mandarine 0,100 g
aroma pomaranče 0,100 g
Pripravek 3
Fosfomicin Trometamol 5,631 g
natrijev bikarbonat 1,127 g
natrijev karbonat 0,200 g
saharoza 2,000 g
aroma mandarine 0,100 g
aroma limone 0,100 g
Pripravek 4
Fosfomicin Trometamol 5,631 g natrijev citrat dihidrat 0,734 g
natrijev citrat monokislina 0,987 g
fruktoza 2,500 g
aroma mandarine 0,100 g
aroma limone 0,100 g
Pripravek 5
Fosfomicin Trometamol 5,631 g
L-arginin 1,470 g
natrijev saharin 0,010 g
saharoza 2,100 g
aroma mandarine 0,100 g
aroma pomaranče 0,100 g
Pripravek 6
Fosfomicin Trometamol 5,631 g
L-arginin 0,500 g
lizin 0,100 g
aspartam 0,100 g
aroma mandarine 0,100 g
aroma pomaranče 0,070 g
Pripravek 7
Fosfomicin Trometamol 5,631 g
5 natrijev citrat dihidrat natrijev karbonat aspartam aroma mandarine aroma pomaranče 0,500 g 0,500 g 0,100g 0,070 g 0,070 g
Pripravek 8 Fosfomicin Trometamol 5,631 g
natrijev citrat dihidrat 1,000 g
10 L-arginin 0,500 g
aspartam 0,070 g
aroma pomaranče 0,150 g
aroma limone 0,030 g
15 Pripravek 9
Fosfomicin Trometamol 5,631 g
natrijev citrat dihidrat 1,800 g
natrijev saharin 0,040 g
šaha roza 1,500 g
20 aroma mandarine 0,100 g
aroma limone 0,100 g
Pripravek 10
Fosfomicin Trometamol 5,631 g
natrijev citrat dihidrat 1,125 g
sorbitol 1,000 g
aspartam 0,070 g
aroma mandarine 0,100 g
aroma pomaranče 0,100 g

Claims (8)

  1. PATENTNI ZAHTEVKI
    1. Uporaba snovi, izbrane izmed naslednjih:
    - tribazni natrijev ali kalijev citrat
    5 - monokislinski natrijev ali kalijev citrat
    - tribazni natrijev ali kalijev fosfat
    - monokislinski natrijev ali kalijev fosfat
    - natrijev ali kalijev karbonat
    - natrijev ali kalijev bikarbonat io - natrijev aii kalijev tartrat
    - arginin
    - lizin ali njihove mešanice, za stabiliziranje Fosfomicin Trometamola.
  2. 2. Uporaba stabilizatorja spojine po zahtevku 1, označene s tem, da je spojina izbrana izmed tribaznega natrijevega citrata, natrijevega karbonata ali arginina.
  3. 3. Uporaba stabilizatorja spojine po zahtevku 1, označene s tem,
    -1111 da se spojina uporabi v molarnem razmerju glede na vsebovani FT med 10% in 100%, po možnosti med 30% in 70% in še bolje okoli 50%.
  4. 4. Farmacevtski pripravki, ki vsebujejo Fosfomicin Trometamol, spojino s izbrano izmed naslednjih:
    - tribazni natrijev ali kalijev citrat
    - monokislinski natrijev ali kalijev citrat
    - tribazni natrijev ali kalijev fosfat
    - monokislinski natrijev ali kalijev fosfat io - natrijev ali kalijev karbonat
    - natrijev ali kalijev bikarbonat
    - natrijev ali kalijev tartrat
    - arginin
    - lizin is ali njihove mešanice, in pomožne snovi, primerne za farmacevtsko uporabo.
  5. 5. Pripravek po zahtevku 4 v obliki topnega granulata.
    20
  6. 6. Pripravek po zahtevku 5, pri 6emer je količina vsebovanega FT za en odmerek 5,631 g.
    -1212
  7. 7. Pripravek po zahtevku 4. pri čemer je snov s stabiiizirnim delovanjem izbrana izmed tribaznega natrijevega citrata, natrijevega karbonata in arginina.
  8. 8. Pripravek po zahtevku 4. pri čemer se snov s stabiiizirnim delovanjem uporabi v molarnem razmerju glede na vsebovani FT med 10% in 100%, po možnosti med 30% in 70% in še bolje okoli 50%,
SI200300194A 2002-08-01 2003-07-24 Farmacevtski pripravki z antibiotičnim delovanjem SI21259B (sl)

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IT001725A ITMI20021725A1 (it) 2002-08-01 2002-08-01 Composizioni farmaceutiche ad attivita' antibiotica.

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HUP0302441A2 (hu) 2005-07-28
ITMI20021725A1 (it) 2002-10-31
FR2852845B1 (fr) 2006-01-06
AT500521B1 (de) 2007-11-15
DE10334820A1 (de) 2004-03-11
CZ20032096A3 (cs) 2004-03-17
CA2434927C (en) 2011-10-18
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PL209644B1 (pl) 2011-09-30
KR20040012569A (ko) 2004-02-11
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NL1023790A1 (nl) 2004-02-03
BRPI0302496C1 (pt) 2021-05-25
AT500521A1 (de) 2006-01-15
FI20031078A0 (fi) 2003-07-16
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CA2434927A1 (en) 2004-02-01
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SI21259B (sl) 2012-12-31
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