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LOW-VISCOUS HIGH-flocculated Suspensions of Triamcinolone Acetonide for Intravitreal Injections
专利权人:
ЛТД. (US);АЛЬКОН РИСЕРЧ
发明人:
КАБРА Бхагвати П. (US),САРКАР Рума (US)
申请号:
RU2010141542/15
公开号:
RU2010141542A
申请日:
2009.03.10
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. An aqueous suspension composition, in particular suitable for ophthalmic injection, wherein said suspension composition does not contain a preservative, has a pH of from 6 to 7.5, a viscosity of 2-12 cPs and a flocculation degree above 5 and consists essentially of:! a) 3.5-4.5% (wt./about.) of a poorly soluble drug, the drug has a volumetric average diameter of 3-10 microns; ! b) 0.45-0.55% (w / v) sodium carboxymethyl cellulose; ! c) 0.002-0.02% (w / v) polysorbate 80 or tyloxapol; ! g) one or more pharmaceutically acceptable chloride salts as agents for summing up the tonicity in a total amount sufficient for the osmolality of the suspension composition 250-300 mOsm; ! e) a buffering agent; ! e) water for injection; and! g) optional agent for adjusting the pH to 6-7.5. ! 2. The suspension composition according to claim 1, where the suspension composition has a degree of flocculation above 6.! 3. The suspension composition according to claim 2, where the suspension composition has a degree of flocculation above 7.! 4. The suspension composition according to claim 1, where the concentration of triamcinolone acetonide is 4% (wt./vol.). ! 5. The suspension composition according to claim 1, where the sodium carboxymethyl cellulose has a molecular weight such that a 2% (w / v) solution of sodium carboxymethyl cellulose in water at 25 ° C. has a viscosity of 25-50 cps. ! 6. The suspension composition according to claim 1, where the concentration of sodium carboxymethyl cellulose is 0.5% (wt./vol.). ! 7. The suspension composition according to claim 1, where the concentration of polysorbate 80 is 0.01-0.02% (wt./vol.). ! 8. The suspension composition according to claim 7, where the concentration of polysorbate 80 is 0.015% (wt./vol.). ! 9. The suspension composition according to claim 1, containing sodium chloride, potassium chloride, calcium chloride and magnesium chloride. ! 10. Composition1. Водная композиция суспензии, в частности, подходящая для глазных инъекций,
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