首页> 外国专利> STERILE INJECTABLE AQUEOUS COMPOSITION BASED ON crosslinked HYALURONIC ACID AND HYDROXYAPATITIS FOR THERAPEUTIC USE

STERILE INJECTABLE AQUEOUS COMPOSITION BASED ON crosslinked HYALURONIC ACID AND HYDROXYAPATITIS FOR THERAPEUTIC USE

机译:基于交联的透明质酸和羟磷灰石的无菌注射用水组合物,用于治疗

摘要

1. A sterile aqueous injectable composition, sterilized with moist heat, used for therapeutic purposes, in the form of a cohesive, viscoelastic gel based on particles, containing: i) crosslinked hyaluronic acid or one of its salts in a concentration of from 1% to 4% (weight / volume) ; the crosslinking performed makes it possible to obtain a gel based on crosslinked hyaluronic acid having a so-called cohesive structure, and ii) hydroxyapatite in a concentration of from 10% to 70% (mass / volume), wherein said hydroxyapatite is present in the form of particles having an average size of less than or equal to from 80 μm to 500 nm; wherein said sterile injectable aqueous composition has viscoelastic properties in which Tanδ at a frequency of 1 Hz is less than or equal to 0.60 as determined by performing a frequency sweep from 0.01 d about 100 Hz using a rheometer with a plate geometry of 40 mm, a working air gap of 1000 micrometers and an analysis temperature of 25 ° C. 2. The sterile injectable aqueous composition according to claim 1, characterized in that the molecular weight of hyaluronic acid or one of its salts is from 2.5 × 10 Da to 4 × 10 Da. 3. A sterile injectable aqueous composition according to claim 1, characterized in that the concentration of crosslinked hyaluronic acid or one of its salts is from 1% to 3% (weight / volume). Sterile injectable aqueous composition according to paragraphs. 1-3, characterized in that the concentration of hydroxyapatite is from 20% to 60% (mass / volume), preferably from 30% to 50% .5. Sterile injectable aqueous composition according to paragraphs. 1-3, characterized in that the composition may further comprise one or more ceramic materials, such as tricalcium phosphate. 6. Sterile injectable aqueous composition according to claim 5, characterized in that the ceramic material
机译:1.湿热灭菌的无菌水性注射用组合物,用于治疗目的,是基于颗粒的粘性粘弹性凝胶形式,包含:i)交联的透明质酸或其盐之一,浓度为1%到4%(重量/体积);进行的交联使得可以获得具有所谓的内聚结构的基于交联的透明质酸的凝胶,并且ii)羟基磷灰石的浓度为10%至70%(质量/体积),其中所述羟基磷灰石存在于平均尺寸小于或等于80μm至500 nm的颗粒形式;其中所述无菌注射用水性组合物具有粘弹性质,其中Tanδ在1Hz的频率下小于或等于0.60,如通过使用具有40mm的板几何形状的流变仪从0.01d约100Hz进行扫频所确定的, 2.根据权利要求1所述的无菌注射用水性组合物,其特征在于,透明质酸或其盐之一的分子量为2.5×10 Da至4×。 10天3.根据权利要求1的无菌可注射水性组合物,其特征在于交联的透明质酸或其盐之一的浓度为1%至3%(重量/体积)。根据段落的无菌可注射水性组合物。 1-3。特征在于羟基磷灰石的浓度为20%至60%(质量/体积),优选为30%至50%.5。根据段落的无菌可注射水性组合物。参照图1-3,其特征在于所述组合物可进一步包含一种或多种陶瓷材料,例如磷酸三钙。 6.根据权利要求5的无菌注射用水性组合物,其特征在于陶瓷材料

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