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    Self-Preserved Aqueous Pharmaceutical Compositions
    2.
    发明申请
    Self-Preserved Aqueous Pharmaceutical Compositions 有权
    自保水性药物组合物

    公开(公告)号：US20110195132A1

    公开(公告)日：2011-08-11

    申请号：US13086950

    申请日：2011-04-14

    申请人： Bhagwati P. Kabra ,  Masood A. Chowhan ,  L. Wayne Schneider ,  Wesley Wehsin Han

    发明人： Bhagwati P. Kabra ,  Masood A. Chowhan ,  L. Wayne Schneider ,  Wesley Wehsin Han

    IPC分类号： A61K33/30 ,  A61P27/02 ,  A61P31/00

    CPC分类号： A61K9/0048 ,  A61K47/02 ,  A61K47/10 ,  A61K47/26 ,  Y02A50/465 ,  Y02A50/473

    摘要： The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borate or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.

    摘要翻译： 本发明涉及提供多剂量，自我保存的眼用组合物。 组合物具有足够的抗微生物活性以满足USP防腐功效要求，以及类似的防腐标准品（例如EP和JP），而不需要存在常规的抗微生物防腐剂，例如苯扎氯铵。 通过含有浓度为0.04至0.9mM，优选0.04至0.4mM的锌离子的平衡离子缓冲系统有效地保护了组合物。 平衡缓冲系统的一个方面是存在的缓冲剂阴离子的量的限制为15mM或更低，优选5mM或更低的浓度。 在优选的实施方案中，组合物还含有硼酸盐或最优选一种或多种硼酸盐/多元醇络合物。 在这种络合物中使用丙二醇作为多元醇是非常优选的。 限制锌以外的二价金属的量和存在的离子盐的量也被确定为使平衡缓冲体系的抗菌活性最大化是重要的。

    Self preserved aqueous pharmaceutical compositions
    3.
    发明授权
    Self preserved aqueous pharmaceutical compositions 有权
    自我保护的水性药物组合物

    公开(公告)号：US08268299B2

    公开(公告)日：2012-09-18

    申请号：US11858781

    申请日：2007-09-20

    申请人： Bhagwati P. Kabra ,  Masood A. Chowhan ,  L. Wayne Schneider ,  Wesley Wehsin Han

    发明人： Bhagwati P. Kabra ,  Masood A. Chowhan ,  L. Wayne Schneider ,  Wesley Wehsin Han

    IPC分类号： A61K31/74 ,  A61K33/32 ,  A61K33/22 ,  A01N25/00 ,  A01N59/16 ,  A01N59/14

    CPC分类号： A61K9/0048 ,  A61K47/02 ,  A61K47/10 ,  A61K47/26 ,  Y02A50/465 ,  Y02A50/473

    摘要： The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borat or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.

    摘要翻译： 本发明涉及提供多剂量，自我保存的眼用组合物。 组合物具有足够的抗微生物活性以满足USP防腐功效要求，以及类似的防腐标准品（例如EP和JP），而不需要存在常规的抗微生物防腐剂，例如苯扎氯铵。 通过含有浓度为0.04至0.9mM，优选0.04至0.4mM的锌离子的平衡离子缓冲系统有效地保护了组合物。 平衡缓冲系统的一个方面是存在的缓冲剂阴离子的量的限制为15mM或更低，优选5mM或更低的浓度。 在优选的实施方案中，组合物还含有硼酸盐或最优选一种或多种硼酸盐/多元醇配合物。 在这种络合物中使用丙二醇作为多元醇是非常优选的。 限制锌以外的二价金属的量和存在的离子盐的量也被确定为使平衡缓冲体系的抗菌活性最大化是重要的。

    Self-preserved aqueous pharmaceutical compositions
    9.
    发明授权
    Self-preserved aqueous pharmaceutical compositions 有权
    自我保护的水性药物组合物

    公开(公告)号：US08323630B2

    公开(公告)日：2012-12-04

    申请号：US13086950

    申请日：2011-04-14

    申请人： Bhagwati P. Kabra ,  Masood A. Chowhan ,  L. Wayne Schneider ,  Wesley Wehsin Han

    发明人： Bhagwati P. Kabra ,  Masood A. Chowhan ,  L. Wayne Schneider ,  Wesley Wehsin Han

    IPC分类号： A61K31/74 ,  A61K33/32 ,  A61K33/22 ,  A01N25/00 ,  A01N59/16 ,  A01N59/14

    CPC分类号： A61K9/0048 ,  A61K47/02 ,  A61K47/10 ,  A61K47/26 ,  Y02A50/465 ,  Y02A50/473

    摘要： The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borate or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.

    摘要翻译： 本发明涉及提供多剂量，自我保存的眼用组合物。 组合物具有足够的抗微生物活性以满足USP防腐功效要求，以及类似的防腐标准品（例如EP和JP），而不需要存在常规的抗微生物防腐剂，例如苯扎氯铵。 通过含有浓度为0.04至0.9mM，优选0.04至0.4mM的锌离子的平衡离子缓冲系统有效地保护了组合物。 平衡缓冲系统的一个方面是存在的缓冲剂阴离子的量的限制为15mM或更低，优选5mM或更低的浓度。 在优选的实施方案中，组合物还含有硼酸盐或最优选一种或多种硼酸盐/多元醇络合物。 在这种络合物中使用丙二醇作为多元醇是非常优选的。 限制锌以外的二价金属的量和存在的离子盐的量也被确定为使平衡缓冲体系的抗菌活性最大化是重要的。