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    2-PYRROLIDONE DERIVATIVES FOR PRESERVATION OF OPHTHALMIC, OTIC AND NASAL COMPOSITIONS
    1.
    发明申请
    2-PYRROLIDONE DERIVATIVES FOR PRESERVATION OF OPHTHALMIC, OTIC AND NASAL COMPOSITIONS 审中-公开
    2-吡咯烷酮衍生物用于保存眼睛，眼睛和鼻子组成

    公开(公告)号：US20080095863A1

    公开(公告)日：2008-04-24

    申请号：US11877979

    申请日：2007-10-24

    申请人： Bhagwati Kabra

    发明人： Bhagwati Kabra

    IPC分类号： A01N43/36 ,  A01N59/16 ,  A01P1/00

    CPC分类号： A01N43/36 ,  A01N33/12 ,  A01N59/16 ,  A01N59/14 ,  A01N37/44 ,  A01N2300/00

    摘要： 2-Pyrrolidone derivatives are provided as preservatives for topical formulations, particularly for ophthalmic, otic, and nasal formulations. N-octyl-2-pyrrolidone, without any other preservative or preservative aid in an isotonic pH 7.5 formulation, provided sufficient preservation to comply with the European Pharmacopoeia 5.0 standards in addition to the United States Pharmacopoeia 24 standards for parenteral and ophthalmic preparations. On the other hand, N-dodecyl-2-pyrrolidone requires a second anti-microbial agent to achieve such preservation standards.

    摘要翻译： 提供2-吡咯烷酮衍生物作为局部制剂的防腐剂，特别是眼用，耳用和鼻制剂。 在等渗pH 7.5配方中没有任何其他防腐剂或防腐剂的N-辛基-2-吡咯烷酮，除了适用于胃肠外和眼用制剂的美国药典24标准外，提供足够的保存以符合欧洲药典5.0标准。 另一方面，N-十二烷基-2-吡咯烷酮需要第二种抗微生物剂来达到这种保存标准。

    SELF PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS
    2.
    发明申请
    SELF PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS 有权
    自我保留的水性药物组合物

    公开(公告)号：US20080075790A1

    公开(公告)日：2008-03-27

    申请号：US11858781

    申请日：2007-09-20

    申请人： Bhagwati Kabra ,  Masood Chowhan ,  L. Schneider ,  Wesley Han

    发明人： Bhagwati Kabra ,  Masood Chowhan ,  L. Schneider ,  Wesley Han

    IPC分类号： A61K33/30 ,  A61P27/02

    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。