A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/127 (2006.01) A61K 31/13 (2006.01) G01N 33/15 (2006.01)
Patent
CA 2588012
Stable liposome composition for delivering a pharmaceutical agent, the composition comprising: (a) a suitable aqueous medium; (b) liposomes formed from a suitable phospholipid; (c) at least one pharmaceutical agent being at least partially encapsulated in the liposomes, and being selected from: (i) a lipophilic amine and a pharmaceutically acceptable acid, wherein the pharmaceutically acceptable acid is selected from an organic or inorganic acid, and (ii) a pharmaceutically acceptable organic acid salt of a lipophilic amine, and optionally a pharmaceutically acceptable organic acid; wherein the quantity of the pharmaceutically acceptable acid present in the composition is such that the pH of the liposome composition is less than or approximately equal to the pKa of the amino group of the pharmaceutically active lipophilic amine. Compositions, kits, and methods for the preparation of same, as well as methods for further enhancing the stability of the compositions by autoclaving, and methods for the identification of stable liposome compositions of the present invention are likewise provided.
L'invention concerne une composition liposomale stable destinée à l'administration d'un agent pharmaceutique. Cette composition comprend (a) un milieu aqueux approprié, (b) des liposomes formés à partir d'un phospholipide approprié, (c) au moins un agent pharmaceutique au moins partiellement encapsulé dans les liposomes et choisi parmi (i) une amine lipophile et un acide pharmaceutiquement acceptable, l'acide pharmaceutiquement acceptable étant choisi parmi un acide organique et un acide inorganique, et (ii) un sel d'acide organique pharmaceutiquement acceptable d'une amine lipophile, et éventuellement un acide organique pharmaceutiquement acceptable. La quantité d'acide pharmaceutiquement acceptable présent dans la composition permet d'obtenir une composition liposomale présentant un pH inférieur ou approximativement égal au pK¿a? du groupe amino de l'amine lipophile pharmaceutiquement active. L'invention concerne également des compositions, des trousses et des procédés de préparation de ces compositions, ainsi que des procédés destinés à augmenter la stabilité desdites compositions par autoclavage et des procédés d'identification des compositions liposomales stables de la présente invention.
Boylan James Charles
Li Hong
Pliura Diana Helen
Ristevski Blagoja
Delex Therapeutics Inc.
Ridout & Maybee Llp
Ym Biosciences Inc.
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