Stable solutions of rebeccamycin analog and preparations...

Details Stable solutions of rebeccamycin analog and preparations... Stable solutions of rebeccamycin analog and preparations...

A - Human Necessities

61

K

167/202

A61K 47/02 (2006.01) A61K 47/12 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2015632

Stable solutions of rebeccamycin analog consist essentially of (a) water, (b) 8-N-(diethylaminoethyl)rebeccamycin in an effective dosage amount, and (c) pharmaceutically acceptable acid such that the presence of a molar equivalence thereof would solubilize (b), said acid being present in excess of said molar equivalence to provide a stabilizing pH ranging from 3 to 4, preferably from 3.0 to 3.6. A preferred solution contains 10 mg/ml of the free base and tartaric acid in equimolar amount with the free base to provide a pH of 3.5. Preferably, the solution is prepared by forming a suspension of 8-N-(diethylaminoethyl)rebeccamycin in water and adding acid to provide a pH ranging from 3 to 4.

Solutions stables d'analogue de rébeccamycine, constituées essentiellement (a) d'eau, (b) d'une dose efficace de 8-N-(diéthylaminoéthyl)-rébeccamycine (c) et d'un acide acceptable en pharmacie, de telle façon que la présence d'un équivalent molaire de cet acide solubilise (b), l'acide étant présent en excès de cet équivalent molaire pour stabiliser le pH dans une plage de 3 à 4, et de préférence de 3,0 à 3,6. On privilégie une solution renfermant 10 mg/mL de la base libre et de l'acide tartrique en quantité équimolaire par rapport à la base libre, pour avoir un pH de 3,5. La solution est préparée de préférence par formation d'une suspension de 8-N-(diéthylaminoéthyl)rébeccamycine dans l'eau et addition d'acide pour obtenir un pH de 3 à 4.

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