STABLE DOSAGE FORM OF ETIDRONATE-CYTARABINE CONJUGATE, AND USE THEREOF

The invention relates to the field of medicine and pharmaceuticals and particularly to a novel dosage form of an antitumour preparation, which ensures the hydrolytic and physical stability of said preparation, as well as to a method for producing a dosage form of this type. The present stable dosage...

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Bibliographische Detailangaben
Hauptverfasser: ZINNEN, SHAWN P, SALURIALAM, RINA DIANA, IVANOVA, EKATERINA ALEKSEEVNA, KARPEISKY, ALEXANDER, CARALLI, LISA LYNN
Format: Patent
Sprache:eng ; fre
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Beschreibung
Zusammenfassung:The invention relates to the field of medicine and pharmaceuticals and particularly to a novel dosage form of an antitumour preparation, which ensures the hydrolytic and physical stability of said preparation, as well as to a method for producing a dosage form of this type. The present stable dosage form is a lyophilisate comprising an etidronate-cytarabine conjugate or a pharmaceutically acceptable salt thereof, and a stabiliser which is a divalent metal salt, in a molar ratio of stabiliser to conjugate of 1:1 to 20:1. A dosage form of this type ensures the hydrolytic and physical stability of the conjugate during long-term storage, and the stability of solutions of the conjugate for parenteral administration during clinical use of same.