STABLE DOSAGE FORM OF ETIDRONATE-CYTARABINE CONJUGATE

The invention relates to the field of medicine and pharmaceuticals and particularly to a novel dosage form of an antitumor 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 stable dosage form is...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: CARALLI, Lisa Lynn, IVANOVA, Ekaterina Alekseevna, SALURIALAM, Rina Diana, KARPEISKY, Alexander, ZINNEN, Shawn P
Format: Patent
Sprache:eng ; fre ; ger
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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 antitumor 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 stable dosage form is a lyophilizate comprising an etidronate-cytarabine conjugate or a pharmaceutically acceptable salt thereof, and a stabilizer, which is a divalent metal salt, in a molar ratio of stabilizer 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.