Abstract
The GMP process has been developed for manufacturing DAVANAT®, a modified galactomannan from Cyamopsis tetragonoloba, or guar gum. The material was structurally identified and characterized by standard analytical techniques as well as by the following methods: 13 C Nuclear Magnetic Resonance ( 13 C-NMR); Size Exclusion Chromatography with Multi-Angle Laser Light Scattering (SEC-MALLS) for absolute molecular weight determination; and Anion Exchange Liquid Chromatography with Pulsed Amperometric Detection (AELC-PAD) for carbohydrate composition and to verify the uniformity and purity of the final products. Both in the manufacturing of the bulk material and the final drug product, precautions were taken to control degradation by thermal or microbial/enzymatic activity. As a parental/i.v., the slow-dissolving polymer was formulated as a sterile solution to make it easy to handle in a hospital. The shelf life of the polymer solution has been estimated to be at least three years at room temperature. Preclinical studies with 5-fluorouracil, doxorubicin, irinotecan, and cisplatin have shown significant degrees of efficacy enhancement both in colon and breast-cancer models in nude mice.
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