Stability of docetaxel diluted to 0.3 or 0.9 mg/mL with 0.9% sodium chloride injection and stored in polyolefin or glass containers.

PURPOSE: The stability of docetaxel diluted to 0.3 or 0.9 mg/mL with 0.9% sodium chloride injection and stored in polyolefin or glass containers was studied. METHODS: Vials of docetaxel injection concentrate were reconstituted with the entire contents of the solvent vial and carefully homogenized to avoid the formation of foam. Solutions were aseptically prepared with nominal docetaxel concentrations of 0.3 and 0.9 mg/mL by adding the appropriate quantities to polyolefin containers or glass bottles, to which had been added the appropriate volume of 0.9% sodium chloride injection, yielding a final volume of 50 mL. Three identical polyolefin containers and one control glass bottle for each concentration were prepared. All test solutions were stored at 19-21 degrees C and protected from light. Chemical stability was measured by using a stability-indicating high-performance liquid chromatographic (HPLC) assay with ultraviolet-light detection. Physical stability was determined by visual inspection. RESULTS: No evidence of precipitation was observed during the first 24 hours of the study. However, after a day of storage, the HPLC assay revealed large relative standard deviation values for diluted docetaxel solutions in some containers. These values were predictive for the formation of precipitates and compatible with the existence of microprecipitates at 24 hours. These results suggest that the diluted docetaxel infusions were not stable when stored at 19-21 degrees C. CONCLUSION: Docetaxel 0.3 and 0.9 mg/mL in 0.9% sodium chloride injection was not physically stable for more than one day when stored at 19-21 degrees C. Docetaxel stability in diluted solutions appears sensitive to slight changes in temperature and degree of agitation.

A kind of novel biodegradable hydrogel made from copolymerization of gelatin with polypseudorotaxanes based on alpha-CDs.

A kind of novel biodegradable supramolecular hydrogel was synthesized via copolymerization of gelatin methacrylamide with photocurable and biodegradable polypseudorotaxanes under UV irradiation. These polypseudorotaxanes were prepared by supramolecular self-assemblies of alpha-cyclodextrins threaded onto amphiphilic LA-PEG-LA copolymers end-capped with methacryloyl groups. The hydrogels are injectable, and their structure was characterized in detail with FTIR, (1)H NMR, XRD, TG and DSC techniques. Their swelling behaviour and morphologies were also examined. The analytical results demonstrated that the channel-type crystalline structure of the polypseudorotaxanes remains in the as-obtained hydrogels. Moreover, the SEM pictures showed that the hydrogels having gelatin methacrylamide are more suitable for cell seeding and proliferation than those without gelatin added.