Crystallization of toxic glycol solvates of rifampin from glycerin and propylene glycol contaminated with ethylene glycol or diethylene glycol
De Villiers, Melgardt M.
Strydom, Schalk J.
Caira, Mino R.
MetadataShow full item record
This study was initiated when it was suspected that syringe blockage experienced upon administration of a compounded rifampin suspension was caused by the recrystallization of toxic glycol solvates of the drug. Single crystal X-ray structure analysis, powder X-ray diffraction, thermal analysis and gas chromatography were used to identify the ethylene glycol in the solvate crystals recovered from the suspension. Controlled crystallization and solubility studies were used to determine the ease with which toxic glycol solvates crystallized from glycerin and propylene glycol contaminated with either ethylene or diethylene glycol. The single crystal structures of two distinct ethylene glycol solvates of rifampin were solved while thermal analysis, GC analysis and solubility studies confirmed that diethylene glycol solvates of the drug also crystallized. Controlled crystallization studies showed that crystallization of the rifampin solvates from glycerin and propylene glycol depended on the level of contamination and changes in the solubility of the drug in the contaminated solvents. Although the exact source of the ethylene glycol found in the compounded rifampin suspension is not known, the results of this study show how important it is to ensure that the drug and excipients comply with pharmacopeial or FDA standards.
Showing items related by title, author, creator and subject.
The in vitro and in vivo pharmacokinetic parameters of polylactic–co–glycolic acid nanoparticles encapsulating anti–tuberculosis drugs Booysen, Laetitia Lucretia Ismarelda Josephine (North-West University, 2012)Tuberculosis (TB) is an infectious, deadly disease, caused by Mycobacterium tuberculosis (M.tb). In 2010, there were 8,8 million incident cases of TB globally. South Africa currently has the third highest TB incident ...
Steyn, Minette (North-West University, 2010)Malaria continues to be a major serious health problem and public health threat, with over two billion people at risk of contracting this deadly disease. Malaria is endemic in 92 countries and more than one million deaths ...
In vivo/in vitro pharmacokinetic and pharmacodynamic study of spray-dried poly-(dl-lactic-co-glycolic) acid nanoparticles encapsulating rifampicin and isoniazid Booysen, L.L.I.J.; Kotzé, A.F.; Du Plessis, L.H.; Kalombo, L.; Brooks, E. (Elsevier, 2013)Poly-(dl-lactic-co-glycolic) acid (PLGA) nanoparticles were prepared by a double emulsion solvent evaporation spray-drying technique and coated with polyethylene glycol (PEG 1% v/v). The PLGA nanoparticles had a small ...