International journal of pharmaceutical compounding
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Compounders engaged in making sterile preparations need to employ a quality assurance system of documented policies and procedures to attempt to reduce the possibility of contamination. The quality-assurance program will be monitored through the facility's quality control system. Compounders should be aware of the requirements of each state they are licensed in as well as the inspection observations commonly noted in 483s issued by the U. ⋯ Food and Drug Administration. In part 1 of this 2-part article, we discuss the currently evolving regulatory environment and why sterile compounding requires planning and monitoring to deliver quality compounds to patients. Part 2 will examine the United States Pharmacopeia's discussion on the principles of quality assurance and quality control in sterile compounding.
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Herceptin is a humanized monoclonal antibody that selectively binds to the extracellular domain of human epidermal growth factor receptor 2 (HER2). Herceptin has an important role in the treatment of HER2-positive breast cancer when used in the neoadjuvant, adjuvant, and metastatic settings, and in the treatment of HER2-positive metastatic gastric cancer, and gastroesophageal junction adenocarcinoma. Prior to intravenous infusion, Herceptin must be reconstituted with sterile water for injection and then diluted in intravenous bags with normal saline. ⋯ The pH values remained consistent between T0 and T7+1, and osmolality values were consistent across low-concentration and high-concentration samples. Protein content, size, and potency remained consistent throughout storage and simulated infusion. In conclusion, Herceptin remains physicochemically stable for 7 days when stored at 2°C to 8°C, followed by an additional 24 hours at 30°C when diluted in 0.9% sodium chloride and stored in commercially available polyvinylchloride or polyolefin/polyethylene/polypropylene infusion bags.