International journal of pharmaceutical 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.
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Compounding pharmacists must separately and collectively evaluate multiple aspects of a compounded sterile preparation when determining their beyond-use date. Considerations include the microbiological risk level, storage temperature, chemical stability, batch size, and whether or not a sterility test will be performed. The United States Pharmacopeia Chapter <797> provides guidance on the maximum beyond-use date allowed solely based on the microbiological risk level associated with the compounding of a sterile preparation. ⋯ When compounding pharmacists intend to provide a compounded sterile preparation with a beyond-use date that exceeds the risk-level based recommendations in United States Pharmacopeia Chapter <797>, they must ensure that their formulations are sterility tested in compliance with United States Pharmacopeia Chapter <71>. United States Pharmacopeia Chapter <71> compliance includes conducting method suitability that is applicable to the strength and batch size that they plan to prepare. Chemical stability must be a separate consideration for each formulation.
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Fibromyalgia is a syndrome associated with chronic, widespread musculoskeletal pain, fatigue, depression, and cognitive dysfunction. With few U. S. ⋯ Based on our study results, the beyond-use date for compounded low-dose naltrexone formulations stored at room temperature and protected from light can be extended to 1 year. The longer beyond-use dating allows patients greater flexibility in using these capsules during the flare-ups associated with fibromyalgia without needing a refill immediately at the onset of symptoms. In addition, it may help compounding pharmacies reduce waste associated with small-batch preparation of these capsules.
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One is generally introduced to density in the pharmacy calculations class with exercises in converting weights to liquid measurements, etc. However, density has far more applications than that. ⋯ Density/specific gravity is used in both nonsterile and sterile compounding, as in using automated compounders for parenteral nutrition solutions. Equipment available is both manual and automated, depending upon the preferences of the user and is reasonably priced.
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The purpose of this study was to evaluate the effectiveness and adverse effects of topical ketamine in the treatment of complex regional pain syndrome. Retrospective charts were reviewed of patients 18 years or older diagnosed with complex regional pain syndrome and treated with topical ketamine during the study period of May 2006 to April 2013 in an academic medical center specialty pain clinic. Exclusion criteria consisted of subjects who 1) were treated with topical ketamine for pain syndromes other than complex regional pain syndrome, 2) initiated other pain therapies concurrently with topical ketamine, 3) had less than two documented visits, 4) began use of topical ketamine prior to the start of the study period, 5) were under 18 years of age. ⋯ No subjects reported adverse effects. Based on the findings in this study, the use of topical ketamine in the treatment of complex regional pain syndrome shows promise due to the overall limited options available to treat this condition, as well as the favorable safety profile of topical agents. Future prospective controlled studies are needed to demonstrate a clear benefit.