ABSTRACT
A qualidade de cápsulas tem sua exatidão da dosagem assegurada por ensaios de teor e uniformidade de conteúdo (UC). Assim, os Laboratórios de Controle de Qualidade auxiliam as farmácias magistrais a guiarem sua conduta buscando a garantia da qualidade dos seus produtos. O presente trabalho teve por objetivo analisar o perfil dos resultados de UC de cápsulas magistrais, a partir dos relatórios de análise realizados entre janeiro de 2008 a fevereiro de 2010, por um Laboratório de Controle de Qualidade em Santa Catarina (Brasil). Identificou-se em 2009 um aumento no número e na proporção de farmácias que passaram a solicitar a UC de cápsulas de baixa dosagem em relação a 2008. Das análises, 78,6% tiveram aprovação como resultado, sendo o maior índice de reprovação relacionado ao teor de ativo fora do limite de 85-115%, dos quais 83,6% estavam abaixo do especificado no rótulo. Das análises reprovadas, 59,2% foram aprovadas na análise posterior e apenas 7% mantiveram o mesmo status. Neste estudo, as reprovações nas análises de UC não tiveram correlação com a dose preparada. A análise global dos resultados de uniformidade de conteúdo das cápsulas magistrais reflete a preocupação dos estabelecimentos farmacêuticos com a qualidade do produto oferecido.
The dose accuracy of capsules produced in compounding pharmacies is ensured mainly by testing their uniformity of content (UC). In order to guarantee the quality of such pharmaceuticals in Brazil, entities such as Quality Control Laboratories work together with these pharmacies. The aim of this study was to analyze the profile of results on the UC of capsules, in the reports of analyses performed from January 2008 to February 2010 by a Quality Control Laboratory in Santa Catarina state (Brazil). It was found that an increase occurred in both the number and proportion of pharmacies requesting UC tests of low dose capsules in 2009, relative to 2008. Among the products tested, 78.6% were approved and the largest failure rate was related to drug contents outside the 85-115% limits, of which 83.6% were below the content specified on the label. Among the failures, 59.2% passed in a subsequent test and only 7% maintained the same error. In this study, no correlation was found between disapprovals and dose. These results reflect the compounding pharmacie?s concern for product quality.
Subject(s)
Capsules , Pharmacies , Small DosesABSTRACT
Allogeneic stem cell transplantation has been increasingly performed for a variety of hematologic diseases. Clinically significant acute graft-versus-host disease (GVHD) occurs in 9 to 50 percent of patients who receive allogeneic grafts, resulting in high morbidity and mortality. There is no standard therapy for patients with acute GVHD who do not respond to steroids. Studies have shown a possible benefit of anti-TNF-a (infliximab)for the treatment of acute GVHD. We report here on the outcomes of 10 recipients of related or unrelated stem cell transplants who received 10 mg/kg infliximab, iv, once weekly for a median of 3.5 doses (range: 1-6) for the treatment of severe acute GVHD and who were not responsive to standard therapy. All patients had acute GVHD grades II to IV (II = 2, III = 3, IV = 5). Overall, 9 patients responded and 1 patient had progressive disease. Among the responders, 3 had complete responses and 6 partial responses. All patients with cutaneous or gastrointestinal involvement responded, while only 2 of 6 patients with liver disease showed any response. None of the 10 patients had any kind of immediate toxicity. Four patients died, all of them with sepsis. Six patients are still alive after a median follow-up time of 544 days (92-600) after transplantation. Considering the severity of the cases and the bad prognosis associated with advanced acute GVHD, we find our results encouraging. Anti-TNF-a seems to be a useful agent for the treatment of acute GVHD.