Recovery of drug residues in equipment and utensils used by compounding pharmacies after standard cleaning procedure

Abstract

Compounding pharmacies have been cited by some athletes as being responsible for compounding capsules contaminated with drugs banned by the International Olympic Committee (IOC). Therefore, the present study was carried out to quantify the amount of residue remaining in the equipment and utensils used for compounding capsules after standard cleaning procedures. For this purpose, captopril (CAP) and acetylsalicylic acid (ASA) were used since these are hard to clean, in addition to hydrochlorothiazide (HTZ) as a banned drug by the IOC. The amounts of residues found in the equipment were: 181.0 ± 91.8, 1208 ± 483.8 and 431.7 ± 71.3 ppm for ASA, CAP and HTZ, respectively. The continuous compounding of these drugs, followed each time by the standard cleaning procedure, showed a linear accumulation of residues for ASA (r 2 =0.96) and CAP (r 2 = 0.88). The residues quantified were greater than the FDA limit for impurities for CAP (>0.1%) but not for HTZ. However, the HTZ residue may be detected in the urine of athletes on IOC tests. Therefore, it was concluded that compounding pharmacies should therefore improve their cleaning procedures and test these in order to attain limits below 10 ppm, thereby avoiding the contamination of other products. Uniterms:Compounding pharmacy/cleaning procedure/equipments. Pharmacy equipaments/cleaning. Pharmaceutical products/contamination. Captopril. Acetylsalicylic acid. Hydrochlorothiazide.As farmácias de manipulação têm sido citadas por alguns atletas como sendo responsáveis pela manipulação de cápsulas contaminadas com fármacos proibidos pelo Comitê Olímpico Internacional (COI). Portanto, o presente estudo foi realizado para quantificar o montante de resíduo remanescente nos equipamentos e utensílios usados para manipular cápsulas após o procedimento padrão de limpeza. Para este propósito, o captopril (CAP) e o ácido acetilsalicílico (ASA) foram usados por serem fármacos de difícil remoção e a hidroclorotiazida (HTZ), por ser um fármaco proibido pelo COI. As quantidades de resíduos encontradas nos equipamentos após a limpeza foram 181,0 ± 91,8, 1208 ± 483,8 e 431,7 ± 71,3 ppm para ASA, CAP e HTZ, respectivamente. A manipulação contínua dos fármacos seguida pelo procedimento de limpeza mostrou acúmulo de resíduo linear para ASA (r 2 =0,96) e CAP (r 2 =0,88). A quantidade de resíduo de CAP foi maior que o limite de impureza sugerido pelo FDA (>0,1%), mas não para HTZ, mas mesmo assim, o resíduo de HTZ pode ser detectado na urina dos atletas submetidos aos testes do COI. Em conclusão, as farmácias de manipulação deveriam, portanto, melhorar o procedimentos de limpeza e testá-los para que alcancem limites abaixo de 10 ppm para evitar contaminação nos outros produtos.

Opinion and Expectation of Pharmacists on Providing Extemporaneous Compounding in Jogjakarta and Central Java Provinces, Indonesia

“…Pharmacists are expected to be experts about medicines [8]. The current study shows that pharmacists usually prepared compounding based solely on habits and experiences.…”

The presence of doping agents in dietary supplements: A glimpse into the Brazilian situation

“…26 Nevertheless, the risk of cross-contamination of a CDS during the preparation process in compounding pharmacies should not be discarded, considering the possible presence of residues after standard cleaning procedures. 27 In 2018, for instance, the United States Anti-Doping Agency (USADA) concluded that Brazilian compounding pharmacies were the source behind the AAFs of three athletes from the Ultimate Fighting Championship (UFC). The substances detected were hydrochlorothiazide (HCTZ) and anastrozole, both prohibited at all times under the UFC Anti-Doping Policy 28 and WADA.…”

“…Considering the increasing number of doping cases potentially associated with DS consumption, athletes should have been advised by the healthcare professional that CDS intake, besides its potential benefits, could also pose a risk to their health and career. 27 The results of contaminated CDS samples linked to doping findings are shown in product types, such as vitamins, probiotics, slimming products, and mass-gaining supplements, among others. Observing the disclaimers about the limitations in quantitative approaches of the methods employed, when comparing CDS to correlated findings in MDS samples, there was a clear difference between the range of doping agents' estimated concentrations.…”

Farmácia magistral e as boas práticas de manipulação de preparações magistrais e oficinais no Brasil nos últimos 10 anos: revisão de literatura / Master pharmacy and good handling practices in Brazil over the last 10 years: literature review

“…3.3 CONTAMINAÇÃO CRUZADA Prioste et a.l (2015) e Souza et al (2012) utilizaram método espectrofotometria UV para analisar a contaminação cruzada. Prioste et al (2015), em seu trabalho verificou que grandes quantidades de resíduos foram recuperadas para todos os fármacos testados, sendo o procedimento de recuperação dos resíduos realizado nos dispositivos de encapsulamento, sendo feito após limpeza padrão com lenços de papel secos. As bandejas foram agitadas por 10 minutos a 50 rpm e os solventes foram coletados, filtrados e os resíduos analisados pelo método do espectrofotômetro UV, sendo que estes procedimentos preenchiam os requisitos dos métodos de validação analítica.…”