Análise e validação do procedimento de manipulação de cápsulas por encapsulamento manual por nivelamento / Analysis and validation of manual filling procedure for capsules

Entre as formas farmacêuticas sólidas de uso oral mais preparadas nas farmácias magistrais está a cápsula gelatinosa dura. O processo de manipulação de cápsulas apresenta alguns pontos críticos como a mistura e o fluxo dos pós, que podem interferir na obtenção de cápsulas na dose certa. Assim o objetivo foi analisar e validar o procedimento de manipulação de cápsulas por encapsulamento manual por nivelamento, considerando as características de fluxo e dose das formulações magistrais. A seleção dos produtos farmacêuticos (6) foi baseada na dose, fluxo e metodologia analítica validada por UV. A validação do processo consistiu na análise do peso médio, uniformidade de dose e teor de cinco lotes de cada produto preparados por dois manipuladores. Foi elaborado um procedimento escrito pelo método de nivelamento manual para os produtos metformina 500mg (MTF); paracetamol 250 mg (PCT); cetoconazol 200mg (CTZ); nimesulida 150 mg (NIM); riboflavina 20 mg(RIB) e glibenclamida 5 mg (GLB). O procedimento de manipulação foi validado para os produtos MTF, PCT,CTZ, NIM e RIB, exceto para o produto GLB, devido a reprovação de quatro lotes no teste de uniformidade de conteúdo. Os resultados nos levam a concluir que fármacos de dose acima de 20 mg (fluxo bom ou ruim) são menos susceptíveis à reprovação. O mesmo não acontece para fármacos de doses ≤ 5 mg, demonstrando que quanto menor a dose, maior a dificuldade de obter um produto na dose correta. Também foi possível verificar que o manipulador interfere na obtenção do produto de qualidade...

Among the solid dosage forms for oral use prepared regularly in compounding pharmacies is the hard gelatin capsule. The process of com pounding capsuleshas some critical features, such as the mixing and flow of powders, which can interfere with the production of capsules containing the right dose. Thus, the aim here was to analyze and validate the procedure for encapsulation of the dose by manual spreading of the formulated powder in relation to the flow characteristics and dose of the compounding formulas. The selection of the 6 pharmaceutical products was based on dose, flow and existence of a validated method of analysis by UV spectroscopy. The validation process consisted of the analysis of average weight, uniformity of dose and content of five batches of each product prepared by two handlers. A written operating procedure was prepared for the method of manual encapsulation by spreading, for capsules of 500 mg metformine (MTF), 250 mg paracetamol (PCT), 200 mg ketoconazole (CTZ), 150mg nimesulide (NIM), 20 mg riboflavin (RIB) and 5mg glibenclamide (GLB). The procedure was validated for compounding the products MTF, PCT, CTZ, NIM and RIB, but not for the product GLB, as 4 lots were rejected in the test for uniformity of content. The results lead us to conclude that, for drug doses above 20 mg (with good or bad flow), this filling procedure is less susceptible to failure. The same is not true for drugs with doses ≤ 5 mg, showing that the smaller the dose, the harder it is to produce a capsule in the correct dose. It was also observed that the handler interferes with the quality of the capsules compounded, according to official pharmaceutical criteria...

Utilization of Family Members to Provide Hospital Care in Malawi: the Role of Hospital Guardians

Aim :Like most of sub-Saharan Africa; Malawi suffers from a paucity of human resources in the health sector. With an average of one physician for every 50;000 persons; and a health care professional to in-patient population ratio of 1:277; patient care suffers. At Kamuzu Central Hospital (KCH) of Lilongwe; Malawi; family members; termed Hospital Guardians; are utilized to provide basic care for patients. The aim of our study is to characterize this population and explore their role in the health care system of KCH. Methods Seventy three semi-qualitative surveys and nineteen in-depth interviews were conducted with hospital administrators; Guardians; nurses; and physicians from these wards. The results were analyzed using descriptive analysis and emergent coding. ResultsIt was found that Hospital Guardians were primarily female family members of patients and have a low literacy rate. They performed a wide range of daily tasks in patient care from wound care to advocacy. Despite their essential role in the health care system; the Guardians were provided with little support from the hospital. There was often conflict between the Guardians and hospital personnel due to overcrowding with more than one Guardian per patient; a lack of understanding of hospital rules and regulations; and a lack of respect for the Guardian role by hospital staff.Conclusions :Until their role can be reduced by additional trained health care professionals; patient care could be improved by institutional support including a clarification of the role of the Hospital Guardians. Recommendations include a one-patient one-guardian policy; Guardian education; and enhancing Guardian resources