Analysis of the effect of in vitro dissolution on the pharmacokinetics of albendazole

Abstract Albendazole is an anthelmintic drug commonly used in parenchymal neurocysticercosis and cystic echinococcosis. The aim of this study was to explore whether disparities in the dissolution profiles of albendazole products lead to significant differences in pharmacokinetic parameters. Three generic products and the innovator were evaluated in vitro. Quality control tests were performed, and dissolution profiles were obtained according to the Mexican Pharmacopeia. Although all products passed the quality control tests, none of the generic products complied with the similarity factor (f 2). The product with the lowest f 2 value in respect to the reference was chosen for in vivo evaluation. The study was carried out in 12 healthy volunteers who received 400 mg of the generic or reference product according to a crossover design. No significant differences were found in Cmax and AUC for albendazole and its main metabolite, albendazole sulfoxide, between products. Two absorption peaks were observed in the pharmacokinetic profile, and a population (22%) with different absorption rates and delay time for the the second peak was found. Based on the results, due to the high variability in the absorption process the differences observed in vitro could not be observed in vivo.

Impacto de la estrategia Plan de Invierno en el uso de medicamentos en el Hospital Pediátrico del Centro Hospitalario Pereira Rossell (CHPR) / Impact of the Winter Plan strategy on the use of medications in the Pediatric Hospital of the Pereira Rossell Hospital Center (CHPR)

Introducción: Con el objetivo de mejorar la calidad de la atención hospitalaria de los niños que ingresan por infección respiratoria aguda baja al Centro Hospitalario Pereira Rossell, se aplicó entre mayo y setiembre de 1999 una estrategia que se denominó Plan de Invierno. Objetivo: Evaluar el impacto que tuvo esta estrategia en el gasto en antibióticos (ATB), broncodilatadores (?2 agonistas) y corticoides en el Hospital Pediátrico. Metodología: Se compararon las unidades consumidas y el gasto (en pesos uruguayos) en ATB, ?2 agonistas y corticoides en el período enero-setiembre 1998 versus enero-setiembre 1999. Los datos fueron obtenidos del programa de uso de medicamentos de la farmacia clínica del hospital. Resultados: El gasto, entre enero y setiembre de 1999, fue menor que en el mismo período de 1998 (28,6% versus 37,6%). El gasto en ATB y corticoides disminuyó en los servicios de pediatría general (PG) y unidad de cuidados intensivos pediátricos (UCIN). El gasto en ?2 disminuyó sólo en UCIN. El gasto por día cama ocupado (DCO) en ATB disminuyó en PG y aumentó en UCIN. Conclusión: Es posible que el cumplimiento de las pautas terapéuticas recomendadas y la mejoría en la calidad de los diagnósticos realizados durante la aplicación de esta estrategia asistencial hayan contribuido a un menor gasto en ATB, ?2 y corticoides en los niños con infección respiratoria aguda baja (IRAB) que ingresaron al hospital.

Summary Introduction: A strategy called Plan de Invierno was developed between May and September of 1999 in order to improve the attention at the Centro Hospitalario Pereira Rossell on children affected by low respiratory tract infections. Objective: To evaluate the impact of this strategy on the spending related to the purchase of antibiotics (ATB), bronchodilators (2agonists) and corticosteroids in the Paediatric Hospital. Methods: Numbers of consumed units and money spent on ATB, (2agonistas) and corticosteroids were compared during the periods of January to September of 1998 and January to September of 1999. Data were obtained from the hospital clinical pharmacy. Results: During the period January - September of 1999, the spending was lower than during the period January - September 1998 (28.6% and 37.6% respectively). Spending on ATB and corticosteroids diminished in the general paediatric service (GP) and in the intensive paediatric care unit (UCIN). Spending related to ?2 agonists diminished only at the UCIN. Bed/day spending (DCO) on ATB decreased at the GP but was increased at the UCIN. Conclusions: Following of the recommended therapeutic guidelines and the improvement of quality of diagnoses performed during the period of this assistance strategy probably contributed to reduce ATB, ?2 agonists, and expenses.

Résumé Introduction: Afin d'améliorer la qualité de l'assistance hospitalière des enfants qui sont admis au Centre Hospitalier Pereira Rossell avec infection respiratoire aigüe, on met en marche une stratégie appelée Plan d'Hiver entre mai et septembre 1999. But: Evaluer l'impact que cette stratégie a eu dans le frais d'antibiotiques(ATB),broncho-dilatateurs(?2 agonistes) et corticoïdes à l'Hôpital Pédiatrique. Méthodologie: On compare les unités consommées et les frais (en monnaie uruguayenne)de ATB, ?2 agonistes et de corticoïdes pendant la période janvier-septembre 1998 versus janvier-septembre 1999. Les données ont été tirées du programme de la pharmacie clinique de l'hôpital. Résultats: Les frais ont été moins grands en 1999 qu'en 1998 (28,6% versus 37,6%). Les frais de ATB et de corti-coïdes ont diminué dans les services de pédiatrie générale (PG) et UCIN. Conclusion: Il est possible que le respect des lignes thérapeutiques recommandées et l'amélioration de la qualité des diagnostics réalisés pendant l'application de cette stratégie d'assistance, aient contribué à diminuer les frais de ATB, ?2 et de corticoïdes chez les enfants avec IRAB admis à l'hôpital.