Entrar/Registro  
HOME SPANISH
 
Acta Pediátrica de México
   
MENU

Contents by Year, Volume and Issue

Table of Contents

General Information

Instructions for Authors

Message to Editor

Editorial Board






>Journals >Acta Pediátrica de México >Year 2014, Issue 6


García-Álvarez R, Ramírez-Mendiola B, Coria-Jiménez R, Ortiz-Herrera M, Chávez-Pacheco JL, Alemón-Medina R
Physicochemical and microbiological stabilities of a captopril extemporaneous formulation
Acta Pediatr Mex 2014; 35 (6)

Language: Español
References: 19
Page: 459-468
PDF: 432.59 Kb.


Full text




ABSTRACT

Due to the large number of paediatric patients requiring treatment for hypertension (HT), to the seriousness of its consequences there is a need to prepare an extemporaneous oral captopril formulation suitable for administration to children.
Objective. To develop a liquid formulation of captopril from innovative and generic drugs with a uniform content, cheapier and easier to prepare and with good palatability.
Material and method. We have developed oral extemporaneous formulations of captopril stemming from generic brands, at concentrations of 1 and 5 mg/mL, with pleasant taste and odour. Its physicochemical stability and uniformity of content were determined by HPLC on a Waters analyser. Data were analysed with the Millennium software, version 32.0. Microbial growth was represented by colony forming units (CFU) in MacConkey, TSA and Sabouraud media, after 72 and 96 hours of incubation at 37°C. Physicochemical and microbiological stabilities of different extemporaneous formulations on days 1, 7, 14, 21 and 30 were determined. Comparative statistics were made by ANOVA test run in Microsoft Excel.
Results. Two generic captopril brands and innovative in formulations containing 1mg/mL and 5mg/mL were physicochemical stable at 30 and 21 days respectively, and no growth of bacteria or fungi common pathogens occurred when stored at 4°C for 30 days.
Conclusion. Extemporaneous formulations can be prepared with captopril innovative drug and some generic brands, which maintain their physical and chemical characteristics and are microbiologically stable when stored at 4°C.


Key words: Captopril, Innovative Drug, Generic Drug, Extemporaneous Formulation, Arterial Hypertension, Physicochemical Stability, Chromatography, High Performance Liquid, HPLC.


REFERENCIAS

  1. Juárez-Olguín H. Uso de fórmulas magistrales en pediatría. Acta Pediatr Mex 2011;32(3):175-176.

  2. Alemón-Medina R, Chávez-Pacheco JL, Ramírez-Mendiola B, Rivera-Espinosa L, García-Álvarez R. Estabilidad fisicoquímica de tres marcas genéricas de metformina en solución. Acta Pediat Mex 2014;35:104-110.

  3. Karimi-Maleh H, Moazampoura M, Kumar-Guptab V, Sanati AL. Electrocatalytic determination of captopril in real samples using NiO nanoparticle modified (9,10-dihydro- 9,10-ethanoanthracene-11,12-dicarboximido)- 4ethylbenzene-1,2-diol carbon paste electrode. Sensors and actuators B. Chemical 2014;199:47-53.

  4. Heel RC, Brogden RN, Sperght TM, Avery GS. Captopril: a preliminary review of its pharmacological properties and therapeutic efficacy. Drugs 1980;20(6):409-52.

  5. Brogden RN, Todd PA, Serkin EM. Captpril: An update of its pharmacodynamics and pharmacokinetic properties, and therapeutic use in hypertension and congestive heart failure. Drugs 1988;36(5):540-600.

  6. Ohman KP, Kariberg BE, Nilsson OR, Wettre S. Captopril in primary hypertension. Effects related to the renin angiotensin aldosterone and kalikrein kinin systems. Acta Med Scand Suppl 1981;646:98-105.

  7. Rabinad EE, Ingelmo MM, Martínez AA, Alsina J, Balcells GA. Captopril in esencial hypertension. Br J Pharmacol 1982;14(Suppl 2):103S-105S.

  8. Pabari RM, McDermott C, Barlow J, Ramtoola Z. Stability of an alternative extemporaneous captopril fast-dispersing tablet formulation versus an extemporaneous oral liquid formulation. Clinical Therapeutics 2012;34(11):2221-2229.

  9. Witting de Penna E. Evaluación Sensorial. Una metodología actual para tecnología de alimentos. Biblioteca Digital de la Universidad de Chile. Sistema de Servicios de información y Bibliotecas. 2001. http://mazinger.sisib.uchile.cl/repositorio/ lb/ciencias_quimicas_y_farmaceuticas/wittinge01/ index.html

  10. Farmacopea de los Estados Unidos Mexicanos. 8ª Edición. México. 1994.

  11. Norma Oficial Mexicana NOM 177- SSA1-2013. Diario Oficial de la Federación 2013.

  12. Glass BD, Haywood A. Stability considerations in liquid dosage forms extemporaneously prepared from commercially available products. J Pharm Sci 2006;9(3):98-426.2

  13. Pereira CM, Tam YK. Stability of captopril in in tap water. Am J Hosp Pharm 1992;49:612-5.

  14. Pramar Y, Das Gupta V, Bethea C. Stability of captopril in some aqueous systems. J Clin Pharm Ther 1992;17:185-9.

  15. Nahata MC, Morosco RS, Hipple TF. Stability of captopril in three liquid dosage forms. Am J Hosp Pharm 1994;51(13):1707-8.

  16. Allen LV Jr, Erickson MA. Stability of baclofen, captopril, diltiazeam hydrochloride, dipyridamole, and fleicainide acetate in extemporaneously compounded oral liquids. Am J Health-Syst Pharm 1996;53:2179-84.

  17. Lye MY, Yow KL, Lim LY, Chan SY, Chan E, Ho PC. Effects of ingredients on stability of captopril in extemporaneously prepared oral liquids. Am J Health-Syst Pharm 1997;1;54(21):2483-7.

  18. Brustugun J, Lao YE, Fagernaes C, Braenden J, Kristensen S. Long-term stability of extemporaneously prepared captopril oral liquids in glass bottles. Am J Health-Syst Pharm 2009;66:1722-1725.

  19. Escribano García MJ, Torrado Durán S, Torrado Durán JJ. Estudio de estabilidad de soluciones acuosas de captopril en concentraciones de 1 mg/ml. Farm Hosp 2005;291:30-36.






>Journals >Acta Pediátrica de México >Year 2014, Issue 6
 

· Journal Index 
· Links 






       
Copyright 2019