Assessment of the quality of simvastatin capsules from compounding pharmacies

Revista de Saude Publica

Volumn 44, Issue 6, 2010, Pages 1055-1062

  Markman, Blanca Elena Ortega ^a   Rosa, Paulo César Pires ^b   Koschtschak, Maria Regina Walter ^a  

^a INSTITUTO ADOLFO LUTZ   (Brazil)

^b UNIVERSITY OF CAMPINAS   (Brazil)

Author keywords

Capsules; Chemistry; Drug compounding; Drug quality; Pharmaceutical; Simvastatin; Standards

Indexed keywords

ANTILIPEMIC AGENT; SIMVASTATIN;

ARTICLE; DRUG FORMULATION; EVALUATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MICROCAPSULE; PHARMACY; SOCIOECONOMICS; STANDARD; STATISTICS; VALIDATION STUDY;

CAPSULES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG COMPOUNDING; HUMANS; HYPOLIPIDEMIC AGENTS; PHARMACIES; SIMVASTATIN; SOCIOECONOMIC FACTORS;

EID: 78649452384     PISSN: 00348910     EISSN: None     Source Type: Journal    
DOI: 10.1590/S0034-89102010000600010     Document Type: Article

References (23)

1. Alencar BRJ, Souza Jr BM, Neto RJP, Lopes EC. Uso de controle estatístico de processo para avaliação da estabilidade e validação da fase de compressão de formas farmacêuticas sólidas. Acta Farm Bonaerense. 2005;24(3):426-35.
2. Alvarez-Lueje A, Valenzuela C, Squella JA, Nunez-Vergara LJ. Stability study of simvastatin under hydrolytic conditions assessed by liquid chromatography. J AOAC Int. 2005;88(6):1631-6.
3. Andelija M, Darko I, Mirjana M, Biljana J, Slavko M. Influence of structural and interfacial properties of microemulsion eluent on chromatographic separation of simvastatin and its impurities. J Chromatogr A. 2006;1131(1-2):67-73. DOI:10.1016/j. chroma.2006.07.020
4. Askin D, Verhoeven TR, Liu TMH, Shinkai J. Synthesis of synovinolin: extremely high conversion alkylation of an ester enolate. J Org Chem. 1991;56:4929-36. DOI:10.1021/jo00016a023
5. Baracat MM, Montanher LSC, Kubacki CA, Martinez MR, Zonta ANG, Duarte CJ, et al. Avaliação da qualidade de formulações manipuladas e industrializadas de sinvastatina. Lat Am J Pharm. 2009;28(3):427-32.
6. Ellison DK, Moore WD, Petts CR. Simvastatin. Anal Profiles Drug Subst Excip. 1993;22:359-88. DOI:10.1016/S0099-5428(08)60246-4
7. Erk N. Rapid spectrophotometric method for quantitative determination of simvastatin and fluvastatin in human serum and pharmaceutical formulations. Pharmazie. 2002;57(12):817-19.
8. Ministério da Saúde. Farmacopéia Brasileira. Uniformidade de Doses Unitárias. Parte II. 4. ed. São Paulo: Atheneu; 1988.
9. Ferreira WP, Bertolami MC, Santos SN, Barros MR, de Matos Barreto RB, Pontes Jr SC, et al. One-month therapy simvastatin restores endothelial function in hypercholesterolemic children and adolescents. Pediatr Cardiol. 2007;28(1):8-13. DOI:10.1007/s00246-005-1304-x
10. Ghayour-Mobarhan M, Lamb DJ, Taylor A, Vaidya N, Livingstone C, Wang T, et al. Effect of statin therapy on serum trace element status in dyslipidaemic subjects. Trace Elem Med Biol. 2005;19(1):61-7. DOI:10.1016/j.jtemb.2005.06.003
11. Giannini SD, Santos RD, Fonseca FH, Moriguchi EH, Maranhão RC, Da Luz Pl, et al. III Diretrizes Brasileiras sobre Dislipidemias e Diretriz de Prevenção da Aterosclerose do Departamento de Aterosclerose da Sociedade Brasileira de Cardiologia. Arq Bras Cardiol. 2001;77(Suppl 3):1-165. DOI:10.1590/S0066-782X2001001500001
12. International Conference on Harmonization of Technical Requirements for the Registration of Drugs for human Use. Q2b: Tex on Validation of analytical procedures methodology. International Conference on Harmonization of Technical Requirements for the Registration of Drugs for human Use, Geneva, Switzerland, March 1979. Fed Regist. 1997;62(96):27463-7.
13. Leonard G, Bertrand F, Chaouki J, Gosselin PM. An experimental investigation of effusive as an indicator of power blend uniformity. Powder Technol. 2008;18:149-59. DOI:10.1016/j.powtec.2006.12.007
14. Magalhães CME. Mecanismos de rabdomiólise com as estatinas. Arq Bras Cardiol. 2005;85(Suppl 5):1-6. DOI:10.1590/S0066-782X2005002400011
15. Marikh K, Berthiaux H, Gatumel C, Mizonov V, Barantseva E. Influence of stirrer on mixture homogeneity in continuous power mixing: A model case and a pharmaceutical case. Chem Eng Res Des. 2008;86(9):1027-37. DOI:10.1016/j.cherd.2008.04.001
16. Markman BEO, Koschtschak MRW, Auricchio MT. Otimização e validação de método farmacopeico para verificar possíveis desvios de qualidade de matérias primas e cápsulas manipuladas contendo hormônios tireoidianos. Rev Inst Adolfo Lutz. 2007;66(3):268-74
17. Pasha MK, Muzeeb S, Basha SJ, Shashikumar D, Mullangi R, Srinivas NR. Analysis of five HMG-CoA reductase inhibitors-atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin: pharmacological, pharmacokinetic and analytical overview and development of a new method for use in pharmaceutical formulations analysis and in vitro metabolism studies. Biomed Chromatogr. 2006;20(3):282-93. DOI:10.1002/bmc.561
18. Pereira EC, Bertolami MC, Faludi AA, Sevanian A, Abdalla DS. Antioxidant effect of simvastatin is not enhanced by its association with alphatocopherol in hypercholesterolemic patients. Free Radic Biol Med. 2004;37(9):1440-8. DOI:10.1016/j. freeradbiomed.2004.07.019
19. Reinhardt SC, Vaughan CJ. Statins in acute coronary syndromes. Drugs Today (Barc). 2002;38(5):339-50. DOI:10.1358/dot.2002.38.5.677135
20. United States. Pharmacopeia. 31 ed. Rockville: United States Pharmacopeial Conventions; 2008. p.1770-2.
21. Vickers S, Duncan CA, Vyas KP, Kari PH, Arison B, Prakash SR, et al. In vitro and in vivo biotransformation of simvastatin, an inhibitor of HMG CoA reductase. Drug Metab Dispos. 1990;18(4):476-83.
22. ierzbicki AS, Mikhailidis DP. Dose-response effects of atorvastatin and simvastatin on high-density lipoprotein cholesterol in hypercholesterolaemic patients: a review of five comparative studies. Inter J Cardiol. 2002;84(1):53-7. DOI:10.1016/S0167-5273(02)00118-3
23. Yang H, Feng Y, Luan Y. Determination of simvastatin in human plasma by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;785(2):369-75. DOI:10.1016/S1570-0232(02)00800-0