Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

1. EMA/428172/2012. European Medicines Agency with its Paediatric Committee. 5-year Report to the European Commission. General report on the experience acquired as a result of the application of the Paediatric Regulation; http://ec.europa.eu/health/files/paediatrics/2012-09_pediatric_report-annex1-2_en.pdf; access date October 28, 2014.Search in Google Scholar

2. F. Brion, A. J. Nunn and A. Rieutord, Extemporaneous (magistral) preparation of oral medicines for children in European hospitals, Acta Paediatr. 92 (2003) 486-490.10.1111/j.1651-2227.2003.tb00583.x12801118Search in Google Scholar

3. J. Hempenstall and C. Tuleu, Formulating better medicines for children, Int. J. Pharm. 379 (2009) 143-145; DOI: 10.1016/j.ijpharm.2009.06.033.10.1016/j.ijpharm.2009.06.03319576979Search in Google Scholar

4. Atacand (Candesartan Cilexetil) Drug Information: Description, User Reviews, Drug Side Effects, Interactions - Prescribing Information at RxList; http://www.rxlist.com/atacand-drug.htm; access date October 28, 2014.Search in Google Scholar

5. Atacand. Patient Information approved by the U.S. Food and Drug Administration, 2013; http:// www1.astrazeneca-us.com/pi/Atacand.pdf; access date October 28, 2014.Search in Google Scholar

6. Diovan (Valsartan) Drug Information: Description, User Reviews, Drug Side Effects, Interactions - Prescribing Information at RxList; http://www.rxlist.com/diovan-drug.htm; access date October 28, 2014.Search in Google Scholar

7. Diovan. Patient Information approved by the U.S. Food and Drug Administration, 2012; http:// www.pharma.us.novartis.com/product/pi/pdf/diovan.pdf; access date October 28, 2014.Search in Google Scholar

8. G. N. Darwhekar and D. K. Jain, Biopharmaceutical classification of candesartan and candesartan cilexetil, Asian J. Pharm. Life Sci. 2 (2012) 295-302.Search in Google Scholar

9. J. Liu, I. R. Younis, K. R. Madabushi and P. R. Jadmav. Office of Clinical Pharmacology Review. NDA 20-838 Review - candesartan; http://www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/ucm189128.pdf; access date October 28, 2014.Search in Google Scholar

10. M. Saydam and S. Takka, Bioavailability file: valsartan, Fabad J. Pharm. Sci. 32 (2007) 185-196.Search in Google Scholar

11. P. Tosco, B. Rolando, R. Frottero, Y. Henchoz, S. Martel, P. A. Carrput and A. Gasco, Physiochemical profiling of sartans: a detailed study of ionization constants and distribution coefficients, Helv. Chim. Acta. 91 (2008) 468-482; DOI: 10.1002/hlca.200890051.10.1002/hlca.200890051Search in Google Scholar

12. F. Schaefer, J. van de Walle, A. Zurowska, C. Gimpel, K. van Hoeck, D. Drozd, G. Montini, I.V. Bagdasorova, J. Sorof, J., Sugg, R. Teng and J. W. Hainer, Efficiency, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age, J. Hypertens. 28 (2010) 1083-1090; DOI: 10.1097/HJH.0b013e328336b86b.10.1097/HJH.0b013e328336b86b20160654Search in Google Scholar

13. F. Schaefer, R. Coppo, A. Bagga, P. Senquttuvan, R. Schlosshauer, Y. Zhang and M. Kadwa, Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age, J. Hypertens. 31 (2013) 993-1000; DOI: 10.1097/HJH.0b013e32835f5721.10.1097/HJH.0b013e32835f572123511339Search in Google Scholar

14. J. Hempenstall and C. Tuleu, Meeting commentary - Formulating better medicines for children, Int. J. Pharm. 379 (2009) 143-142; DOI: 10.1016/j.ijpharm.2009.06.033.10.1016/j.ijpharm.2009.06.033Search in Google Scholar

15. Ora® Products Data Sheets; http://www.perrigo.com/business/prodsearch.aspx?group=paddock; access date October 28, 2014.Search in Google Scholar

16. M. C. Nahata and V. A. Loyd, Extemporaneous drug formulations, Clin. Ther. 30 (2008) 2112-2119; DOI: 10.1016/j.clinthera.2008.11.020.10.1016/j.clinthera.2008.11.02019108799Search in Google Scholar

17. USP/NF 36/31. United States Pharmacopeia 2012, The United States Pharmacopeial Convention 1206, Rockville 2012, pp. 1958; 1964; 2116; 2118; 2262.Search in Google Scholar

18. S. M. El-Gizawy, O. H. Abdelmageed, M. A. Omar, S. M. Deryea and A. M. Abdel-Megied, Development and validation of HPLC method for simultaneous determination of amlodipine, valsartan hydrochlorothiazide in dosage form and spiked human plasma, Am. J. Anal. Chem. 3 (2012) 422-430; DOI: 10.4236/ajac.2012.36055.10.4236/ajac.2012.36055Search in Google Scholar

19. B. M. Sudesh and K. S. Uttamrao, Determination and validation of valsartan and its degradation products by isocratic HPLC, J. Chem. Metrl. 3 (2009) 1-12.Search in Google Scholar

20. M. Pérez, G. Ramírez, M. Pérez and P. Restrepo, Validation of an analytical method for the determination of valsartan in human plasma by HPLC/UV with addition standard using losartan as an internal standard, Colomb. Med. 38 (2007) 13-20.Search in Google Scholar

21. K. Hoppe, M. Sznitowska, The effect of polysorbate 20 on solubility and stability of candesartan cilexetil in dissolution media, AAPS PharmSciTech. (in press, accepted March 6, 2014).10.1208/s12249-014-0109-8417965524871550Search in Google Scholar

22. G. Lunn, HPLC Methods for Recently Approved Pharmaceuticals, John Wiley & Sons Inc., Hoboken, New Jersey, 2005, p. 104; 671.10.1002/0471711683Search in Google Scholar

23. S. S. Chitlange, K. Bagri and D. M. Sakarkar, Stability indicating RP- HPLC Method for simultaneous estimation of valsartan and amlodipine in capsule formulation, Asian J. Research Chem. 1 (2008) 15-18.Search in Google Scholar

24. S. K. Patro, S. K. Kanungo, V. J. Patro and N. S. K. Choudhury, Stability indicating RP-HPLC method for determination of valsartan in pure and pharmaceutical formulation, E-J. Chem. 7 (2010) 246-252; DOI: 10.1155/2010/487197.10.1155/2010/487197Search in Google Scholar

25. V. A. Loyd, Stability of extemporaneously prepared oral liquid formulations - part VI, Secundum Artem 15 (2008); http://www.perrigo.com/business/pdfs/Sec%20Artem%2015.1.pdf; access date October 28, 2014.Search in Google Scholar

26. V. A. Loyd, Valsartan 4 mg mL-1 oral liquid, Int. J. Pharmac. Compd. 12 (2008) 269.Search in Google Scholar

27. N. Siddiqui, A. Husain, L. Chaudhry, A. M. Shamsher, M. Mitra and P. S. Bhasin, Pharmacological and pharmaceutical profile of valsartan: a review, J. App. Pharm. Sci. 1 (2011) 12-19. Search in Google Scholar