Comparison of six different suspension vehicles in compounding of oral extemporaneous nifedipine suspension for paediatric patients

European Journal of Hospital Pharmacy

Volumn 19, Issue 5, 2012, Pages 432-437

  Helin Tanninen, Minna ^a   Autio, Kati ^b   Keski Rahkonen, Pekka ^b   Naaranlahti, Toivo ^a   Järvinen, Kristiina ^b  

^a KUOPIO UNIVERSITY HOSPITAL   (Finland)

^b UNIVERSITY OF EASTERN FINLAND   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROCHLORIC ACID; HYDROGEN PEROXIDE; HYDROXYPROPYLMETHYLCELLULOSE; METHYLCELLULOSE; N 7634; NIFEDIPINE; SODIUM HYDROXIDE; UNCLASSIFIED DRUG;

AGITATION; ARTICLE; DRUG CONCENTRATION; DRUG STABILITY; DRUG SYNTHESIS; DRUG VEHICLE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MEDICAL LITERATURE; PEDIATRICS; PH; PHOTODEGRADATION; ROOM TEMPERATURE; SEDIMENTATION RATE; SINGLE DRUG DOSE; SUSPENSION; SYRINGE; VALIDATION PROCESS;

EID: 84875394090     PISSN: 20479956     EISSN: 20479964     Source Type: Journal    
DOI: 10.1136/ejhpharm-2012-000159     Document Type: Article

References (26)

1. Standing JF, Tuleu C. Paediatric formulations-getting to the heart of the prob-lem. Int J Pharm 2005;300:56-66.
2. Billany MR. Suspensions and emulsions. In: Aulton ME, ed. Aulton's phar-maceutics. The design and manufacture of medicines. 3rd edn. Hungary: Churchill Livingstone Elsevier, 2007:383-405.
3. USP pharmacists' pharmacopoeia 2008-2009. 2nd edn. Rockville, MD: The United States Pharmacopeial Convention, 2008.
4. Attwood D. Disperse systems. In: Aulton ME, ed. Aulton's pharmaceutics. The design and manufacture of medicines. 3rd edn. Hungary: Churchill Livingstone Elsevier, 2007:70-98.
5. Costello I, Long PF, Wong IK, et al. Paediatric drug handling. 1st edn. Cornwall: Pharmaceutical Press, 2007.
6. Hurtado J, Moffett BS. Pediatric oral formulations: a continual challenge. Int J Pharm Comp 2007;11:17-19.
7. Thompson JE. Suspensions. In: Thompson JE, ed. A practical guide to contempo-rary pharmacy practice. 3rd edn. Baltimore, MD: Lippincott Williams & Wilkins, 2009:421-51.
8. Helin-Tanninen M, Naaranlahti T, Kontra K, et al. Enteral suspension of nifedi-pine for neonates. Part 1. Formulation of nifedipine suspension for hospital use. J Clin Pharm Ther 2001;26:49-57.
9. Nahata MC, Pai VB, Hipple TF. Pediatric drug formulations. 5th edn. Cincinnati: Harvey Whitney Books Company, 2003.
10. Jew RK, Soo-Hoo W, Erush SC. Extemporaneous formulations for pediatric, geriatric and special needs patients. 2nd edn. Bethesda, MD: American Society of Health-System Pharmacists, 2003.
11. Van Schijndel D, ed. Pharmacy compounding manual, Compounded Drug Formulas 2002. Calgary: Alberta Children's Hospital, Calgary Health Region, 2002.
12. De Villiers M. Viscosity-inducing agents. Vehicles for liquid preparations. In: Thompson JE, ed. A practical guide to contemporary pharmacy practice. 3rd edn. Baltimore, MD: Lippincott Williams & Wilkins, 2009:231-50, 267-76.
13. Glass BD, Haywood A. Stability considerations in liquid dosage forms extempo-raneously prepared from commercially available products. J Pharm Pharmaceut Sci 2006;9:398-426.
14. Rappaport PL. Extemporaneous dosage preparations for pediatrics. Can J Hosp Pharm 1983;36:66-74.
15. Dentinger PJ, Swenson CF, Anaizi NH. Stability of nifedipine in an extempora-neously compounded oral solution. Am J Health-Syst Pharm 2003;15:1019-22.
16. Nahata MC, Morosco RS, Willhite EA. Stability of nifedipine in two oral sus-pensions stored at two temperatures. J Am Pharm Assoc 2002;42:865-7.
17. Tuleu C, Grangé J, Seurin S. The need for paediatric formulation: oral administra-tion of nifedipine in children, a proof concept. J Drug Del Sci Tech 2005;15:319-24.
18. Helin-Tanninen M, Naaranlahti T, Kontra K, et al. Enteral suspension of nifedipine for neonates. Part 2. Stability of an extemporaneously compounded nifedipine suspension. J Clin Pharm Ther 2001;26:59-66.
19. International Conference on Harmonisation of T echnical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures. ICH Harmonised Tripartite Guideline: T ext and Methodology Q2(R1), 2005.
20. International Conference on Harmonisation of T echnical Requirements for Registration of Pharmaceuticals for Human Use. Stability T esting of New Drug Substances and Products Q1A(R2), 2003.
21. European Pharmacopoeia. 6th edn. Strasbourg: Council of Europe, 2008.
22. The United States Pharmacopeia USP 32, The National Formulary NF 27. vol. 1. Rockville, MD: The United States Pharmacopeial Convention, 2008.
23. Ghulam A, Keen K, Tuleu C, et al. Poor preservation efficacy versus quality and safety of pediatric extemporaneous liquids. Ann Pharmacother 2007;41:857-60.
24. Pawar A, Kumar A. Issues in the formulation of drugs for oral use in children: role of excipients. Paediatr Drugs 2002;4:371-9.
25. Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of pharmaceutical excipients. 6th edn. London: Pharmaceutical Press and American Pharmacists Association, 2011. http://www.medicinescomplete.com (accessed 27 Jan 2012).
26. Polo AF, Poy MJC, Bautista C, et al. Osmolality of oral liquid dosage forms to be administered to newborns in a hospital. Farm Hosp 2007;31:311-14.