369
Views
10
CrossRef citations to date
0
Altmetric
Research Article

Stability study of a clonidine oral solution in a novel vehicle designed for pediatric patients

, &
Pages 1067-1076 | Received 27 Apr 2017, Accepted 01 Oct 2017, Published online: 24 Oct 2017

References

  • Agence Nationale de Sécurité du Médicament (ANSM). 2007. Bonnes pratiques de préparation [Good preparation practices]. http://ansm.sante.fr (Accessed 2017 Mar 15).
  • Bada HS, Sithisarn T, Gibson J, Garlitz K, Caldwell R, Capilouto G, Li Y, Leggas M, Breheny P. 2015. Morphine versus clonidine for neonatal abstinence syndrome. Pediatrics. 135:383–391.
  • Baertschi SW, Jansen JP, Alsante KM. 2011. Pharmaceutical stress testing: predicting drug degradation. 2nd ed. Boca Raton: CRC Press. Chapter 2, Stress testing: a predictive tool; p.10–48.
  • Bagley SM, Wachman EM, Holland E, Brogly SB. 2014. Review of the assessment and management of neonatal abstinence syndrome. Addict Sci Clin Pract. 9:19.
  • Batchelor H, Salunke S, Tuleu C. 2015. Formulating better medicines for children-reflections. Int J Pharm. 492:301–303.
  • Bellis JR, Kirkham JJ, Thiesen S, Conroy E. 2013. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital. BMC Med. 11:238.
  • Brayfield A. 2014. The 38th edition of Martindale: the complete drug reference. London: Pharmaceutical Press.
  • Clonidine hydrochloride. 2010. In: Jackson M, Lowey A, editors. Handbook of extemporaneous preparation. A Guide to Pharmaceutical Compounding. London: Pharmaceutical Press; p. 144–149.
  • Clonidine hydrochloride, 2008. Monograph 01/2008:0477. European Pharmacopoeia, 9th ed. Conseil de l’Europe. F-Strasbourg.
  • Davies H, Gilbert R, Johnson K, Petersen I, Nazareth I, O’Donnell M, Guttmann A, Gonzalez-Izquierdo A. 2016. Neonatal drug withdrawal syndrome: cross-country comparison using hospital administrative data in England, the USA, Western Australia and Ontario, Canada. Arch Dis Child Fetal Neonatal Ed. 101:26–30.
  • de Goede AL, Boedhram RR, Eckhardt M, Hanf LM, Koch BCP, Vermaat CH, Vermes A. 2012. Development and validation of a paediatric oral formulation of clonidine hydrochloride. Int J Pharm. 433:119–120.
  • EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food). 2015. Scientific opinion on the re-evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) as food additives. EFSA J. 13:4144.
  • Ensom MHH, Decarie D. 2014. Stability of extemporaneously compounded clonidine in glass and plastic bottles and plastic syringes. Can J Hosp Pharm. 67:308–310.
  • Erickson SJ, Duncan A. 1998. Clonidine poisoning. An emerging problem: epidemiology, clinical features, management and preventive strategies. J Paediatr Child Health. 34:280–282.
  • European Medicines Agency (EMA). 2012. Guideline on pharmaceutical development of medicines for paediatric use. EMA/CHMP/QWP/805880/2012 Rev.2. www.ema.europa.eu (Accessed 2017 Mar 30).
  • European Medicines Evaluation Agency (EMEA). 2001. Note for guidance on in-use stability testing of human medicinal products. CPMP/QWP/2934/99.2001. www.ema.europa.eu (Accessed 2017 Apr 15).
  • European Paediatric formulation initiative (EUPFI). http://www.eupfi.org.
  • European Pharmacopoeia, 2017. Physical and physicochemical methods (2.2.), Microbiological examination of non-sterile products: test for specified micro-organisms (2.6.13.) and Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.1.4.). 9th ed. F-Strasbourg: Conseil de l’Europe.
  • Fernández PA, Cabañas PM, Clemente BS, Oliveras AM, Castillo SF, Hidalgo AE. 2007. Osmolality of oral liquid dosage forms to be administered to newborns in a hospital. Farm Hosp. 3:311–314.
  • Guilli T, Tall ML, Raymond F, Rome P, Diouf E, Gerard P, Perraud M, Pivot C, Pirot F. 2012. Validation de l’activité antimicrobienne du sorbate de potassium dans un excipient liquide. SNPHPU 2012: Syndicat National des Pharmaciens Praticiens Hospitaliers et Praticiens Hospitaliers Universitaires; Sept 19–21; AJACCIO (FR).
  • Helin-Tanninen M, Autio K, Keski-Rahkonen P, Naaranlahti T, Järvinen K. 2012. Comparison of six different suspension vehicles in compounding of oral extemporaneous nifedipine suspension for paediatric patients. Eur J Hosp Pharm. 19:432–437.
  • International Council for Harmonisation. ICH Q2 (R1). Validation of analytical procedures: text and methodology. www.ich.org (Accessed 2016 Mar 30).
  • Ivanovska V, Rademaker CMA, van Dijk L, Mantel-Teeuwisse AK. 2014. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 134:2013–2032.
  • Kappagoda C, Schell DN, Hanon RM, Hutchins P. 1998. Clonidine overdose in childhood: implications of increased prescribing. J Paediatr Child Health. 34:508–512.
  • Kostecka D, Duncan MR, Wagenknecht D. 1998. Formulation of a stable parenteral product; clonidine hydrochloride injection. J Pharm Sci Technol. 52:320–325.
  • Levinson M, Johnson C. 1992. Stability of an extemporaneously compounded clonidine hydrochloride oral liquid. Am J Hosp Pharm. 49:122–125.
  • Ma C, Decarie D, Ensom MHH. 2014. Stability of clonidine suspension in oral plastic syringes. Am J Health Syst Pharm. 71:657–661.
  • Mason J, Pirmohamed M, Nunn T. 2012. Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature. Eur J Clin Pharmacol. 68:21–28.
  • Michael Davidson P, Sofos JN, Branen AL. 2005. Antimicrobials in food. 3rd ed. Boca Raton (FL): Taylor & Francis; p. 11–90.
  • Nellis G, Metsvaht T, Varendi H, Toompere K, Lass J, Mesek I, Nunn AJ, Turner MA, Lutsar I, ESNEE consortium. 2015. Potentially harmful excipients in neonatal medicines: a pan-European observational study. Arch Dis Child. 100:694–699.
  • Pediatric Formulations Platform. BPCA, National Institutes of Health. Inter-agency agreement between the Eunice Kennedy Shriver National Institute of Children Health and Human Development (ICHD) and the US Food and Drug Administration (FDA). https://bpca.nichd.nih.gov/Pages/Index.aspx (Accessed 2016 Dec 15).
  • Romano MJ, Dinh A. 2001. A 1000-fold overdose of clonidine caused by a compounding error in a 5-year-old child with attention-deficit/hyperactivity disorder. Pediatrics. 108:471–472.
  • Rood JM, Engels MJ, Ciarkowski SL, Wagenknecht LD, Dickinson CJ, Stevenson JG. 2014. Variability in compounding of oral liquids for pediatric patients: a patient safety concern. J Am Pharm Assoc. 54:383–389.
  • Rowe RC, Sheskey PJ, Cook WG, Fenton ME. 2012. Handbook of pharmaceutical excipients [electronic database]. 7th ed. London: Pharmaceutical Press and American Pharmacists Association.
  • Sauberan JB, Phuong P, Ilog ND, Rossi SS. 2016. Stability and osmolality of extemporaneously prepared clonidine oral liquid for neonates. Ann Pharmacother. 50:243–244.
  • Schlatter J, Bourguignon E, Majoul E, Kabiche S, Issa-bella B, Cisternino S, Fontan J-E. 2016. Stability study of oral paediatric idebenone suspensions. Pharm Dev and Tech. 22:296–299.
  • Siu A, Robinson CA. 2014. Neonatal abstinence syndrome: essentials for the practitioner. J Pediatr Pharmacol Ther. 19:147–155.
  • Standing JF, Tuleu C. 2005. Paediatric formulations-getting to the heart of the problem. Int J Pharm. 300:56–66.
  • Streetz VN, Gildon BL, Thompson DF. 2016. Role of clonidine in neonatal abstinence syndrome: a systematic review. Ann Pharmacother. 50:301–310.
  • Suchard J, Graeme K. 2002. Pediatric clonidine poisoning as a result of pharmacy compounding error. Pediatr Emerg Care. 18:295–296.
  • Tolia V, Patrick V, Bennett M, Murthy K, Sousa J, Smith P, Clark R, Spitzer A. 2015. Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. N Engl J Med. 372:2118–2126.
  • Wachman EM, Schiff DM. 2016. Bringing attention to a need for a standardized treatment and weaning protocol for neonatal abstinence syndrome. Transl Pediatr. 5:12–15.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.