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Volumn 172, Issue 6, 2013, Pages 717-720

Educational Paper: Formulation-related issues in pediatric clinical pharmacology

Author keywords

Biopharmaceutics; Dosage forms; Drug delivery; Drug formulations; Palatability

Indexed keywords

EXCIPIENT; ISONIAZID; LOPINAVIR PLUS RITONAVIR;

EID: 84878701667     PISSN: 03406199     EISSN: 14321076     Source Type: Journal    
DOI: 10.1007/s00431-012-1872-8     Document Type: Review
Times cited : (41)

References (35)
  • 4
    • 57849084850 scopus 로고    scopus 로고
    • European perspectives on pediatric formulations
    • 10.1016/j.clinthera.2008.11.016 19108802 10.1016/j.clinthera.2008.11.016
    • Breitkreutz J (2008) European perspectives on pediatric formulations. Clin Ther 30:2146-2154. doi: 10.1016/j.clinthera.2008.11.016
    • (2008) Clin Ther , vol.30 , pp. 2146-2154
    • Breitkreutz, J.1
  • 5
    • 33846316714 scopus 로고    scopus 로고
    • Paediatric and geriatric drug delivery
    • 10.1517/17425247.4.1.37 10.1517/17425247.4.1.37 1:CAS:528: DC%2BD2sXhsFSjsr4%3D
    • Breitkreutz J, Boos J (2007) Paediatric and geriatric drug delivery. Exp Opin Drug Deliv 4:37-45. doi: 10.1517/17425247.4.1.37
    • (2007) Exp Opin Drug Deliv , vol.4 , pp. 37-45
    • Breitkreutz, J.1    Boos, J.2
  • 7
    • 84864692139 scopus 로고    scopus 로고
    • Assessing taste without using humans: Rat brief access aversion model and electronic tongue
    • 10.1016/j.ijpharm.2012.05.056 22883698 10.1016/j.ijpharm.2012.05.056 1:CAS:528:DC%2BC38XhtFGrtLfK
    • Clapham D, Kirsanov D, Legin A, Rudnitskaya A, Saunders K (2012) Assessing taste without using humans: rat brief access aversion model and electronic tongue. Int J Pharm 435:137-139. doi: 10.1016/j.ijpharm.2012.05.056
    • (2012) Int J Pharm , vol.435 , pp. 137-139
    • Clapham, D.1    Kirsanov, D.2    Legin, A.3    Rudnitskaya, A.4    Saunders, K.5
  • 8
    • 57049111496 scopus 로고    scopus 로고
    • Challenges of developing palatable oral paediatric formulations
    • 10.1016/j.ijpharm.2008.09.015 18848611 10.1016/j.ijpharm.2008.09.015 1:CAS:528:DC%2BD1cXhsVKntbfK
    • Cram A, Breitkreutz J, Desset-Brèthes S, Nunn AJ, Tuleu C (2009) Challenges of developing palatable oral paediatric formulations. Int J Pharm 365:1-3. doi: 10.1016/j.ijpharm.2008.09.015
    • (2009) Int J Pharm , vol.365 , pp. 1-3
    • Cram, A.1    Breitkreutz, J.2    Desset-Brèthes, S.3    Nunn, A.J.4    Tuleu, C.5
  • 9
    • 84893028391 scopus 로고    scopus 로고
    • EMA/CHMP/QWP/180157/2011 last Accessed 06 september 2012
    • EMA/CHMP/QWP/180157/2011 (2011) Draft guideline on pharmaceutical development of medicines for paediatric use. Available via http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2011/06/WC500107908. pdf, last Accessed 06 september 2012
    • (2011) Draft Guideline on Pharmaceutical Development of Medicines for Paediatric Use
  • 11
    • 67649932264 scopus 로고    scopus 로고
    • EMEA CPMP/PWP/EWP/1401/98 Rev.1/Corr** Accessed 06 september 2012
    • EMEA CPMP/PWP/EWP/1401/98 Rev.1/Corr** (2010) Guideline on the investigation of bioequivalence Available via http://www.emea.europa.eu/ docs/en-GB/document-library/Scientific-guideline/2010/01/WC500070039.pdf Accessed 06 september 2012
    • (2010) Guideline on the Investigation of Bioequivalence
  • 13
    • 59349094410 scopus 로고    scopus 로고
    • EMEA/CHMP/PEG/194810/2005 Accessed 06 september 2012
    • EMEA/CHMP/PEG/194810/2005 (2006) Reflection paper: formulations of choice for the paediatric population. Available via http://www.ema.europa.eu/docs/en- GB/document-library/Scientific-guideline/2009/09/WC500003782.pdf Accessed 06 september 2012
    • (2006) Reflection Paper: Formulations of Choice for the Paediatric Population
  • 14
    • 84864709458 scopus 로고    scopus 로고
    • Preparation of medicines for children - A hierarchy of classification
    • 10.1016/j.ijpharm.2011.06.040 22677416 10.1016/j.ijpharm.2012.05.070 1:CAS:528:DC%2BC38XpvVSrsLc%3D
    • Ernest TB, Craig J, Nunn A, Salunke S, Tuleu C, Breitkreutz J, Alex R, Hempenstall J (2012) Preparation of medicines for children - a hierarchy of classification. Int J Pharm 435:124-130. doi: 10.1016/j.ijpharm.2011.06.040
    • (2012) Int J Pharm , vol.435 , pp. 124-130
    • Ernest, T.B.1    Craig, J.2    Nunn, A.3    Salunke, S.4    Tuleu, C.5    Breitkreutz, J.6    Alex, R.7    Hempenstall, J.8
  • 15
    • 84857685877 scopus 로고    scopus 로고
    • The efficacy of bitter blockers on health-relevant bitterants
    • 10.1016/j.jff.2011.10.003 10.1016/j.jff.2011.10.003 1:CAS:528: DC%2BC38Xjt1ansrc%3D
    • Gaudette NJ, Pickering GJ (2012) The efficacy of bitter blockers on health-relevant bitterants. J Funct Foods 4:177-184. doi: 10.1016/j.jff.2011.10. 003
    • (2012) J Funct Foods , vol.4 , pp. 177-184
    • Gaudette, N.J.1    Pickering, G.J.2
  • 16
    • 0033862322 scopus 로고    scopus 로고
    • The molecular physiology of taste transduction
    • 10.1016/S0959-4388(00)00118-5 10981623 10.1016/S0959-4388(00)00118-5 1:CAS:528:DC%2BD3cXlvFCns7c%3D
    • Gilbertson TA, Damak S, Margolskee RF (2000) The molecular physiology of taste transduction. Curr Opin Neurobiol 10:519-527. doi: 10.1016/S0959-4388(00) 00118-5
    • (2000) Curr Opin Neurobiol , vol.10 , pp. 519-527
    • Gilbertson, T.A.1    Damak, S.2    Margolskee, R.F.3
  • 17
    • 0141857724 scopus 로고    scopus 로고
    • Developmental pharmacology - Drug disposition, action, and therapy in infants and children
    • 10.1056/NEJMra035092 13679531 10.1056/NEJMra035092 1:CAS:528: DC%2BD3sXnsV2jtbo%3D
    • Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE (2003) Developmental pharmacology - drug disposition, action, and therapy in infants and children. N Engl J Med 349:1157-1167. doi: 10.1056/NEJMra035092
    • (2003) N Engl J Med , vol.349 , pp. 1157-1167
    • Kearns, G.L.1    Abdel-Rahman, S.M.2    Alander, S.W.3    Blowey, D.L.4    Leeder, J.S.5    Kauffman, R.E.6
  • 18
    • 40449102971 scopus 로고    scopus 로고
    • Improving drug delivery in pediatric medicine
    • 10.1007/BF03256681 10.1007/BF03256681
    • Krause J, Breitkreutz J (2008) Improving drug delivery in pediatric medicine. Pharm Med 22:41-50. doi: 10.1007/BF03256681
    • (2008) Pharm Med , vol.22 , pp. 41-50
    • Krause, J.1    Breitkreutz, J.2
  • 19
    • 84864717784 scopus 로고    scopus 로고
    • The propylene glycol research project to illustrate the feasibility and difficulties to study toxicokinetics in neonates
    • 10.1016/j.ijpharm.2012.05.014 22641171 10.1016/j.ijpharm.2012.05.014 1:CAS:528:DC%2BC38Xos1Gjsrs%3D
    • Kulo A, de Hoon JN, Allegaert K (2012) The propylene glycol research project to illustrate the feasibility and difficulties to study toxicokinetics in neonates. Int J Pharm 435:112-114. doi: 10.1016/j.ijpharm.2012.05.014
    • (2012) Int J Pharm , vol.435 , pp. 112-114
    • Kulo, A.1    De Hoon, J.N.2    Allegaert, K.3
  • 20
    • 0022476785 scopus 로고
    • Effect of dose formulation on isoniazid absorption in two young children
    • 3086830 1:STN:280:DyaL283jt1eltQ%3D%3D
    • Notterman DA, Nardi M, Saslow JG (1986) Effect of dose formulation on isoniazid absorption in two young children. Pediatrics 77:850-852
    • (1986) Pediatrics , vol.77 , pp. 850-852
    • Notterman, D.A.1    Nardi, M.2    Saslow, J.G.3
  • 21
    • 77955732231 scopus 로고    scopus 로고
    • Inappropriate oral formulations and information in paediatric trials
    • 10.1136/adc.2009.175661 20605870 10.1136/adc.2009.175661
    • Pandit S, Shah U, Kirby DJ, Nunn T, Tuleu C (2010) Inappropriate oral formulations and information in paediatric trials. Arch Dis Child 95:754-756. doi: 10.1136/adc.2009.175661
    • (2010) Arch Dis Child , vol.95 , pp. 754-756
    • Pandit, S.1    Shah, U.2    Kirby, D.J.3    Nunn, T.4    Tuleu, C.5
  • 22
    • 84864325702 scopus 로고    scopus 로고
    • The manipulation of drugs to obtain the required dose: Systematic review
    • 10.1111/j.1365-2648.2011.05916.x 22221111 10.1111/j.1365-2648.2011.05916. x
    • Richey RH, Craig JV, Shah UU, Ford JL, Barker CE, Peak M, Nunn AJ, Turner MA (2012) The manipulation of drugs to obtain the required dose: systematic review. J Adv Nurs 68:2103-2112. doi: 10.1111/j.1365-2648.2011.05916.x
    • (2012) J Adv Nurs , vol.68 , pp. 2103-2112
    • Richey, R.H.1    Craig, J.V.2    Shah, U.U.3    Ford, J.L.4    Barker, C.E.5    Peak, M.6    Nunn, A.J.7    Turner, M.A.8
  • 23
    • 84864666274 scopus 로고    scopus 로고
    • The STEP (safety and toxicity of excipients for paediatrics) database. Part 1 - A need assessment study
    • 10.1016/j.ijpharm.2012.05.004 22583848 10.1016/j.ijpharm.2012.05.004 1:CAS:528:DC%2BC38XnvVymt7g%3D
    • Salunke S, Giacoia G, Tuleu C (2012) The STEP (safety and toxicity of excipients for paediatrics) database. Part 1 - a need assessment study. Int J Pharm 435:101-111. doi: 10.1016/j.ijpharm.2012.05.004
    • (2012) Int J Pharm , vol.435 , pp. 101-111
    • Salunke, S.1    Giacoia, G.2    Tuleu, C.3
  • 24
    • 68849130244 scopus 로고    scopus 로고
    • Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates
    • 10.1097/PCC.0b013e31819a383c 19188870 10.1097/PCC.0b013e31819a383c
    • Shehab N, Lewis CL, Streetman DD, Donn SM (2009) Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med 10:256-259. doi: 10.1097/PCC. 0b013e31819a383c
    • (2009) Pediatr Crit Care Med , vol.10 , pp. 256-259
    • Shehab, N.1    Lewis, C.L.2    Streetman, D.D.3    Donn, S.M.4
  • 26
    • 84857234243 scopus 로고    scopus 로고
    • Acceptance of uncoated mini-tablets in young children - Results from a prospective exploratory cross-over study
    • 10.1136/archdischild-2011-300958 22253279 10.1136/archdischild-2011- 300958
    • Spomer N, Klingmann V, Stoltenberg I, Lerch C, Meissner T, Breitkreutz J (2012) Acceptance of uncoated mini-tablets in young children - results from a prospective exploratory cross-over study. Arch Dis Child 97:283-286. doi: 10.1136/archdischild-2011-300958
    • (2012) Arch Dis Child , vol.97 , pp. 283-286
    • Spomer, N.1    Klingmann, V.2    Stoltenberg, I.3    Lerch, C.4    Meissner, T.5    Breitkreutz, J.6
  • 27
    • 61549095823 scopus 로고    scopus 로고
    • Minitablets: New modality to deliver medicines to preschool-aged children
    • 10.1542/peds.2008-2059 19171575 10.1542/peds.2008-2059
    • Thomson SA, Tuleu C, Wong IC, Keady S, Pitt KG, Sutcliffe AG (2009) Minitablets: new modality to deliver medicines to preschool-aged children. Pediatrics 123(2):e235-e238. doi: 10.1542/peds.2008-2059
    • (2009) Pediatrics , vol.123 , Issue.2
    • Thomson, S.A.1    Tuleu, C.2    Wong, I.C.3    Keady, S.4    Pitt, K.G.5    Sutcliffe, A.G.6
  • 28
    • 84875983306 scopus 로고    scopus 로고
    • European Study for Neonatal Excipient Exposure (ESNEE)
    • doi: 10.1136/ejhpharm-2012-000065
    • Turner M, Storme T (2012) European Study for Neonatal Excipient Exposure (ESNEE). Eur J Hosp Pharm. doi: 10.1136/ejhpharm-2012-000065
    • (2012) Eur J Hosp Pharm.
    • Turner, M.1    Storme, T.2
  • 29
    • 77954793874 scopus 로고    scopus 로고
    • EFFECTS of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: A systematic literature review
    • 10.1016/j.clinthera.2010.05.005 20685501 10.1016/j.clinthera.2010.05.005
    • Van Riet-Nales DA, Schobben AF, Egberts TC, Rademaker CM (2010) EFFECTS of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: a systematic literature review. Clin Ther 32:924-938. doi: 10.1016/j.clinthera.2010.05.005
    • (2010) Clin Ther , vol.32 , pp. 924-938
    • Van Riet-Nales, D.A.1    Schobben, A.F.2    Egberts, T.C.3    Rademaker, C.M.4
  • 30
    • 79960196391 scopus 로고    scopus 로고
    • Delivery devices for the administration of paediatric formulations: Overview of current practice, challenges and recent developments
    • Walsh J, Bickmann D, Breitkreutz J, Chariot-Goulet M (2011) Delivery devices for the administration of paediatric formulations: overview of current practice, challenges and recent developments. Int J Pharm 415: 221-231. DOI: http://dx.doi.org/10.1016/j.ijpharm.2011.05.048
    • (2011) Int J Pharm , vol.415 , pp. 221-231
    • Walsh, J.1    Bickmann, D.2    Breitkreutz, J.3    Chariot-Goulet, M.4
  • 32
    • 84868276745 scopus 로고    scopus 로고
    • WHO Working document QAS/08.257/Rev.3 October 2011 Accessed 06 september 2012
    • WHO Development of paediatric medicines: points to consider in pharmaceutical development, Working document QAS/08.257/Rev.3 October 2011. Available via http://www.who.int/medicines/areas/quality-safety/quality- assurance/Rev3-PaediatricMedicinesDevelopment-QAS08-257Rev3-17082011.pdf. Accessed 06 september 2012
    • Development of Paediatric Medicines: Points to Consider in Pharmaceutical Development
  • 33
    • 77957686851 scopus 로고    scopus 로고
    • Rational development of taste masked oral liquids guided by an electronic tongue
    • 10.1016/j.ijpharm.2010.08.042 20816732 10.1016/j.ijpharm.2010.08.042 1:CAS:528:DC%2BC3cXht1Kgt7fN
    • Woertz K, Tissen C, Kleinebudde P, Breitkreutz J (2010) Rational development of taste masked oral liquids guided by an electronic tongue. Int J Pharm 400:114-123. doi: 10.1016/j.ijpharm.2010.08.042
    • (2010) Int J Pharm , vol.400 , pp. 114-123
    • Woertz, K.1    Tissen, C.2    Kleinebudde, P.3    Breitkreutz, J.4
  • 34
    • 79952246688 scopus 로고    scopus 로고
    • Taste sensing systems (electronic tongues) for pharmaceutical applications
    • 10.1016/j.ijpharm.2010.11.028 21094230 10.1016/j.ijpharm.2010.11.028 1:CAS:528:DC%2BC3MXhtVygsLzM
    • Woertz K, Tissen C, Kleinebudde P, Breitkreutz J (2011) Taste sensing systems (electronic tongues) for pharmaceutical applications. Int J Pharm 417:256-271. doi: 10.1016/j.ijpharm.2010.11.028
    • (2011) Int J Pharm , vol.417 , pp. 256-271
    • Woertz, K.1    Tissen, C.2    Kleinebudde, P.3    Breitkreutz, J.4
  • 35
    • 79958827059 scopus 로고    scopus 로고
    • Safety issues with ethanol as an excipient in drugs intended for pediatric use
    • 10.1517/14740338.2011.565328 21417862 10.1517/14740338.2011.565328 1:CAS:528:DC%2BC3MXntlOksr0%3D
    • Zuccotti GV, Fabiano V (2011) Safety issues with ethanol as an excipient in drugs intended for pediatric use. Expert Opin Drug Saf 10:499-502. doi: 10.1517/14740338.2011.565328
    • (2011) Expert Opin Drug Saf , vol.10 , pp. 499-502
    • Zuccotti, G.V.1    Fabiano, V.2


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