A report from the pediatric formulations task force: Perspectives on the state of child-friendly oral dosage forms

AAPS Journal

Volumn 15, Issue 4, 2013, Pages 1072-1081

  Zajicek, Anne ^a   Fossler, Michael J ^b   Barrett, Jeffrey S ^c   Worthington, Jeffrey H ^d   Ternik, Robert ^e   Charkoftaki, Georgia ^f   Lum, Susan ^g   Breitkreutz, Jörg ^h   Baltezor, Mike ⁱ   Macheras, Panos ^f   Khan, Mansoor ^j   Agharkar, Shreeram ^k   MacLaren, David Douglas ^e  

^a EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^b GLAXOSMITHKLINE   (United States)

^c CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^d Senopsys LLC   (United States)

^e ELI LILLY AND COMPANY   (United States)

^f UNIVERSITY OF ATHENS   (Greece)

^g HEALTH CANADA   (Canada)

^h HEINRICH HEINE UNIVERSITY   (Germany)

ⁱ UNIVERSITY OF KANSAS   (United States)

^j CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^k SANOFI   (France)

more..

Author keywords

children; drugs; formulations; manufacturing; palatability; pediatrics; regulatory

Indexed keywords

AGE DISTRIBUTION; BIOEQUIVALENCE; DISPERSIBLE TABLET; DRUG ABSORPTION; DRUG COATING; DRUG DESIGN; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG LABELING; DRUG MANUFACTURE; DRUG PENETRATION; DRUG SAFETY; DRUG SOLUBILITY; DRUG STABILITY; INTESTINE MUCOSA PERMEABILITY; MAXIMUM PLASMA CONCENTRATION; ORAL DRUG ADMINISTRATION; PALATABILITY; PEDIATRICS; REVIEW; SHELF LIFE; TABLET DISINTEGRATION;

ADMINISTRATION, ORAL; ADVISORY COMMITTEES; CHEMISTRY, PHARMACEUTICAL; CHILD; HUMANS; PHARMACEUTICAL PREPARATIONS; RESEARCH REPORT; TASTE;

EID: 84888011528     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9511-5     Document Type: Review

References (52)

1. Thompson KC. Extemporaneous formulations: Comparison with labeled pediatric formulations. American Pharmaceutical Review 2010 (March); 13(2).
2. Baguley D, Lim E, Bevan A, et al. Prescribing for children-taste and palatability affect adherence to antibiotics: a review. Arch Dis Child. 2012;97(3):293-7.
3. Hendeles L. Selecting a systemic corticosteroid for acute asthma in children. J Peds. 2003;142:S40-4.
4. Steele RW, Russo TM, Thomas MP. Adherence issues related to the selection of antistaphylococcal or antifungal antibiotic suspensions for children. Clin Pediatr. 2006;45(3):245-50.
5. EMEA Reflection Paper. Reflection paper formulations of choice for the paediatric population, 28 Jul 2006 EMEA/CHMP/PEG?194810/2005. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003782.pdf. Accessed 19 Jul 2013.
6. EMA Guideline on Pharmaceutical Development of Medicines for Paediatric Use. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/ 2011/06/WC500107908.pdf. Accessed 19 Jul 2013.
7. Spomer N, Klingmann V, Stoltenberg I, et al. Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study. Arch Dis Child. 2012;97(3):283-6.
8. Shah R, Collier J, Saveed V, Bryandt A, Habib M, Khan MA. Tablet splitting of a narrow therapeutic index drug: a case study with levothyroxine sodium. AAPS Pharm Sci Technol. 2010;11(2):818-25.
9. Zhao N, Zidan A, Tawakkul M, Sayeed V, Khan MA. Tablet splitting: product quality assessment of metropolol succinate extended release tablets. Int J Pharm. 2010;401:25-31.
10. FDA Guidance to Industry. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System, 2000. http://www.fda.gov/downloads/ Drugs/./Guidances/ucm070246.pdf. Accessed 19 July 2013.
11. Abdel-Rahman S, Amidon GL, Kaul A, et al. Summary of the National Institute of Child Health and Human Development-Best Pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System Working Group. Clin Ther. 2012;34(11):S11-24.
12. Cella M, Gorter de Vries F, Burger D, Danhof M, Della Pasqua O. A model-based approach to dose selection in early pediatric development. Clin Pharmacol Ther. 2010;87(3):294-302.
13. Knibbe CA, Danhof M. Individualized dosing regimens in children based on population PKPD modeling: are we ready for it? Int J Pharm. 2011;415(1-2):9-14.
14. Cella M, Danhof M, Della Pasqua O. Adaptive trials in pediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children. Br J Clin Pharmacol. 2012;74(2):346-53.
15. De Cock RF, Allegaert K, Schreuder MF, Sherwin CM, de Hoog M, van den Anker JN, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet. 2012;51(2):105-17.
16. Rinaki E, Valsami G, Macheras P. Quantitative biopharmaceutics classification system: the central role of dose/solubility ratio. Pharm Res. 2003;20(12):1917-25.
17. Charkoftaki G, Dokoumetzidis A, Valsami G, Macheras P. Elucidating the role of dose in the biopharmaceutics classification of drugs: the concepts of critical dose, effective in vivo solubility, and dose-dependent BCS. Pharm Res. 2012;29(11):3188-98.
18. Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11-23.
19. Amidon G. Best Pharmaceuticals for Children Act Pediatric Formulations Initiative Workshop, Potomac, 2011, http://bpca.nichd.nih.gov/ collaborativeefforts/upload/PFI-Workshop-11-1-2-11.pdf. Accessed 19 Jul 2013.
20. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipient benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-9.
21. Strickley RG, Iwata Q, Will S, Dahl TC. Pediatric drugs - a review of commercially available oral formulations. J Pharm Sci. 2008;97(5):1731-74.
22. Inactive Ingredients Database URL: http://www.fda.gov/Drugs/ InformationOnDrugs/ucm113978.htm. Accessed 19 Jul 2013.
23. European Union Pediatric Formulations Initiative. http://www.eupfi.org/. Accessed 19 Jul 2013.
24. Meilgaard M, Civille GV, Carr BT. Sensory evaluation techniques. III ed. Boca Raton: CRC; 1999.
25. Legin A, Rudnitskaya A, Clapham D, Seleznev B, Lord K, Vlasov Y. Electronic tongue for pharmaceutical analytics: quantification of tastes and masking effects. Anal Bioanal Chem. 2004;380(1):36-45. Epub 2004 Jul 29.
26. Lorenz JK, Reo JP, Hendl O, Worthington JH, Petrossian VD. Evaluation of a taste sensor instrument (electronic tongue) for use in formulation development. Int J Pharm. 2009;367(1-2):65-72.
27. Woertz K, Tissen C, Kleinebudde P, Breitkreutz J. Performance qualification of an electronic tongue based on ICH guideline Q2. J Pharm Biomed Anal. 2010;51(3):497-506.
28. Guffon N, Kibleur Y, Copalu W, Tissen C, Breitkreutz J. Developing a new formulation of sodium phenylbutyrate. Arch Dis Child. 2012;97:1081-5.
29. Chen ML, Straughn AB, Sadrich N, Meyer M, Faustino PJ, Ciavarella AB, et al. A modern view of excipient effects on bioequivalence: case study of sorbitol. Pharm Res. 2007;24(1):73-80.
30. Richey RH, Craig JV, Shah UU, Ford JL, Barker CE, Peak M, et al. The manipulation of drugs to obtain the required dose: systematic review. J Adv Nurs. 2012;68(9):2103-12.
31. Stegemann S, Gosch M, Breitkreutz J. Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy. Int J Pharm. 2012;430:197-206.
32. Hoffmann EM, Breitenbach A, Breitkreutz J. Advances in orodispersible films for drug delivery. Exp Opin Drug Deliv. 2011;8:299-316.
33. Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) - a novel solid dosage form for pediatric use. Eur J Pharm Biopharm. 2011;78:462-9.
34. Walsh J, Bickmann D, Breitkreutz J, Chariot-Goulet M. Delivery devices for the administration of pediatric formulations: overview of current practice, challenges and recent developments. Int J Pharm. 2011;415:221-31.
35. Aziz MAHH, Jameela KA. How accurate are household spoons in drug administration? Med Princ Pract. 1990;2:106-9.
36. Madlon-Kay DJ, Mosch FS. Liquid medication dosing errors. J Fam Pract. 2000;49:741-4.
37. Griessmann K, Breitkreutz J, Schubert-Zsilavecz M, Abdel-Tawab M. Dosing accuracy of measuring devices provided with antibiotic oral suspensions. Paediatr Perinat Drug Ther. 2007;8:61-70.
38. Dockhorn S, Feuersenger D, Schuenemann S, Knauf B, Duerr S, Schubert-Zsilavecz M, et al. Study of microbial contamination and dosing accuracy of oral dispensers. J Clin Pharm Ther. 2010;35:279-87.
39. Breitkreutz J, Boos J. Paediatric and geriatric drug delivery. Expert Opin Drug Deliv. 2007;4:37-45.
40. Charkoftaki G, Kytariolos J, Macheras P. Novel milk-based oral formulations: proof of concept. Int J Pharm. 2010;390:150-9.
41. Rieder M. If children ruled the pharmaceutical industry: the need for pediatric formulations. Drug News Perspect. 2010;23:458-64.
42. Booth, B. Pediatric formulations: what we want to know. Presentation to the FDA Pediatric Advisory Committee, 15 December 2009. www.fda.gov/downloads/ AdvisoryCommittees/./UCM197942.pdf. Accessed 19 Jul 2013.
43. Raw AS, Lionberger R, Yu LX. Pharmaceutical equivalence by design for generic drugs: modified release products. Pharm Res. 2011;28(7):1445-53.
44. Health Canada Guidance Document. Comparative bioavailability standards: formulations used for systemic effects. May 22, 2012. http://www.hc-sc.gc.ca/ dhp-mps/prodpharma/applic-demande/guide- ld/bio/gd-standards-ld-normes-eng.php. Accessed 19 Jul 2013.
45. Holford N. Dosing in children. Clin Pharmacol Ther. 2010;87:367-70.
46. Barrett JS. Physiologically-based pharmacokinetic (PBPK) modeling in children. Clin Pharmacol Ther. 2012;92(1):40-9.
47. Johnson TN, Rostami-Hodjegan A. Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice. Paediatr Anaesth. 2011;21:291-301.
48. Laer S, Barrett JS, Meibohm B. The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy. J Clin Pharmacol. 2009;49:889-904.
49. Meibohm B, Läer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005;7:E475-87.
50. Wang Y, Jadhav PR, Lala M, Gobburu JV. Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies. J Clin Pharmacol. 2012;52(10):1601-6.
51. Strachan I, Greener M. Medication-related swallowing difficulties may be more common than we realise. Pharm Pract. 2005;15:411-4.
52. Milne CP, Bruss JB. The economics of pediatric formulation development for off-patent drugs. Clin Ther. 2008;30(11):2133-45.