Medicines for children: Flexible solid oral formulations

Bulletin of the World Health Organization

Volumn 95, Issue 3, 2017, Pages 238-240

  Orubu, Ebiowei S F ^a   Tuleu, Catherine ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

WATER; ZINC; DRUG; ESSENTIAL DRUG;

CHEWABLE TABLET; DISPERSIBLE TABLET; DRUG COST; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; EFFERVESCENT TABLET; HUMAN; LOW INCOME COUNTRY; MEDICATION COMPLIANCE; NOTE; PALATABILITY; QUALITY CONTROL; STOMATOLOGY; WORLD HEALTH ORGANIZATION; CAREGIVER; CHILD; ORAL DRUG ADMINISTRATION; PRESCHOOL CHILD;

ADMINISTRATION, ORAL; CAREGIVERS; CHILD; CHILD, PRESCHOOL; DRUGS, ESSENTIAL; HUMANS; PHARMACEUTICAL PREPARATIONS;

EID: 85014722217     PISSN: 00429686     EISSN: 15640604     Source Type: Journal    
DOI: 10.2471/BLT.16.171967     Document Type: Note

References (14)

1. Standing JF, Tuleu C. Paediatric formulations-getting to the heart of the problem. Int J Pharm. 2005 Aug 26;300(1-2):56-66 doi:http://dx.doi.org/10.1016/j.ijpharm.2005.05.006 PMID: 15979830
2. Fabiano V, Mameli C, Zuccotti GV. Paediatric pharmacology: remember the excipients. Pharmacol Res. 2011 May;63(5):362-5 doi:http://dx.doi.org/10.1016/j.phrs.2011.01.006 PMID: 21241804
3. Robertson J, Forte G, Trapsida JM, Hill S. What essential medicines for children are on the shelf? Bull World Health Organ. 2009 Mar;87(3):231-7 doi:http://dx.doi.org/10.2471/BLT.08.053645 PMID: 19377720
4. World Health Organization. Annex 5. Development of paediatric medicines: points to consider in formulation. World Health Organ Tech Rep Ser. 2012;(970):197-225.
5. Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, et al. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40 doi:http://dx.doi.org/10.1016/S0140-6736(14)61698-6 PMID: 25280870
6. Orubu ESF. Flexible solid oral dosage forms as the preferred formulations for children [PhD thesis]. London: University College London School of Pharmacy; 2016.
7. WHO model list of essential medicines for children (3rd list, March 2011). Geneva: World Health Organization; 2011. Available from: http://apps.who.int/iris/bitstream/10665/70641/1/a95054_eng.pdf [cited 2017 Jan 24].
8. WHO support for medicines regulatory harmonization in Africa: focus on East African community. WHO Drug Information. 2014;28(1):11-5. Available from: http://www.who.int/medicines/publications/druginformation/DI_28-1_Africa.pdf [cited 2016 Dec 30].
9. Leane M, Pitt K, Reynolds G; Manufacturing Classification System (MCS) Working Group. A proposal for a drug product manufacturing classification system (MCS) for oral solid dosage forms. Pharm Dev Technol. 2015 Jan;20(1):12-21 doi:http://dx.doi.org/10.3109/10837450.2014.954728 PMID: 25162770
10. Suñé-Negre JM, Roig M, Fuster R, Hernández C, Ruhí R, García-Montoya E, et al. New classification of directly compressible (DC) excipients in function of the SeDeM Diagarm Expert System. Int J Pharm. 2014 Aug 15;470(1-2):15-27 doi:http://dx.doi.org/10.1016/j.ijpharm.2014.04.068 PMID: 24792976
11. Ogutu BR, Onyango KO, Koskei N, Omondi EK, Ongecha JM, Otieno GA, et al. Efficacy and safety of artemether-lumefantrine and dihydroartemisininpiperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children aged less than five years: results of an open-label, randomized, single-centre study. Malar J. 2014 01 28;13(1):33 doi:http://dx.doi.org/10.1186/1475-2875-13-33 PMID: 24472156
12. Camus-Bablon F. Identifying and moving levers of acceptance and uptake of recommended quality-assured paediatric ACTs for noncomplicated malaria in six francophone Africa countries. Geneva: Medicines for Malaria Venture; 2012. Available from: http://www.mmv.org/sites/default/files/uploads/docs/publications/Identifying_and_moving_levers_3.pdf [cited 2015 Aug 7].
13. Clinical investigation of medicinal products in the pediatric population. Final concept paper E11 (R1). Geneva: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2014. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/E11_R1__Final_Concept_Paper_July_2014.pdf [cited 2015 Jun 5].
14. EMA modelling and simulation working group plan 2015. London: European Medicines Agency; 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2015/04/WC500185865.pdf [cited 2015 Sep 4].