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Division for Clinical Trials, National Centre for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
Department of Pharmacy, National Centre for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
A R T I C L E I N F O
A B S T R A C T
Article history:
Received 26 February 2014
Received in revised form 28 March 2014
Accepted 28 March 2014
Available online 1 April 2014
In Japan, powders for reconstitution are often dispensed in sachets, and parents add small amount of
water or syrups to make the powders paste-like or condensed syrup and have their children take the
medicines. Compounding is common just like any other parts of the world. According to the survey in
2005, most commonly compounded medicines include warfarin, digoxin and enalapril. Crushed tablets
or capsules are often mixed with sucrose or starch and kept in bottles at pharmacy departments for
regular use. There is no regulation so far to mandate pediatric drug/formulation development in Japan.
The pediatric premium can be given to drugs whose indications and dosage are clearly for children, but
this is not sufcient for many drug companies especially when their drug prices are cheap. In 2013, new
MHLW grant-supported project for regulatory science in pediatric drug development started, and
discussion on key issues related to pediatric drug development including formulations, modeling and
simulation and neonatal drug evaluation is ongoing including the possible change on legal framework to
facilitate pediatric drug development in the country. Initiation of international collaboration with global
partners including the European Paediatric Formulation Initiative is to be expected.
2014 Elsevier B.V. All rights reserved.
* Corresponding author at: Division for Clinical Trials, Deparment of Development Strategy, Centre for Social and Clinical Research, National Centre for Child
Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan. Tel.:
+81 3 3416 0181x5373; fax: +81 3 3417 5691.
E-mail address: nakamura-hd@ncchd.go.jp (H. Nakamura).
http://dx.doi.org/10.1016/j.ijpharm.2014.03.053
0378-5173/ 2014 Elsevier B.V. All rights reserved.
250
Fig. 1. Powder packing machine at the National Centre for Child Health and
Development.
Table 1
Top 10 drugs for dosage form changes on prescription number basis at 32
institutions in 2005 (Kato, 2006).
1
2
3
4
5
6
7
8
9
10
Drug names
Form
Prescription numbers/month
Warfarin
Digoxin
Enalapril
Dantrium
Lisinopril
Beraprost
Hydrocortisone
Bacrofen
Chloral hydrate
Propranolol
Tablet
Tablet
Capsule
Tablet
Tablet
Tablet
Tablet
Tablet
Powder
Tablet
1052
568
550
482
456
444
406
374
364
356
Kato, H., 2006. Survey of paediatric dosage form changes in Japan. In: Ishikawa, Y.
(Ed.), The Annual Report of MHLW Grant Supported Project Research on Data
Network for Paediatric Therapeutics (In Japanese), pp. 1932 (Not available
online).