Development with focus on Paediatric Formula在儿科配方药物发展重点课件.ppt

World Health Organization Pharmaceutical Development Suitable dosage forms for pediatric medicine Presenter: Jean-Marc AIACHE Emeritus Professor, Auvergne University, Faculty of Pharmacy, 28 Place Henri Dunant 63000 Clermont-Ferrand, France jm.aiache@wanadoo.fr Pharmaceutical Development Outline and Objectives of presentation What are the problems? 1) Children characteristics: 2) Prescription and administration of drug products Are there suitable dosage forms for paediatric medicines? 1) Specific dosage forms for long or chronic diseases 2) Specific dosage forms for acute or common illness a) D.F to help the parents for drug administration b) To help the parents for drug acceptance by children c) To help the child to take his medicine What are the problems? 1) Children characteristics: Children are “SPECIFIC patients”, and not “small ADULTS Classification What are the problems? Their metabolism is different from adults Their reaction to drugs may be also different (pharmacokinetics, pharmacodynamic…..) Their preference in term of taste or colour is quite fundamentally different of adults What are the problems? 2) Prescription and administration of drug products The drug product prescription is done by Paediatricians (for heavy diseases or long or chronic diseases) or more often by a General Practitioner (for common or acute diseases) The administration of drug products to children is made by their PARENTS So their role is of most importance in the drug product acceptability, size, colour, shape, aspect, taste…. Furthermore it is compulsory to treat their stress! ALL THESE FACTORS CANNOT BE DISSOCIATED Are there suitable dosage forms for paediatric medicines? There are two different issues in relation to the type of diseases to be treated. Specific dosage forms for long or chronic diseases Specific dosage forms for acute or common illness Specific dosage forms for long or chronic diseases In a decreasing order: Cancers, Aids,