WHO TRS 970, 2012 Annex 5

WHO TRS (Technical Report Series) 970, 2012 Annex 5

WHO Guidelines For Development of Pediatric Medicines: points to consider in formulation

General Note:

The “points to consider” document should not contain detailed instructions for development but rather it should make reference to relevant literature. Some matters dealt with in the draft on development of multi source products have, therefore, been omitted in this proposal.

Click on the titles below for complete guidelines

TABLE CONTENTS

1. INTRODUCTION 

2. GLOSSARY 

3. PAEDIATRIC DOSAGE FORMS

3.1 Convenient, Reliable Administration 

3.2 Acceptability and Palatability 

3.3 Minimum Dosing Frequency 

3.4 End-User Needs 

4. PARTICULAR DOSAGE FORMS TO BE CONSIDERED

4.1 Flexible Solid Dosage Forms 

4.2 Oral Medicines

4.3 Medicines For Severe Conditions

4.4 Rectal Preparations 

5. FORMULATION DESIGN 

5.1 Quality 

5.2 Biopharmaceutics Classification System

5.3 Excipients 

5.4 Colouring Agents 

5.5 Antimicrobial Preservatives

5.6 Sweetening Agents 

5.7 Taste Masking 

5.8 Solubility Enhancers

6. ORAL ADMINISTRATION 

6.1 Oral Liquid Preparations 

6.2 Administration Through Feeding Tubes

6.3 Oral Solid Dosage Forms

7. RECTAL ADMINISTRATION 

7.1 Suppositories

7.2 Rectal Liquids (Enemas)

8. PARENTERAL ADMINISTRATION

8.1 Formulation

8.2 Additional Points To Consider For Parenteral Preparations

9. DERMAL AND TRANSDERMAL ADMINISTRATION 

9.1 Transdermal Patches

10. INHALATIONS

11. PACKAGING AND LABELING

REFERENCES 

Development of Pediatric Medicines: points to consider in formulation, 

(WHO Technical Report Series 970, 2012 Annex 5)