| Slide 1 of 63 April 2007 Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront Cape Town, South Africa Date: 16 to 20 April 2007 Pharmaceutical Development

| Slide 2 of 63 April 2007 Pharmaceutical Development Workshop on paediatric dosage forms Presenter: Jean-Marc AIACHE Emeritus Professor, Auvergne University, Faculty of Pharmacy, 28 Place Henri Dunant Clermont-Ferrand, France

| Slide 3 of 63 April 2007 Pharmaceutical Development Outline and Objectives of presentation Presentation and discussion of the last guideline of EMEA Aim of the document Influences on the Administration of medicinal products. Developmental pharmacology. Routes of administration Drug dosage form in function of route of administration General considerations on the choice of excipient Conclusion

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| Slide 16 of 63 April 2007 conclusion

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| Slide 18 of 63 April 2007 Oral administration

| Slide 19 of 63 April 2007 Oral administration

| Slide 20 of 63 April 2007 Oral administration

| Slide 21 of 63 April 2007 Oral administration

| Slide 22 of 63 April 2007 Oral administration

| Slide 23 of 63 April 2007 Oral administration

| Slide 24 of 63 April 2007 Oral administration

| Slide 25 of 63 April 2007 Oral administration

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| Slide 27 of 63 April 2007 Buccal dosage form

| Slide 28 of 63 April 2007 Buccal dosage form

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| Slide 31 of 63 April 2007 Nasal dosage form

| Slide 32 of 63 April 2007 Buccal dosage forms

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| Slide 34 of 63 April 2007 Rectal administration

| Slide 35 of 63 April 2007 Rectal administration

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| Slide 37 of 63 April 2007 Topicals

| Slide 38 of 63 April 2007 Transdermal patches

| Slide 39 of 63 April 2007 Transdermal patches

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| Slide 41 of 63 April 2007 Parenteral administration

| Slide 42 of 63 April 2007 Parenteral administration

| Slide 43 of 63 April 2007 Parenteral administration

| Slide 44 of 63 April 2007 Parenteral administration

| Slide 45 of 63 April 2007 Parenteral administration

| Slide 46 of 63 April 2007 Parenteral administration

| Slide 47 of 63 April 2007 Parenteral administration

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| Slide 50 of 63 April 2007 Inhalation dosage forms

| Slide 51 of 63 April 2007 Inhalation dosage forms

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| Slide 55 of 63 April 2007 Matrix for dosage forms

| Slide 56 of 63 April 2007 Matrix for dosage forms

| Slide 57 of 63 April 2007 Matrix for dosage forms

| Slide 58 of 63 April 2007 Preservatives Sweeteners. Fillers and solvents. Coloring agents. Coating materials

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| Slide 61 of 63 April 2007 Household spoons droppers measuring spoons and cups cylindrical measuring spoons graduated pipettes and oral dosing syringes

| Slide 62 of 63 April 2007 Must be done with children, but carefully selected and well organized to recognize the different taste.

| Slide 63 of 63 April 2007 Pharmaceutical Development Summary and conclusion The choice of a dosage form as well as the excipients allowing the manufacturing process of this form, most to be done in function not only of the children disease but also to the possible side reaction of the parents or caregivers and children. The EMEA guideline may help the companies to reach this aim.