| slide 1 of 63 april 2007 training workshop on pharmaceutical development with focus on paediatric...

63
| 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

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Page 1: | Slide 1 of 63 April 2007 Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront

| 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 DevelopmentPharmaceutical Development

Page 2: | Slide 1 of 63 April 2007 Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront

| Slide 2 of 63 April 2007

Pharmaceutical DevelopmentPharmaceutical Development

Workshop on paediatric dosage forms

Presenter: Jean-Marc AIACHEEmeritus Professor,

Auvergne University,

Faculty of Pharmacy,

28 Place Henri Dunant

63000 Clermont-Ferrand, France

[email protected]

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Pharmaceutical DevelopmentPharmaceutical 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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conclusionconclusion

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Oral administrationOral administration

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Oral administrationOral administration

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Oral administrationOral administration

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Oral administrationOral administration

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Oral administrationOral administration

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Oral administrationOral administration

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Oral administrationOral administration

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Oral administrationOral administration

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Buccal dosage formBuccal dosage form

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Buccal dosage formBuccal dosage form

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Nasal dosage formNasal dosage form

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Buccal dosage formsBuccal dosage forms

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Rectal administrationRectal administration

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Rectal administrationRectal administration

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TopicalsTopicals

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Transdermal patchesTransdermal patches

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Transdermal patchesTransdermal patches

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Parenteral administrationParenteral administration

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Parenteral administrationParenteral administration

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Parenteral administrationParenteral administration

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Parenteral administrationParenteral administration

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Parenteral administrationParenteral administration

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Parenteral administrationParenteral administration

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Parenteral administrationParenteral administration

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Inhalation dosage formsInhalation dosage forms

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Inhalation dosage formsInhalation dosage forms

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Matrix for dosage formsMatrix for dosage forms

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Matrix for dosage formsMatrix for dosage forms

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Matrix for dosage formsMatrix for dosage forms

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PreservativesSweeteners.

Fillers and solvents.Coloring agents.

Coating materials

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Household spoons

droppers

measuring spoons and cups

cylindrical measuring spoons

graduated pipettes and oral dosing syringes

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Must be done with children, but carefully selected and well organized to recognize the different taste.

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Pharmaceutical DevelopmentPharmaceutical 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.