Post on 31-Mar-2015
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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
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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
jm.aiache@wanadoo.fr
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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.