CRED Getting the CMC Dossier Right 2024

05/09/2024

Tablets/Capsules

• Advantages • Generally stable compared with liquid forms • Preparation ensures a single accurate dose • Can be packed to encourage patient compliance • Convenient to handle and robust • Can be mass produced at low cost • Markings can promote product identification

The Organisation for Professionals in Regulatory Affairs

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• Disadvantages Tablets/Capsules

• Oral delivery not suitable for some patients and situations

• Swallowing solid dosage form may not be possible - can be overcome by crushing or breaking for delivery by e.g. nasogastric tube, if verified and on the product label • Only fixed doses possible, not suitable for e.g. paediatric weight-based posology • Active may be unstable at pH of stomach, requires additional design features • Need for disintegration, dissolution and absorption to achieve therapeutic effect (however lyophiles can give rapid release)

The Organisation for Professionals in Regulatory Affairs

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