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Maintain in-use product integrity with specialty film coating

Format: PDF file | Document type: Case Study

The drug combination of amoxicillin and clavulanic acid is moisture sensitive, demanding low humidity manufacturing and moisture barrier packaging. This product is commonly coated with standard hypromellose film coating which is not specifically formulated for moisture protection.

In a two-part Case Study, the in-use product integrity of the drug combination, as uncoated and film coated tablets, was investigated in a variety of packaging formats at room temperature conditions (in-use), where tablets were removed from their primary packaging and transferred to a typical consumer-use tablet organizer.

Opadry amb II, high performance moisture barrier coating, better maintained the stability of the amoxicillin and, more notably, the clavulanic acid in all packaging formats.

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