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SUCHEN

Delivered Dose Uniformity Testing

Delivered Dose Unit TestingWhether used in life critical situations or to help a child run, pmDIs, nebulizers, and other inhaler devices are used every day by millions of people. Each person relies on their inhaler device to provide the exact amount of medication they need - whether it is the first dose of the device or the last, or from capsule to capsule. They expect a consistent and exact active drug delivery. To ensure this is happening, the drug is put through Delivered Dose Uniformity (DDU) Testing.

Meeting standards and guidance for DDU

To ensure a consistent dose, an inhaler device is put through rigorous testing and needs to meet regulatory standards, often using USP guidance <601>. To achieve and maintain FDA approval, typically the inhaler needs to accomplish two things:

  1. Prove consistency – there cannot be variation throughout the lifecycle of an inhaler device or between capsules. Every dose needs to provide the correct amount of active pharmaceutical ingredient (API). Delivered dose is considered a Critical Quality Attribute (CQA).
  2. Provide detailed and proven method development – the same or acceptable methodology is used across all worksites, analysts, manufacturers, etc.

MSP supplies inhalation testing precision equipment that is high performing, reliable, and consistent. We carry a wide range of DUSA equipment and nebulizer filter media to accurately, respectably, and reliably perform the DDU testing per FDA and USP guidelines. Our products make it easier to test for dose uniformity and prove efficient and effective method transfer.