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During the manufacture of a suspension pMDI, it is essential that adequate energy is distributed to the formulation to disperse any API agglomerates present, since insufficient mixing can result in a lower and more variable respirable dose.
Mixing studies are often overlooked in early phase development, where quick feasibility assessments are performed. However, during this phase, critical product decisions are often made and it is therefore desirable to employ a robust manufacturing process to reduce inherent product variability.
Understanding the product’s susceptibility to mixing parameters at an early phase can provide valuable information for scale-up and potentially minimise studies that have to be performed at a much larger, more expensive scale.
This study investigated the impact of varying high shear mixer speed and mixing time on the pharmaceutical performance of an IBM and albuterol combination pMDI.
