Abstract
Effect of process scale-up on granulate, tablets properties and dissolution behavior in immediate release fixed-dose combination product
Highlights
Fixed-dose combination immediate release (IR) tablets of a Biopharmaceutical classification system (BCS class) II antihyperlipidemic and I antihypertensive drug was developed as a generic product using wet granulation technology
Process and product understanding are needed in order to define the critical process parameters (CPP) and the critical quality attributes (CQAs)
In our study the dimensionless Froude number approach was used to scale the wet-granulation mixing speed from laboratory scale trial of 1 kg IR fixed-dose combination product from 4 L high shear mixer, to production scale trial of 32 kg produced in 65 L pilot high shear mixer by two granulation sub-batches
Summary
Fixed-dose combination immediate release (IR) tablets of a Biopharmaceutical classification system (BCS class) II antihyperlipidemic and I antihypertensive drug was developed as a generic product using wet granulation technology. Obtaining similarity to the reference product (RP) in order to assure similar release profile and further similar drug pharmacokinetics is a challenge, assuming that there are many influences on the active components dissolution behavior, where one of the main challenges is the process scale-up. Further successful process parameters scaling and adaptation from laboratory scale to production scale is needed in order to assure the desired product quality. In our study the dimensionless Froude number approach was used to scale the wet-granulation mixing speed from laboratory scale trial of 1 kg IR fixed-dose combination product from 4 L high shear mixer, to production scale trial of 32 kg produced in 65 L pilot high shear mixer by two granulation sub-batches
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