Manufacturing Process Development for Low-Dose Drug Products

5 MANUFACTURING PROCESS DEVELOPMENT FOR LOW-DOSE DRUG PRODUCTS 

DEVELOPMENT OF LOW-DOSE SOLID ORAL TABLETS USING DIRECT COMPRESSION 

It is important to understand the nature of the agglomerates to be dispersed. If the agglomerates are only held together by cohesive surface forces, the techniques 

TABLE 7.11 Process Variables and Quality Attributes Using Direct Compression for Tablet Manufacture 

Unit Operation Variables Product Quality Attributes 

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In summary, the process challenges that impacted quality considerations included 1, 4, 5, and 6, whereas 2, 3, 7, and 8 affected manufacturing considerations during drug product development for these low-dose products. 

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