Excipient Control strategy

Larner G, Schoneker DR, Sheehan C, Uppoor R, Walsh P, Wiens R. 2006. PQRI survey of pharmaceutical excipient testing and control strategies used by excipient manufactures, excipient distributors, and drug-product manufactures. Pharm. Technol. 30(9) 90-98. 

The objective of control strategy is to make sure that the product of required quality is produced consistently. The control strategy includes controls of in-process variables, input materials (drug substance and excipients), intermediates (in-process materials), packaging system, and drug product attributes. These controls should be based on... 

Functional excipient characterization and control strategy, if applicable Certificates of analysis for the API and drug product to be used in the clinic... 

Controlled release strategy Method of design Mean particle diameter (pm) Molecule of interest Excipients/delivery vehicle Evidence of controlled release Reference... 

Implantable DDSs can be used for antibiotic administration and immunization, treatment of diseases such as diabetes and bone infections. The latter can be treated via sustained release, cyclic release, multi-phase release, pulse release and the controlled release of multiple drugs. Traditionally, the most common method for manufacturing implants is to blend the drug with the excipients and then use a compression- or injection-molding technique to manufacture the devices. However, this technique has some disadvantages regarding the optimal control of the structure and internal architecture of the DDS. Biotextiles may provide novel strategies for the development of implantable DDSs. 

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