Considerations in product design concepts introduced in CFR 820 and expanded for drug development in ICH Q8 have brought greater attention to identifying Target Product Parameters (TPP).  Also referred to as Quality Target Product Parameters (QTPP), identifying product attributes provides focus during development.  This encompasses identifying those attributes that are deemed desirable and essential.

  

A project team at LTI comprised of Carrie Shults, Development Sciences, Denise Miller, Quality Assurance, and Ed Trappler, President, has been researching aspects and considerations in identifying TPPs for lyophilized preparations.  Product design aspects with an emphasis on the intended use that includes considerations such as therapeutic indication, therapy regimen, and route of administration are factors that direct identifying product design objectives.  These objectives are so crucial for discerning product attributes that are desired as compared to those that are essential.  A hierarchy of product characteristics, their relationships to the general requirements for a parenteral product, and those unique to a lyophilized preparation has been developed to highlight the various considerations in design for a lyophilized product.

  

A presentation of the hierarchy that outlines product design attributes and considerations has been presented at the PDA Annual Meeting, with additional presentations at the DIA, CPPR Conference on Freeze Drying of Pharmaceuticals and Biologicals and AAPS conferences for soliciting comments and feedback.  It is becoming clear that product attributes are strongly influenced by the intended use; those essential for some products are simply desirable for others.  To request a copy of the presentation, click here.