Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers
Center for Dermal Research a pharmaceutical product development working group was formed. The
group known as the Q3 Working Group selected the following five areas of focus: Particle
Globule Size and Distribution Viscosity Rheology Spreadability In Vitro Testing State of API
State of Excipients. A committee was appointed for each of these five areas. The committees
were tasked to review the literature identify best practices list experimental details
required for an independent lab to duplicate the test and propose scientific studies that may
meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs)
that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical
reviewers of each chapter making suggestions that improve the quality of the document and that
make each of the five chapters uniform in scope and content.Pharmaceutical development
scientists that formulate topical products (creams lotions gels suspensions foams etc) and
all the allied raw material suppliers packaging suppliers contract laboratories including
CROs CMOs and regulators need access to this book. Overall the topic of semisolid
microstructure is of equal importance to the generic pharmaceutical companies (filing
Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug
Applications (NDAs). In addition to products applied to the skin hair and nails The Role of
Microstructure in Topical Drug Product Development¿ crosses over and is essential reading to
developers of oral suspensions ophthalmic ointments and gels otic suspension vaginal
semisolids and retention enemas.
