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Preliminary clinical studies indicated that a combination of a steroidal compound and an enzyme inhibitor were effective in treating an unmet medical need. However, the clinical formulation was not commercially viable and the steroidal component had limited bioavailability and solubility issues. The drug product was not physically stable and the formulation not acceptable for progression for further clinical studies.


To develop a fixed-dose combination product that was safe, effective and stable for treatment of the unmet medical need. To develop a facility that could accommodate drug product manufacture with an API occupational exposure limit of 0.3mcg/m3 (8 HR TWA.) and 3 mcg/m3 (Short Term Excursion).


  • To identify a formulation and method of manufacture for an oral fixed dose combination drug product that demonstrated safety, increased bioavailability and stability based on Quality by Design (QbD) principles.
  • Evaluation of multiple technologies that would improve bioavailability and provide a controlled release product (i.e. nano-milling spray drying, matrix controlled release, osmotic pump tablet, semi-permeable membrane coating, geometric blending).
  • Selection of appropriate primary packaging components.
  • Development of product and ingredient specifications and methods based on scientific data, supported by method validation.
  • Manufacture of Clinical Trial Supplies with appropriate documentation (batch records, batch release documentation).
  • Stability studies to support shelf life stability of the drug product.
  • Modification of an existing facility to accommodate the spray drying of a highly potent compound for development and to produce a clinical and commercial product.

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