Verta Life Sciences consultants have experience developing drug products in all dosage forms.

We work with clients on the selection of drug substances and excipients based on sound scientific principles to present drug products (dosage forms) that are safe, effective and acceptable for a desired route of administration.

On behalf of clients we conduct preformulation studies as necessary to characterize drugs physical properties and compatibility with excipients.

Formulation development in many cases is development phase appropriate, simple formulations may be used for Phase I clinical studies, with more advanced formulations used for Phase II and beyond.

Oral Route
  • Tablets
  • Capsules
  • Solutions and Syrups
  • Suspensions
  • Sublingual
  • tablets/lozenges
Topical Route
  • Ointments
  • Creams (o/w or w/o)
  • Lotions (o/w or w/o)
  • Suppositories
  • Transdermal patch
Injectables
  • Intravenous
  • Intramuscular
  • Subcutaneous
  • IV infusions
Formulation development – case study
Issue:

Prior studies indicated that a topical drug may be effective in treating an unmet medical need based on limited clinical studies. However, the drug product was not physically stable and the formulation not acceptable for progression to further investigations.

Objective:

To develop a safe, effective and stable formulation of a drug for treatment of the unmet medical need.

Deliverable:
  • To identify a formulation and method of manufacture for a drug product for topical administration with demonstrated safety , efficacy and stability based on Quality by Design (QbD) principles.
  • Selection of appropriate primary packaging components.
  • Development of product and ingredient specifications and methods based on scientific data , supported by method validation.
  • Manufacture Clinical Trial Supplies for with appropriate documentation (batch records, batch release documentation).
  • Stability studies to support shelf life stability of drug product.