Formulation Development

APS’ approach to formulation development is based on Quality by Design (QBD) and statistical design-of-experiment (DOE). Our experts can help you establish a comprehensive understanding of thermal, physical, and chemical stability of drug substance and product. We can develop robust formulations by eliminating uncontrolled stability variables in order to focus solely on therapeutic performance and clinical outcome. Our scientific based approach results in significant savings to the client by eliminating the variables associated with suboptimal formulations.

We leverage initial design space to develop formulations and processes which are tailored to the unique requirement of your products and regulatory provisions. We perform forced degradation and accelerated stability studies to assess suitability of drug formulation based on ICH guidelines.

Please see the list below for some of the many formulation research solutions we offer:

  • - Stress Testing and Forced Degradation

  • - Formulation Design and Development, Lead Selection and Form Selection

  • - Defining Shelf Life and Storage Conditions of Drug Substance and Product (non-cGMP/cGMP)

  • - Determination of Intrinsic Stability, Chemical Stability Screening, Physical Stability, Thermal Stability, and Photo Stability of Drug Substance and Product (non-cGMP/cGMP)

  • - Determination of Formulation Stability and Bio-relevant Stability

  • - Drug-Excipient Compatibility Study

  • - Determination of Particle Size, Solubility (LogS), and Permeability (LogP)

  • - Design and Develop Conventional and Biorelevant Dissolution

  • - Biowaiver Study and In-Vivo/In-Vitro Correlation

  • - Drug Substance Physical Form Characterization and Selection