Pre-formulation and Formulation

 

Examining and getting a firm understanding of your compound’s characteristics early on is a vital first step in a successful development process. Atlas Pharmaceutical’s scientists combine drug pre-formulation and formulation development expertise with an extensive understanding of commercial pharmaceutical manufacturing processes to help you develop and commercialize pharmaceutical products in solid, semi-solid and liquid dosage forms.

 

Pre-formulation Solutions

• Raw material sourcing
• Solubility profiles and partition coefficient of active pharmaceutical ingredients (API)
• API compatibility with excipients
• Stability of API and factors affecting stability (including heat, light and pH)
• Particle size determination (for both API and the formulation)
• API characterization by differential scanning calorimetry (DSC), powder x-ray diffraction, fourier transform infrared (FTIR) spectroscopy and particle morphology by optical microscopy
• Formulation and packaging capability
• Surface tension of aqueous and non-aqueous liquids

 

Formulation Solutions

• Physical characterization of API, excipients and formulation
• Rheology/viscosity
• pH
• Specific gravity
• Informal stability/formulation stress testing (both physical and chemical)
• Antimicrobial effectiveness testing (AET) and inhibitory testing
• Formulation container closure compatibility assessment

 

Because Atlas Pharmaceutical scientists work in integrated teams, discoveries are passed seamlessly from one group to the next, efficiently moving your project through the development process to commercial-scale drug manufacturing.