+44 (0)115 787 0175 enquiry@upperton.com

Formulation Development

Optimising the performance of your drug.

Pre formulation screening

Our pre-formulation screening service provides detailed physical characterisation of the API. This will provide all of the information required to enable us to develop a stable dry powder formulation.

For solutions of Biological Molecules, pre-formulation services may include:

  • Determination of API concentration (HPLC / UV)
  • API integrity assay (SEC HPLC)
  • Activity assay
  • pH
  • Buffer exchange
  • Concentration adjustment

For small molecule APIs, the services may include:

  • Crystallinity / Amorphous content by differential scanning calorimetry and X-ray diffraction
  • Laser particle size analysis
  • Moisture / Solvent content
  • Hygroscopicity by dynamic vapour sorption / desorption
  • Solubility screening, in a range of organic / aqueous solvent systems
  • Chemical / Physical stability testing (heat, light, pH, humidity)
  • Development or transfer of analytical methods (HPLC, UV, Fluorescence assays)
  • Dissolution/Solubility testing in a range of physiological buffers
  • API / Excipient miscibility screening using differential scanning calorimetry

Formulation Development

Upperton Pharma Solutions can provide a comprehensive formulation development service for a range of solid dosage forms. These can be simple powders that can be filled into bottles or capsules through to precisely engineered particles required for pulmonary or nasal delivery or for subsequent reconstitution into parenteral dosage forms.

Formulation development studies typically include some, or all, of the following steps:

  • Spray drying feed solution development; API and excipient solubility screening
  • Optimisation of API : Excipient ratio(s)
  • Optimisation of spray drying process parameters
  • Production of spray dried feasibility batches (100mg – 5g scale)
  • Detailed characterisation of spray dried powders (physical, chemical and performance testing)
  • Post drying formulation (dosage form selection)
  • Tableting / Capsule filling study
  • Characterisation of reconstituted API solutions (for iv formulations)
  • Storage stability studies
  • Process scale up studies
  • Manufacture of material for toxicology testing
  • cGMP manufacture

About Us

With over 20 years of experience we have successfully spray dried, formulated and characterised a vast range of pharmaceutical and biotechnology products for companies across the globe.

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Contact Us

Would you like to find out more about our services or how we can help advance your project?

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- Address

Upperton Ltd
BioCity Nottingham
Pennyfoot Street
Nottingham
NG1 1GF

- Contact
+44 (0)115 787 0175
enquiry@upperton.com