Formulation Development

formulation development

The Complete Formulation Development Service

When you move from discovery to development the process will involve:

  • Preformulation – assessing solubility, stability, physical form etc
  • Selection of the best form – salt / polymorph
  • Developability screen
  • Development of a preclinical formulation
  • Development of a phase 1 clinical trial formulation
  • Development of later phase clinical trial formulations and finally adaptation of this to a commercial form

Pharmaterials can help with every step on this path:

  • Select the salt and polymorphic forms
  • Assess formulation options
  • Develop pre-clinical formulations
  • Develop clinical formulation
  • GMP manufacture
  • Stability testing

All with Pharmaterials in our facility with the same staff involved throughout.

Solid Oral Dosage Forms

Pharmaterials offers a range of conventional approaches for formulation:

  • Xcelodose powder in capsule – GMP manufacture, fast to man
  • Micronisation, ordered mixing and granulation
  • Tablets
  • Capsules (Powder blends or liquid fill)
  • Amorphous formulation – full GMP spray drying and Hot Melt Extrusion
  • Microfluidised formulations – size reduction and dissolution enhancement, GMP manufacture
  • Modified release solid oral dosage forms
  • Film coating

We provide seamless transfer of any formulation to our in house GMP manufacturing facility.

The complete quality service:

We aim to get you the information faster, to communicate effectively and to provide the consultancy help and support you need to maximise the success of your API.

Pharmaterials have great experience in formulation of poorly soluble drug substances for oral and parenteral routes and of formulation of small and macromolecules for inhaled routes of delivery.

Approximately 60% of all new chemical entities coming from the discovery phases are poorly bioavailable, leading to many potentially innovative drug candidates being abandoned due to poor pharmacokinetic properties (such as poor water solubility or poor intestinal permeability). At Pharmaterials, our expertise is in finding formulation solutions to rescue such challenging compounds.

We have developed several drug delivery technologies to enable us to act on low solubility and/or low permeability drugs. Through our experience our team of formulators advise our clients as to the risks, timelines and expenses related to progressing their compounds in order to develop a viable and cost effective formulation.

Each formulation is designed around the physicochemical properties of the molecule in question and also on the dosage form desired.

For more information on how Pharmaterials can assist with your company’s product development, please contact us for further details.