Formulation Development
Formulae for success
Eramol offers clinical formulation development and manufacturing services to enable you to develop your product and speed up your time to market. We’ll work with you to develop an effective formulation – either in solid tablet, capsule or liquid form - giving you optimal clinical outcomes that can support your product across all clinical trial phases.
Getting the very best clinical and commercial value from your product means making sure it’s manufactured in a viable, efficient way and its benefits are delivered quickly and effectively. In our MRHA-approved, state-of-the-art manufacturing facilities our formulation scientists can develop your IMP formulations, for whatever stage of your clinical trial:
From developing a fit-for-purpose formulation for First-in-Human trials, to scaling up for late phase trials and ultimately commercialisation, our pharmaceutical drug product development solutions are customised to meet your needs.
Eramol can also provide innovating placebo formulation development services to ensure blinding is maintained throughout the supply chain.
Meeting increased client demand, we have expanded our pharmaceutical drug product development services through the acquisition of new facilities located in Sevenoaks, UK. These purpose-built facilities provide a significant increase in our solid oral dose drug product development, manufacturing and analytical testing capacity ensuring we can meet your future pharmaceutical development and manufacturing needs.
Pre-formulation services:
- Chemical compatibility and reactivity to packaging substrates
- Physical properties and product characterisation
- Accelerated degradation
- (API)-excipient interaction studies
- pKa determination
- Hygroscopicity studies
- Photostability of API
- Prototype evaluations
- Reverse engineering & de-formulation
Formulation development services:
- Early Phase I rapid formulation & manufacturing optimisation to reduce time to trial
- Phase II-IV formulation development and reformulations
- Determining blending times for tableting, encapsulation and analysis of characteristics (blending time, bulk density, content uniformity and flow characteristics)
- Over-encapsulation and comparator product blinding
Developing matching placebo formulations and comparator supplies
Placebo Formulation Development
Drug product placebos are made to match the active product physical properties such as colour, shape and size in order to facilitate blinded clinical studies.
Analytical method development & stability studies
To this end, we offer Analytical Method Development services that bring into play new chemical entities, as well as the refinement of existing analytical methods.
Pre-GMP formulation
Eramol provides a comprehensive pre-formulation service with GMP sample production for pre-clinical trial materials. Formulations are rigorously tested and released ready for transfer to study teams.
GMP transfer and scale up
The goal of technology transfer activities is to transfer product and process knowledge from development and GMP clinical production to support early through to later phase studies.
Deformulation & characterisation
De-formulation is the analysis of a product where a lab breaks down a material or product to determine the identity and quantity of its components. Sometimes known as “chemical reverse engineering,” this process enables scientists to take a medication and discover the contents of its core and coatings.