Solid State Services

Through the creation of synergy between solid state chemistry and formulation development, our experienced scientists have the ability to add great value to your pre-clinical project, while decreasing timelines.

Characterisation Physical form Formulation Stability
Small molecules Crystallinity
Hygroscopicity
Particle size, shape surface area
Moisture / solvent content
Polymorph screening
Salt / cocrystal screening
Amorphous dispersion screening
Stable form determination
pH-solubility profile, pKa and logP
Permeability (Caco-2)
BCS classification
Solubility in pharmaceutical solvents & bio-relevant buffers
formufast™ screening
Development of stability indicating LC-MS method

Solid state stability
(heat, humidity, light)

Solution stability
(pH, oxidation, heat, light)

Peptides LC-MS
Absorption and fluorescence spectroscopy
Circular dichroism
NMR
Enabling salt screen Solubility in pharmaceutical solvents & bio-relevant buffers
Precipitation assessment

 

Service Overview

Our Physical Sciences group has a considerable breadth of expertise in form screening and selection, so they can skilfully guide you to make the right decisions at the right time. Read more on our form screening and selection services:

Enabling Salt Screen

If your drug candidate is at risk of failure due to poor oral bioavailability, handling issues or instability, or simply you want to develop a new dosage form, a salt (or cocrystal) form has the potential to dramatically improve the drug properties. An enabling salt screen has a quick turnaround and can be performed on less than 100mg. Almac has a proven track record in getting troublesome discovery candidates into the clinical phase using this method.

Polymorph Screening

Polymorph screening is designed to reduce the risks of drug development by finding the most stable form of the API and to define the form for clinical development and GMP manufacture. Our screening services are directed by highly trained chemists and analysts performing a scientific investigation tailored to your API properties, development phase and budget, rather than generic protocols using robotics.

Salt and Cocrystal Screening

The selection of an appropriate salt provides an opportunity to modify the API’s physicochemical properties and resultant biological characteristics. However, the salt form selected will influence a range of other properties. It should also be noted that screening for developable salt forms could strengthen the intellectual property of the API. A salt or cocrystal can also enable you to go over the next hurdle in the pharmaceutical drug development process, whether this is to move onto the initial toxicity studies or to go into clinical drug development.

Amorphous Solids

Amorphous drug substances can exhibit enhanced solubility over a crystalline form. However, the amorphous solid may be unstable to recrystallisation during the shelf life of a product unless it is stabilised as an amorphous solid dispersion. We can rapidly identify the most suitable polymers at the correct concentration for early drug formulation development. Prototypes are generated by solvent casting, co-melting, freeze drying or spray drying, fully characterised and their stability assessed. The scope will be tailored to your needs, development phase and budget.

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