Working with Industry

Pharmaceutical Formulation Development

With many years of industrial experience, academic expertise and a range of enabling and proprietary technologies CPES offers a range of commercial pharmaceutical formulation development services unmatched by many CRO’s.

Our Aim

• Is the development of robust and compliant formulations for our clients.
• To resolve difficult challenges encountered during preclinical and clinical development.

With immediate access to an impressive range of supporting preformulation analytical equipment the centre can ensure full characterisation of the active and final dosage forms and a rapid turnaround of results. We offer development services for a number of dosage forms including oral (liquid and solid), transdermal, nasal and inhaled. 

Amorphous Forms

Most drug candidates in pharmaceutical development are highly pure and in a thermodynamical‌ly stable crystalline state. However upon initial isolation the active may be obtained in a fully or partially amorphous state, which possesses physical properties different from their corresponding crystalline state. Solid state modification from crystalline to amorphous can be a viable approach for enhancing drug dissolution and thus bioavailability. However, the high internal energy and specific volume of amorphous state relative to crystalline means that during processing or storage the amorphous state may undergo devitrification. Hence, amorphous solids require stabilization, it is common practice to prepare a dispersion in a pharmaceutically-acceptable polymer in order to achieve a stable form. Typically, amorphous forms are prepared via melt extrusion, spray or freeze drying.

Co-Crystal Screening, Characterisation and Scale-up

Identification of the optimized solid form of an API, was previously restricted to the free active or it’s salts. However, today we can add the option of co-crystals which is a form that consists of two or more components that are solid at room temperature but different from salts in that no proton is transferred from the acidic to the basic functionality.

Co-crystals have different physico-chemical properties than the free active or  salt, such as dissolution rate, solubility, melting point, chemical stability and hygroscopicity, and hence can exhibit more desirable critical quality attributes. We have vast knowledge and experience in the discovery of co-crystals and can screen co-formers to identify potential co-crystals via a number of methods, many of which we can perform at a larger scale. Following co-crystal identification our team can characterise and determine it’s physico-chemical properties identifying the benefits over the free drug or  salts.

Particle Size Reduction

Particle size reduction provides a number of attractions to the pharmaceutical formulator for the enhanced delivery of drugs with low aqueous solubility, primarily it markedly increases in surface area to volume ratio.

• Small Scale Micronisation: CPES offers lab scale micronisation minimum requirement c.2g.

• Nanocrystal-processing: Wet Bead Milling or High Pressure Homogenisation; Preparation of liquid /solid dosage forms of crystalline nanoparticulate suspensions/solids.

CPES can offer access to proven, cost effective, rapid and consistent particle size reduction technology that has been shown to produce crystalline nanoparticles (in the range 200-400nm) in aqueous suspension. Controlled stability studies have proven that the suspensions are stable over a period of 6 months. The nanoparticles have successfully been incorporated into solid dosage forms to provide enhanced in-vivo dissolution and absorption for drugs with low aqueous solubility.