Services - Solitek

Solitek offers development stage-appropiate advice to help you reduce the risk of failure during the later development stages and to maximise the returns from potential out-licensing opportunittes.

Solid state characterisation

Solid state characterization is key to understanding the physical properties of solid materials. These physical properties can have an impact on the material’s bulk properties, formulation performance, processability, stability and appearance.

A deep understanding of the physical properties of the molecules will be useful to understand the potential challenges that that form may encounter during development or manufacturing and will feed back into the design of the active ingredients to optimize the physicochemical attributes that will make them more likely to succeed depending on their specific application.

Understanding the crystallinity behavior of the molecule, as well as its thermal properties, hygroscopicity, etc. will help us evaluate the fitness of the current form for development and will establish the basis against which different batches of material produced should be measured.

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Solid form screening and selection

Solid form screening and selection is critical for the successful development of active ingredients. New chemical entities are facing increasing challenges in their physical properties (solubility, dissolution rate, ability to crystallize, stability, etc), and the selection of the right crystalline form is a fantastic way to optimize their physical attributes. Plus, it offers and excellent entry to novel intellectual property.

Salt or cocrystal selection, where physicochemical properties of the molecules can be modulated to suit your development strategy. The formation of a salt or cocrystal will depend on the ability of the drug candidate to ionize (pKa) or in the ability to exploit other interactions (H-bonds or stack interactions) respectively. Other factors depending on the specific application will be taken into consideration to design a screen with high chances of success.

In the pharmaceutical industry, regulatory authorities require that companies have full control on the physical properties of their development candidates, to ensure that no changes will occur during later development, manufacturing or even commercialization that may affect the performance or safety of the drugs. Performing a polymorph screen early during development will help you greatly to manage the risks associated to solid-solid transitions or new potential polymorphs appearing later that may alter the behavior of the drug causing potentially large costs of re-working existing batches and potential losses of revenue if the drug has to be withdrawn from the market. A phase appropriate polymorph screen design will help you manage the risk without committing more resources that are necessary depending on the development stage of the drug.

Other less regulated industries can also benefit from the selection of an optimal solid form depending on the intended application. A deep understanding of the physical properties of the molecules will be useful to understand the potential challenges that that form may encounter during development or manufacturing and will feed back into the design of the active ingredients to optimize the physicochemical attributes that will make them more likely to succeed depending on their specific application.

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Crystallization process development

Once a suitable solid form has been selected, the next step is to know how to reproducibly make this form using a robust and scalable process. As well as the polymorphic form, particle size distribution (PSD) and crystal habit are often key product attributes that affect performance or processability. Unfortunately, the PSD and crystal habit are often highly susceptible to changes as the process is developed and scaled.

Solitek can provide the key knowledge of solubility and crystallization kinetics, growth and nucleation, and how these are affected by chemical engineering factors, thereby avoiding surprises on transfer from lab to kilo-lab, pilot plant and manufacturing.

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Early enabling formulation development

Through the synergy between solid state chemistry and formulation, we can add value to your pre-clinical project, while decreasing timelines. During preformulation, the physicochemical properties of the drug substance are investigated. Understanding the relevant physiochemical and biopharmaceutical properties determines the appropriate formulation and delivery method for pre-clinical and Phase 1 studies. Performed using small-scale analysis techniques, we can determine key characteristics of drug molecules even when solubility is low and drug material is limited.

Our experience and technical knowledge can rapidly identify molecule challenges with protocols which emphasize efficient use of resources. Applying our understanding of drug physicochemical properties, we can offer tailored and rational preclinical formulation development.

Using the Developability Classification System (DCS) as our framework, we examine how the physicochemical characteristic of a compound may affect oral absorption and bioavailability, determining risk and suggesting formulation strategies. Using a rapid excipient screening approach, we can provide preclinical formulations which enhance drug solubility and overcome in vivo sources of pharmacokinetic variability. In vitro testing using biorelevant models can demonstrate formulation abilities to promote supersaturation and resist unfavorable situations such as pH-mediated precipitation and food effects.

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Training and consultancy

Our team of experts would be delighted to share their knowledge and experience with you. These services could be both theoretical and practical, and located either in Solitek’s site in Barcelona or at the customer’s choice of venue. Please contact us for more information.

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Integrated drug discovery

Charnwood Molecular is an award-winning, UK-based CRO which has been providing expert drug discovery and development support for over 20 years. It is a results-driven, dynamic company committed to delivering success for global clients.

Clients range from virtual start-ups to established global agrochemical, materials chemistry, diagnostic, biotechnology and pharmaceutical companies. We undertake projects requiring bioscience, DMPK / ADME, medicinal, computational, and synthetic chemistry services which can vary considerably in terms of scope and deliverables.

These projects typically range from a single scientist, engaged on a short-term “proof-of-concept” research project for a new start-up business, right through to a multi-scientist, multi-year drug discovery and development collaboration with a leading global pharmaceutical or biotechnology company.

An expert scientific team, which enjoys the benefit of substantial and varied industrial and academic experience, they provide expertise at all stages of your research project, aiming for intellectual input and novelty in your programs. Their scientists seek to achieve research excellence in their work and are passionate about maintaining their market-leading status. Sharing the same laboratory space at a cutting-edge campus facility, teams across all disciplines work closely together on client projects.

Charnwood Molecular‘s portfolio of services is wide and currently includes: Integrated drug discovery from target to candidate, customised bioassay development, DMPK / ADME for analysis and insight medicinal chemistry (design, synthesis and multi-parameter optimisation of drug molecules for discovery projects), computational chemistry, custom synthesis preparation of key chemical intermediates on up to 20-litre scale, chemical development and process research including route design, development and optimization. Analytical chemistry supports all of these services.

For more information please visit: www.charnwood-molecular.com or contact the Business Development team: info@charnwood-molecular.com

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Solid state characterisation

Solid form screening and selection

Crystallization process development

Early enabling formulation development

Training and consultancy

Integrated drug discovery

Solid state characterisation

Solid form screening and selection

Crystallization process development​

Early enabling formulation development

Training and consultancy

Integrated drug discovery

Crystallization process development