Solitek, a new company focusing on high-quality solid state development services, has settled in the Barcelona Science Park. The company provides a comprehensive approach of the solid form development for small molecule pharmaceuticals. Solitek combines an excellent understanding of the diversity of the solid form landscape exhibited by small APIs, with the experience and the practical know-how to add value to new chemical entities, while reducing the overall cost of development, protecting intellectual property, and increasing marketing or out-licensing possibilities.

Solitek, founded in 2021, brings a new concept in solid state development services to provide comprehensive and innovative solutions to the pharmaceutical market: preformulation, particle engineering, crystallisation scale-up and intellectual property development.

The founders, Dr. Victor Diaz (Operations Director) and Dr. Steve Winter (Scientific Director), have a combined experience of nearly 50 years in the pharmaceutical industry, working on drug discovery & development in large companies, and in the field of solid state development services for CROs and CDMOs, where they have had an important impact on the successful development of numerous drugs, many of which have come to be commercialized.

The company team is completed with Rosa Maria Espinosa (Lead Scientist), with more than 10 years of experience in leading pharmaceutical companies and solid-state providers in both the UK and Spain, holding roles in both early and late phase development, providing expert physicochemical input into compound selection and developing crystallisation processes.

“We are a small, but agile team. Decision makers also participate in the technical aspects of the work. This enables us to react quickly to changes in scientific findings and priorities, and tailor projects to our clients’ needs without delay. We promote collaboration over competition, and we believe in the synergy of two teams working together towards a common goal”, says, Dr. Steve Winter.  “Our studies carry the inherent flexibility associated to early development programmes. We focus on problem-solving to help our clients reduce the risk of failure during the later development stages and maximizing the returns from potential in-licensing partners, and all of that with the best value for money available in the market”.

Solid state characterisation

Solid state characterisation is highly relevant in the pharmaceutical industry. The therapeutic efficacy of a drug is directly related to the physicochemical properties of the active ingredient or API (Active Pharmaceutical Ingredient). In addition, other physical attributes of the particles such as particle size, morphology, and crystal habit will influence their release rate, bioavailability, and product stability.

“Selection of the optimum solid form is key as it provides control over the attributes of particles containing active ingredients and will influence the efficacy and shelf life of a drug. Different properties of the particles will also play a fundamental role, both in the processability of the material during manufacture or formulation, and in the pharmacokinetic properties of a new drug. One of the best ways to achieve this is to gain a deep understanding of the crystallisation process, but the concepts of physical chemistry and chemical engineering required are often unknown areas to the synthetic organic chemist who is usually in charge of the study”, explains Steve Winter.

Solid forms also generate avenues for intellectual property protection, thus evoking interest of the chemical and pharmaceutical industry.

Solitek offers a global vision of this entire process to reduce the time and costs of preclinical development of new formulations, optimize the physicochemical properties of drugs, minimize risks in the clinical phase, thereby ensuring successful registration, and bringing with it the commercial possibilities of the new products.

“The pharmaceutical industry has seen the emergence of numerous companies offering solid-state services in recent years. Some of our competitors offer these services based on the erroneous idea that it is enough to invest in instrumentation, without considering the real meaning and implications of the science behind the analyses. In some cases, the personnel conducting these studies are young scientists, with no prior experience or knowledge of the drug development process, who have been trained to use the equipment but do not possess a fundamental understanding of solid state science, making it difficult for them to challenge established protocols”, says Dr. Victor Diaz.

“We also have experience and knowledge on the use of automation and how to successfully implement this technology in R&D, leaving scientists more time to plan and interpret the results. Although we will not carry out this project in the first years of the company, but when we are more established, the infrastructure already exists”, he adds.