Delivering Solid Form Solutions with Decades of Expertise – Your Partner for Solid State and Preclinical Formulation Services.
CONTACT
- info@solitekpharma.com
- [+34] 614 65 22 57
- Parc Científic de Barcelona, Carrer de Baldiri Reixac, 10-12 (08028)
Solid Form Screening & Selection Services for API Candidates
We identify the optimal polymorph, salt, or cocrystal to maximize bioavailability, stability, and patent protection.
Experts in integrated Solid State Mapping and Analysis
Comprehensive identification of stable and metastable forms, hydrates and solvates.
Advanced Technology for Screening
Proprietary in silico tools for virtual screening of cocrystals.
Low API Consumption
Virtual screening and small scale protocols designed to maximize the use of valuable APIs in Late Discovery.
+ 40 Years of Solid State
More than 40 years dedicated to the development and optimization of small molecules solid state.
Polymorph Screening Services
The Risks of an Undetected Polymorph:
- Late discovery of a new, more stable but less soluble polymorph invalidates all dissolution and bioavailability data obtained up to that point.
- Leaving blind spots by patenting only a single solid form gives competitors a clear path to discover and file alternative versions with a commercial edge.
- Treating low solubility with complex, costly formulation strategies instead of having chosen the optimal salt or co-crystal from the onset.
- Regulatory delays and multi-million-dollar cost overruns from having to repeat preclinical studies due to crystalline form variability during scale-up.
- Loss of asset value or license rejection during acquisition due diligence, as a result of an incomplete or questionable solid-state data package.
Solid-State Screening Services and Development
We help revolutionize solid-form selection by combining our deep expertise with advanced precision technology:
We develop crystallization processes focused on stability, reproducibility and industrial control from the start:
1) AI-Driven Virtual Cocrystal Screening
We leverage quantum computational technology to simulate the interaction between your API and vast libraries of pharmaceutical coformers. We rank candidate pairs by affinity before any work reaches the bench, cutting lab time by weeks and multiplying the success rate.
2) Polymorphic Landscape and Phase Diagram Mapping
We explore crystalline diversity using evaporation, cooling, anti-solvent, thermal/humidity stress, and mechanochemical (grinding) crystallization techniques. We map the relative stability of each polymorph and establish the cocrystals' phase diagrams.
3) Salt Screening and Counterion Selection
We identify the ideal salt form through systematic counterion screening, drastically improving your drug's dissolution, hygroscopicity, and stability.
4) Cocrystal Screening for Neutral Active Ingredients
We combine your molecule with safe coformers to enhance dissolution and stability, while keeping the original molecule intact.
Key Benefits of Our Solid Form Screening Service
- Achieve a multi-fold increase in solubility without modifying the molecule. We dramatically improve the dissolution rate and bioavailability of neutral active ingredients while preserving the API's chemical structure and therapeutic efficacy.
- Achieve physical optimization for ionizable molecules. We identify the ideal counterion for your molecule, ensuring greater crystallinity, a superior dissolution profile that simplifies plant-scale processing, and long-term commercial stability.
- We discover and patent the best crystalline forms of your molecule to protect your innovation and extend its market exclusivity against the competition.
- Save material and R&D costs. We carry out the full characterization study using less than 0.5 gram of API, protecting your budget and your most valuable asset.
- Achieve a fast, low-risk path to market: we identify alternative solid forms that support freedom to operate, helping both originator and generic companies secure a clean path to commercial launch.
- Optimize the release profile: we select the physical form that fine-tunes the drug's release rate, matching precisely with your formulation strategy.
- Enable a smooth, robust technology transfer: we design a robust, well-controlled crystallization process around your chosen solid form, ensuring efficient scale-up and a smooth handoff to your CDMO.
- Access faster regulatory approvals: we advise you on the physical characterization required by the FDA and EMA, already knowing what needs to be included in your quality dossier.
Strategic Solid Form Screening
Protect Your Patent and Extend Its Lifecycle: Strategic solid form selection for patent protection and lifecycle extension
Early Development - new form discovery for IP
Discovery of new crystalline forms with superior physical properties, enabling new patent filings and extending market exclusivity.
Late Development - IR/CR formulation support
Selection of specific solid forms to support immediate-release (IR) or controlled/sustained-release (CR) formulations.
Generics - freedom to operate
Development of alternative, non-infringing polymorphs, salts, or cocrystals that support your freedom to operate.
Testimonials from Pharmaceutical Companies That Have Already Put Their Trust in Solitek
About Solitek Pharma
Company specializing in polymorph screening services
Solitek Pharma was founded to reduce risk and prevent costly failures in small molecule drug development, drawing on over 50 years of accumulated experience in the pharmaceutical industry, including more than 40 years focused specifically on solid-state science.
Our expertise was built at internationally recognized pharmaceutical companies such as GSK, Johnson Matthey, and Almac, Spanish companies such as Esteve and Medichem, and specialized solid-state teams such as Pharmorphix and Enantia.
We have participated in more than 1,000 drug development programs, giving us the practical perspective needed to approach each project with a clear sense of what truly needs to be accomplished and decided at every stage.
Our current company, Solitek Pharma, was founded in 2021 and is based at the Barcelona Science Park (Parc Científic de Barcelona), a hub for operations and specialized talent in our sector.
We are an agile team of experts who work closely with our clients, integrating as an extension of their development teams. We focus on what’s needed here and now, helping projects advance with lower risk and greater value for future partners.
"The team at Solitek is world-class. Experts in their field and with a customer-focused attitude, they have supported us on multiple solid state projects over the years, consistently delivering both in terms of technical execution and clean project management and reporting”.
Anthony Debono
Head of R&D API – Medichem, SA
"Solitek provided a highly professional and efficient service, supporting the scale-up process with clear communication, technical expertise, and reliable results".
Marta Monjo
Full Professor at Universitat de Les Illes Balears
“Trabajar con Solitek ha sido un placer. El reto técnico al que se enfrentaban era muy complejo y lo resolvieron con optimismo, eficiencia y rapidez. Colaborar con ellos resultó sencillo y ágil. Su conocimiento técnico y su excelente actitud para afrontar y superar desafíos los convierten en un aliado clave para nuestros proyectos en estado sólido y polimorfismo.”
R&D Director
CDMO & Generics Company
‘Efficient, comprehensive, and budget-friendly, Solitek delivered results that exceeded expectations by identifying polymorphs overlooked by another lab. Their expertise gives me peace of mind when outsourcing my projects.’
Wen Chen
Head of CMC at Eccogene, Inc.
Working Together and Strategic Partners
The Value of Experience in Solid Form Screening
Our 3-Step Work Process
Seamless integration as part of your own laboratory
Frequently Asked Questions About Solid Form Screening Services
1. How can virtual cocrystal screening shorten my drug development timeline?
Rather than experimentally testing hundreds of coformer combinations without prior selection, Solitek Pharma uses virtual cocrystal screening and solid-state expertise to rank coformers according to their likelihood of forming a cocrystal with the API.
This allows us to focus laboratory testing on the most promising candidates, reducing unnecessary experiments, API consumption and the time required to identify viable cocrystal forms.
2. What is the minimum amount of API required for a comprehensive solid form screening program?
By combining computational prioritization, where applicable, with small scale experimental and analytical methods, we can typically design polymorph screening or salt screening studies using as little as 0,5 to 1,5 g of API.
3. Why should salt screening be performed before moving to complex formulation strategies?
For compounds with suitable ionizable groups, salt screening can identify forms with improved solubility, dissolution rate, physical stability or processing properties.
This may provide a simpler, more economical and more scalable development route than complex formulation strategies such as amorphous solid dispersions or nanoemulsions.
4. Can solid form screening help protect our product from generic competition?
Yes. A thorough assessment of the solid form landscape can identify potentially patentable polymorphs, salts, solvates and cocrystals can strengthen the product’s intellectual property position and reduce the number of unexplored solid-form routes available to competitors.
However, solid form screening does not in itself prevent generic entry, and any patent strategy should be developed with qualified intellectual property counsel.
Reduce Risk in Your API Candidate Through Expert Solid Form Screening Analysis
Don’t leave your active ingredient’s solid form selection to chance. Partner with solid-state experts to accelerate your preclinical development with scientific confidence and data-driven insights.
