Solid-State Characterization for the Pharmaceutical Industry

Discover your API's exact crystalline structure to safeguard your patents, avoid CMC surprises, and ensure maximum formulation stabilit

Solid Form Characterization Experts

Comprehensive characterization of stable and metastable forms, hydrates, and solvates to ensure optimal performance.

Efficient API Utilization

Micro-screening protocols designed to maximize the use of valuable API grams during Discovery and Early Development work.

Advanced Analytical Capabilities

Cutting-edge instrumentation and techniques deliver precise, reliable characterization of every solid form.

40+ Years in Solid-State Science

More than 40 years dedicated to solid-state science, its development, and optimization.

Solid State CMC & Regulatory Risks

Avoidable situations that put your program at risk

Critical Regulatory Surprises:

Unexpected polymorphic changes during development or scale-up that stall your regulatory filing.

Physical and Chemical Instability:

API degradation or changes in dissolution rate caused by a poorly understood solid-state form.

Patent Vulnerability:

Filing on an incomplete or incorrect characterization creates a weak patent that fails to protect what you're actually manufacturing.

Scale-Up Surprises:

Incomplete solid state characterization at lab scale leads to unpredictable behavior at plant scale, causing downtime and serious quality failures.

Formulation Incompatibilities:

Advancing to complex formulation systems without fully understanding the API's actual interaction with excipients results in loss of bioavailability and failed stability testing.

Solid State Characterization Services

We give you complete, defensible knowledge of your API's solid-state form

1. Batch-to-Batch Consistency:

We solve unexpected differences in dissolution or hygroscopicity between seemingly identical batches by identifying the root solid-state cause.

2. Advanced Physicochemical Analysis:

High-precision structural characterization using state-of-the-art analytical techniques (XRD, DSC, TGA, DVS).

3. Forced Degradation Studies:

We assess solid-state behavior under thermal stress, humidity, and mechanical stress (grinding) to define optimal storage and process conditions.

Key Benefits of Our Solid-State Characterization Service

Patent Protection: We identify the optimal crystalline forms of your drug so you can patent it, protect your commercial exclusivity, and block the competition for longer.
Reduced Risk: Get the analytical data needed to fully understand your API's solid-state behavior, avoiding costly surprises and regulatory holds during submission.
Efficient Use of Valuable API: Obtain complete physicochemical profiles using minimal amounts of active ingredient during early preclinical phases.

Remove Bottlenecks: Anticipate your API's physical behavior (dissolution, hygroscopicity, thermal stability) before it becomes an unplanned delay later in development.
Predictable Design: Know your molecule's hygroscopicity, melting point, and thermal stability with precision, so you choose the right excipient and formulation the first time.
Inspection-Ready Documentation: Present the FDA or EMA with dossiers backed by rigorous analytical data, ensuring a smooth review with no unexpected findings.

Testimonials from Pharmaceutical Companies That Have Already Put Their Trust in Solitek

    
 
 
       Posted on Google  
   
   Neil Sim 
 
 
 
 Trustindex verifies that the original source of the review is Google. At HFR, we have collaborated with Solitek across numerous projects for a number of years. Across all projects that we have collaborated on, I have felt that Solitek really work to fully understand the project from the outset. Victor, Steve and all of the team provide expert knowledge across the solid state landscape and combine a methodical approach with scientific rigour. Their communication and reporting is thorough and clearly presented, providing further value when working on more challenging and complex landscapes.
  
 
      Posted on Google  
   
   Anthony Debono 
 
 
 
 Trustindex verifies that the original source of the review is Google. I have collaborated directly with Solitek on a number of projects. I highly recommend the team. They combine deep technical expertise and experimental know-how, with an efficient and collaborative customer service. Thanks to their decades of experience in the field they are able to give solid advice on development approaches and are proactive and transparent during project execution.
  
 
      Posted on Google  
   
   Josep Castells 
 
 
 
 Trustindex verifies that the original source of the review is Google. La experiencia con Solitek durante el desarrollo de una molécula activa farmacéuticamente fue muy positiva por su gran profesionalidad y la capacidad de superar los retoques técnicos.
  
 
      Posted on Google  
   
   Adria Espinas Torres 
 
 
 
 Trustindex verifies that the original source of the review is Google. Great experience working with Solitek from Farmhispania Group on solid-state projects. We collaborated in the development of robust and scalable API crystallization processes and solid form selection and characterization, and they always bring clear, practical solutions. Working with Steve, Víctor, and the rest of the team has been very smooth, with close and easy communication throughout. They are agile, adapt well to project needs, and are strongly results-oriented. Strongly recommended!
  
 
      Posted on Google  
   
   David 
 
 
 
 Trustindex verifies that the original source of the review is Google. AKL Therapeutics had approached Solitek regarding an unusual and difficult  issue associated with a liquid eutectic formulation.
Solitek devised a clear and systematic plan of investigations to solve the outstanding problems and were well equipped to conduct the necessary specialist studies in this area. The staff have very good practical knowledge and experience in the area of pharmaceutical formulation development.
The investigations Solitek conducted proved to be fully enlightening as to and understanding of key issues involved in the development of a suitable formulation for the concerned molecules.
The standard of reporting was excellent with regular scheduled updates that were well communicated by the Solitek team.
We would certainly recommend Solitek as a competent and capable partner in the area of pharmaceutical formulation development.
John McCrerie for AKL Therapeutics
  
 
      Posted on Google  
   
   Ernesto Durán López 
 
 
 
 Trustindex verifies that the original source of the review is Google. Over the past few years, we have carried out several collaborations with Solitek to address different aspects related to the solid‑state development of pharmaceutical active ingredients. These projects have included salt‑screening studies to modulate API solubility, the exploration of new polymorphic forms and co‑crystals to help overcome IP barriers, and the optimization of process parameters to enhance the robustness of crystallizations at industrial scale.

Throughout all these collaborations, the Solitek team has consistently demonstrated strong technical expertise, provided high‑value scientific input, met every agreed timeline, and delivered reports of outstanding quality. Without a doubt, having them by our side when complex challenges arise makes a real difference.
  
 
      Posted on Google  
   
   DBS Chen 
 
 
 
 Trustindex verifies that the original source of the review is Google. With over 20 yrs of outsourcing experience, I have to say Solitek is efficient, comprehensive, and budget-friendly. Their expertise gives me peace of mind when they handle my projects.
  
 
      Posted on Google  
   
   Marta Monjo 
 
 
 
 Trustindex verifies that the original source of the review is Google. Solitek nos ha ayudado muchísimo en la optimización y el escalado de nuestro proceso. Han demostrado un gran conocimiento técnico y una excelente capacidad para encontrar soluciones prácticas a los retos que han ido surgiendo durante el proyecto.

Los estudios de familiarización realizados posteriormente en planta kilo-lab fueron todo un éxito y nos aportaron información muy útil para seguir avanzando. Además, durante todo el proceso de industrialización han seguido brindándonos apoyo y asesoramiento ante cualquier consulta o necesidad que ha surgido, demostrando un gran compromiso con el éxito del proyecto.

Ha sido un placer trabajar con un equipo tan profesional, cercano y comprometido. Muchas gracias!
  
 
      Posted on Google  
   
   I Maikel 
 
 
 
 Trustindex verifies that the original source of the review is Google. Nuestras colaboraciones con Solitek han sido muy satisfactorias. Su profundo conocimiento del estado sólido, y de los procesos de optimización y escalado han rendido procesos sólidos, fiables, bien documentados y fáciles de transferir. Un placer trabajar con ellos.
  
 
      Posted on Google  
   
   Jacques Alain Bauer 
 
 
 
 Trustindex verifies that the original source of the review is Google. The experience with Solitek Pharma projects were perfect, with real-time communication, very flexible collaboration and excellent reporting.

About Solitek Pharma

Company specializing in solid state characterization 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

Extensive Experience and Cutting-Edge Technology at Your Team's Disposal

Our 3-Step Work Process

Seamless integration as part of your own laboratory

STEP 01

Technical Assessment and Scope Definition

We analyze your existing API data, identify crystallization risks, and define key objectives (polymorph, PSD, purity, yield)

STEP 02

Testing Execution and Process Optimization

We execute the work plan at our facilities in the Barcelona Science Park, using advanced characterization and screening tools to reduce risk and optimize every phase of the process.

STEP 03

Clear, Data-Driven Action Plan

We deliver a detailed, actionable technical report, ready for use in regulatory audits or direct transfer to your CDMO.

Frequently Asked Questions About Solid-State Characterization

1. How much API is required for solid-state characterization?

Our microscale protocols are optimized to work with very small quantities (100 – 500 mg), making them ideal for early-stage phases where material is scarce and expensive.

2. How does solid-state characterization support patent protection?

Thoroughly characterizing a crystalline form’s thermodynamic properties and stability allows patent claims to be drafted with precision and defensibility — ensuring the patent accurately reflects and protects the actual form you’re manufacturing.

3. Are Solitek's reports valid for submission to the FDA or EMA?

Yes. All of our studies are conducted under strict quality standards with full traceability, specifically designed to integrate seamlessly into the chemistry sections of your IND or IMPD filings.

4. What is the difference between polymorph screening and in-depth structural characterization?

Polymorph screening focuses on the systematic discovery and mapping of all possible crystalline forms (polymorphs, salts, hydrates, and solvates) that an API can adopt.

On the other hand, in-depth structural characterization, thoroughly analyzes the thermodynamic stability, phase behavior, and physicochemical properties of selected forms to confirm their viability for pharmaceutical development and regulatory submission.

Uncertain About Your API's Crystalline Structure or Behavior?

Don’t let polymorphism risks or solid-state instability stall your patents or delay your regulatory filing.

Partner with Solitek’s advanced characterization experts to ensure maximum stability, safeguard your intellectual property, and confidently accelerate your path to clinical trials.