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)
Enabling Preclinical Formulation Services
Take your drug from the lab to clinical trials by overcoming solubility challenges.
At Solitek, we transform poorly soluble active pharmaceutical ingredients (APIs) into effective, stable formulations to ensure the success of your toxicology, efficacy, and pharmacokinetic studies.
Maximum Solubility
We have achieved concentrations up to more than 800 mg/mL for complex molecules through custom-tailored formulations.
API Savings
We used optimized protocols to obtain maximum results while consuming the minimum amount of material (milligrams).
Biorelevant Simulation
We evaluate drug response in simulated gastric and intestinal fluids to predict behavior in animal and human studies.
+ 40 Years of Solid State Science
Over 40 years dedicated to solid-state science, its development, and optimization.
Formulation Development Services
Nearly 80% of drugs suffer from poor solubility, and advancing to preclinical trials without the right formulation is practically a guarantee of failure. This can result in:
Insufficient Absorption in Preclinical Trials:
Poor solubility prevents the drug from entering the bloodstream in the concentration needed to achieve a therapeutic effect.
Variable Preclinical Data:
Drug precipitation in the intestine causes absorption results to vary too widely between subjects, undermining the reliability of the study.
Waste of Promising Drug Candidates:
Formulating without a prior strategy quickly depletes valuable active pharmaceutical ingredient before valid results can be obtained.
Regulatory Roadblock:
Lacking a tolerable formulation stalls program progress and delays the submission of dossiers to regulatory bodies.
Devaluation of the Candidate:
A poor absorption profile undermines buyer or licensee confidence, devaluing the candidate's commercial potential.
Our Enabling Formulation Services
Solitek helps you find safe, stable vehicles that maximize your API's exposure in the body
1. Rapid Excipient Screening
We rapidly screen different approved cosolvents, lipids, and additives at microscale to find the perfect blend that dissolves your drug without causing toxicity.
2. Amorphous Solid Dispersion (ASD) Development
We stabilize your drug in its high-energy amorphous form using polymer matrices, preventing recrystallization back to the more stable — but less soluble — crystalline form, and unlocking superior dissolution.
3. Lipid-Based Formulations and Nanoemulsions
We design self-emulsifying, lipid-based systems that keep poorly soluble drugs fully dissolved and ready for absorption throughout the entire intestine.
4. Biorelevant Dissolution Testing
We test how the drug dissolves and behaves in simulated gastric and intestinal fluids under different conditions, to ensure its stability before advancing development.
Strategic Benefits of Partnering with Solitek for Early Formulations
- We develop enabling formulations that dramatically boost the solubility of complex molecules, allowing you to reach the doses required for demanding toxicology studies.
- We carefully select the ideal excipients to ensure safe, stable, reproducible dissolution profiles, eliminating variability in PK studies.
- We save API during the preclinical phase by optimizing microscale formulation protocols to consume the minimum amount necessary.
- We de-risk and accelerate development with high-confidence predictive testing, evaluating the drug in vitro using biorelevant media to anticipate in vivo behavior before the first animal study.
- We know how to select combinations of tolerable excipients that are compatible with preclinical routes of administration, avoiding toxic side effects attributable to the vehicle or formulation.
- We establish the technical formulation foundation that facilitates subsequent scale-up to solid or liquid clinical dosage forms, reducing the failures during the critical CMC phase.
- We reduce costs and accelerate preclinical development timelines through our proprietary rapid screening protocols and predictive modeling.
- We deliver detailed analytical reports documenting formulation solubility, stability, and behavior, essential for critical decision-making.
Enabling Formulation & Bioavailability Enhancement
Overcome solubility challenges and accelerate your transition to the clinical phase:
If You're a Biotech:
We optimize microscale protocols, maximizing your API material while meeting the highest safety and toxicity standards.
If You're a Generics Company:
We design advanced, non-infringing formulations to overcome patent barriers, ensure success in bioequivalence studies, and accelerate your time to market with reliable protocols and formulations.
If You're a Pharma Company:
We accelerate your clinical programs with advanced, scalable formulations that resolve regulatory challenges, ensuring a frictionless transition to animal or human trials.
Testimonials from Pharmaceutical Companies That Have Already Put Their Trust in Solitek
About Solitek Pharma
Company specializing in enabling formulation 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 Enabling Formulation
Our 3-Step Work Process
Seamless integration as part of your own laboratory
Frequently Asked Questions About Enabling Formulations Services
1. What is an enabling formulation in the early stages of drug development?
An enabling formulation is a technical vehicle designed to temporarily solubilize and stabilize molecules with poor solubility (BCS Class II/IV). Its purpose is to ensure adequate in vivo exposure during PK, efficacy, and preclinical toxicology studies.
2. How does Solitek minimize API consumption during formulation evaluation?
At Solitek Pharma, we use microscale screening protocols that allow us to evaluate dozens of excipient combinations while consuming only fractions of a gram of API — making this approach highly cost-effective for early-stage development programs.
3. What formulation technologies does Solitek offer?
We specialize in oral and injectable solutions, as well as stabilized oral suspensions, designed from a deep foundation in solid-state science and crystallization behavior.
This approach allows us to select the optimal solid form and formulation system from the outset — avoiding the trial-and-error excipient screening typical of generalist providers. Other technologies, such as ASD or HME, can be used to address specific challenges.
4. How is formulation performance validated before PK or Tox studies?
We evaluate in vitro dissolution, solubility and precipitation behavior using physiological, biorelevant media (FaSSIF/FeSSIF) that simulate the human or animal species gastrointestinal environments, providing strong predictive insight ahead of in vivo studies.
Do You Have a Promising Drug That's Insoluble?
Don’t let solubility issues stand between your molecule and clinical trials.
Partner with Solitek Pharma’s solid-state and enabling formulation experts to maximize in vivo bioavailability.
