Advanced
Formulation
Unlocking the full potential of bioactive molecules through advanced pharmaceutical formulations
At RCPE, Advanced Formulations combines academic and scientific excellence with industrial experience to address drug formulations and drug delivery challenges for small and large molecule APIs, as well as new modalities.
We work across a range of administration routes and dosage forms, such as:
oral, pulmonary, parenteral, topical, vaginal
Our experienced team enables pharma companies to develop delivery vehicles for next-generation molecules, and thus, improve patients’ lives.
What we Do
Knowledge-Driven Design
Knowledge driven and model supported material and advanced formulation design to address solubility and stability challenges for small and large molecule APIs
Formulation Route Selection
Guidance on advanced formulation route selection, covering amorphous solid dispersions, dispersed systems, co-amorphous and co-crystalline systems, nanostructured drugs, encapsulation and complexation approaches
High Drug-Load Development
Performance & Manufacturability
Early integration of formulation performance and manufacturability throughout development
Low-Material Screening
Efficient formulation screening using minimal amounts of material, enabling rapid decision making for many formulation designs, including those made via melt based and solvent based manufacturing platforms
Generics & Lifecycle Support
Areas of Application
Our capabilities enable advanced drug delivery solutions from solubility enhancement and high concentration biologics to oral peptides and long acting dosage forms. By combining formulation expertise, process technologies and advanced analytics with in silico modeling, we address key challenges in stability, bioavailability and manufacturability for complex pharmaceutical products.
Solubility enhancement strategies
RCPE develops advanced formulations, such as polymer- or lipid-based amorphous and crystalline solid dispersions (ASD/CSD), co-amorphous systems, co-crystals or self-emulsifying drug delivery systems (SEDDS) to address low solubility, limited permeability, and stability challenges. Using characterization methods, such as DSC, X-ray diffraction, solubility determination methods and in vitro testing (biorelevant and compendial), we answer questions around the structure, performance and stability of multiphasic systems of APIs and excipients. Building on our in-depth process knowledge (e.g., hot melt extrusion, spray drying, mechanochemistry, etc.), expertise in material science and our capabilities in product performance and structure characterization, we deliver solutions for complex molecules.
High-concentration biologics for subcutaneous injections
RCPE develops strategies to increase the feasible concentration of monoclonal antibodies and other biologics. We address viscosity, aggregation and manufacturability risks through tailored formulations and in silico modeling. Small-scale screening and in-house characterization are complemented by molecular dynamics modeling to explore interactions among drugs, excipients, proteins, and receptors.
Oral peptide delivery
Building on current research on oral peptide delivery, permeation enhancers, lipid-based systems and nano-formulations we work on strategies for improving the oral bioavailability of peptides and similar molecules. This supports next-generation oral dosage forms that respond to strong patient preference for oral alternatives to injectable peptides.
Pulmonary delivery
RCPE advances pulmonary delivery by combining particle engineering with spray drying expertise to develop next-generation dry powder inhalation (DPI) products. We focus on high drug-load, carrier-free formulations (e.g., lipid nano/microparticles, nanocrystals, co-amorphous/co-crystalline systems) and inhalable biologics, while expanding support for both innovative and generic inhalation medicines. Using in silico/in vitro models, device simulation, and intensified machine-learning-enabled screening (e.g., co-former selection), we accelerate the development of stable, differentiated, and effective inhalation therapies.
Long-acting specialized dosage forms for women’s health
We design and optimize long-acting modified inserts and implants, as specialized dosage forms tailored to therapeutic needs of diverse patient populations, with a special focus on women’s health. Our expertise covers high-loaded biologics, tailored dose and shape, and controlled release over extended periods with rapid prototyping (3D printing) and predictive modeling accelerating development and scale-up.
Reverse engineering and analytics
Applying state-of-the-art analytics for reverse engineering (“deformulation”), we deconstruct existing products or prototypes to understand critical excipients, particle characteristics, and formulation structures. We characterize thermodynamical, kinetical and microstructural factors via advanced analytics (mDCS, SWAXS, XRD, Raman microscopy, ssNMR, etc.) and relate them to the performance as well as physical and chemical stability in solid drug products. This knowledge supports formulation optimization, generic development, and life‑cycle management.
Why collaborate with RCPE in Advanced Formulations?
End-to-end formulation expertise
Industry-relevant infrastructure
Complete excipient and material insight
Innovative, fundable ideas
Ready to discuss advanced formulations or new dosage forms for your most challenging molecules?
Contact
Tamás Solymosi, PhD
Dr. Theresa Hörmann-Kincses