Accelerate your drug development
Formulation development for small molecule drug products is a multifaceted process that integrates scientific research, technological innovation, and regulatory compliance. Each step, from pre-formulation studies to commercial production, plays a crucial role in creating a safe, effective, and high-quality drug product. Through careful design, optimization, and validation, pharmaceutical scientists at Eurofins CDMO develop formulations that maximize therapeutic benefits and improve patient outcomes.
At Eurofins CDMO, we specialize in developing innovative formulations that provide solutions to enhance bioavailability e.g. Highway to clinic platform for poorly soluble compounds) and control drug release (e.g colon targeting), especially for challenging-to-formulate drug candidates:
- Multiparticulate systems like mini tablets or beads
- Bilayer / Multilayer tablets
- Hard capsules
- Tablets
- Orodispersible tablets
- Amorphous solid dispersions
- Solutions
- Micro- and nanosuspensions
- (Micro-) Emulsions
- Creams / Gels / Ointments
- Powders
With over two decades of experience in drug development and manufacturing and a global presence with state-of-the-art facilities, we deliver high-quality, customized solutions for complex products and unique production processes.
Our Expertise
Our expertise extends to a wide range of drug product development and manufacturing technologies, enabling us to produce various liquid, solid, and semi-solid dosage forms for oral, nasal, buccal, topical, ocular and parenteral delivery. The drug products we develop can be easily scaled-up for clinical trial manufacturing, allowing for seamless transitions from development to GMP manufacturing.
Key aspects of the formulation development are:
- Pre-formulation studies: focusing on understanding the physical and chemical properties of the drug molecule (e.g. solubility, stability, polymorphism)
- Formulation design: based on pre-formulation data, various formulation strategies are explored based on a quality by design approach to develop a stable and effective drug product. This involves selecting appropriate excipients and dosage forms (dependent on the drug’s characteristics and intended route of administration)
- Compatibility studies: testing the interaction between the drug substance and excipients.
- Formulation optimization: to achieve the desired drug release profile, stability, and manufacturability.
- Scale-up and manufacturing
- Regulatory considerations: comprehensive documentation of all formulation development activities and data, preparing regulatory submissions
Particle Size Reduction / Micronization
Our micronization development and GMP manufacturing services are supported by a dedicated team of scientists and state-of-the-art solid state laboratory. The pre-formulation and solid state teams work together using their expertise and proven track record to quickly advance programs from API through Drug Product Development.
Particle size reduction is one of the many tools available to our team to improve solubility and enhance the effectiveness of the drug. Based on your program needs, micronization can be performed as proof of concept at gram scale or at a larger GMP production scale.
Our Micronization services can help you:
- Control particle size through the API and Drug Product development lifecycle
- Perform solid state characterization to assess and control physicochemical properties
- Conduct pre-formulation studies to evaluate solubility and permeability
- Perform IND enabling API and Drug Product development
- Perform clinical and commercial manufacturing for both non-potent and highly potent compounds
- Integrate services that enables you to solve technical challenges in real time under one roof
Talk to our experts