OSD Formulation Development
From Molecule to Scalable Drug Product
Formulation development is where scientific insight becomes a functional drug product. At Corealis, we develop oral solid dosage formulations that are tailored to the physiochemical properties of your API while aligning with the clinical and manufacturing requirements.
Our approach ensures that formulations are not only effective in early studies, but are also designed with scalability, reproducibility, and future manufacturing in mind.
Our Formulation Development Workflow
Formulation Strategy Design
We define formulation approaches based on API properties, target product profile, and clinical requirements.
Prototype Development
Excipient compatibility and stress testing identify potential formulation risks early.
Compatibility & Stability Studies
Excipient compatibility and stress testing identify potential formulation risks early.
Prototype Formulation Development
Phase-appropriate prototype formulations are developed for early evaluation and toxicology studies.
Optimization & Process Development
Formulations are refined for performance, stability, and manufacturability, with consideration for scale-up and GMP production.
Scale-Up Readiness
Corealis designs processes that translate seamlessly into GMP manufacturing, reducing risk during clinical production.
Typical Timeline
From Molecule to Clinical Supply
A structured development pathway designed to accelerate oral solid dose programs from early formulation to GMP clinical manufacturing. While timelines vary depending on API complexity and formulation strategy, a typical development pathway may include:
Pre-Formulation & Method Evaluation:
1-2 weeks
Prototype Development 5-8 Prototypes:
4-5 weeks
Engineering Batch:
2-3 weeks
GMP Batch Preparation & Planning:
2 weeks
GMP Manufacturing, Release and QA Review:
6 weeks
Report:
4-6 weeks
Typical duration:
4–6 months or less.
*Timelines may vary depending on program complexity and development strategy.
Key Formulation & Processing Equipment
Corealis utilizes a wide-range of formulation and processing technologies to support development and scale-up.
Representative equipment includes:
Blending systems (V-blenders and bin benders)
Wet and dry granulation equipment
Fluid bed dryers and coaters
Tablet compression presses
Encapsulation equipment (dosator systems)
Coating pans
Extrusion and spheronization systems
Spray drying and solid dispersion systems
These technologies support the development of scalable and robust oral solid dosage formulations.
See Our Development Facilities
Corealis operates more than 60,000 square feet of integrated formulation, analytical, and GMP manufacturing facilities located in Laval, Canada.
Visiting our laboratories provides an opportunity to meet the scientists supporting your program and see firsthand how our teams collaborate to solve complex formulation challenges.
FAQ
What is formulation development in drug development?
What types of formulations does Corealis develop?
How do you ensure formulations are scalable?
Can Corealis work with complex or poorly soluble APIs?
How long does formulation development take?
Do you support reformulation or lifecycle management?
Learn more how Corealis can support your drug product development needs.
