OSD Pre-Formulation
Understanding Your Drug Substance Before Drug Product Development Begins
Pre-formulation is the first step in transforming an active pharmaceutical ingredient into a reliable drug product. At Corealis, our scientists evaluate key API properties (including particle characteristics, crystallinity, morphology, hygroscopicity, solubility and compressibility) to identify potential challenges early and guide the formulation strategy.
This structured approach allows clients to make informed decisions about formulation process design, manufacturability, and clinical development pathways before significant resources are invested.
Our Pre-Formulation Workflow
API Characterization
We analyze the physicochemical properties of the API to understand solubility, crystallinity, particle size, and bulk and tap density/flow properties. The following assessments would be typically involved and can include solubility or other early assessments as required:
Particle morphology (SEM with image analysis & optical microscopy)
Particle size and distribution (laser diffraction)
Hygroscopicity from 10–90% relative humidity (dynamic vapor sorption, DVS)
Bulk and tap density / flow properties
Crystal state evaluation and stress testing under moisture, wetting, heat, grinding, and pressure (XRPD)
Suitability tests for solid dosage form manufacturing (compressibility)
Thermal analysis (DSC, TGA)
Analytical method evaluation
Corealis will transfer the API analytical methods (such as assay and related substances) from the client and evaluate them to establish appropriate parameters. These methods will then be prepared and optimized to support the development and analysis of drug product prototype formulations in subsequent phases.
Development Strategy Recommendations
Based on the data generated, our scientists interpret to define formulation process pathways and manufacturing strategies that support downstream development and scale-up.
Typical OSD Timeline
From Molecule to Clinical Supply
Corealis Pharma can initiate a pre-formulation study with as little as 2 weeks notice (on average). A structured development pathway designed to accelerate oral solid dose programs from early formulation to GMP clinical manufacturing.
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 Analytical & Characterization Tools
Corealis uses advanced analytical instrumentation to evaluate the physical and chemical properties of APIs.
Representative instruments include:
Scanning Electron Microscopy (SEM)
X-Ray Powder Diffraction (XRPD)
Differential Scanning Calorimetry (DSC)
Thermogravimetric Analysis (TGA)
Dynamic Vapor Sorption (DVS)
Laser diffraction particle size analyzers
Powder rheology and density testing equipment
These tools provide the data needed to guide formulation strategy and reduce downstream development risk. Corealis also supports the safe handling and development of high-potent compounds through specialized containment controls and experienced scientific teams.
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
Why are pre-formulation studies important?
When should companies start pre-formulation studies?
What types of molecules benefit from pre-formulation studies?
How long do pre-formulation studies take?
Can pre-formulation data support later development phases?
Do pre-formulation studies support toxicology programs?
Learn more how Corealis can support your drug product development needs.
