Formulation development built around the final product
Pharmaceutical formulation development is most useful when the final product requirements are considered from the beginning. Pre-formulation, prototyping, optimization, and product rescue are treated as one connected sequence.
What is assessed before formulation work begins
Capabilities may include the following assessments, grouped here by what each one governs. Open a group to see the full list.
- API characteristics
- Solubility evaluation
- Excipient compatibility
- pH considerations
- Moisture sensitivity
- Heat sensitivity
- Light sensitivity
- Hygroscopicity
- Particle characteristics
- Taste profile
- Organoleptic properties
- Potential degradation pathways
- Dosage-form suitability
- Packaging considerations
- Manufacturing risk assessment
- Supply-chain considerations
- Cost implications
- Potential clinical-development considerations
Develop multiple prototype formulations, then compare them
Compare
Prototypes are developed in parallel and assessed against the same criteria.
Test
Analytical and performance results describe how each candidate actually behaves.
Refine
Iteration continues toward a form that can be made repeatedly at scale.
Comparison criteria
- Appearance
- Uniformity
- Texture
- Taste
- Mouthfeel
- Dissolution or disintegration behavior
- Palatability
- Stability
- Manufacturability
- Yield
- Processing time
- Packaging compatibility
- Patient experience
- Production economics
- Clinical-study readiness where applicable
Evaluate variables such as these
Structure
- Binders
- Fillers
- Disintegrants
- Texture modifiers
Processing
- Lubricants
- Glidants
- Surfactants
- Wetting agents
Stability
- Preservative systems
- Viscosity modifiers
- Suspensing agents
Delivery
- Solubilizers
- Penetration enhancers
- Bases
- Vehicles
Performance
- API concentration
- Excipient ratios
When a formulation needs to be fixed
Support formulations experiencing the problems below — diagnosed by where the failure shows up, then traced back to the formulation, the process, or the packaging.
Stability & potency
- Poor stability
- Inconsistent potency
- Short BUD
- Packaging incompatibility
Taste & patient experience
- Excessive bitterness
- Bad taste
- Poor patient experience
Solid-form processing
- Poor powder flow
- Excessive stickiness
- Tablet defects
- Cracking
- Capping
- Lamination
- Poor dissolution
Liquid & production
- Sedimentation
- Phase separation
- Excessive viscosity
- Difficult processing
- Low yield
- Manufacturing inefficiency
A formulation decision is never the last decision
- Formulation
- Analytical testing
- Stability
- Scale-up