Formulation bench with excipients, weighing equipment and prototype blends
Formulation Development

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.

Pre-formulation assessment

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
Prototype development

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
Formulation variables

Evaluate variables such as these

Select a variable class

Structure

  • Binders
  • Fillers
  • Disintegrants
  • Texture modifiers
Product rescue

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
What comes next

A formulation decision is never the last decision

  1. Formulation
  2. Analytical testing
  3. Stability
  4. Scale-up
Start a conversation

Tell us what the product has to do.

Share the development stage, the scientific question, the evidence you need, and the market you are working toward. We will come back with a technical view of the work.