Making difficult APIs more patient-friendly
Many active pharmaceutical ingredients have inherently bitter, metallic, chemical, or otherwise unpleasant taste profiles. Taste-masking work sits at the intersection of formulation performance and patient experience.
Seven factors decide the strategy
The Pharmacy Hub R&D and Innovation team can develop customized flavor and bitterness-masking strategies designed around the factors below. Each one constrains what the others can do.
API characteristics
Dosage form
Target patient population
Route of administration
Product stability
Dissolution requirements
Desired patient experience
Twenty-one capabilities, in five working groups
- Bitterness profiling
- API taste characterization
- Flavor screening
- Flavor system development
- Sweetener system optimization
- Multi-layer flavor systems
- Flavor-release optimization
- Cooling sensory agents
- Warming sensory agents
- Mouthfeel optimization
- Aftertaste reduction
- Odor masking
- Texture modification
- pH-based taste modification where appropriate
- Excipient-based taste masking
- Coating approaches where technically appropriate
- Encapsulation strategies where applicable
- Flavor compatibility with stability requirements
- Flavor performance through shelf life
- Comparative prototype testing
- Patient preference assessment where appropriate
Where taste-masking work applies
Flavor and masking strategies are developed for the oral formats below. The chosen form changes how much masking is possible and how it must be tested.
- ODTs
- Chewable tablets
- Troches
- Lozenges
- Sublingual tablets
- Buccal dosage forms
- Oral liquids
- Suspensions
- Powders
- Rapid-dissolve products
Taste is not cosmetic.
Taste, texture, mouthfeel, and aftertaste can directly influence the patient experience and willingness to continue therapy.
Our formulation scientists can evaluate multiple taste-masking strategies while balancing:
- Palatability
- Manufacturability
- Stability
- Dissolution
- Dosage size
- Processing
- Cost
- Product performance
Masking systems work in combination
The Pharmacy Hub has experience developing approaches to improve the palatability of difficult pharmaceutical ingredients, including highly bitter APIs. Customized bitterness-masking systems may involve combinations of:
- Flavor systems
- Sweeteners
- Cooling agents
- Texture modifiers
- Coating strategies
- API-excipient interactions
- Dosage-form engineering
- Controlled dissolution concepts
- Mouthfeel optimization
Where applicable, proprietary know-how and intellectual property may be utilized pursuant to the relevant commercial agreement.
