The Need for Taste Masking

Why is taste masking important?  Because palatability should never be the reason a medicine fails.

Many drugs are known to be bitter or have other aversive taste, aroma, mouthfeel or texture attributes. But what about new drugs and formulations in early-stage clinical development? Senopsys helps fill this knowledge gap.

A Data-Driven Approach to Taste Masking

Senopsys has built one of the industry’s most extensive proprietary datasets of aversive flavor attributes of investigational drugs, generated using our trained human sensory panels. This continuously expanding dataset supports early risk assessment, guides formulation strategy, and reduces development uncertainty.

In 2024, Senopsys published* results from 155 human taste assessments (summarized below) of sponsor-provided investigational drugs, primarily new chemical entities. The analysis revealed substantial diversity in the modality, intensity, and duration of aversive sensory attributes—highlighting the need for structured, data-driven approaches to taste masking.

Primary Taste Masking Challenge

Bitterness was the primary taste masking challenge for 66% of the drug actives. Malodors (e.g., rancid oil, fishy, solvent, fecal) were the second most common challenge, impacting 8% of drug actives.

Approximately 5% produced aversive mouthfeels (e.g., burning, numbing), and a smaller subset were sour or salty (4%). Notably, 14% of drug actives were “bland”, with the taste masking challenge due to the aversive attributes of the excipient system (e.g., solubility enhancers).

      Primary Taste Masking Challenge of 155 APIs

Secondary Taste Masking Challenge

Complicating development, most actives (>90%) were found to have multiple aversive attributes.

Approximately half of the APIs had a secondary malodor. The remaining secondary aversive attributes were more evenly distributed between basic tastes (bitter, sour, salty), mouthfeels (irritancy) and “others” (e.g., texture).

       Secondary Taste Masking Challenge of 155 APIs

*Medical Research Arhives Vol 12 No 10 (2024): October Issue, Issue 10, VOl.12

Proper Diagnosis is Key to Taste Masking

These findings highlight the need to determine the aversive attributes early in clinical development (Phase 1) to guide dosage form selection and formulation design.

Taste, smell, and irritation represent different perception pathways and importantly, the technical approach for dealing with each is fundamentally different. Adding orange, grape of cherry (smell) does nothing for reducing bitterness or burning. Some APIs may need to be “sequestered” from sensory receptors via encapsulation, coating, complexation, or other technology.

When drug products are not properly taste-masked, dosing compliance and health outcomes suffer. This is especially true for pediatric formulations or drugs for adults who have difficulty swallowing.

Common Taste Masking Issues

Developing palatable pharmaceuticals is filled with many formulation, regulatory, clinical and commercial challenges that Senopsys helps clients address.

Formulation

  • Quantify the taste masking challenge of the APIs – taste, aroma, mouthfeel, texture
  • Identify appropriate taste masking technologies
  • Select suitable dosage forms
  • Develop palatable, taste-masked formulations
  • Ensure formulation compatibility and stability

Regulatory

  • Guide development of age-appropriate drug products to meet regulatory requirements:
    • EMA Paediatric Investigation Plan (PIP)
    • FDA Pediatric Study Plan (PSP)
  • Ensure global acceptability of excipients

Clinical

  • Diagnose palatability of formulations poorly tolerated in first in human volunteers
  • Identify candidate dosing vehicles – pharmacy preparations, foods, beverages
  • Develop palatable, age-appropriate formulations
  • Conduct GCP-compliant taste assessment studies
  • Develop taste-matched placebo formulations to reduce unblinding risk

Commercial

  • Specify target Product Profile for taste, aroma, texture, and mouthfeel
  • Identify globally accepted flavor types
  • Manage product lifecycle – new dosage forms, e.g., 505(b)(2).
  • Benchmark competing products

The Senopsys Difference

Our name, Senopsys, is derived from Sensory Optimization Systems. It’s what we do. Importantly, it’s all we do.

Senopsys scientists are experts in taste assessment, taste modulation, taste masking, excipient functionality and flavor construction.  

We have decades of experience developing palatable liquid, powder and solid dosage forms of investigational and approved drugs.

Senopsys partners with pharmaceutical, biotechnology and drug delivery companies to develop palatable drug formulations that meet the needs of diverse patient populations

We are independent, objective and “technology agnostic” and do not license technology, sell ingredients or manufacture products. We are collaborative and routinely work with our client’s CDOs, CDMOs, and CROs.

A Proven Approach

Senopsys pioneered and honed a proven process for developing palatable drugs through decades of experience in the field.

Step 1: Taste Assessment

We use our experienced human taste panels and analytic tools suite to quantify the taste masking challenge early in clinical development to guide formulation development, applying internationally recognized methods in a CGP-compliant environment

The outcome is a quantitative taste profile and roadmap for developing a palatable formulation.

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Step 2: Taste Masking

We apply a structured, sensory-directed development approach, pioneered in the food industry, to create palatable, taste masked drug formulations for liquids, powders and solids.

The result is a palatable formulation ready for clinical and commercial development.

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Enabling Capabilities

Senopsys has built the capabilities and infrastructure to support taste assessment and taste masking studies to meet the unique needs of the pharmaceutical industry.

Our resources include experienced investigators, sensory panelists, and formulation scientists supported by formulation laboratories, sensory evaluation facilities, and more.

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Senopsys is the only company that offers both a robust taste assessment analytics platform and a proven taste masking formulation development process.

Explore the Art and Science of Taste Masking

We invite you to explore the art and science of taste masking by viewing a recent case study or downloading our white paper.

Palatability Should Never Be The Reason A Medicine Fails

Trusted by 15 of the top 25 global pharma companies, Senopsys brings sensory science and formulation expertise to the most challenging taste masking problems.

Reach out to schedule a technical discussion with our experts.

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