Pioneering
Sensory Pharmaceutics™
& Paediatric
Formulation Development

The Only Specialist Pharmaceutical Sensory Evaluation Company Worldwide Offering a Full Spectrum Of Integrated Preclinical, Clinical and Formulation Services

APIs taste bitter and aversive
senCeuTics is dedicated to making medicines palatable and acceptable for patients

We offer expert consultancy and industry leading solutions to evaluate the taste and organoleptic properties of drugs and inform patient-centric product design

Professor Catherine Tuleu

Founder & CEO
Professor of Paediatric Pharmaceutics, UCL School of Pharmacy

  • Internationally recognised subject matter expert
  • 15+ years experience in paediatric pharmaceutical development 
  • Founder and chairperson of the European Paediatric Formulation Initiative (EuPFI)
  • The Medicine Maker Power List 2015 and 2016 (Ranked #2)
  • Former technical expert for the EMA, MHRA & WHO
  • Key partner in global multi-disciplinary grant projects including Global Research in Paediatrics (GRiP) & conect4children (c4c)

About Us

A spin-out from UCL School of Pharmacy founded by Prof. Catherine Tuleu

Catherine’s research is inherently translational and bridges traditional drug delivery science with patient-centric methodologies integrating Sensory PharmaceuticsTM. Her unique expertise covers a breadth of pharmaceutical development themes including:

In Vitro & In Vivo Taste Assessment
Acceptability & Palatability Research Methodologies
Safety of Excipients
Innovation in Age-Appropriate Dosage Form Design, Especially for Under 5s
Administration Issues Including Co-Administration with Food & Use of Devices
Reformulation & Repurposing for Low Resource Settings

Leverage our in-depth knowledge and niche expertise in both
sensory and formulation science to expedite your product development pathway for
pharmaceutical, consumer health, nutraceutical or veterinary medicinal products

scientist in laboratory

Contract Services

State-of-the-art preclinical models providing early insights into drug taste
to help guide formulation design and taste-masking strategies

Brief Access Taste Assessment (BATA) Model

Rapidly screen and benchmark the taste of your compounds as early as discovery and preclinical development

This accurate and cost-effective tool has been used by numerous industry partners to aid the selection of palatable drug candidates and screen novel formulations for commercial development.

Our specialist services extend beyond simply generating data – we can compare the taste characteristics of your API against our exclusive library of in-house research data, including BATA results that have been accurately correlated with real-life human sensory responses, to guide the selection of appropriate taste-masking techniques.

Biorelevant Buccal Drug Release Model

Bespoke flow-through dissolution apparatus mimicking the human oral cavity to accurately evaluate drug release

Our novel model serves as a predictive as well as discriminative test in the context of taste masking and has been specially designed for this unique purpose in the absence of adequate dissolution methodologies.

It can be used to help optimise the type and levels of functional polymers coatings for taste-masked oral dosage forms, including multiparticulates, regular or matrix tablets, and hard or soft-gel capsules. We have successfully demonstrated the model’s ability to distinguish between both different coating technologies and predict in vivo taste masking efficacy.

Human Panel Studies for Sensory Analysis

The gold-standard approach to evaluating the acceptability and palatability of pharmaceutical formulations

Sensory panels with healthy young adult volunteers can be used to determine the taste profile of drug candidates and evaluate the organoleptic properties of pharmaceutical formulations. 

We have extensive knowledge of sensory evaluation techniques and first-hand experience planning and conducting studies for pharmaceutical applications. Whether it’s establishing taste detection thresholds early in development, or a holistic sensory profile of the final formulation, we can support you all the way from study design and protocol development through to statistical analysis and data interpretation.

Contact us to discuss how we can provide a comprehensive and streamlined package
tailored to maximise the speed and value of your formulation development projects

Global Clients

We work with multinational pharmaceutical companies and have an excellent track record for supporting multiple pipeline programmes

Team & Facilities

We have full R&D capabilities and an experienced team of pharmaceutical scientists, registered pharmacists, and medical supervisors.

Data Package

We will provide detailed study reports including appropriate statistical analysis completed by an independent consultant statistician.

Consultancy

Our in depth knowledge and expertise will help you meet regulatory expectations
and optimise your product development strategy

Global legislative and regulatory reforms mandate the development of well designed,
age-appropriate and acceptable medicines for children

We can appraise your development programme and provide impartial and tailored advice to streamline your path to clinic. Based on the properties of your API and intended patient demographic, therapeutic indications and posology, we can provide strategic advice on:

  • Route of administration, dosage form design and pharmaceutical composition 
  • Pharmaceutical technologies to enhance product performance
  • Taste-masking strategies including selection of suitable flavours and aromas
  • Acceptability and palatability assessments prior to and as an integral part of clinical studies

Acquiring independent advice early in the development process will help minimise risks and identify opportunities to create a more a cost-effective and efficient work programme.

Almost all APIs, and indeed many excipients, have unfavourable organoleptic properties that pose critical formulation development challenges. Human sensory studies are considered the definitive method for describing and quantifying critical attributes of your API or finished formulation such as taste, after-taste, aroma and mouthfeel. We can provide technical expertise in executing these studies outside of traditional clinical trial routes requiring regulatory authorisation, including:

  • Identifying suitable quantitative and qualitative methodologies in sensory and consumer research
  • Trial design and protocol development
  • Selecting endpoint measurements, designing data collection tools and statistical analyses

Integrating user perception studies in your development programme is essential to guide the development of medicines that are palatable and well accepted by patients.

The judicious selection of excipients is critical, as children, particularly neonates and infants, have significant physiological differences in their developing organ systems compared to adults. Excipients known to be safe and acceptable for adult formulations (e.g. benzyl alcohol, ethanol, propylene glycol, parabens) are associated with elevated toxicological risks in the paediatric population, even at age-adapted lower concentrations.

The EuPFI consortium has created the STEP: Safety and Toxicity of Excipients for Paediatrics database, a comprehensive repository including the pharmacological, toxicological and safety data available for over 75 different excipients. Together with this invaluable resource, we can help you complete a comprehensive excipient risk assessment including:

  • Screening and selecting the most suitable excipients for your product development needs
  • Defining the safety profile of all excipients in the target age group(s) to support regulatory filings
  • Develop strategies to expedite further product-specific toxicological studies where required

Having spearheaded research in paediatric formulation development for over 15 years, Catherine and the senCeuTics team have unique insights into how global legislations and regulatory obligations have evolved. We understand the importance of developing a global regulatory strategy as early as possible to consolidate R&D efforts. Our niche expertise in the field places us in a unique position to provide specialist regulatory support including:

  • Input and review of EU Paediatric Investigation Plans (PIPs), US Pediatric Study Plans (PSPs) and Paediatric Use Marketing Authorisations (PUMAs)
  • Preparation and review of regulatory dossiers throughout the development and  approval process
  • Strategies to address queries from regulatory authorities to facilitate product approval

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