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
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
Publications
Proposed Tool to Compare and Assess the Applicability of Taste Assessment Techniques for Pharmaceuticals.
Clapham D, et al. J Pharm Sci. 2021 Sep 6:S0022-3549(21)00471-8.
Bitter-blockers as a taste masking strategy: A systematic review towards their utility in pharmaceuticals.
Andrews D, et al. Eur J Pharm Biopharm. 2021 Jan;158:35-51.
Non-human tools for the evaluation of bitter taste in the design and development of medicines: a systematic review.
Mohamed-Ahmed AH, et al. Drug Discov Today. 2016 Jul;21(7):1170-80.
Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients.
Walsh J, et al. Adv Drug Deliv Rev. 2014 Jun;73:14-33.
Medicines for children: a matter of taste.
Davies EH, et al. J Pediatr. 2008 Nov;153(5):599-604, 604.e1-2.
Challenges of developing palatable oral paediatric formulations.
Cram A, et al. .Int J Pharm. 2009 Jan 5;365(1-2):1-3.
Human mouthfeel panel investigating the acceptability of electrospun and solvent cast orodispersible films.
Abdelhakim HE, et al. Int J Pharm. 2020 Jul 30;585:119532.
In vitro and sensory tests to design easy-to-swallow multi-particulate formulations.
Marconati M, et al. Eur J Pharm Sci. 2019 Apr 30;132:157-162.
Acceptability of placebo multiparticulate formulations in children and adults.
Lopez FL, et al. Sci Rep. 2018 Jun 15;8(1):9210.
The effect of administration media on palatability and ease of swallowing of multiparticulate formulations.
Lopez FL, et al. Int J Pharm. 2018 Nov 15;551(1-2):67-75.
Effect of formulation variables on oral grittiness and preferences of multiparticulate formulations in adult volunteers.
Lopez FL, et al. Eur J Pharm Sci. 2016 Sep 20;92:156-62.
Acceptability of orodispersible films for delivery of medicines to infants and preschool children.
Orlu M, et al. Drug Deliv. 2017 Nov;24(1):1243-1248.
Co-Processed Excipients for Dispersible Tablets-Part 2: Patient Acceptability.
Dziemidowicz K, et al. AAPS PharmSciTech. 2018 Aug;19(6):2646-2657.
Rats can predict aversiveness of Active Pharmaceutical Ingredients.
Soto J, et al. Eur J Pharm Biopharm. 2018 Dec;133:77-84.
Multi-Methodological Quantitative Taste Assessment of Anti-Tuberculosis Drugs to Support the Development of Palatable Paediatric Dosage Forms.
Keating AV, et al. Pharmaceutics. 2020 Apr 17;12(4):369.
Solid state characterisation and taste masking efficiency evaluation of polymer based extrudates of isoniazid for paediatric administration.
Keating AV, et al. Int J Pharm. 2018 Feb 5;536(2):536-546.
Taste evaluation of a novel midazolam tablet for pediatric patients: In vitro drug dissolution, in vivo animal taste aversion and clinical taste perception profiles.
Cheung LC, et al. Int J Pharm. 2018 Jan 15;535(1-2):194-200.
Comparative in vitro and in vivo taste assessment of liquid praziquantel formulations.
Münster M, et al. Int J Pharm. 2017 Aug 30;529(1-2):310-318.
New generalized poisson mixture model for bimodal count data with drug effect: An application to rodent brief-access taste aversion experiments.
Sheng Y, et al. CPT Pharmacometrics Syst Pharmacol. 2016 Aug;5(8):427-36.
Development of a model for robust and exploratory analysis of the rodent brief-access taste aversion data.
Soto J, et al. Eur J Pharm Biopharm. 2015 Apr;91:47-51.
In Vitro Dissolution Model Can Predict the in Vivo Taste Masking Performance of Coated Multiparticulates.
Keeley A, et al. Mol Pharm. 2019 May 6;16(5):2095-2105.
Direct Powder Extrusion 3D Printing of Praziquantel to Overcome Neglected Disease Formulation Challenges in Paediatric Populations.
Boniatti J, et al. Pharmaceutics. 2021 Jul 21;13(8):1114.
The STEP database through the end-users eyes–USABILITY STUDY.
Salunke S, et al. Int J Pharm. 2015 Aug 15;492(1-2):316-31.
The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 – the pilot version.
Salunke S, et al. Int J Pharm. 2013 Nov 30;457(1):310-22.
The STEP (safety and toxicity of excipients for paediatrics) database. Part 1-A need assessment study.
Salunke S, et al. Int J Pharm. 2012 Oct 5;435(2):101-11.
Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure).
Alessandrini E, et al. Pharmaceutics. 2021 May 15;13(5):730.
WHO essential medicines for children 2011-2019: age-appropriateness of enteral formulations.
Orubu ESF, et al. Arch Dis Child. 2021 Sep 3:archdischild-2021-321831.
Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children.
Hanning SM, et al. Drug Deliv Transl Res. 2021 Jun;11(3):944-955.
I Spy with My Little Eye: A Paediatric Visual Preferences Survey of 3D Printed Tablets.
Januskaite P, et al. Pharmaceutics. 2020 Nov 17;12(11):1100.
The rectal route of medicine administration for children: Let’s get to the bottom of it!
Hanning SM, et al. Eur J Pharm Biopharm. 2020 Dec;157:25-27.
How Do Orodispersible Tablets Behave in an In Vitro Oral Cavity Model: A Pilot Study.
Desai N, et al. Pharmaceutics. 2020 Jul 9;12(7):651.
Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine.
O’Brien F, et al. Int J Mol Sci. 2019 May 31;20(11):2688.
Electrospinning Optimization of Eudragit E PO with and without Chlorpheniramine Maleate Using a Design of Experiment Approach.
Abdelhakim HE, et al. Mol Pharm. 2019 Jun 3;16(6):2557-2568.
Co-Processed Excipients for Dispersible Tablets-Part 1: Manufacturability.
Bowles BJ, et al. AAPS PharmSciTech. 2018 Aug;19(6):2598-2609.
Access to age-appropriate essential medicines: a retrospective survey of compounding of medicines for children in hospitals in Nigeria and implications for policy development.
Orubu ES, et al. Health Policy Plan. 2017 Mar 1;32(2):225-235.
Medicines for children: flexible solid oral formulations.
Orubu ES, et al. Bull World Health Organ. 2017 Mar 1;95(3):238-240.
The Milky Way: paediatric milk-based dispersible tablets prepared by direct compression – a proof-of-concept study.
Orubu SE, et al. J Pharm Pharmacol. 2017 Apr;69(4):417-431.
Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study.
Ranmal SR, et al. Int J Pharm. 2016 Nov 30;514(1):296-307.
Ink-jet printing versus solvent casting to prepare oral films: Effect on mechanical properties and physical stability.
Buanz ABM, et al. Int J Pharm. 2015 Oct 30;494(2):611-618.
Rectal route in the 21st Century to treat children.
Jannin V, et al. Adv Drug Deliv Rev. 2014 Jun;73:34-49.
Specific aspects of gastro-intestinal transit in children for drug delivery design.
Bowles A, et al. Int J Pharm. 2010 Aug 16;395(1-2):37-43.
Minitablets: new modality to deliver medicines to preschool-aged children.
Thomson SA, et al. Pediatrics. 2009 Feb;123(2):e235-8.
Accuracy of enteral syringes with commonly prescribed paediatric liquid medicines.
Arenas-López S, et al. Arch Dis Child. 2017 Jul;102(7):655-659.
Characterisation of zinc delivery from a nipple shield delivery system using a breastfeeding simulation apparatus.
Scheuerle RL, et al. PLoS One. 2017 Feb 3;12(2):e0171624.
Can a Flavored Spray (Pill Glide) Help Children Swallow Their Medicines? A Pilot Study.
Jagani M, et al. Pediatrics. 2016 Dec;138(6):e20160680.
Modeling the physiological factors that affect drug delivery from a nipple shield delivery system to breastfeeding infants.
Gerrard SE, et al. J Pharm Sci. 2013 Oct;102(10):3773-83.
‘Big Data’ informed drug development: a case for acceptability.
Desai N, et al. Drug Discov Today. 2021 Apr;26(4):865-869.
Acceptability of generic versus innovator oral medicines: not only a matter of taste.
Tuleu C, et al. Drug Discov Today. 2021 Feb;26(2):329-343.
Sex Differences in Medicine Acceptability: A New Factor to Be Considered in Medicine Formulation.
Ruiz F, et al. Pharmaceutics. 2019 Aug 1;11(8):368.
Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review.
Ranmal SR, et al. Drug Discov Today. 2018 Apr;23(4):830-847.
Formulation factors affecting acceptability of oral medicines in children.
Liu F, et al. Int J Pharm. 2015 Aug 15;492(1-2):341-3.
Demonstrating evidence of acceptability: the “catch-22” of pediatric formulation development.
Ranmal S, et al. Clin Pharmacol Ther. 2013 Nov;94(5):582-4.
Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper.
Walsh J, et al. Br J Clin Pharmacol. 2021 Jul 15.
Formulating better medicines for children-Collaborate to innovate.
Salunke S, et al. Int J Pharm. 2018 Feb 5;536(2):487-489.
Better medicines for children: are we there yet?
Tuleu C.J Pharm Pharmacol. 2017 May;69(5):497.
European Paediatric Formulation Initiative (EuPFI)-Formulating Ideas for Better Medicines for Children.
Salunke S, et al .AAPS PharmSciTech. 2017 Feb;18(2):257-262.
Patient centric formulations for paediatrics and geriatrics: Similarities and differences.
Hanning SM, et al. Int J Pharm. 2016 Oct 30;512(2):355-359.
Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms.
Lopez FL, et al. Expert Opin Drug Deliv. 2015;12(11):1727-40.
Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations.
Liu F, et al. Drugs. 2014 Oct;74(16):1871-1889.
Preparation of medicines for children – a hierarchy of classification.
Ernest TB, et al. Int J Pharm. 2012 Oct 5;435(2):124-30.
‘Formulating better medicines for children’ – still paving the road.
Tuleu C. Int J Pharm. 2012 Oct 5;435(2):99-100.
Paediatric formulations–getting to the heart of the problem.
Standing JF, et al. Int J Pharm. 2005 Aug 26;300(1-2):56-66.
News
It was wonderful seeing our colleagues, collaborators, and friends at another scientifically invigorating and insightful EuPFI conference in Rome this September 2022.
This unique event brings together global researchers, scientists, and industry partners in the paediatric drug development community to share ideas and innovations, and collaborate towards our shared goal of making better medicines for children. We look forward to seeing everyone again in Dublin next year!
Catherine was honoured to contribute to the first edition of the Summer School “Paediatric perRsonalized ExtemPorAneous foRmulAtions PREPARA” in July 2022. Thirty young pharmacists, researchers, doctoral students and Master’s students from all over Italy participated in training activities on galenic formulations for paediatrics.
This event promoted by the University of Bari Aldo Moro (Department of Pharmacy-Drug Sciences) and funded by the Puglia Region – Adisu Puglia, with the contribution of Farmalabor srl.
Listen to Catherine’s talk with the Anti-Waffle Podcast team about devising medicine delivery for children. She talks about the difficulties balancing the need to make medicines easy for children to take, but not too attractive, how much work goes into the process, the tools used, and making the experience a positive one for the patient. First point of contact in treatment is so important.
It was a pleasure to catch up with colleagues at the C4C General Assembly on 13-15th June in Ghent, Belgium. Catherine is involved in Work Package 4 (lead for the formulation experts group) and Work Package 6 (formulation module coordinator on the Advanced Course of Paediatric Clinical Trials and Paediatric Drug Development).
This new paper has been published in the British Journal of Clinical Pharmacology. The paper proposes use of a paediatric Quality Target Product Profile (pQTPP) to facilitate early planning and decision making across all teams in paediatric formulation development during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs.
Prof. Tuleu has been invited as a Keynote Speaker on “Pediatric Drug Product Development and Taste Evaluation Methodologies” at the BMS Pharmaceutical Development Pediatric Symposium (Hybrid Virtual and On-site) in New Brunswick, NJ, USA on 4th & 5th April.
The senCeuTics team delivered a Science and Pharmacy Taster Session at an East London primary school as part of British Science Week. Pupils at Henry Maynard Primary School took part in educational activities and contributed to real-life research studies. This work has been published as a research paper, “I Spy with My Little Eye: A Paediatric Visual Preferences Survey of 3D Printed Tablets”, the first study to investigate children’s perceptions of different 3D printed tablets (Printlets™).