About the conference

Continuing on its mission and conference series to raising awareness and understanding of paediatric-specific issues in the development of age apprortiate formulations, the European Paediatric Formulation Initiative (EuPFI) convoked its 8th annual conference with the International Association of Pharmaceutical Technology (APV) on 21st and 22nd September 2016 at the Hotel Novotel in Lisbon, Portugal. The participation of 158 delegates from Industry, Academia, Regulatory and other organizations from 26 countries with diverse backgrounds and involvement in both formulation development and regulatory submissions provided a productive setting for the exchange of information and views and was very encouraging.

The two pre-conference workshops as usual provided much needed focus and interactive session to both the experienced and participants who were new to the area. 1) Benefit risk approach to dosage form design for paediatrics illustrated how design selection may require compromise of certain elements of the design. It helped identify the key components of the Quality Target Product Profile (QTPP) that may influence design selection. 2) Introduction to the regulatory framework/quality section of PIPs and the data package that comes into licensing division when the product has reached the market authorisation submission stage.

The programme for this 2-day conference was completely participants driven and touched upon the range of topics for paediatric product development with the patient’s point of view. The presentations include the view of a young person on effectively engaging patients and the public in R&D, highlight on how UK Pharma and Academia are working collaboratively and innovatively to accelerate the development of new paediatric medicines and information on how to improve the quality of data submitted on paediatric pharmaceutical development. Although this is a European meeting, collaborations with the US have always been integral to the success of facilitating formulation development of pediatric drug products. This was reflected through the key take away points and next steps from MCERSI/IQ/EuPFI workshop on challenges and strategies to facilitate paediatric drug development, which took place in June this year in Baltimore, US.

The informative talks in focus sessions were centered around each EuPFI workstream (Excipients, Taste assessment and Taste Masking, Administration devices, Age appropriateness of formulations, and Biopharmaceutics. An Innovation Show Case gave an opportunity for companies to present less traditional yet relevant technologies for children medicines.

The Professional Compounding Centers of America (PCCA) sponsored three poster awards and one oral presentation award.

Of course, not to forget the social activities of the meeting, the guided Lisbon city tour allowed maximal interactions between participants.

Once again this was a very successful meeting with a take home message to address the knowledge gaps more effectively through precompetitive collaboration.

We are counting on your participation for our 9th conference, which is planned for 20th and 21st Sept 2017, somewhere in Europe. Watch the space!!!

Workshops Presentations

Workshop 1: Benefit risk approach to dosage form design for paediatrics

Opening Presentation

Wrap up Presentation

Jenny Walsh, Jennywalshconsulting,UK

Workshop 2: How to construct/evaluate Paediatric Investigation Plans (PIPs).

Nasir Hussain, Medicines and Healthcare Products Regulatory Agency (MHRA),UK

Plenary Presentations

Patient and Public Involvement – Views of young person
Simon Stones, EULAR Young PARE, NIHR CRN: Children/Arthritis Research UK Paediatric Rheumatology Clinical Studies Group, UK

SPaeDD-UK: Smart Paediatric Drug Development - UK Accelerating paediatric formulation development - An open innovation R&D project
Alastair Coupe, Pfizer Pharmaceuticals, UK

Minimum data/information set needed for the PIP submission or to improve the quality of data submitted on pharmaceutical development
Brian Aylward, Irish Health Products Regulatory Authority, Ireland

Snapshot on EuPFI-IQ workshop - Challenges and Strategies to Facilitate Formulation Development of Pediatric Drug Products
Trupti Dixit, Takeda Development Center Americas, US

Focus Session Presentations

Taste Assessment & Taste Masking (TATM)

Amoeba Tastes Bitter: A Novel Non-animal Model for Bitterness Research
Marco Cocorocchio, School of Biological Sciences, Royal Holloway University of London,United Kingdom

BitterDB Database and Predicting Bitterness In-silico
Masha Niv, The Institute of Biochemistry, Food and Nutrition,The Hebrew University of Jerusalem, Israel

Administration Devices

The Combination Product Development Roadmap
Esmeralda Lousia Hermans, Janssen Research & Development,Belgium

Kinderleicht- Usability Testing with Kids
Torsten Gruchmann, Use-Lab GmbH, Steinfurt, Germany

Age Approriateness of Formulations

Paediatric Development for Poorly Water Soluble Drugs
Carsten Timpe, F. Hoffmann-La Roche,Switzerland

Medicine Acceptability in Children : An Original Tool for Standardized Evaluation
Fabrice Ruiz, ClinSearch, France

Excipients

Excipients update – Interactions between FDA, IPEC and IQ on Inactive ingredient database and paediatric formulations
Dave Schonecker, Colorcon, IPEC America, US

Lactose in medicines: safety concerns?
Massimo Montalto, Università Cattolica del Sacro Cuore,Italy

Biopharmaceutics

Assessing Food and Vehicle Effects for Pediatric Formulations: Preclinical and Clinical Approaches
David Harris, Merck & Co Inc., US

Feedback from EuPFI – IQ / M-CERSI Workshop Session on Co-administration with Food
Ann Marie Kaukonen, Fimea Finnish Medicines Agency, Finland

Predicting Performance in Paediatric Populations with PBPK Modeling and Biorelevant invitro Data
Nikoletta Fotaki, University of Bath, United Kingdom

Poster Presentations

An Instant Pudding-like Gel Formulation for the Delivery of Oral Medicines to Patients with Swallowing Difficulties
Viralkumar F. Patel and Huda Salih, University of Hertfordshire, UK

Introducing a new model for bitter taste assessment - the social amoeba Dictyostelium
Marco Cocorocchio, Centre of Biomedical Sciences, School of Biological Sciences, Royal Holloway University of London, UK

Overcoming Zinc Deficiency in Children: An Assessment of Zinc Permeation across Buccal Mucosa
Viralkumar F. Patel and Huda Salih, University of Hertfordshire, UK

Dilute Solutions of Parahydroxybenzoates (Parabens) As Possible Alternative For Antimicrobial Preservation In Oral Formulations For Pediatrics
A.Santoveña, UDI de Tecnología Farmacéutica,Universidad de La Laguna, Spain

Dose Uniformity Test As Quality Control of Pediatric Oral Formulations
JB Fariña, UDI de Tecnología Farmacéutica, Universidad de La Laguna, Spain

An evaluation of tools via patient-reported outcome measures to assess the acceptability of existing oral liquid medicines within a paediatric inpatient population
Punam Mistry, University of Birmingham, UK

Evaluating the acceptability and mouthfeel of multiparticulates within a paediatric population
Punam Mistry, University of Birmingham, UK

Palatability and acceptability of multiparticulate formulations: adults vs. children comparison
Felipe Lopez, UCl School of Pharmacy, UK

Critical Process Parameters Of Orodispersible Films (ODFs)
Branca M. A. Silva,Bluepharma, Coimbra Portugal

Development of a Sugar-Free Vehicle with Universal Characteristics for Extemporaneous Preparation of Paediatric Oral Suspensions
Carlos Maurício Barbosa, Faculdade de Farmácia da Universidade do Porto, Portugal

Playing Hide and Seek with Isoniazid – Masking the Taste, Minimising Changes to Dissolution Performance
Alison Keating, UCl School of Pharmacy, UK

Development And Evaluation of Taste- Masked Pediatric Minitablet Formulations With Bitter Model Drugs
Stefanie Keser,Hoffmann-La Roche, Switzerland

Coated Dispersible Tablets: Formulation Factors Impacting The Performance And Processability
Peter Kühl, F. Hoffmann-La Roche Ltd, Switzerland

Identification Of Medicine Taste During A Phase IIa Paediatric Trial And Development Of Alternative Formulations To Improve Patient Compliance Using The Rat Brief Access Taste Aversion Assay And The Electronic Tongue
Robert Ives, Comparative and Translational Sciences, GSK, UK

A Novel Approach To Assess And Improve Palatability Of An Inhaled Asset Using The Rat Brief Access Taste Aversion Assay And An In Silico Model Of Salivary Flow
Danielle Andrews, King’s College, UK

Explorations Of Factors Affecting Medicine Acceptability Using Standardized Evaluations
Thibault Vallet, ClinSearch, France & Laboratoire Conception de Produits et Innovation (LCPI), Arts et Métiers ParisTech, Paris,France

Synergy Of Maltitol And Intense Sweetener In Taste Masking Of Acetaminophen Chewable Tablets
Xavier Parissaux, Roquette, France

Use Of Stevia Rebaudiana Purified Extract As A Sweetener On Pediatric Oral Formulations
Jacqueline Sepúlveda, Faculty of Biological University of Concepción, Chile

Individual Drug Dosing By Printing Enalapril Maleate Onto Orodispersible Films Using Various Devices
Dina Kottke, Heinrich Heine University Duesseldorf

Availability Of Paediatric Dosage Forms In The Inpatient Setting: Gap Between Prescribing And Dispensing
A.C. van der Vossen, Department of Hospital Pharmacy, Erasmus MC, The Netherlands

Biorelevant Dissolution And Compatibility Of Hydrocortisone Granules Following Exposure To Water, Breast-, Whole- And Artificial (Formula) Milk
Erik Wollmer, Ernst-Moritz-Arndt University Greifswald,Germany

Simulating Different Dosing Scenarios For A Paediatric Valproic Acid ER Formulation In A New Paediatric Multistage Dissolution Model
Frank Karkossa, Ernst-Moritz-Arndt University Greifswald,Germany

Development of a Zebrafish Model for Bitter Taste Assessment
J. Bennett, Pfizer Global R & D, USA

Three poster award winners:

  • Danielle Andrews (Poster ID 54)- A Novel Approach To Assess And Improve Palatability Of An Inhaled Asset Using The Rat Brief Access Taste Aversion Assay And An In Silico Model Of Salivary Flow
  • Frank Karkossa (Poster ID 54)- Simulating Different Dosing Scenarios For A Paediatric Valproic Acid ER Formulation In A New Paediatric Multistage Dissolution Model
  • Stefanie Keser (Poster ID 54)- Development And Evaluation of Taste-Masked Pediatric Minitablet Formulations With Bitter Model Drugs
  • Oral presentation award winner:

  • Felipe Lopez (Poster ID 20)- Palatability and acceptability of multiparticulate formulations: adults vs. children comparison
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