Nos publications

Improving patient experience with sensorial topical dosage forms

  • Poster

PBP World Meeting – Granada (Spain)  - 2018

E Dauphin-Chanard, D Hoste and D Marchaud

Gels, crèmes, formes semi-solides : de leur développement à leur enregistrement. [Gels, creams, semi-solid forms: from their development to their registration]

  • Scientific publication

STP Pharma Pratiques – September October 2018 – 28(5) 181-250 – ISSN 1157-1497 - 2018

E. Beyssac, V. Boudy, E. Dauphin-Chanard, S. Delehouzé, L. Frances, B. Gos, C. Lacaze, V. Laffineur, A. Mestres, I. Ribeiro Dos Santos, X. Thomas and N. Zeng

The SFSTP commission on topical dosage forms published an article reviewing all the steps for their development to registration.

Interestingly this article is both in French and English languages.

Table of content:

 

Introduction

I Definition of a semi-solid

II Tests and studies applicable in evaluation of semi-solid forms from development up to the phase of routine use

2.1 Regulatory requirements
2.2 Relevant tests in development
    2.2.1 Conventional characterization tests
    2.2.2 Characterization tests specified to evaluate performance of the formulation
    2.2.3 Additional characterization tests specified to evaluate performance of the formulation

III QbD approach related to the formulation

3.1 Different elements of the QbD
3.2 When to set up QbD ?
3.3 Definition of QTPP
3.4 CQAs toward evaluation of risks of process
3.5 Example of CMAs studied in case of a semi-solid formulation
3.6 Example of CPPs studied in case of a semi-solid formulation

Conclusion
IV Conclusions and perspectives

Lipid-based nanosuspensions for oral delivery of peptides, a critical review

  • Scientific publication

International Journal of Pharmaceutics, Volume 541, Issues 1–2, Pages 117–135 - avr 2018

Camille Dumont, Sandrine Bourgeois, Hatem Fessi, Vincent Jannin

In this review article, the authors describe:


the different techniques used to prepare Solid Lipid Nanoparticles and Nanostructured Lipid Carriers
the methods used to assess the protective effects of the carriers on peptides


the techniques used to measure the permeability enhancement

Self-emulsifying peptide drug delivery systems: How to make them highly mucus permeating

  • Scientific publication

International Journal of Pharmaceutics, Volume 538, Issues 1–2, Pages 159-166 - mar 2018

Janine Griesser, Gergely Hetényi, Hatice Kadas, Frédéric Demarne, Vincent Jannin and Andreas Bernkop-Schnürch

The aim of this study was to evaluate the mucus permeating properties of self-emulsifying drug delivery systems (SEDDS). Small droplet size and negative zeta potential of SEDDS could be identified as key parameters for their mucus permeating properties.

Size characterization of lipid-based self-emulsifying pharmaceutical excipients during lipolysis using Taylor dispersion analysis with fluorescence detection

  • Scientific publication

International Journal of Pharmaceutics, Volume 537, Issues 1–2, Pages 94–101 - fév 2018

Joseph Chamieh, Habib Merdassi, Jean-Christophe Rossi, Vincent Jannin, Frédéric Demarne, Hervé Cottet

In this work, the lipolysis of Labrasol® and Gelucire® 44/14 , two lipid based self-emulsifying drug delivery systems, by pancreatic enzymes and under conditions mimicking the gastrointestinal tract is followed by Taylor dispersion analysis. Results show that, Labrasol® droplets decrease exponentially in size with lipolysis time, whereas Gelucire® 44/14 droplets increased sigmoïdally in size. Even after 120 min lipolysis, both systems maintain a solubilizing capacity of the hydrophobic marker.

Evaluation of the digestibility of solid lipid nanoparticles of glyceryl dibehenate produced by two techniques: Ultrasonication and spray-flash evaporation

  • Scientific publication

European Journal of Pharmaceutical Sciences , Volume 111, Pages 91-95 https://doi.org/10.1016/j.ejps.2017.09.049 - jan 2018

In this study, solid lipid nanoparticles (SLN) of glyceryl dibehenate are produced by two methods and evaluated for digestion using the in vitro lipolysis test.


By ultrasonication, SLN have a mean particle size of 180 nm and showed a limited digestion by lipase.


By spray-flash evaporation, SLN particle size ranges from 235 to 411 nm, depending on process conditions and were not digested by lipase.

QbD - How particle size and glyceride composition affect the performance of sustained-release tablets with Compritol 888 ATO

  • Poster

AAPS Annual Meeting & Exposition – San Diego (USA)  - nov 2017

Yvonne Rosiaux, Amandine Forrest, Jean-Michel Girard, Carole Deleglise, Delphine Marchaud

A Systematic Approach to Lipid-Based Formulation Development for a Poorly Soluble API, Fenofibrate

  • Poster

AAPS Annual Meeting & Exposition – San Diego (USA)  - nov 2017

Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph.