Publications on characterization methods
Thermal Activity Monitoring
Formulation forum – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
Dr. Masumi Dave, Rollie Fuller – Gattefossé USA
In this study, the authors monitor acetylsalicylic acid (ASA) hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, we assess the impact of the excipient choices on the stability of the ASA.
TAM Technique for Identifying API-Lipid Excipient Compatibility Issues Upstream in the Development Process
Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
AAPS PharmSci 360 – 2018
In this study the authors showed that Thermal Activity Monitoring is a useful technique to detect at early stage potential interaction between APi and excipients, using less time and resources than conventional techniques.
TAM technique is used routinely in Gattefossé North America Technical Center of Excellence to speed up formulation development.
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PIT deviation for fast and accurate measure of HLB
An efficient method to determine the Hydrophile-Lipophile Balance of surfactants using the phase inversion temperature deviation of Ci Ej /n-octane/water emulsions.
Nollet M, Boulghobra H, Calligaro E, Rodier JD
Int J Cosmet Sci. 2019 Apr; 41(2):99-108. doi: 10.1111/ics.12516. Epub 2019 Mar 7.
Taylor dispersion analysis
Peptide release from SEDDS containing hydrophobic ion pair therapeutic peptides measured by Taylor dispersion analysis
Joseph Chamieh, Anna Domènech Tarrat, Cérine Doudou, Vincent Jannin, Frederic Demarne and Hervé Cottet
International Journal of Pharmaceutics, Jan 2019
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Size characterization of lipid-based self-emulsifying pharmaceutical excipients during lipolysis using Taylor dispersion analysis with fluorescence detection
Joseph Chamieh, Habib Merdassi, Jean-Christophe Rossi, Vincent Jannin, Frédéric Demarne, Hervé Cottet
Hydrodynamic size characterization of a self-emulsifying lipid pharmaceutical excipient by Taylor dispersion analysis with fluorescent detection
Vincent Jannin, Frédéric Demarne, Hervé Cottet International Journal of Pharmaceutics, Volume 513, Issues 1–2, 20 November 2016, Pages 262-269
In this study the size of microemulsion droplets is carried out using Tailor Dispersion Analysis in comparison to Dynamic Light Scattering. The size evolution of a Labrasol® self emulsifying drug delivery system as a function of concentration and temperature is evaluated. The influence of physical parameters and polydispersity is discussed.
Size characterization of commercial micelles and microemulsions by Taylor dispersion analysis
Joseph Chamieh, Florian Davanier, Vincent Jannin, Frédéric Demarne, Hervé Cottet
International Journal of Pharmaceutics, Volume 492, Issues 1–2, 15 August 2015, Pages 46-54
Lipolysis test
In vitro lipolysis tests on lipid nanoparticles: comparison between lipase/co-lipase and pancreatic extract.
Jannin V, Dellera E Chevrier S, Chavant Y, Voutsinas C, Bonferoni C, Demarne F.
Drug Dev Ind Pharm. 2015;41(10):1582-8. doi: 10.3109/03639045.2014.972412. Epub 2014 Oct 24.
In vitro digestion test
Toward the Establishment of Standardized in Vitro Tests for Lipid-Based Formulations. 5. Lipolysis of representative formulations by gastric lipase.
Bakala-N’Goma, J.C., Williams, H.D., Sassene, P., Kleberg, K., Calderone, M., Jannin, V., Igonin, A., Partheil, A., Marchaud, D., Jule, E., Vertommen, J., Maio, M., Blundell, R., Benameur, H., Müllertz, A., Pouton, C.W., Porter, C.J.H., Carrière, F. Pharm Res. 2015 Apr; 32(4):1279-87. doi: 10.1007/s11095-014-1532-y. Epub 2014 Oct 7.
This research article focuses on the effect of gastric lipases on various LFCS formulation types. Gastric lipase is active on all formulations tested but presents the highest activity on self (micro)emulsifying drug delivery systems composed of medium chain lipids (LFCS type II & III).
Toward the Establishment of Standardized In Vitro Tests for Lipid-Based Formulations, Part 6: Effects of Varying Pancreatin and Calcium Levels.
Sassene, P.J., Kleberg, K., Williams, H.D., Bakala-N’Goma, J.C., Carrière, F., Calderone, M., Jannin, V., Igonin, A., Partheil, A., Marchaud, D., Jule, E., Vertommen, J., Maio, M., Blundell, R., Benameur, H., Porter, C.J.H., Pouton, C.W., Müllertz, A.
AAPS J. 2014 Nov;16(6):1344-57. doi: 10.1208/s12248-014-9672-x. Epub 2014 Oct 2.
This article continues a series of publication on the establishment of a standardized method of lipolysis. In this article the effect of varying quantities of pancreatin (the selected enzyme) and calcium on the extent of lipolysis and drug repartition (precipitation / micellar phase / lipid phase) has been evaluated. The repartition of the drug is not significantly affected by these two parameters, hence physiological levels of enzyme and calcium (1.4 mM) are recommended.
Co-culture model
Biorelevant media resistant co-culture model mimicking permeability of human intestine.
Delphine Antoine, Yann Pellequer, Camille Tempesta, Stefan Lorscheidt, Bernadette Kettel, Lana Tamaddon, Vincent Jannin, Frédéric Demarne, Alf Lamprecht, Arnaud Béduneau
International Journal of Pharmaceutics, Volume 481, Issues 1–2, 15 March 2015, Pages 27-36
Cell culture models are currently used to predict absorption pattern of new compounds and formulations in the human gastro-intestinal tract (GIT). One major drawback is the lack of relevant apical incubation fluids allowing mimicking luminal conditions in the GIT. Here, we suggest a culture model compatible with biorelevant media, namely Fasted State Simulated Intestinal Fluid (FaSSIF) and Fed State Simulated Intestinal Fluid (FeSSIF).
