Sublingual Diffusion of Epinephrine Microcrystals from Rapidly Disintegrating Tablets for the Potential First-Aid Treatment of Anaphylaxis: In Vitro and Ex Vivo Study

AAPS PharmSciTech
Mutasem Rawas-QalajiKeith J Simons

Abstract

For the first-aid treatment of anaphylaxis, epinephrine (Epi) 0.3 mg intramuscular (IM) injection in the thigh is the drug of choice. Epi auto-injectors are widely recommended for anaphylaxis treatment in community settings but not necessarily carried or used as prescribed when anaphylaxis occurs. We therefore developed rapidly disintegrating sublingual tablets (RDSTs) as an alternative noninvasive dosage form. Our objective in this study was to evaluate the effect of reducing Epi particle size on its in vitro and ex vivo diffusion, with the goal of enhancing Epi sublingual absorption from Epi RDSTs. Epi particle size was reduced by top-bottom technique using a microfluidizer for one pass at 30,000 Psi. The micronized Epi crystals (Epi-MC) were characterized using Zetasizer, Fourier transform infrared (FT-IR), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM). Epi RDSTs were formulated and manufactured using our previously developed method. In vitro and ex vivo diffusion of Epi 10, 20, and 40 mg RDSTs and Epi-MC 10 and 20 mg RDSTs (n = 4) were evaluated using Franz cells. Epi 10 mg solution was used as a control. Mean (±standard deviation (SD)) Epi particle size was successfully reduced from 131.8 ...Continue Reading

References

Feb 8, 2006·The Journal of Allergy and Clinical Immunology·Mutasem M Rawas-QalajiKeith J Simons
Jun 27, 2006·AAPS PharmSciTech·Mutasem M Rawas-QalajiKeith J Simons
May 24, 2007·Drug Development and Industrial Pharmacy·Mutasem M Rawas-QalajiKeith J Simons
Mar 25, 2008·Resuscitation·Jasmeet SoarUNKNOWN Working Group of the Resuscitation Council (UK)
Aug 12, 2008·Allergy·S F KempUNKNOWN World Allergy Organization ad hoc Committee on Epinephrine in Anaphylaxis
Oct 7, 2008·International Journal of Pharmaceutics·Charlene M Y Ong, Charles M Heard
Jun 15, 2010·Current Opinion in Allergy and Clinical Immunology·Keith J Simons, F Estelle R Simons
Jan 27, 2011·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Rainer H MüllerCornelia M Keck
Jan 1, 2010·Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Société Canadienne Des Sciences Pharmaceutiques·Yinghui LiuSiling Wang
Apr 28, 2011·AAPS PharmSciTech·Ousama RachidKeith J Simons
Jun 12, 2012·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Ousama RachidKeith J Simons
Nov 28, 2012·The Journal of Allergy and Clinical Immunology·Ousama RachidKeith J Simons
Feb 14, 2013·BMJ : British Medical Journal·F Estelle R Simons, Aziz Sheikh
Nov 26, 2013·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Mutasem M Rawas-QalajiKeith J Simons
Jul 1, 2014·British Journal of Clinical Pharmacology·Paul RolanValeria Molnar
Sep 27, 2014·The Journal of Pharmacy and Pharmacology·Mutasem Rawas-QalajiKeith J Simons

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Citations

Jan 26, 2016·The Journal of Allergy and Clinical Immunology·Linus B GrabenhenrichMargitta Worm
Nov 19, 2020·The World Allergy Organization Journal·Victoria CardonaMargitta Worm

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Anaphylaxis

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.

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