Crushed and Injected Buprenorphine Tablets: Characteristics of Princeps and Generic Solutions

Régis Bouquié 1, 2, * Laura Wainstein 1 Paul Pilet 3 Jean-Marie Mussini 4 Guillaume Deslandes 1 Johann Clouet 3, 5 Eric Dailly 1, 6 Pascale Jolliet 1 Caroline Victorri-Vigneau 7, 1
* Corresponding author
1 Service de Pharmacologie Clinique [CHU Nantes]
2 Biostatistique, Pharmacoépidémiologie et Mesures Subjectives en Santé
3 LIOAD - Laboratoire d'ingénierie osteo-articulaire et dentaire
4 Laboratoire d'anatomie et cytologie pathologiques [CHU Nantes]
5 Pôle hospitalo-universitaire PHU7 - BPPC - Biologie–Pharmacie, Pharmacie Centrale [CHU Nantes]
6 EA 3826 - Thérapeutiques cliniques et expérimentales des infections (EA 3826)
7 CHU Nantes - Centre hospitalier universitaire de Nantes
Abstract : Self-injection of high-dose buprenorphine is responsible for well-described complications. In 2011, we have been alerted by unusual but serious cutaneous complication among injection buprenorphine users. A prospective data collection identified 30 cases of necrotic cutaneous lesions after injection of filtered buprenorphine solution, among which 25 cases occurred following injection of buprenorphine generics. The main goal of our study was to put forward particularities that could explain the cutaneous complications, by qualitatively and quantitatively confronting particles present in Subutex and generics solutions. We used the same protocol that injected-buprenorphine users: generic or subutex tablets were crushed in sterile water and filtered through 2 filters commonly used (cotton-pad and sterifilt). Solutions were analyzed by laser granulometry, flow cytometry and scanning electron microscopy. We have highlighted the wide variation of the quantity and the size of the particles present in solution between the two drugs after cotton-pad filtration. The proportion of particles < 10 µm is systematically higher in the generic solutions than with Subutex. All of the insoluble particles found in generic solutions contain silica, whereas non-organic element was to be identified in the insoluble particles of Subutex. One skin biopsy obtained from one patient who developed a necrotic lesion after intravenous injection of filtrated solution of buprenorphine generic, shows non-organic elements. Identification of particles in situ enables us to confirm the presence of silica in the biopsy. Actually the monitoring of patient receiving generic of buprenorphine must be strengthened.
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Régis Bouquié, Laura Wainstein, Paul Pilet, Jean-Marie Mussini, Guillaume Deslandes, et al.. Crushed and Injected Buprenorphine Tablets: Characteristics of Princeps and Generic Solutions. PLoS ONE, Public Library of Science, 2014, 9 (12), pp.113991 - 113991. ⟨10.1371/journal.pone.0113991⟩. ⟨inserm-01847209⟩

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