Particulate matter assessment of a clinical investigation on filtration and infusion phlebitis

Schroeder, Hans G.; DeLuca, Patrick P.

doi:10.1093/ajhp/33.6.543

Cited by 13 publications

(6 citation statements)

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“…The risks related to the presence of particles in an injectable solution are well known: from the end of the 60′s, studies on animals have shown how quantity, size, form, and chemical nature of the particles influence the damage caused by the injected solution [5] , [6] . At the same period of time, the first clinical trials assessing the use of a terminal filter placed right before a perfusion injection site all reported a decrease in phlebitis [7] – [9] . Over the year 2011, a new type of complications linked to buprenorphine self-injection appeared, which alerted the center of evaluation and information on pharmacodependence (CEIP-A).…”

Section: Introductionmentioning

confidence: 96%

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

et al. 2014

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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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Section: Introductionmentioning

confidence: 96%

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

et al. 2014

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“…For the extrinsic and intrinsic subvisible particles, the main concern is the possibility of occlusion of small capillaries of the circulatory system. 1,[9][10][11] For the protein subvisible particles, capillary occlusion is considered less of an issue, in part because of the compressibility of protein particles relative to materials such as glass or metal. Instead, the primary focus is on their potential for immunogenicity, based on the work carried out in the vaccine field to elicit an immune response from particles containing protein antigens.…”

Section: Introductionmentioning

confidence: 99%

“…For all particles present in drug product, there is the possibility that they can affect the safety and/or efficacy of the product. For the extrinsic and intrinsic subvisible particles, the main concern is the possibility of occlusion of small capillaries of the circulatory system . For the protein subvisible particles, capillary occlusion is considered less of an issue, in part because of the compressibility of protein particles relative to materials such as glass or metal.…”

Section: Introductionmentioning

confidence: 99%

Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy

Narhi

Corvari

Ripple³

et al. 2015

Journal of Pharmaceutical Sciences

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“…Nevertheless, workers in clinics still need to treat ampoules carefully on opening them, because glass contamination occurs on opening single-dose glass ampoules [1][2][3][4][5][6][7] . These insoluble particles have been reported to damage various organs such as lung, brain, kidney, liver and spleen [8][9][10] . The intravenous administration of drugs with glass particles may lead to complications, including pulmonary thrombi and micro-emboli 11 , infusion phlebitis, end-organ granuloma formation and inflammation [12][13][14][15] .…”

Section: Introductionmentioning

confidence: 99%

A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application

Lee

Chae

Cho

et al. 2011

Drug Development and Industrial Pharmacy

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A single-dose glass ampoule was developed for ease of administration. When glass ampoules are opened, resulting in contamination by particulate matter. Reducing its contamination may minimize the risk in patients due to particulates. This study reports on an attempt to reduce insoluble particulate contamination by developing methods for the precise measurement of this. A vacuum machine (VM) was used to reduce the level of insoluble particulate contamination, and a microscopy, scanning electron microscopy-energy dispersive X-ray spectrometer (SEM-EDS) and inductively coupled plasma-atomic emission spectrometer (ICP-AES) were used to evaluate the level of reduction. The method permitted the insoluble particle content to be reduced by up to 87.8 and 89.3% after opening 1 and 2 mL-ampoules, respectively. The morphology of the glass particulate contaminants was very sharp and rough, a condition that can be harmful to human health. The total weight of glass particles in the opened ampoules was determined to be 104 ± 72.9 μg and 30.5 ± 1.00 μg after opening 1 and 2 mL-ampoules when the VM was operated at highest power. The total weights were reduced to 53.6 and 50.6%, respectively for 1 and 2 mL-ampoules, compared to opening by hand. The loss of ampoule contents on opening by the VM was 6.50 and 4.67% for 1 and 2 mL-ampoules, respectively. As a result, the VM efficiently reduced glass particulate contamination and the evaluation methods used were appropriate for quantifying these levels of contamination.

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Particulate matter assessment of a clinical investigation on filtration and infusion phlebitis

Cited by 13 publications

References 0 publications

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

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

Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy

A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application

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