2016
DOI: 10.1016/j.xphs.2016.05.029
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Subcutaneous Injection Volume of Biopharmaceuticals—Pushing the Boundaries

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Cited by 136 publications
(105 citation statements)
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“…Despite the growing research interest in subcutaneous administration of higher volumes of drugs using a single large dose [17,19,37,38,55], the understanding of the feasibility of longer injection duration for handheld autoinjectors remains limited. The non-interventional simulated use study reported here provides initial empirical insights on the effect of injection duration on user's force as proxy for the user's ability to hold a handheld autoinjector against the skin.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Despite the growing research interest in subcutaneous administration of higher volumes of drugs using a single large dose [17,19,37,38,55], the understanding of the feasibility of longer injection duration for handheld autoinjectors remains limited. The non-interventional simulated use study reported here provides initial empirical insights on the effect of injection duration on user's force as proxy for the user's ability to hold a handheld autoinjector against the skin.…”
Section: Discussionmentioning
confidence: 99%
“…The healthcare industry, however, has started to explore the self-administration of single-dose volumes above 1 mL, thus triggering debate around the feasible limits of injectable volume, methods, and rates for subcutaneous drug administration [2,[17][18][19]. The growing interest in subcutaneous injection of large-volume single doses up to 2 mL or more can be attributed to three major causes.…”
Section: Introductionmentioning
confidence: 99%
“…41 This volume limitation precludes the formulation with therapeutically relevant concentrations of many lipophilic drugs without the use of organic solvents or other solubilizing agents, which may irritate tissues and lead to induration, sloughing, or abscess formation. However, the volume of an SC dose should be less than 2 mL to avoid adverse events at the injection site, such as injection pain and leakage.…”
Section: Subcutaneousmentioning
confidence: 99%
“…However, the volume of an SC dose should be less than 2 mL to avoid adverse events at the injection site, such as injection pain and leakage. 41 This volume limitation precludes the formulation with therapeutically relevant concentrations of many lipophilic drugs without the use of organic solvents or other solubilizing agents, which may irritate tissues and lead to induration, sloughing, or abscess formation. 26,42 If frequent injections are necessary, the injection site should be rotated to allow time for the tissue to recover.…”
Section: Subcutaneousmentioning
confidence: 99%
“…A literature search on the state-of-the-art knowledge on subcutaneous back-pressure was carried out. Five relevant articles were found together with a Ph.D. thesis [2][3][4][5][6][7]. The study by Allmendinger et al calculated the tissue back-pressure by measuring the injection forces during subcutaneous injection [2].…”
Section: Introductionmentioning
confidence: 99%