Evidence map›Paper›PMID 40838048›Full record

ArticleFrontiers in drug delivery2023

Characterization of large volume subcutaneous injections using computed tomography imaging and simultaneous pressure measurements.

Mona Purcell, Sahab Babaee, Michael Galluppi, John Cline, Guangli Hu, Ioan Petrescu, Jennifer Hughes, Meredith Allen, Eric Messina, Steven Persak and 3 more

Abstract read
In one paragraph

Article in Frontiers in drug delivery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Mona PurcellTranslational Imaging, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Sahab BabaeeDevice Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Michael GalluppiDevice Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
John ClineDevice Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Guangli HuDevice Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Ioan PetrescuLaboratory Animal Resource, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Jennifer HughesLaboratory Animal Resource, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Meredith AllenLaboratory Animal Resource, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Eric MessinaTranslational Imaging, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Steven PersakDevice Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Yogita KrishnamachariPreclinical Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Ashley Lay-FortenberyPreclinical Development, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.
Corin O MillerTranslational Imaging, Merck Research Laboratories, Merck and Co., Inc., Rahway, NJ, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many commercially available biologics, previously delivered only intravenously, are being re-formulated for subcutaneous delivery to improve patient access and compliance. However, due to inherent solubility limitations, large volume injections (more than 2 mL) are typically required. Different strategies are being explored to improve the tolerability of such injections, including the co-formulation with hyaluronidase and/or implementing different needle designs. While there have been separate reports of measuring injection forces and using imaging to track injection delivery and tissue response, there is no current set of methods to simultaneously characterize the injection delivery (bleb) and measure injection pressures. In this study we describe the development of Computed Tomography imaging methods in minipigs to characterize the morphology of the bleb following injection, along with inline pressure measurements to assess subcutaneous pressure during injection using two different injection volumes, 4.5 mL and 9 mL. We show that these parameters change with injection volume, and that inclusion of hyaluronidase in the injection increases bleb dispersion and reduces skin distention while also lowering the injection pressure. This method will likely be a valuable tool for assessing and comparing different injection delivery methods and formulations.

Indexed as

computed tomographyhyaluronidasein vivominipigSubcutaneous

Identifiers

PMID40838048
PMCPMC12363303

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.