PMID- 34962225
OWN - NLM
STAT- MEDLINE
DCOM- 20220223
LR  - 20220223
IS  - 1521-0464 (Electronic)
IS  - 1071-7544 (Print)
IS  - 1071-7544 (Linking)
VI  - 29
IP  - 1
DP  - 2022 Dec
TI  - Novel cannula design improves large volume auto-injection rates for high 
      viscosity solutions.
PG  - 43-51
LID - 10.1080/10717544.2021.2018069 [doi]
AB  - A prototype reusable large-volume (2 mL) autoinjector (LVAI) was designed to 
      compare injection performance of a novel 27 gauge ultra-thin wall (UTW) 
      pre-filled syringe (PFS) cannula (8 mm external cannula length, 14.4 mm total 
      needle length) against an existing 27 gauge special thin wall (STW) PFS cannula 
      (12.7 mm external cannula length, 19 mm total needle length) across a range of 
      injectate viscosities (2.3-30 cP) in a series of in vivo feasibility studies in 
      swine. The UTW cannula had an approximately 30% greater cross-sectional lumen 
      area than the STW cannula. The target exposed needle length was adjusted to 
      ensure appropriate needle penetration depth and achieve injectate deposition in 
      the subcutaneous (SC) tissue. Delivery time and volume, injection site leakage, 
      injectate depot location, and local tissue effects were examined. The STW and UTW 
      cannulae both provided effective SC delivery of contrast placebo solutions, and 
      were able to accommodate injectate viscosity up to 30 cP without quantifiable 
      leakage from the tissue and with minor tissue effects which resolved within 
      1-2 hours. Delivery times at each viscosity were significantly different between 
      PFS types with the UTW PFS producing faster delivery times. In a histological 
      substudy of the UTW cannula using injectate viscosities up to 50 cP, injection 
      site reactions were rare and, when present, were of minimal severity. This series 
      of studies demonstrates the feasibility of LVAI SC injection and informs 
      autoinjector and PFS design considerations. Use of a UTW cannula may enable more 
      rapid LVAI injections with minimal tissue effects, especially for higher 
      viscosity formulations.
FAU - Roberts, Bruce C
AU  - Roberts BC
AD  - Translational and Clinical Sciences Center of Excellence, BD Technologies and 
      Innovation, Research Triangle Park, NC, USA.
FAU - Rini, Christopher
AU  - Rini C
AD  - Translational and Clinical Sciences Center of Excellence, BD Technologies and 
      Innovation, Research Triangle Park, NC, USA.
FAU - Klug, Rick
AU  - Klug R
AD  - Translational and Clinical Sciences Center of Excellence, BD Technologies and 
      Innovation, Research Triangle Park, NC, USA.
FAU - Sherman, Douglas B
AU  - Sherman DB
AD  - Translational and Clinical Sciences Center of Excellence, BD Technologies and 
      Innovation, Research Triangle Park, NC, USA.
FAU - Morel, Didier
AU  - Morel D
AD  - BD Clinical Development, Pont-de-Claix, France.
FAU - Pettis, Ronald J
AU  - Pettis RJ
AD  - Translational and Clinical Sciences Center of Excellence, BD Technologies and 
      Innovation, Research Triangle Park, NC, USA.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Drug Deliv
JT  - Drug delivery
JID - 9417471
SB  - IM
MH  - Animals
MH  - *Cannula
MH  - Equipment Design/*methods
MH  - Female
MH  - Injection Site Reaction/prevention & control
MH  - Injections, Subcutaneous/*instrumentation
MH  - Swine
MH  - Time Factors
MH  - *Viscosity
PMC - PMC8725910
OTO - NOTNLM
OT  - Large volume subcutaneous injection
OT  - autoinjector
OT  - high viscosity
OT  - injection depth
OT  - in vivo
OT  - pre-filled syringe
OT  - tissue response
OT  - ultra-thin wall cannula
COIS- Bruce Roberts, Christopher Rini, Rick Klug, Douglas B. Sherman, Didier Morel, and 
      Ronald J. Pettis are employees and potential stockholders of BD, which sponsored 
      this work.
EDAT- 2021/12/29 06:00
MHDA- 2022/02/24 06:00
PMCR- 2021/12/28
CRDT- 2021/12/28 08:44
PHST- 2021/12/28 08:44 [entrez]
PHST- 2021/12/29 06:00 [pubmed]
PHST- 2022/02/24 06:00 [medline]
PHST- 2021/12/28 00:00 [pmc-release]
AID - 2018069 [pii]
AID - 10.1080/10717544.2021.2018069 [doi]
PST - ppublish
SO  - Drug Deliv. 2022 Dec;29(1):43-51. doi: 10.1080/10717544.2021.2018069.