PMID- 32378675 OWN - NLM STAT- MEDLINE DCOM- 20200911 LR - 20200911 IS - 1347-5231 (Electronic) IS - 0031-6903 (Linking) VI - 140 IP - 5 DP - 2020 TI - [Research on Gliding and Discharge Performance of Suspended Injection from Syringe -Effect of Diameter Ratio of Suspending Particle against Needle Hole on Needle Passageability]. PG - 711-722 LID - 10.1248/yakushi.19-00254 [doi] AB - Suspended injectable formulations such as sustained-release luteinizing hormone-releasing hormone (LH-RH) analogue loaded in polylactic acid-glycolic acid copolymer (PLGA) particles have been developed on market. Such formulations have potential issue of suspended particles blocking the injection needle. In this research, two types of injectability tests (gliding force, particles discharge) were developed to evaluate the needle passageability of suspended particles. The model suspension was newly designed using mono-dispersed polyethylene (PE) spheres and qualified dispersing fluid to enhance universality and validity of the test. The suspension-filled syringe, in which three sizes of spheres (L, M, S) were dispersed, was vertically fixed and pushed by auto-compression/tensile tester. The gliding force was continuously detected during testing time and all discharged PE spheres were collected and weighed. The combination of sphere (L, M, S) and injection needle were varied to evaluate the effect of the diameter ratio of sphere against needle hole (D/W) on passageability through needle. These injectability tests revealed that the blockage of a needle hole was occasionally observed when the D/W value increased up to 0.35-0.5, which was detected by jump-up of gliding force and drastic decrease of discharged sphere. In addition, the effect of the formulation properties (concentration of suspended spheres, viscosity of dispersing fluid) and operational factor (injection speed) on injectability was also investigated. The results from this study would be valuable in developing suspended injections and predicting injection trouble at the medical scene. FAU - Niwa, Toshiyuki AU - Niwa T AD - Laboratory of Industrial Pharmacy, Faculty of Pharmacy, Meijo University. FAU - Morisaki, Megumi AU - Morisaki M AD - Laboratory of Industrial Pharmacy, Faculty of Pharmacy, Meijo University. FAU - Kondo, Keita AU - Kondo K AD - Laboratory of Industrial Pharmacy, Faculty of Pharmacy, Meijo University. FAU - Nakashima, Atsushi AU - Nakashima A AD - Laboratory of Industrial Pharmacy, Faculty of Pharmacy, Meijo University. LA - jpn PT - Journal Article PL - Japan TA - Yakugaku Zasshi JT - Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan JID - 0413613 RN - 0 (Suspensions) RN - 1SIA8062RS (Polylactic Acid-Polyglycolic Acid Copolymer) RN - 9002-88-4 (Polyethylene) SB - IM MH - Drug Compounding MH - *Equipment Design MH - Injections MH - Mechanical Phenomena MH - *Needles MH - *Particle Size MH - Polyethylene MH - Polylactic Acid-Polyglycolic Acid Copolymer MH - Suspensions MH - *Syringes OTO - NOTNLM OT - discharge OT - gliding force OT - injectability OT - needle passageability OT - suspended injection EDAT- 2020/05/08 06:00 MHDA- 2020/09/12 06:00 CRDT- 2020/05/08 06:00 PHST- 2020/05/08 06:00 [entrez] PHST- 2020/05/08 06:00 [pubmed] PHST- 2020/09/12 06:00 [medline] AID - 10.1248/yakushi.19-00254 [doi] PST - ppublish SO - Yakugaku Zasshi. 2020;140(5):711-722. doi: 10.1248/yakushi.19-00254.