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Characterization of Polymeric Syringes Used for Intravitreal Injection.
J Pharm Sci. 2020 Sep; 109(9):2812-2818.JP

Abstract

Intravitreal (IVT) injection is currently the state of the art for drug delivery to the back of the eye. Drug Products (DP) intended for IVT injections usually pose challenges such as a very low injection volume (e.g. 50 μL) and high injection forces. DPs in vials are typically transferred and injected using disposable polymer syringes, which can feature a silicone oil (SO) coating. In our syringe in-use study, we compared dead volume, total SO content and SO layer distributions of three IVT transfer injection syringes. We assessed multiple potential impact factors such as protein concentration, needle gauge, injection speed, surfactant type and the impact of the in-use hold time on sub-visible particle (SvP) formation and injection forces. Pronounced differences were observed between the syringes regarding SvP generation. Siliconized syringes showed higher SvP counts as compared to non-siliconized syringes. In some cases injection forces exceeded 20 N, which caused needles to burst off during injection. The syringes also showed relevant differences in total SO content and dead volume. In conclusion, specific consideration in the selection of an adequate transfer injection syringe are required. This includes extensive testing and characterization under intended and potential in-use conditions and the development of in-use handling procedures.

Authors+Show Affiliations

Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland.Lonza Drug Product Services, Basel, Switzerland. Electronic address: roman.mathaes@lonza.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32534032

Citation

Peláez, Sarah S., et al. "Characterization of Polymeric Syringes Used for Intravitreal Injection." Journal of Pharmaceutical Sciences, vol. 109, no. 9, 2020, pp. 2812-2818.
Peláez SS, Mahler HC, Koulov A, et al. Characterization of Polymeric Syringes Used for Intravitreal Injection. J Pharm Sci. 2020;109(9):2812-2818.
Peláez, S. S., Mahler, H. C., Koulov, A., Joerg, S., Matter, A., Vogt, M., Chalus, P., Zaeh, M., Sediq, A. S., Jere, D., & Mathaes, R. (2020). Characterization of Polymeric Syringes Used for Intravitreal Injection. Journal of Pharmaceutical Sciences, 109(9), 2812-2818. https://doi.org/10.1016/j.xphs.2020.06.003
Peláez SS, et al. Characterization of Polymeric Syringes Used for Intravitreal Injection. J Pharm Sci. 2020;109(9):2812-2818. PubMed PMID: 32534032.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Characterization of Polymeric Syringes Used for Intravitreal Injection. AU - Peláez,Sarah S, AU - Mahler,Hanns-Christian, AU - Koulov,Atanas, AU - Joerg,Susanne, AU - Matter,Anja, AU - Vogt,Martin, AU - Chalus,Pascal, AU - Zaeh,Maximilian, AU - Sediq,Ahmad S, AU - Jere,Dhananjay, AU - Mathaes,Roman, Y1 - 2020/06/11/ PY - 2020/02/28/received PY - 2020/06/01/revised PY - 2020/06/01/accepted PY - 2020/6/14/pubmed PY - 2020/6/14/medline PY - 2020/6/14/entrez KW - In-use handling KW - Injection force KW - Intravitreal injection KW - Ophthalmic drug product KW - Polymeric syringe KW - Silicone oil droplets KW - Sub-visible particles SP - 2812 EP - 2818 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 109 IS - 9 N2 - Intravitreal (IVT) injection is currently the state of the art for drug delivery to the back of the eye. Drug Products (DP) intended for IVT injections usually pose challenges such as a very low injection volume (e.g. 50 μL) and high injection forces. DPs in vials are typically transferred and injected using disposable polymer syringes, which can feature a silicone oil (SO) coating. In our syringe in-use study, we compared dead volume, total SO content and SO layer distributions of three IVT transfer injection syringes. We assessed multiple potential impact factors such as protein concentration, needle gauge, injection speed, surfactant type and the impact of the in-use hold time on sub-visible particle (SvP) formation and injection forces. Pronounced differences were observed between the syringes regarding SvP generation. Siliconized syringes showed higher SvP counts as compared to non-siliconized syringes. In some cases injection forces exceeded 20 N, which caused needles to burst off during injection. The syringes also showed relevant differences in total SO content and dead volume. In conclusion, specific consideration in the selection of an adequate transfer injection syringe are required. This includes extensive testing and characterization under intended and potential in-use conditions and the development of in-use handling procedures. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/32534032/Characterization_of_Polymeric_Syringes_Used_for_Intravitreal_Injection_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(20)30311-7 DB - PRIME DP - Unbound Medicine ER -
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