Injectability evaluation: An open issue

AAPS PharmSciTech

Volumn 12, Issue 2, 2011, Pages 604-609

  Cilurzo, Francesco ^a   Selmin, Francesca ^a   Minghetti, Paola ^a   Adami, Marco ^b   Bertoni, Elisa ^b   Lauria, Sara ^b   Montanari, Luisa ^a  

^a UNIVERSITY OF MILAN   (Italy)

^b Italfarmaco SpA   (Italy)

Author keywords

Injectability; Panel test; Texture analyzer

Indexed keywords

ARTICLE; COMPARATIVE STUDY; HUMAN; IN VITRO STUDY; INJECTION; INJECTION SITE; NEEDLE GAUGE; NEEDLE LENGTH; PRIORITY JOURNAL; SUBCUTANEOUS TISSUE; SYRINGE NEEDLE; VISCOMETRY; VISCOSITY;

EID: 84991821226     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9625-y     Document Type: Article

References (13)

1. Groves MJ. Parenteral Technology Manual. Interpharm Press. 1988;9:99-100.
2. Veldhuis G, Gironès M, Bingham D. Monodisperse microspheres for parenteral drug delivery. Drug Deliv Tech. 2009;9 (1):24-31.
3. Kumar R, Palmieri MJ. Points to consider when establishing drug product specifications for parenteral microspheres. AAPS J. 2010;12:27-32.
4. Overcashier DE, Chan EK, Hsu CC. Technical considerations in the development of prefilled syringes for protein products. Am Pharm Rev. 2006;9(7):77-83.
5. Jaber A, Bozzato GB, Vedrine L, Prais WA, Berube J, Laurent PE. A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol. 2008;8:38.
6. EMEA, ICH Q6A, Note for Guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (CPMP/ICH/367/ 96), May 2000.
7. FDA, CDER, Guidance for Industry Container Closure System for Packaging Human Drugs and Biologics, May 1999.
8. Ritschel WA, Suzuki K. In vitro testing of injectability. Pharm Ind. 1979;41:468-75.
9. Capes DF, Herring D, Sunderland VB, McMillan D, McDonald C. The effect on syringe performance of fluid storage and repeated use: implications for syringe pumps. PDA J Pharm Sci Technol. 1996;50(1):40-50.
10. Dexter MB, Schott MJ. The evaluation of the force to expel oily injection vehicles from syringes. J Pharm Pharmacol. 1979;31:497-500.
11. Allahham A, Stewart P, Marriott J, Mainwaring DE. Flow and injection characteristics of pharmaceutical parenteral formulations using a micro-capillary rheometer. Int J Pharm. 2004;270:139-48.
12. Allahham A, Mainwaring DE, Stewart P, Marriott J. Development and application of a micro-capillary rheometer for in-vitro evaluation of parenteral injectability. J Pharm Pharmacol. 2004;56:709-16.
13. Chien YW, Przybyszewski P, Shami EG. Syringeability of nonaqueous parenteral formulations-development and evaluation of a testing apparatus. J Parenter Sci Technol. 1981;35(6):281-4.