Document Detail


Injectability evaluation: an open issue.
MedLine Citation:
PMID:  21553165     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The current work aimed to propose a system of scoring to rationalize and support the selection of the optimal diameter and length of needles. Four formulations at different viscosity and needles ranging from 21 to 26 G and length ranging from 16 to 40 mm were used. Plunger-stopper breakloose force, maximum force (F(max)), and dynamic glide force were measured by a texture analyzer at the crosshead speed of 1 mm/s. Testing was carried out into air or human subcutaneous tissue. The manual injectability of the highest viscosity product was assessed by ten evaluators. The comparison of the panel test score and the quantitative measurements of the forces permitted to score a given needle-syringe-formulation system keeping also in consideration the pressure created in the subcutaneous space and muscles at the injection site. In particular, the following relationship was drawn: at the F(max) up to 250 mPa, the injection was practically impossible; at F(max) ranging from 160 to 250 mPa, the injection was very difficult; at F(max) in the 125-160 mPa range, the injection was feasible, though with some difficulty; when the values of F(max) were lower 125 mPa, the injection went smoothly. On the basis of these preliminary data, a system of scoring the needle-syringe-formulation system is proposed to rationalize and support the selection of the optimal diameter and length of needles, keeping also in consideration the pressure created in the subcutaneous space and muscles at the injection site.
Authors:
Francesco Cilurzo; Francesca Selmin; Paola Minghetti; Marco Adami; Elisa Bertoni; Sara Lauria; Luisa Montanari
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Publication Detail:
Type:  Comparative Study; Evaluation Studies; Journal Article     Date:  2011-05-07
Journal Detail:
Title:  AAPS PharmSciTech     Volume:  12     ISSN:  1530-9932     ISO Abbreviation:  AAPS PharmSciTech     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-07-13     Completed Date:  2012-05-16     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  100960111     Medline TA:  AAPS PharmSciTech     Country:  United States    
Other Details:
Languages:  eng     Pagination:  604-9     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutical Sciences "Pietro Pratesi", Università degli Studi di Milano, Milan, Italy. francesco.cilurzo@unimi.it
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MeSH Terms
Descriptor/Qualifier:
Chemistry, Pharmaceutical / methods*,  standards
Injections / instrumentation,  standards
Needles / standards*
Pharmaceutical Preparations / administration & dosage,  chemistry*,  standards
Viscosity
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations
Comments/Corrections

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