Thus, conventional TFF technique stands to be one of the preferred methods for manufacturing of ultra-high concentration IgG1 formulations. Also, formulation of IgG1 diafiltered with proline using TFF, reduce viscosity from ∼21.9 cP to ∼11 cP at 25☌ and had better stability. Whereas, the stability data suggested reconstituted SFD IgG1 was comparable to control IgG1 formulation concentrated by TFF. Formulations developed by reconstitution of SPD IgG1, demonstrated increase in high and low molecular weight impurities, at accelerated and stressed conditions. Reconstituted, SPD and SFD IgG1 formulations, increased viscosity beyond an acceptable range for subcutaneous injections (<20 cP). Alternatively, spray dried (SPD) and spray freeze dried (SFD) IgG1, was reconstituted in 30%v/v propylene glycol to form ultra-high concentration (∼200 mg/mL) injectable formulation. IgG1 was concentrated to ∼200mg/mL using tangential flow filtration (TFF). Present research summarizes impact of manufacturing conditions on ultra-high concentration (≥150mg/mL) IgG1 formulation, which can be administered as one subcutaneous injection. Monoclonal antibodies requiring higher doses for exerting therapeutic effect but having lower stability, are administered as dilute infusions, or as two (low concentration) injections both resulting in reduced patient compliance. The 1 mL syringe with original 26G needle shows the best combination. On the contrary, both the highest initial and maintenance forces were shown by the combination of 10 mL syringe and 30G needle. The lowest maintenance force was measured in the combination of 1 mL syringe and its original 26G needle. However, the 1 mL syringe showed no significant difference across the needles. The lowest initial force was shown by the combination of 1 mL syringe and 27G spinal needle. Statistical analysis was performed using One-way ANOVA.
#SYRINGE NEEDLE POINT MEASURE SERIES#
Each combination was tested three times using a compression testing Instron 5940 Series to measure initial and maintenance forces. A series of syringes sized 1 mL, 3 mL, 5 mL, 10 mL and 20 mL were paired with the original needles, 27G, 27G spinal and 30G. This study aimed to measure the least initial and maintenance forces of syringe and needle combinations to provide a reference for local anesthetic injection.Īn experimental study was conducted in our Physics Laboratory during September 2015.
0 kommentar(er)
