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The reconstitution strategy of reduced diluent volume, however, has enabled significant decrease in reconstitution time (4 7-fold) of lyophilized high protein concentration formulations.
An alternate reconstitution method was devised, using 18 mL 0.9% saline with manual inversion, with the goal of shortening reconstitution time while maintaining a high quality, efficacious product.
Unique challenges, such as long reconstitution time for a lyophilized high protein concentration drug product, can limit practical usage and commercial marketability of the product.
The objectives of this study were to identify l-arginine chloride-based formulations and optimize freeze-drying process conditions to deliver a freeze-dried product with good physical quality attributes (including cake appearance, residual moisture, and reconstitution time).
To evaluate the drug constitution of dantrolene by comparing reconstitution with diluent at ambient and warmed temperatures, so as to determine whether differences in reconstitution time might provide clinical or therapeutic advantages.
Independent and dependent variables were optimized using central composite design (CCD) to obtain TP-TY NPs which were then characterized in terms of zeta potential, surface morphology, residual PVA content, injectability, syringeability, and reconstitution time.
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The focus is on achieving reasonable reconstitution times with multidisciplinary strategies.
Many strategies have been shown to provide nominal improvement in reconstitution times, such as adding wetting agents in the diluents, incorporating high annealing steps in the lyophilization cycle and reconstituting under vacuum.
Conceptually, the engraftment of mature human peripheral blood lymphocytes (PBL) into immunodeficient murine recipients overcomes the need for long reconstitution times required when using human CD34+ cord blood derived HSC and should allow for a rapid assessment of immune responsiveness of diverse individuals, for example, young and aged humans.
Moreover, concentrating this expertise in one place reduces the risk of errors and optimises reconstitution times for the whole hospital.
It was found that average reconstitution times were 2.96 and 4.25 minutes for 80 and 120 mg degarelix doses, respectively (Ferring Pharmaceuticals, data on file).
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