Key factors governing the reconstitution time of high concentration lyophilized protein formulations.

Lyophilized protein formulations containing highly concentrated proteins often have long and variable reconstitution times. Reconstitution time is dependent on a number of factors in a complex manner. Furthermore, factors influencing the reconstitution of partially crystalline cakes are reportedly different from those of amorphous cakes.

Determination of Holdup Volume and Transient Contact Compatibility of Closed System Transfer Devices for a Reconstituted Lyophilized Drug Product.

Closed system transfer devices (CSTD) are broadly used in healthcare settings as an adjunct engineering control to limit personnel exposure to hazardous drugs (HD). Mechanistic and material differences between CSTD and traditional in-use devices warrant assessment of their impact to product quality and deliverable dose. A lyophilized antibody-drug conjugate (ADC) product was assessed for holdup volume and material compatibility with 14 diverse CSTD sets in a simulated dose compounding scheme.

Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations.

Lyophilized high concentration protein formulations often have long and variable reconstitution times. The aim is to understand the role of crystalline mannitol in lowering the reconstitution time of these formulations. Novel methods were developed for quantifying the effect of crystalline mannitol on cake attributes influencing reconstitution, specifically, cake wettability, liquid penetration into the cake and cake disintegration.

Roller compaction, granulation and capsule product dissolution of drug formulations containing a lactose or mannitol filler, starch, and talc.

This study investigated the influence of excipient composition to the roller compaction and granulation characteristics of pharmaceutical formulations that were comprised of a spray-dried filler (lactose monohydrate or mannitol), pregelatinized starch, talc, magnesium stearate (1% w/w) and a ductile active pharmaceutical ingredient (25% w/w) using a mixed-level factorial design. The main and interaction effects of formulation variables (i.e.