PubMed · 8085536
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L V Allen. 1994. Compounding: a professional prerogative.. https://doi.org/10.1016/s0160-3450(15)30379-2
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Roller compaction (RC) is an important dry granulation technique. Since pilot and commercial scale roller compactors, which operate continuously on a large scale, usually require kilograms of material per run, formulation and process development directly on such roller compactors is not practical. In contrast, a compaction simulator (CS) can produce ribblets, also known as "slugs", using only a few grams of material with sinusoidal displacement profile replicating the motion of a specific point on the roll surface. Thus, it is possible to develop RC formulation and process in laboratory using a CS-based material-sparing approach. However, because of the inherently different configurations for applying pressure between die compression and roll compression, translating uniaxial pressure from CS experiments to roll pressure during RC is often unreliable, leading to significant uncertainties in the critical quality attributes of ribbons, such as ribbon solid fraction (or porosity) and mechanical strength. The objective of this study was to identify a correction factor (Kp = uniaxial die compression pressure/roll pressure), by correlating the compressibility profiles from CS and a roller compactor of interest, to enable more reliable process translation from CS to roller compactor. In this study, a Kp value of 0.5 was determined for Alexanderwerk WP120 and validated for Gerteis Mini-Pactor and Bepex Pharmapactor. This value may serve as a starting point for translating the optimal compaction pressure identified based on CS investigation to common roller compactors, requiring only minor adjustments to attain optimal RC process parameters (i.e., roll force and roll gap) for a chosen roller compactor.
The creation of an offsite i.v. admixture center shared by four affiliated health care facilities is described. The i.v. admixture center was developed to consolidate the admixture services of four Carilion Health System (Roanoke, Virginia)-affiliated facilities: Roanoke Memorial Hospital (RMH), RMH's Cancer and Rehabilitation Center, Community Hospital of Roanoke Valley (CHRV), and the Roanoke Memorial Home Health Parenteral Therapy Program. The proposed advantages of a shared i.v. admixture service included providing full i.v. services for CHRV, increasing the ability to prepare home i.v. admixtures on a daily basis, increasing space for preparing i.v. admixtures, avoiding adding admixture staff members at any of the facilities, reducing supply duplication and admixture waste, and standardizing and improving quality. The Carilion Admixture Center was built in Carilion's materials management building at a total cost for construction and new equipment of $80,000; it opened in April 1992. The facility is responsible for providing piggyback admixtures, premixed piggyback solutions, injectable antineoplastic agents, total parenteral nutrient solutions, prefilled syringes for pediatric patients, large-volume solutions containing additives, and all admixtures required for the home health care patients. The facility was certified as a Class 20,000 environment. Start-up problems included computer glitches and a heavier-than-anticipated workload during the first year of operation. Nearly 700,000 i.v. admixtures were compounded at the center between October 1992 and September 1994. There were 95 reports of missing doses during the day shift at RMH between November 1992 and January 1993; only 6% were due to errors at the admixture center. The estimated total cost avoidance for salaries, benefits, and nonbillable supplies for October 1992 through September 1994 was $437,000. Intravenous admixture services provided by three hospital facilities and one home health agency were successfully consolidated into one shared offsite center.
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