PubMed · 7928604
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C E Myers. 1994-07-15. Compounding for human use in the future.. https://pubmed.ncbi.nlm.nih.gov/7928604/
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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.
A newly commercialized high-resolution ultrasonic spectrometer was evaluated for simultaneously measuring concentrations of a model excipient (hypromellose acetate succinate polymer, HPMCAS, CAS No. 71138-97-1) and a model drug (Fenofibrate, CAS No. 49562-28-9) in acetone solution. It was demonstrated that the measurements of both velocity and attenuation had sufficient accuracy and precision. The velocity was found to be directly proportional to concentrations of both HPMCAS polymer and Fenofibrate in solution. The attenuation was found to be directly proportional to concentration of HPMCAS polymer in solution. By establishing linear relationships of measured velocity and attenuation to the concentrations of HPMCAS polymer and the Fenofibrate in a series of standard solutions, it was feasible to simultaneously analyze concentrations of both HPMCAS polymer and Fenofibrate in a test solution. However, it was found that both temperature and moisture had significant influence on the measurement. While the change in velocity was inversely proportional to the change in temperature, the change in velocity was directly proportional to the change in moisture content in solutions.
PURPOSE: The estimated microbial contamination rate for complex, multiple-step, medium-risk-level compounding was studied. METHODS: The results of evaluations of the aseptic technique of pharmacists and technicians in compounding complex USP medium-risk-level sterile preparations were compiled to estimate the microbial contamination rate. The testing took place in 2002 and 2003 at a single institution and involved reconstitution of sterile dry growth medium and a series of complicated transfers of the medium from vials and ampuls to intravenous bags. The bags were incubated at 25-35 degrees C for 14 days and observed for microbial growth. RESULTS: Of 539 evaluations, 28 (5.2%) resulted in preparations that yielded microbial growth. Pharmacists' compounding resulted in a slightly lower contamination rate (4.4%) than that of technicians (6.2%). Inadvertent touch contamination may have been the principal source of the contamination. CONCLUSION: . A two-year series of 539 evaluations of the aseptic technique of pharmacists and technicians conducted with sterile growth medium and designed to simulate the compounding of USP medium-risk-level sterile preparations yielded an overall contamination rate of 5.2%.