PubMed · 5737045
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I Setnikar. 1968. [Problems in drug control].. https://pubmed.ncbi.nlm.nih.gov/5737045/
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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.
In this study, we investigated the use of microchannel (MC) emulsifications in producing monodisperse gelatin/acacia complex coacervate microcapsules of soybean oil. This is considered to be a novel method for preparing monodisperse O/W and W/O emulsions. Generally, surfactants are necessary for MC emulsification, but they can also inhibit the coacervation process. In this study, we investigated a surfactant-free system. First, MC emulsification using gelatin was compared with that using decaglycerol monolaurate. The results demonstrated the potential use of gelatin for MC emulsification. MC emulsification experiments conducted over a range of conditions revealed that the pH of the continuous phase should be maintained above the isoelectric point of the gelatin. A high concentration of gelatin was found to inhibit the production of irregular-sized droplets. Low-bloom gelatin was found to be suitable for obtaining monodisperse emulsions. Finally, surfactant-free monodisperse droplets prepared by MC emulsification were microencapsulated with coacervate. The microcapsules produced by this technique were observed with a confocal laser scanning microscope. Average diameters of the inner cores and outer shells were 37.8 and 51.5 microm; their relative standard deviations were 4.9 and 8.4%.
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