DESIGN AND EVALUATION OF PHYSICAL TEST DEVICES FOR PHARMACEUTICAL SOLIDS: THE INTERRUPTED FLOW FLOWOMETER AND THE HARD GELATIN CAPSULE TESTER
Abstract
Two physical test devices for pharmaceutical solids were designed and evaluated; the Interrupted Flow Flowometer (IFF) and the Hard Gelatin Capsule Tester (HGCT). The IFF was used to evaluate the uninterrupted and interrupted flow rates of granular and nongranular materials. Two granular materials were found to have a minimum interrupted flow rate when the device was operated at 50 and 75 RPM. The minimum flow rate for these materials corresponded to approximately 20% of the uninterrupted flow rate. Extrapolated 0 RPM interrupted flow rates for the materials were found to equal the fractional area for flow (FAF) times the uninterruped flow rate. Differences in flow rates for the materials were correlated to changes in particle size and particle size distribution for the materials. The IFF was used to evaluate the flow properties of selected directly and nondirectly compressible excipients. The device could distinguish between good, poor, and irregular flowing materials. The influence of magnesium stearate as a flow promoter was demonstrated for these materials. Possible relationships between IFF flow properties and tabletting characteristics were investigated for directly compressible excipients containing an active medicinal agent. The IFF was found to identify materials which may produce frictional problems on a tablet press. No correlation was found to exist between interrupted flow rate and tablet weight uniformity or content uniformity as evaluated by means of a forced feed tablet machine. The HGCT was found to be a sensitive device capable of measuring physical changes occurring in intact hard gelatin capsules. The effect of capsule prestressing on transducer response was investigated. It was found that the capsule transducer response decreased between the initial HGCT test cycle and subsequent test cycles. This change in response was associated with the freeing of the cap from the body of the capsule. The effect of humidity storage conditions on the transducer response of empty capsules was studied. It was found that capsule response was inversely related to humidity conditions during storage and to the moisture content of the gelatin capsule. The effect of a preconditioning humidity procedure on the capsule response was also investigated. It was found that high humidity pretreated capsules had a higher transducer response than control or low humidity pretreated capsules. . . . (Author's abstract exceeds stipulated maximum length. Discontinued here with permission of school.) UMI
Degree
Ph.D.
Subject Area
Pharmaceuticals
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