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Biomedical subjects

F J Cioffi

Publications and source records attributed to F J Cioffi.

3 recordsLinked to original sources

ADS-12: an automated programmable 12-tablet dissolution testing system.

A novel computerized automated system is described which conforms to the basic requirements set forth in the compendia for testing the dissolution characteristics of solid dosage forms. This modular system can test 12 tablets simultaneously. It can maintain sink conditions at all times and can handle any chemistry amenable to an automatic analyzer. Dissolution, sampling, chemistry, and readout are all accomplished simultaneously, reducing the complete test time for 12 tablets to the dissolution time itself.

Chemistry, Pharmaceutical

Semiautomated system for high-pressure liquid chromatographic determination of dissolution rate of fludrocortisone acetate tablets.

A new semiautomated high-pressure liquid chromatographic (HPLC) system is described to determine the dissolution rate of fludrocortisone acetate tablets. The system uses a miniaturized dissolution basket and shaft assembly having the same geometry as that given in USP XIX. This reduced size permits use of smaller volumes of dissolution medium, allowing most very low dose oral solid dosage forms to be handled. The USP dissolution kettle was also replaced with a new miniaturized vessel that continuously filters the sample solution before it enters the flow system. Volumes of dissolution medium as small as 15 ml can be accommodated, depending on the sensitivity of the assay employed and the solubility of the drug substance under study. The concentration of fludrocortisone acetate in solution was monitored by a new HPLC system employing a reversed-phase column compatible with the aqueous dissolution medium used. A comparative dissolution study of different lots was made using different basket rotation speeds.

Autoanalysis

Computerized automated system for determining dissolution rate profiles for solid dosage forms.

A unique automated system was developed for the measurement of dissolution rates of tablets and capsules. This system, which adheres to principles set forth in the compendia, can test six dosage forms simultaneously. It is modular in form and capable of maintaining sink conditions, and it can handle any type of chemistry amenable to an automatic analyzer. In addition to the usual dissolution apparatus, the system includes a 12-channel combination sampling and solvent addition pump, a sequence control module, pertinent automated analyzer components, a spectrophotometer or fluorometer, an optional recorder, a specially designed digitizing system, and a teletype equipped with a paper tape punch reader and acoustic coupler. Each dissolution flask is automatically sampled every 6 min. Standards may be run either before or after the samples. Since dissolution, sampling, chemistry, and readout are all accomplished simultaneously, the complete test time is essentially reduced to the dissolution time itself. At the completion of sample dissolution, raw dissolution profile data are on the punched paper tape ready for computer processing via a time-sharing system. Developed software provides for the printout of a complete test report in less than 15 min.

Capsules