The tabletting machine as an analytical instrument: Qualification of the tabletting machine and the instrumentation with respect to the determination of punch separation and validation of the calibration procedures

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 47, Issue 3, 1999, Pages 231-245

  Belda, Petra M ^a   Mielck, Jobst B ^a  

^a UNIVERSITY OF HAMBURG   (Germany)

Author keywords

Calibration; Eccentric tabletting machine; Inductive displacement transducers; Punch deformation; Punch displacement; Punch separation; Qualification; Validation

Indexed keywords

ARTICLE; CALIBRATION; COMPRESSION; CONTROLLED STUDY; NONHUMAN; TABLET MACHINE; VALIDATION PROCESS;

CALIBRATION; CHEMISTRY, PHARMACEUTICAL; EQUIPMENT DESIGN; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; TABLETS;

EID: 0033035814     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0939-6411(98)00093-9     Document Type: Article

References (16)

1. P.H. Krause, Einflüsse des Geschwindigkeitsverlaufs in Exzenter-Tablettiermaschinen auf die Verdichtungseigenschaften von pharmazeutischen Haufwerken, Ph. D. thesis, University of Hamburg, Hamburg, 1991.
2. U. Tenter, Preßkraft- und Weg-Zeit-Charakteristik von Rundlauftablettenpressen - Instrumentierung und Auswertung, Ph. D. thesis, University of Marburg, Marburg, 1986.
3. Pedersen M.A., Rubinstein M.H., Bateman S.D., Stetsko G. Measuring punch-time displacement profiles on a rotary tabletting machine using a high-speed video system. Pharm. Technol. 17(4):1993;44-52.
4. Armstrong N.A., Palfrey L.P. Punch velocities during the compaction process. J. Pharm. Pharmacol. 39:1987;497-501.
5. A. Bauer, Untersuchungen zur Prozessdatengewinnung, Viskoelastizität und Struktur von Tabletten, Ph. D. thesis, University of Bonn, Bonn, 1990.
6. Lammens R.F., Polderman J., de Blaey C.J., Armstrong N.A. Evaluation of force-displacement measurements during powder compaction. Part II: precision and accuracy of powder height and punch displacement measurements. Int. J. Pharm. Tech. Prod. Mfr. 1(3):1980;26-35.
7. M. Krumme, Entwicklung rechnergestützter Verfahren zur Kompressions- und Festigkeitsanalyse von Tabletten, Ph. D. thesis, University of Berlin, Berlin, 1992.
8. Ho A., Barker J.F., Spence J., Jones T.M. A comparison of three methods of mounting a linear variable displacement transducer on an instrumented tablet machine. J. Pharm. Pharmacol. 31:1979;471-472.
9. Heckel R.W. Density-pressure relationships in powder compaction. Trans. Metall. Soc. A.I.M.E. 221:1961;671-675.
10. P. Ridgway Watt, Tablet machine instrumentation in pharmaceutics: principles and Practise, Ellis Horwood, Chichester, 1988, p. 330.
11. Lloyd J., York P., Cook G.D. Punch elasticity compensation in the calibration of displacement measurements on a compaction simulator. J. Pharm. Pharmacol. 43(Suppl.):1991;80.
12. Muñoz-Ruiz A., Gallego R., del Pozo M., Jiménez-Castellanos M.R., Domínguez-Abascal J. A comparison of three methods of estimating displacement on an instrumented single punch machine. Drug. Dev. Ind. Pharm. 21:1995;215-227.
13. P.M. Belda, J.B. Mielck, The tabletting machine as an analytical instrument: qualification of the measurement devices for punch forces and validation of the calibration procedures, Eur. J. Pharm. Biopharm. 46 (1998) 381-395.
14. Konkel P., Mielck J.B. A compaction study of directly compressible vitamin preparations for the development of a chewable tablet: part II. Pharm. Technol. 16(5):1992;42-54.
15. R. Dietrich, Versuch einer Parametrisierung des zeitlichen Verlaufs der Verdichtung bei der Tablettierung am Beispiel zweier polymorpher Modifikationen von Chlorpropamid, Ph. D. thesis, University of Hamburg, Hamburg, 1983.
16. T. Laich, Regelung eines externen Schmiersystems (Preßkammerbeschichtung) und Messung axialer Matrizenwandkräfte beim Tablettieren, Ph. D. thesis, University of Marburg, Marburg, 1995.