Mass uniformity: Influence of operational compression conditions of breakability of scored tablets as part of manufacturing robustness evaluation

Journal of Food and Drug Analysis

Volumn 13, Issue 1, 2005, Pages 22-29

  De Spiegeleer, Bart ^a   Van Vooren, Lieven ^b   Thonissen, Thomas ^a   Joye, Philippe ^a   Cornelissen, Bart ^a   Lammens, Geert ^b   Slegers, Guido ^a  

^a GHENT UNIVERSITY   (Belgium)

^b Health Engineering and Assurance   (Belgium)

Author keywords

Compression validation; Robustness development; Scored tablets; Statistical control; Tablet breakability; Weight uniformity

Indexed keywords

VETERINARY DRUG;

ANALYSIS OF VARIANCE; ARTICLE; CONTROLLED STUDY; CORRELATION ANALYSIS; DRUG DOSE; DRUG MANUFACTURE; DRUG QUALITY; FORCE; SCORING SYSTEM; TABLET COMPRESSION; TABLET FRIABILITY; TABLET MANUFACTURE; VALIDATION PROCESS; VELOCITY; WEIGHT;

EID: 20344375236     PISSN: 10219498     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (27)

1. EDQM. 2002. Tablets. European Pharmacopoeia (0478).
2. EDQM. 2004. Tablets. Pharmeuropa 16: 250-253.
3. EMEA. 1998. Note for Guidance on Development Pharmaceutics, CPMP/QWP/155/96. pp. 1-9.
4. EMEA. 2003. Variations: guideline on dossier requirements for type IA and type IB notifications. Notice to Applicants. Vol. 2A. pp. 1-40.
5. EMEA. 2003. Scientific Discussion Carbaglu, CPMP/5346/02. pp. 1-20.
6. EMEA. 2004. Scientific Discussion Incurin, CVMP/265/00. pp. 1-20.
7. FDA. 1995. Scoring configuration of generic drug products. MAPP5223.2. Office of Generic Drugs. pp. 1-4.
8. USP-NF. 2004. Uniformity of Dosage Units, USP-NF (905).
9. Bachynsky, J., Wiens, C. and Melnychuk, K. 2002. The practice of splitting tablets: cost and therapeutic aspects. Pharmacoeconomics 20: 339-346.
10. Rodenhuis, N., de Smet, P. A. and Barends, D. M. 2003. Patient experiences with the performance of tablet score lines needed for dosing. Pharm. World Sci. 25: 173-176.
11. McDevitt, J. T., Gurst, A. H. and Chen, Y. 1998. Accuracy of tablet splitting. Pharmacotherapy 18: 193-197.
12. Vaes, L. P. J., Frijlink, H. W. and Barends, D. M. 2002. The breaking of scored tablets prior to the Ph. Eur. Test. Pharmeuropa 14: 317-319.
13. Duman, E., Yuksel, N., Olin, B. and Sakr, A. 2000. Effect of scoring design on the uniformity of extended release matrix tablet halves. Pharm. Ind. 62: 547-550.
14. Ito, A. and Sugihara, M. 1991. The relationship between dividing properties of scored tablets and dynamic characteristics of powder. Yakugaku Zasshi 111: 606-611.
15. Ito, A., Dobashi, Y. and Sugihara, M. 1992. The effect of stationary time of punch in the process of compression on dividing properties of scored tablets. Yakugaku Zasshi 112: 757-762.
16. Costa, P., Amaral, H. and Sousa Lobo, J. M. 2000. Dissolution characteristics of divisible tablets. STP Pharma Science 10: 373-377.
17. Pesez, M., Arnold, J. C., Bon, R., Catterini, A. M., Debrock, C., Gachon, M., Papin, J. P., Russotto, R., Terracol, D. and Trottmann, D. 1989. Sécabilité des comprimés. STP Pharma pratique 5: 499-500.
18. Kristensen, H. G., Jørgensen, G. H. and Møller-Sonnergaard, J. 1995. Mass uniformity of tablets broken by hand. Pharmeuropa 7: 298-302.
19. Rodenhuis, N., De Smet, P. and Barends, D. 2004. The rationale of scored tablets as dosage form. Europe. J. Pharm. Sci. 21: 305-308.
20. Van Santen, E., Barends, D. M. and Frijlinck, H. W. 2002. Breaking of scored tablets: a review. Europe. J. Pharm. Biopharm. 53: 139-145.
21. Lammens, G. and De Spiegeleer, B. 2004. The use of scored tablets: technical, clinical and pharmacoeconomic considerations. Submitted for publication in Annales Medicinae Militaris Belgicae.
22. Van Vooren, L., De Spiegeleer, B., Thonissen, T., Joye, P., Van Durme, J. and Slegers, G. 2002. Statistical analysis of tablet breakability methods. J. Pharm. Pharm. Sci. 5: 190-198.
23. Loeffler, G. F. 1981. Pharmaceutical dosage forms: tablets. In "Pharmaceutical Tablet Compression Tooling". pp. 451-484. Lieberman, L. A. and Lachman, L. eds. Marcel Dekker Inc. New York, U. S. A.
24. Fell, J. T. and Newton, J. M. 1970. Determination of tablet strength by the diametral-compression test. J. Pharm. Sci. 59: 688-691.
25. Massart, D. L., Vandeginste, B. G. M., Deming, S. N., Michotte, Y. and Kaufman, L. 1988. Chemometrics: a textbook. pp. 1-488. Elsevier. New York, U. S. A.
26. Levene, H. 1960. Robust tests for equality of variance. Contributions to Probability and Statistics: Essays in honor of Harold Hotelling. pp. 278-292. Olkin, I., Ghurye, S. G., Hoeffding, W., Madow, W. G. and Mann, H. B. eds. Stanford University Press. California, U. S. A.
27. EMEA. 2004. Request for comments from industry on the application of the future harmonized Ph. Eur. text "Uniformity of dosage units" to new and existing marketing authorizations. CPMP/QWP/1526/04-EMEA/CVMP/483/04.