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Use of in-die powder densification parameters in the implementation of process analytical technologies for tablet production on industrial scale.
Int J Pharm. 2014 Dec 30; 477(1-2):140-7.IJ

Abstract

The use of process analytical technologies (PAT) to ensure final product quality is by now a well established practice in pharmaceutical industry. To date, most of the efforts in this field have focused on development of analytical methods using spectroscopic techniques (i.e., NIR, Raman, etc.). This work evaluated the possibility of using the parameters derived from the processing of in-line raw compaction data (the forces and displacement of the punches) as a PAT tool for controlling the tableting process. To reach this goal, two commercially available formulations were used, changing the quantitative composition and compressing them on a fully instrumented rotary pressing machine. The Heckel yield pressure and the compaction energies, together with the tablets hardness and compaction pressure, were selected and evaluated as discriminating parameters in all the prepared formulations. The apparent yield pressure, as shown in the obtained results, has the necessary sensitivity to be effectively included in a PAT strategy to monitor the tableting process. Additional investigations were performed to understand the criticalities and the mechanisms beyond this performing parameter and the associated implications. Specifically, it was discovered that the efficiency of the apparent yield pressure depends on the nominal drug title, the drug densification mechanism and the error in pycnometric density. In this study, the potential of using some parameters derived from the compaction raw data has been demonstrated to be an attractive alternative and complementary method to the well established spectroscopic techniques to monitor and control the tableting process. The compaction data monitoring method is also easy to set up and very cost effective.

Authors+Show Affiliations

School of Pharmacy, University of Camerino, via S. Agostino 1, 62032 Camerino, MC, Italy.School of Pharmacy, University of Camerino, via S. Agostino 1, 62032 Camerino, MC, Italy.Department of Biomolecular Sciences, University of Urbino, Piazza Rinascimento 6, PU, 61029 Urbino, Italy.School of Pharmacy, University of Camerino, via S. Agostino 1, 62032 Camerino, MC, Italy.Janssen-Pharmaceutical Company of Johnson & Jonhson, via C. Janssen, Borgo S. Michele, Latina, Italy.Janssen-Pharmaceutical Company of Johnson & Jonhson, via C. Janssen, Borgo S. Michele, Latina, Italy.School of Pharmacy, University of Camerino, via S. Agostino 1, 62032 Camerino, MC, Italy. Electronic address: gianfilippo.palmieri@unicam.it.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25304091

Citation

Cespi, Marco, et al. "Use of In-die Powder Densification Parameters in the Implementation of Process Analytical Technologies for Tablet Production On Industrial Scale." International Journal of Pharmaceutics, vol. 477, no. 1-2, 2014, pp. 140-7.
Cespi M, Perinelli DR, Casettari L, et al. Use of in-die powder densification parameters in the implementation of process analytical technologies for tablet production on industrial scale. Int J Pharm. 2014;477(1-2):140-7.
Cespi, M., Perinelli, D. R., Casettari, L., Bonacucina, G., Caporicci, G., Rendina, F., & Palmieri, G. F. (2014). Use of in-die powder densification parameters in the implementation of process analytical technologies for tablet production on industrial scale. International Journal of Pharmaceutics, 477(1-2), 140-7. https://doi.org/10.1016/j.ijpharm.2014.10.009
Cespi M, et al. Use of In-die Powder Densification Parameters in the Implementation of Process Analytical Technologies for Tablet Production On Industrial Scale. Int J Pharm. 2014 Dec 30;477(1-2):140-7. PubMed PMID: 25304091.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Use of in-die powder densification parameters in the implementation of process analytical technologies for tablet production on industrial scale. AU - Cespi,Marco, AU - Perinelli,Diego R, AU - Casettari,Luca, AU - Bonacucina,Giulia, AU - Caporicci,Giuseppe, AU - Rendina,Filippo, AU - Palmieri,Giovanni F, Y1 - 2014/10/07/ PY - 2014/06/30/received PY - 2014/09/30/revised PY - 2014/10/02/accepted PY - 2014/10/12/entrez PY - 2014/10/12/pubmed PY - 2016/3/22/medline KW - Acetaminophen (PubChem CID: 1983) KW - Compression KW - Heckel KW - Ibuprofen lysine salt (PubChem CID: 9,841,440) KW - PAT KW - QbD KW - Tablets KW - Tramadol hydrochloride (PubChem CID: 63,013) KW - Yield pressure SP - 140 EP - 7 JF - International journal of pharmaceutics JO - Int J Pharm VL - 477 IS - 1-2 N2 - The use of process analytical technologies (PAT) to ensure final product quality is by now a well established practice in pharmaceutical industry. To date, most of the efforts in this field have focused on development of analytical methods using spectroscopic techniques (i.e., NIR, Raman, etc.). This work evaluated the possibility of using the parameters derived from the processing of in-line raw compaction data (the forces and displacement of the punches) as a PAT tool for controlling the tableting process. To reach this goal, two commercially available formulations were used, changing the quantitative composition and compressing them on a fully instrumented rotary pressing machine. The Heckel yield pressure and the compaction energies, together with the tablets hardness and compaction pressure, were selected and evaluated as discriminating parameters in all the prepared formulations. The apparent yield pressure, as shown in the obtained results, has the necessary sensitivity to be effectively included in a PAT strategy to monitor the tableting process. Additional investigations were performed to understand the criticalities and the mechanisms beyond this performing parameter and the associated implications. Specifically, it was discovered that the efficiency of the apparent yield pressure depends on the nominal drug title, the drug densification mechanism and the error in pycnometric density. In this study, the potential of using some parameters derived from the compaction raw data has been demonstrated to be an attractive alternative and complementary method to the well established spectroscopic techniques to monitor and control the tableting process. The compaction data monitoring method is also easy to set up and very cost effective. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/25304091/Use_of_in_die_powder_densification_parameters_in_the_implementation_of_process_analytical_technologies_for_tablet_production_on_industrial_scale_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(14)00732-7 DB - PRIME DP - Unbound Medicine ER -