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Effect of temperature increase during the tableting of pharmaceutical materials.
Int J Pharm. 2013 May 01; 448(1):320-6.IJ

Abstract

Scale-up of tableting process is particularly difficult due to specific concerns related exclusively to the process itself and that cannot be determined on a smaller scale, which are the effect of compression speed and the build-up of heat due to the length of the compaction operations. In this work, it has been simulated the rise of temperature observed during the tablets manufacturing in a full production scale by means of an appropriate modification of a R&D rotary tablet machine. Four common pharmaceutical excipients, characterized by different chemical nature, consolidation behaviour and temperature sensitiveness have been analysed in terms of compaction mechanism (Heckel and energy analysis) and tabletability, in order to verify any effect of the increase of temperature. The results showed a relevance of the temperature on mechanical tablets properties only on materials characterized by low temperature thermal transitions (melting or glass transition), while, for compounds which do not exhibit thermal events at low temperature, it becomes less important for ductile materials and irrelevant for brittle materials. Heckel analysis highlighted a noticeable increase of ductility only in those materials whose tablets mechanical properties depended on the temperature. On the other hand, energy analysis showed low sensitivity failing to identify any temperature effect on compaction materials properties. This work showed how to simulate the process of temperature rise on a small scale and the influence of temperature on materials compaction properties. The use of a modified tableting machine, able to control the temperature and moisture levels and also capable of monitoring the punch movements, resulted in identifying the effect of temperature both on mechanical and compaction properties on materials. Thus, it represents a valuable tool in order to provide useful information at an early stage during the development of tablets formulations.

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Authors+Show Affiliations

Cespi M
University of Camerino, School of Pharmacy, Camerino, MC, Italy.
Bonacucina G
No affiliation info available
Casettari L
No affiliation info available
Ronchi S
No affiliation info available
Palmieri GF
No affiliation info available

MeSH

Drug CompoundingExcipientsHardnessPowdersTabletsTemperatureTensile Strength

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23518365

Citation

Cespi, Marco, et al. "Effect of Temperature Increase During the Tableting of Pharmaceutical Materials." International Journal of Pharmaceutics, vol. 448, no. 1, 2013, pp. 320-6.
Cespi M, Bonacucina G, Casettari L, et al. Effect of temperature increase during the tableting of pharmaceutical materials. Int J Pharm. 2013;448(1):320-6.
Cespi, M., Bonacucina, G., Casettari, L., Ronchi, S., & Palmieri, G. F. (2013). Effect of temperature increase during the tableting of pharmaceutical materials. International Journal of Pharmaceutics, 448(1), 320-6. https://doi.org/10.1016/j.ijpharm.2013.03.014
Cespi M, et al. Effect of Temperature Increase During the Tableting of Pharmaceutical Materials. Int J Pharm. 2013 May 1;448(1):320-6. PubMed PMID: 23518365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of temperature increase during the tableting of pharmaceutical materials. AU - Cespi,Marco, AU - Bonacucina,Giulia, AU - Casettari,Luca, AU - Ronchi,Sara, AU - Palmieri,Giovanni Filippo, Y1 - 2013/03/19/ PY - 2013/01/24/received PY - 2013/02/28/revised PY - 2013/03/01/accepted PY - 2013/3/23/entrez PY - 2013/3/23/pubmed PY - 2013/11/12/medline SP - 320 EP - 6 JF - International journal of pharmaceutics JO - Int J Pharm VL - 448 IS - 1 N2 - Scale-up of tableting process is particularly difficult due to specific concerns related exclusively to the process itself and that cannot be determined on a smaller scale, which are the effect of compression speed and the build-up of heat due to the length of the compaction operations. In this work, it has been simulated the rise of temperature observed during the tablets manufacturing in a full production scale by means of an appropriate modification of a R&D rotary tablet machine. Four common pharmaceutical excipients, characterized by different chemical nature, consolidation behaviour and temperature sensitiveness have been analysed in terms of compaction mechanism (Heckel and energy analysis) and tabletability, in order to verify any effect of the increase of temperature. The results showed a relevance of the temperature on mechanical tablets properties only on materials characterized by low temperature thermal transitions (melting or glass transition), while, for compounds which do not exhibit thermal events at low temperature, it becomes less important for ductile materials and irrelevant for brittle materials. Heckel analysis highlighted a noticeable increase of ductility only in those materials whose tablets mechanical properties depended on the temperature. On the other hand, energy analysis showed low sensitivity failing to identify any temperature effect on compaction materials properties. This work showed how to simulate the process of temperature rise on a small scale and the influence of temperature on materials compaction properties. The use of a modified tableting machine, able to control the temperature and moisture levels and also capable of monitoring the punch movements, resulted in identifying the effect of temperature both on mechanical and compaction properties on materials. Thus, it represents a valuable tool in order to provide useful information at an early stage during the development of tablets formulations. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/23518365/Effect_of_temperature_increase_during_the_tableting_of_pharmaceutical_materials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(13)00233-0 DB - PRIME DP - Unbound Medicine ER -