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Development of new shaped punch to predict scale-up issue in tableting process.
J Pharm Sci. 2014 Jan; 103(1):235-40.JP

Abstract

Scale-up issues in the tableting process, such as capping, sticking, or differences in tablet thickness, are often observed at the commercial production scale. A new shaped punch, named the size adjusted for scale-up (SAS) punch, was created to estimate scale-up issues seen between laboratory scale and commercial scale tableting processes. The SAS punch's head shape was designed to replicate the total compression time of a laboratory tableting machine to that of a commercial tableting machine. Three different lubricated blends were compressed into tablets using a laboratory tableting machine equipped with SAS punches, and any differences in tablet thickness or capping phenomenon were observed. It was found that the new shaped punch could be used to replicate scale-up issues observed in the commercial tableting machine. The SAS punch was shown to be a useful tool to estimate scale-up issues in the tableting process.

Authors+Show Affiliations

Global Demand Chain Technology Japan, New Chemical Entity, Eisai Demand Chain Systems, Eisai Company Ltd., Kakamigahara-Shi, Gifu, 501-6195, Japan.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24218176

Citation

Aoki, Shigeru, et al. "Development of New Shaped Punch to Predict Scale-up Issue in Tableting Process." Journal of Pharmaceutical Sciences, vol. 103, no. 1, 2014, pp. 235-40.
Aoki S, Uchiyama J, Ito M. Development of new shaped punch to predict scale-up issue in tableting process. J Pharm Sci. 2014;103(1):235-40.
Aoki, S., Uchiyama, J., & Ito, M. (2014). Development of new shaped punch to predict scale-up issue in tableting process. Journal of Pharmaceutical Sciences, 103(1), 235-40. https://doi.org/10.1002/jps.23781
Aoki S, Uchiyama J, Ito M. Development of New Shaped Punch to Predict Scale-up Issue in Tableting Process. J Pharm Sci. 2014;103(1):235-40. PubMed PMID: 24218176.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of new shaped punch to predict scale-up issue in tableting process. AU - Aoki,Shigeru, AU - Uchiyama,Jumpei, AU - Ito,Manabu, Y1 - 2013/11/11/ PY - 2013/08/05/received PY - 2013/10/02/revised PY - 2013/10/16/accepted PY - 2013/11/13/entrez PY - 2013/11/13/pubmed PY - 2014/8/5/medline KW - capping KW - compaction KW - compression KW - hardness KW - mathematical model KW - punch KW - solid dosage form KW - tableting KW - thickness SP - 235 EP - 40 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 103 IS - 1 N2 - Scale-up issues in the tableting process, such as capping, sticking, or differences in tablet thickness, are often observed at the commercial production scale. A new shaped punch, named the size adjusted for scale-up (SAS) punch, was created to estimate scale-up issues seen between laboratory scale and commercial scale tableting processes. The SAS punch's head shape was designed to replicate the total compression time of a laboratory tableting machine to that of a commercial tableting machine. Three different lubricated blends were compressed into tablets using a laboratory tableting machine equipped with SAS punches, and any differences in tablet thickness or capping phenomenon were observed. It was found that the new shaped punch could be used to replicate scale-up issues observed in the commercial tableting machine. The SAS punch was shown to be a useful tool to estimate scale-up issues in the tableting process. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/24218176/Development_of_new_shaped_punch_to_predict_scale_up_issue_in_tableting_process_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(15)30764-4 DB - PRIME DP - Unbound Medicine ER -
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