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Development of a New Punch Head Shape to Replicate Scale-Up Issues on a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation by Checking the Tablet Surface Using 3-D Laser Scanning Microscope.
J Pharm Sci. 2018 08; 107(8):2144-2151.JP

Abstract

Sticking is a common observation in the scale-up stage on the punch tip using a commercial tableting machine. The difference in the total compression time between a laboratory tableting machine and a commercial one is considered one of the main root causes of scale-up issues in the tableting processes. The proposed "Size Adjusted for Scale-up punch" can be used to adjust the consolidation and dwell times for commercial tableting machine. As a result, the sticking phenomenon is able to be replicated at the pilot scale stage. As reported in this article, the quantification of sticking was done using a 3-D laser scanning microscope to check the tablet surface. It was shown that the sticking area decreased with the addition of magnesium stearate in the formulation, but the sticking depth was not affected by the additional amount of magnesium stearate. It is proposed that the use of a 3-D laser scanning microscope can be applied to evaluate sticking as a process analytical technology tool, and so sticking can be monitored continuously without stopping the machine.

Authors+Show Affiliations

Formulation Research, PST Unit, Medicine Development Center, Eisai Co., Ltd. Kakamigahara-Shi, Gifu 501-6195, Japan. Electronic address: m4-ito@hhc.eisai.co.jp.Formulation Technology, DI Plus Unit, EDCS, Eisai Co., Ltd., Kakamigahara-Shi, Gifu 501-6195, Japan.Formulation Technology, DI Plus Unit, EDCS, Eisai Co., Ltd., Kakamigahara-Shi, Gifu 501-6195, Japan.Formulation Technology, DI Plus Unit, EDCS, Eisai Co., Ltd., Kakamigahara-Shi, Gifu 501-6195, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29684408

Citation

Ito, Manabu, et al. "Development of a New Punch Head Shape to Replicate Scale-Up Issues On a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation By Checking the Tablet Surface Using 3-D Laser Scanning Microscope." Journal of Pharmaceutical Sciences, vol. 107, no. 8, 2018, pp. 2144-2151.
Ito M, Aoki S, Uchiyama J, et al. Development of a New Punch Head Shape to Replicate Scale-Up Issues on a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation by Checking the Tablet Surface Using 3-D Laser Scanning Microscope. J Pharm Sci. 2018;107(8):2144-2151.
Ito, M., Aoki, S., Uchiyama, J., & Yamato, K. (2018). Development of a New Punch Head Shape to Replicate Scale-Up Issues on a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation by Checking the Tablet Surface Using 3-D Laser Scanning Microscope. Journal of Pharmaceutical Sciences, 107(8), 2144-2151. https://doi.org/10.1016/j.xphs.2018.04.012
Ito M, et al. Development of a New Punch Head Shape to Replicate Scale-Up Issues On a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation By Checking the Tablet Surface Using 3-D Laser Scanning Microscope. J Pharm Sci. 2018;107(8):2144-2151. PubMed PMID: 29684408.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a New Punch Head Shape to Replicate Scale-Up Issues on a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation by Checking the Tablet Surface Using 3-D Laser Scanning Microscope. AU - Ito,Manabu, AU - Aoki,Shigeru, AU - Uchiyama,Jumpei, AU - Yamato,Keisuke, Y1 - 2018/04/22/ PY - 2018/01/07/received PY - 2018/03/31/revised PY - 2018/04/06/accepted PY - 2018/4/24/pubmed PY - 2019/6/25/medline PY - 2018/4/24/entrez KW - 3-D laser scanning microscope KW - PAT KW - compaction KW - compression KW - mathematical model KW - monitor KW - punch KW - solid dosage form KW - sticking KW - tableting SP - 2144 EP - 2151 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 107 IS - 8 N2 - Sticking is a common observation in the scale-up stage on the punch tip using a commercial tableting machine. The difference in the total compression time between a laboratory tableting machine and a commercial one is considered one of the main root causes of scale-up issues in the tableting processes. The proposed "Size Adjusted for Scale-up punch" can be used to adjust the consolidation and dwell times for commercial tableting machine. As a result, the sticking phenomenon is able to be replicated at the pilot scale stage. As reported in this article, the quantification of sticking was done using a 3-D laser scanning microscope to check the tablet surface. It was shown that the sticking area decreased with the addition of magnesium stearate in the formulation, but the sticking depth was not affected by the additional amount of magnesium stearate. It is proposed that the use of a 3-D laser scanning microscope can be applied to evaluate sticking as a process analytical technology tool, and so sticking can be monitored continuously without stopping the machine. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/29684408/Development_of_a_New_Punch_Head_Shape_to_Replicate_Scale_Up_Issues_on_a_Laboratory_Tablet_Press_III:_Replicating_Sticking_Phenomenon_Using_the_SAS_Punch_and_Evaluation_by_Checking_the_Tablet_Surface_Using_3_D_Laser_Scanning_Microscope_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(18)30215-6 DB - PRIME DP - Unbound Medicine ER -