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Article

A Precise Prediction Method for the Properties of API-Containing Tablets Based on Data from Placebo Tablets

1
Formulation Development Department, Development and Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1, Shimoumezawa Namerikawa-shi, Toyama 936-0857, Japan
2
Laboratory of Pharmaceutical Technology, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
3
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Malaya, Kuala Lumpur 50603, Malaysia
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(7), 601; https://doi.org/10.3390/pharmaceutics12070601
Received: 2 May 2020 / Revised: 5 June 2020 / Accepted: 27 June 2020 / Published: 28 June 2020
(This article belongs to the Section Pharmaceutical Technology, Manufacturing and Devices)
We previously reported a novel method for the precise prediction of tablet properties (e.g., tensile strength (TS)) using a small number of experimental data. The key technique of this method is to compensate for the lack of experimental data by using data of placebo tablets collected in a database. This study provides further technical knowledge to discuss the usefulness of this prediction method. Placebo tablets consisting of microcrystalline cellulose, lactose, and cornstarch were prepared using the design of an experimental method, and their TS and disintegration time (DT) were measured. The response surfaces representing the relationship between the formulation and the tablet properties were then created. This study investigated tablets containing four different active pharmaceutical ingredients (APIs) with a drug load ranging from 20–60%. Overall, the TS of API-containing tablets could be precisely predicted by this method, while the prediction accuracy of the DT was much lower than that of the TS. These results suggested that the mode of action of APIs on the DT was more complicated than that on the TS. Our prediction method could be valuable for the development of tablet formulations. View Full-Text
Keywords: tablet; response surface method; quality by design; tensile strength; disintegration time; database tablet; response surface method; quality by design; tensile strength; disintegration time; database
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MDPI and ACS Style

Hayashi, Y.; Shirotori, K.; Kosugi, A.; Kumada, S.; Leong, K.H.; Okada, K.; Onuki, Y. A Precise Prediction Method for the Properties of API-Containing Tablets Based on Data from Placebo Tablets. Pharmaceutics 2020, 12, 601. https://doi.org/10.3390/pharmaceutics12070601

AMA Style

Hayashi Y, Shirotori K, Kosugi A, Kumada S, Leong KH, Okada K, Onuki Y. A Precise Prediction Method for the Properties of API-Containing Tablets Based on Data from Placebo Tablets. Pharmaceutics. 2020; 12(7):601. https://doi.org/10.3390/pharmaceutics12070601

Chicago/Turabian Style

Hayashi, Yoshihiro; Shirotori, Kaede; Kosugi, Atsushi; Kumada, Shungo; Leong, Kok H.; Okada, Kotaro; Onuki, Yoshinori. 2020. "A Precise Prediction Method for the Properties of API-Containing Tablets Based on Data from Placebo Tablets" Pharmaceutics 12, no. 7: 601. https://doi.org/10.3390/pharmaceutics12070601

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