Tags

Type your tag names separated by a space and hit enter

Real-time monitoring of pharmaceutical properties of medical tablets during direct tableting process by hybrid tableting process parameter-time profiles.
Biomed Mater Eng. 2020; 30(5-6):509-524.BM

Abstract

BACKGROUND

Real-time monitoring is required for the pharmaceutical manufacturing process to produce high-quality pharmaceutical products.

OBJECTIVE

Changes in the critical tableting process parameters of single-punch tableting machine due to variability in the moisture content of the raw powders were monitored by hybrid tableting pressure-time profiles.

METHODS

After mixing of the raw powders, which consisted of theophylline, anhydrous lactose, potato starch and crystalline cellulose, they were stored at 0%, 45%, or 75% relative humidity (RH) for 24 h, respectively. Continuous tablet productions were carried out using the mixed powder samples at 10%, 45%, or 75% RH, respectively. The critical process parameters, such as upper and lower puncture pressures, die wall pressures, and inter-punch distances were recoded with the tableting machine, and then, tablet hardness (H), weight (W) and disintegration time (DT) of the tablets were measured.

RESULTS

Hybrid tableting pressure-time profiles were obtained from various critical process parameters, and calibration models to predict pharmaceutical properties were calculated based on the hybrid profiles using a partial-least-squares regression (PLSR) method. In addition, the consistency of the calibration models were verified by constructing robust calibration models.

CONCLUSION

Informetrical analysis for tablets based on hybrid tableting pressure-time profiles could evaluate the change of tablet properties dependent on the moisture content in the raw powders during the tableting process. The changes of tableting properties and elasticity were caused by agglomeration of powder particles at moisture content.

Authors+Show Affiliations

Graduate School of Pharmaceutical Sciences, Musashino University, Nishi-Tokyo, Tokyo, Japan.Graduate School of Pharmaceutical Sciences, Musashino University, Nishi-Tokyo, Tokyo, Japan.Division of Drugs, National Institute of Health Sciences, Kawasaki-ku, Kawasaki City, Kanagawa, Japan.Graduate School of Pharmaceutical Sciences, Musashino University, Nishi-Tokyo, Tokyo, Japan.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

31771033

Citation

Saito, Shuji, et al. "Real-time Monitoring of Pharmaceutical Properties of Medical Tablets During Direct Tableting Process By Hybrid Tableting Process Parameter-time Profiles." Bio-medical Materials and Engineering, vol. 30, no. 5-6, 2020, pp. 509-524.
Saito S, Hattori Y, Sakamoto T, et al. Real-time monitoring of pharmaceutical properties of medical tablets during direct tableting process by hybrid tableting process parameter-time profiles. Biomed Mater Eng. 2020;30(5-6):509-524.
Saito, S., Hattori, Y., Sakamoto, T., & Otsuka, M. (2020). Real-time monitoring of pharmaceutical properties of medical tablets during direct tableting process by hybrid tableting process parameter-time profiles. Bio-medical Materials and Engineering, 30(5-6), 509-524. https://doi.org/10.3233/BME-191071
Saito S, et al. Real-time Monitoring of Pharmaceutical Properties of Medical Tablets During Direct Tableting Process By Hybrid Tableting Process Parameter-time Profiles. Biomed Mater Eng. 2020;30(5-6):509-524. PubMed PMID: 31771033.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Real-time monitoring of pharmaceutical properties of medical tablets during direct tableting process by hybrid tableting process parameter-time profiles. AU - Saito,Shuji, AU - Hattori,Yusuke, AU - Sakamoto,Tomoaki, AU - Otsuka,Makoto, PY - 2019/11/28/pubmed PY - 2020/11/28/medline PY - 2019/11/28/entrez KW - Tableting compression KW - effect of moisture content KW - hybrid tableting pressure–time profiles KW - partial-least-squares-regression KW - process analytical technology KW - tablet disintegration time KW - tablet hardness SP - 509 EP - 524 JF - Bio-medical materials and engineering JO - Biomed Mater Eng VL - 30 IS - 5-6 N2 - BACKGROUND: Real-time monitoring is required for the pharmaceutical manufacturing process to produce high-quality pharmaceutical products. OBJECTIVE: Changes in the critical tableting process parameters of single-punch tableting machine due to variability in the moisture content of the raw powders were monitored by hybrid tableting pressure-time profiles. METHODS: After mixing of the raw powders, which consisted of theophylline, anhydrous lactose, potato starch and crystalline cellulose, they were stored at 0%, 45%, or 75% relative humidity (RH) for 24 h, respectively. Continuous tablet productions were carried out using the mixed powder samples at 10%, 45%, or 75% RH, respectively. The critical process parameters, such as upper and lower puncture pressures, die wall pressures, and inter-punch distances were recoded with the tableting machine, and then, tablet hardness (H), weight (W) and disintegration time (DT) of the tablets were measured. RESULTS: Hybrid tableting pressure-time profiles were obtained from various critical process parameters, and calibration models to predict pharmaceutical properties were calculated based on the hybrid profiles using a partial-least-squares regression (PLSR) method. In addition, the consistency of the calibration models were verified by constructing robust calibration models. CONCLUSION: Informetrical analysis for tablets based on hybrid tableting pressure-time profiles could evaluate the change of tablet properties dependent on the moisture content in the raw powders during the tableting process. The changes of tableting properties and elasticity were caused by agglomeration of powder particles at moisture content. SN - 1878-3619 UR - https://www.unboundmedicine.com/medline/citation/31771033/Real_time_monitoring_of_pharmaceutical_properties_of_medical_tablets_during_direct_tableting_process_by_hybrid_tableting_process_parameter_time_profiles_ L2 - https://content.iospress.com/openurl?genre=article&id=doi:10.3233/BME-191071 DB - PRIME DP - Unbound Medicine ER -