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Application of continuous twin screw granulation for the metformin hydrochloride extended release formulation.
Int J Pharm. 2017 Aug 30; 529(1-2):410-422.IJ

Abstract

This study focuses on evaluating the potential of transferring from a batch process to continuous process for manufacturing of the extended release formulation. Metformin hydrochloride (HCl) was used in the model formulation which was intended to contain the high amount of hydrophilic drug. The effects of barrel temperature, binder type, powder feed rate, and screw speed on granule properties (size and strength) and torque value in twin screw granulation were investigated. Due to the high content of hydrophilic model drug, the granules prepared at a higher temperature with HPMC binding solution had the narrower size distribution and greater strength than the granules prepared with distilled water as a binding solution. After continuous drying and milling steps, the granules (continuous process) satisfied the fundamental purpose of granulation with size and flowability, despite different shape compared with the granules (batch process). Furthermore, there were no significant differences between two granulation processes in tablet properties, such as tablet hardness and in vitro release. The considerations and strategies used in this study to transfer from a batch to continuous process can be applied to other existing formulations based on high shear granulation to enable rapid process transfer in the pharmaceutical industry.

Authors+Show Affiliations

School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.College of Pharmacy, Woosuk University, Wanju-gun 55338, Republic of Korea.College of Pharmacy, Chungbuk National University, Cheongju 19421, Republic of Korea.College of Pharmacy and Research Institute of Pharmaceutical Sciences, Gyeongsang National University, Jinju 52828, Republic of Korea.School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea. Electronic address: espark@skku.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28705620

Citation

Kim, Su-Hyeon, et al. "Application of Continuous Twin Screw Granulation for the Metformin Hydrochloride Extended Release Formulation." International Journal of Pharmaceutics, vol. 529, no. 1-2, 2017, pp. 410-422.
Kim SH, Hwang KM, Cho CH, et al. Application of continuous twin screw granulation for the metformin hydrochloride extended release formulation. Int J Pharm. 2017;529(1-2):410-422.
Kim, S. H., Hwang, K. M., Cho, C. H., Nguyen, T. T., Seok, S. H., Hwang, K. M., Kim, J. Y., Park, C. W., Rhee, Y. S., & Park, E. S. (2017). Application of continuous twin screw granulation for the metformin hydrochloride extended release formulation. International Journal of Pharmaceutics, 529(1-2), 410-422. https://doi.org/10.1016/j.ijpharm.2017.07.019
Kim SH, et al. Application of Continuous Twin Screw Granulation for the Metformin Hydrochloride Extended Release Formulation. Int J Pharm. 2017 Aug 30;529(1-2):410-422. PubMed PMID: 28705620.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Application of continuous twin screw granulation for the metformin hydrochloride extended release formulation. AU - Kim,Su-Hyeon, AU - Hwang,Kyu-Min, AU - Cho,Cheol-Hee, AU - Nguyen,Thi-Tram, AU - Seok,Su Hyun, AU - Hwang,Kyu-Mok, AU - Kim,Ju-Young, AU - Park,Chun-Woong, AU - Rhee,Yun-Seok, AU - Park,Eun-Seok, Y1 - 2017/07/10/ PY - 2017/04/11/received PY - 2017/06/17/revised PY - 2017/07/07/accepted PY - 2017/7/15/pubmed PY - 2018/1/4/medline PY - 2017/7/15/entrez KW - Batch process KW - Continuous process KW - Controlled release formulation KW - Metformin hydrochloride KW - Transfer KW - Twin screw granulation SP - 410 EP - 422 JF - International journal of pharmaceutics JO - Int J Pharm VL - 529 IS - 1-2 N2 - This study focuses on evaluating the potential of transferring from a batch process to continuous process for manufacturing of the extended release formulation. Metformin hydrochloride (HCl) was used in the model formulation which was intended to contain the high amount of hydrophilic drug. The effects of barrel temperature, binder type, powder feed rate, and screw speed on granule properties (size and strength) and torque value in twin screw granulation were investigated. Due to the high content of hydrophilic model drug, the granules prepared at a higher temperature with HPMC binding solution had the narrower size distribution and greater strength than the granules prepared with distilled water as a binding solution. After continuous drying and milling steps, the granules (continuous process) satisfied the fundamental purpose of granulation with size and flowability, despite different shape compared with the granules (batch process). Furthermore, there were no significant differences between two granulation processes in tablet properties, such as tablet hardness and in vitro release. The considerations and strategies used in this study to transfer from a batch to continuous process can be applied to other existing formulations based on high shear granulation to enable rapid process transfer in the pharmaceutical industry. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/28705620/Application_of_continuous_twin_screw_granulation_for_the_metformin_hydrochloride_extended_release_formulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(17)30618-X DB - PRIME DP - Unbound Medicine ER -