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Mechanism of the formation of hollow spherical granules using a high shear granulator.
Eur J Pharm Sci. 2018 May 30; 117:371-378.EJ

Abstract

Recently, we have developed a novel granulation technology to manufacture hollow spherical granules (HSGs) for controlled-release formulations; however, the mechanism of the granulation is still unclear. The aim of this study is to determine the mechanism of the formation of the HSGs using a high shear granulator. Samples of granulated material were collected at various times during granulation and were investigated using scanning electron microscope and X-ray computed tomography. It was observed that the granulation proceeded by drug layering to the polymer, followed by formation of a hollow in the granule. In addition, it was also found that generation of a crack in the adhered drug layer and air flow into the granules might be involved in forming the hollow in the structure. Observation of the granulation of formulations with different types of drugs and polymers indicated that negative pressure in the granules occurred and the granules caved in when the hollow was formed. The hollow-forming speed and the shell density of the hollow granules depended on the particular drug and polymer. Taken together, the granulation mechanism of HSGs was determined and this information will be valuable for HSGs technology development.

Authors+Show Affiliations

Sumitomo Dainippon Pharma Co., Ltd., 3-45 Kurakakiuchi 1-chome, Ibaraki-shi, Osaka 567-0878, Japan. Electronic address: takumi-asada@ds-pharma.co.jp.School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.Sumitomo Dainippon Pharma Co., Ltd., 3-45 Kurakakiuchi 1-chome, Ibaraki-shi, Osaka 567-0878, Japan.Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan.School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29524593

Citation

Asada, Takumi, et al. "Mechanism of the Formation of Hollow Spherical Granules Using a High Shear Granulator." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 117, 2018, pp. 371-378.
Asada T, Nishikawa M, Ochiai Y, et al. Mechanism of the formation of hollow spherical granules using a high shear granulator. Eur J Pharm Sci. 2018;117:371-378.
Asada, T., Nishikawa, M., Ochiai, Y., Noguchi, S., Kimura, S. I., Iwao, Y., & Itai, S. (2018). Mechanism of the formation of hollow spherical granules using a high shear granulator. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 117, 371-378. https://doi.org/10.1016/j.ejps.2018.03.009
Asada T, et al. Mechanism of the Formation of Hollow Spherical Granules Using a High Shear Granulator. Eur J Pharm Sci. 2018 May 30;117:371-378. PubMed PMID: 29524593.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mechanism of the formation of hollow spherical granules using a high shear granulator. AU - Asada,Takumi, AU - Nishikawa,Mitsunori, AU - Ochiai,Yasushi, AU - Noguchi,Shuji, AU - Kimura,Shin-Ichiro, AU - Iwao,Yasunori, AU - Itai,Shigeru, Y1 - 2018/03/07/ PY - 2017/12/21/received PY - 2018/02/15/revised PY - 2018/03/06/accepted PY - 2018/3/11/pubmed PY - 2018/10/3/medline PY - 2018/3/11/entrez KW - Granulation mechanism KW - High shear granulator KW - Hollow spherical granules KW - X-ray computed tomography SP - 371 EP - 378 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 117 N2 - Recently, we have developed a novel granulation technology to manufacture hollow spherical granules (HSGs) for controlled-release formulations; however, the mechanism of the granulation is still unclear. The aim of this study is to determine the mechanism of the formation of the HSGs using a high shear granulator. Samples of granulated material were collected at various times during granulation and were investigated using scanning electron microscope and X-ray computed tomography. It was observed that the granulation proceeded by drug layering to the polymer, followed by formation of a hollow in the granule. In addition, it was also found that generation of a crack in the adhered drug layer and air flow into the granules might be involved in forming the hollow in the structure. Observation of the granulation of formulations with different types of drugs and polymers indicated that negative pressure in the granules occurred and the granules caved in when the hollow was formed. The hollow-forming speed and the shell density of the hollow granules depended on the particular drug and polymer. Taken together, the granulation mechanism of HSGs was determined and this information will be valuable for HSGs technology development. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/29524593/Mechanism_of_the_formation_of_hollow_spherical_granules_using_a_high_shear_granulator_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(18)30124-6 DB - PRIME DP - Unbound Medicine ER -