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An innovative method for the preparation of high API-loaded hollow spherical granules for use in controlled-release formulation.
Int J Pharm. 2017 May 15; 523(1):167-175.IJ

Abstract

The aim of this study was to prepare controlled-release (CR) granules with suitable particle strength, flowability, particle size distribution (PSD) and density characteristics for blending with other excipients. We also wanted these CR granules to contain large quantities of active pharmaceutical ingredient (API). A high shear mixer was used to mix an API with various polymers at various feed ratios, and the resulting granulated materials were sprayed with solvent. The wet granules were dried using a fluidized bed dryer to give CR granules. The API content of the granules was determined to be 95wt%. The granules were found to be spherical in shape with smooth surfaces by scanning electron microscopy. The inner structure of each granule was determined to be hollow by X-ray computed tomography, highlighting the unusual mechanism of this granulation process. The PSD of the granules was found to be dependent on that of the constituent polymer, and a narrow PSD was obtained by adjusting the PSD of the polymer. The dissolution profile of the granules was also dependent on the constituent polymer. Taken together, these results show that we have successfully developed a new manufacturing technology for the simple and low-cost preparation of ideal CR granules.

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.Sumitomo Dainippon Pharma Co., Ltd., 3-45 Kurakakiuchi 1-chome, Ibaraki-shi, Osaka 567-0878, Japan.Sumitomo Dainippon Pharma Co., Ltd., 3-45 Kurakakiuchi 1-chome, Ibaraki-shi, Osaka 567-0878, 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

28323098

Citation

Asada, Takumi, et al. "An Innovative Method for the Preparation of High API-loaded Hollow Spherical Granules for Use in Controlled-release Formulation." International Journal of Pharmaceutics, vol. 523, no. 1, 2017, pp. 167-175.
Asada T, Kobiki M, Ochiai Y, et al. An innovative method for the preparation of high API-loaded hollow spherical granules for use in controlled-release formulation. Int J Pharm. 2017;523(1):167-175.
Asada, T., Kobiki, M., Ochiai, Y., Iwao, Y., & Itai, S. (2017). An innovative method for the preparation of high API-loaded hollow spherical granules for use in controlled-release formulation. International Journal of Pharmaceutics, 523(1), 167-175. https://doi.org/10.1016/j.ijpharm.2017.03.025
Asada T, et al. An Innovative Method for the Preparation of High API-loaded Hollow Spherical Granules for Use in Controlled-release Formulation. Int J Pharm. 2017 May 15;523(1):167-175. PubMed PMID: 28323098.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An innovative method for the preparation of high API-loaded hollow spherical granules for use in controlled-release formulation. AU - Asada,Takumi, AU - Kobiki,Mitsuaki, AU - Ochiai,Yasushi, AU - Iwao,Yasunori, AU - Itai,Shigeru, Y1 - 2017/03/18/ PY - 2016/12/11/received PY - 2017/02/27/revised PY - 2017/03/13/accepted PY - 2017/3/23/pubmed PY - 2017/8/8/medline PY - 2017/3/22/entrez KW - Controlled release KW - Granulation KW - High active pharmaceutical ingredient-loaded granule KW - High shear mixer KW - Hollow spherical particle KW - Low cost SP - 167 EP - 175 JF - International journal of pharmaceutics JO - Int J Pharm VL - 523 IS - 1 N2 - The aim of this study was to prepare controlled-release (CR) granules with suitable particle strength, flowability, particle size distribution (PSD) and density characteristics for blending with other excipients. We also wanted these CR granules to contain large quantities of active pharmaceutical ingredient (API). A high shear mixer was used to mix an API with various polymers at various feed ratios, and the resulting granulated materials were sprayed with solvent. The wet granules were dried using a fluidized bed dryer to give CR granules. The API content of the granules was determined to be 95wt%. The granules were found to be spherical in shape with smooth surfaces by scanning electron microscopy. The inner structure of each granule was determined to be hollow by X-ray computed tomography, highlighting the unusual mechanism of this granulation process. The PSD of the granules was found to be dependent on that of the constituent polymer, and a narrow PSD was obtained by adjusting the PSD of the polymer. The dissolution profile of the granules was also dependent on the constituent polymer. Taken together, these results show that we have successfully developed a new manufacturing technology for the simple and low-cost preparation of ideal CR granules. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/28323098/An_innovative_method_for_the_preparation_of_high_API_loaded_hollow_spherical_granules_for_use_in_controlled_release_formulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(17)30201-6 DB - PRIME DP - Unbound Medicine ER -