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Effects of granulation process variables on the physical properties of dosage forms by combination of experimental design and principal component analysis.
Thapa, Prakash; Choi, Du Hyung; Kim, Min Soo; Jeong, Seong Hoon.
Afiliação
  • Thapa P; College of Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea.
  • Choi DH; Department of Pharmaceutical Engineering, Inje University, Gyeongnam 50834, Republic of Korea.
  • Kim MS; College of Pharmacy, Pusan National University, Busan 46241, Republic of Korea.
  • Jeong SH; College of Pharmacy, Dongguk University, Gyeonggi 10326, Republic of Korea.
Asian J Pharm Sci ; 14(3): 287-304, 2019 May.
Article em En | MEDLINE | ID: mdl-32104459
The current study was to understand how process variables of high shear wet granulations affect physical properties of granules and tablets. The knowledge gained was intended to be used for Quality-by-Design based process design and optimization. The variables were selected based on the risk assessment as impeller speed, liquid addition rate, and wet massing time. Formulation compositions were kept constant to minimize their influence on granules properties. Multiple linear regression models were built providing understanding of the impact of each variable on granule hardness, Carr's index, tablet tensile strength, surface mean diameter of granules, and compression behavior. The experimental results showed that the impact of impeller speed was more dominant compared to wet massing time and water addition rate. The results also revealed that quality of granules and tablets could be optimized by adjusting specific process variables (impeller speed 1193 rpm, water spray rate 3.7 ml/min, and wet massing time 2.84 min). Overall desirability was 0.84 suggesting that the response values were closer to the target one. The SEM image of granules showed that spherical and smooth granules produced at higher impeller speed, whereas rough and irregular shape granules at lower speed. Moreover, multivariate data analysis demonstrated that impeller speed and massing time had strong correlation with the granule and tablet properties. In overall, the combined experimental design and principal component analysis approach allowed to better understand the correlation between process variables and granules and tablet attributes.
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2019 Tipo de documento: Article