TY - JOUR
T1 - Recent trends and future perspective of pharmaceutical wet granulation for better process understanding and product development
AU - Thapa, Prakash
AU - Tripathi, Julu
AU - Jeong, Seong Hoon
N1 - Publisher Copyright:
© 2018 Elsevier B.V.
PY - 2019/2/15
Y1 - 2019/2/15
N2 - Current trends in pharmaceutical wet granulation have been shifted from traditional approach to systematic and modern approaches, enabling the production of highly engineered product. In this context, quality by design (QbD), modelling, and simulation gradually become important tools in the pharmaceutical industry. In this review, several aspects of high-shear wet granulation (HSWG), such as process and formulation variables are introduced and discussed. In addition, potential critical process parameters of various granulation technologies, such as HSWG, twin-screw granulation (TSG), fluid-bed granulation (FBG), and fluid-bed melt granulation, are introduced. The significance of various off-line and on-line/in-line tools for the characterization of granules and tablet attributes are also highlighted along with their application. Moreover, various mechanistic and semi-mechanistic models that are used to improve the granulation process have been summarized as the predictive models. Overall, this review may inform and guide formulation scientists about the systematic approaches of pharmaceutical wet granulation process to improve the formulation and process design.
AB - Current trends in pharmaceutical wet granulation have been shifted from traditional approach to systematic and modern approaches, enabling the production of highly engineered product. In this context, quality by design (QbD), modelling, and simulation gradually become important tools in the pharmaceutical industry. In this review, several aspects of high-shear wet granulation (HSWG), such as process and formulation variables are introduced and discussed. In addition, potential critical process parameters of various granulation technologies, such as HSWG, twin-screw granulation (TSG), fluid-bed granulation (FBG), and fluid-bed melt granulation, are introduced. The significance of various off-line and on-line/in-line tools for the characterization of granules and tablet attributes are also highlighted along with their application. Moreover, various mechanistic and semi-mechanistic models that are used to improve the granulation process have been summarized as the predictive models. Overall, this review may inform and guide formulation scientists about the systematic approaches of pharmaceutical wet granulation process to improve the formulation and process design.
KW - Critical process parameters
KW - Granule attributes
KW - High-shear wet granulation
KW - Modelling
KW - Quality by Design
KW - Simulation
UR - http://www.scopus.com/inward/record.url?scp=85059159043&partnerID=8YFLogxK
U2 - 10.1016/j.powtec.2018.12.080
DO - 10.1016/j.powtec.2018.12.080
M3 - Review article
AN - SCOPUS:85059159043
SN - 0032-5910
VL - 344
SP - 864
EP - 882
JO - Powder Technology
JF - Powder Technology
ER -