TY - JOUR T1 - Twin-screw granulation and high-shear granulation: The influence of mannitol grade on granule and tablet properties. AU - Megarry,Andrew, AU - Taylor,Agnes, AU - Gholami,Aida, AU - Wikström,Håkan, AU - Tajarobi,Pirjo, Y1 - 2020/09/16/ PY - 2020/06/24/received PY - 2020/09/05/revised PY - 2020/09/14/accepted PY - 2020/9/19/pubmed PY - 2021/6/22/medline PY - 2020/9/18/entrez KW - Continuous KW - Formulation development KW - Granule properties KW - Mannitol KW - Polymorphism KW - Twin-screw wet granulation SP - 119890 EP - 119890 JF - International journal of pharmaceutics JO - Int J Pharm VL - 590 N2 - Granule structure has a key influence on tablet critical quality attributes. The ability to control this structure through excipient choice is an important part of formulation development. Mannitol is a popular diluent and the choice of input grade has been shown to impact granule properties. Allopurinol formulations containing two grades of mannitol (Pearlitol 160C and 200SD) were prepared by wet-granulation (twin-screw and high-shear) at different liquid/solid ratios (0.3 and 0.6 g/g). The particle and bulk properties were characterised by a range of techniques and linked to flow performance and tablet tensile strength during compression on a rotary tablet press. During granulation, 200SD underwent a polymorphic transition from a mixture of α and β to predominantly β. This transition was accompanied by a morphology change. Mannitol needles were formed, giving more porous granules with a higher specific surface area, which led to poorer flow properties but higher tablet tensile strength. This study concludes that understanding the effect of mannitol grade is a crucial part of formulation selection. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/32946976/Twin_screw_granulation_and_high_shear_granulation:_The_influence_of_mannitol_grade_on_granule_and_tablet_properties_ DB - PRIME DP - Unbound Medicine ER -