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Dextrose monohydrate as a non-animal sourced alternative diluent in high shear wet granulation tablet formulations.
Drug Dev Ind Pharm. 2018 May; 44(5):817-828.DD

Abstract

The feasibility of dextrose monohydrate as a non-animal sourced diluent in high shear wet granulation (HSWG) tablet formulations was determined. Impacts of granulation solution amount and addition time, wet massing time, impeller speed, powder and solution binder, and dry milling speed and screen opening size on granule size, friability and density, and tablet solid fraction (SF) and tensile strength (TS) were evaluated. The stability of theophylline tablets TS, disintegration time (DT) and in vitro dissolution were also studied. Following post-granulation drying at 60 °C, dextrose monohydrate lost 9% water and converted into the anhydrate form. Higher granulation solution amounts and faster addition, faster impeller speeds, and solution binder produced larger, denser and stronger (less friable) granules. All granules were compressed into tablets with acceptable TS. Contrary to what is normally observed, denser and larger granules (at ≥21% water level) produced tablets with a higher TS. The TS of the weakest tablets increased the most after storage at both 25 °C/60% RH and 40 °C/75% RH. Tablet DT was higher for stronger granules and after storage. Tablet dissolution profiles for 21% or less water were comparable and did not change on stability. However, the dissolution profile for tablets prepared with 24% water was slower initially and continued to decrease on stability. The results indicate a granulation water amount of not more than 21% is required to achieve acceptable tablet properties. This study clearly demonstrated the utility of dextrose monohydrate as a non-animal sourced diluent in a HSWG tablet formulation.

Authors+Show Affiliations

a Drug Product Development , Celgene Corporation , Summit , NJ , USA. b Product Research and Development , Eli Lilly and Company , Indianapolis , IN , USA.b Product Research and Development , Eli Lilly and Company , Indianapolis , IN , USA.b Product Research and Development , Eli Lilly and Company , Indianapolis , IN , USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29300107

Citation

Mitra, Biplob, et al. "Dextrose Monohydrate as a Non-animal Sourced Alternative Diluent in High Shear Wet Granulation Tablet Formulations." Drug Development and Industrial Pharmacy, vol. 44, no. 5, 2018, pp. 817-828.
Mitra B, Wolfe C, Wu SJ. Dextrose monohydrate as a non-animal sourced alternative diluent in high shear wet granulation tablet formulations. Drug Dev Ind Pharm. 2018;44(5):817-828.
Mitra, B., Wolfe, C., & Wu, S. J. (2018). Dextrose monohydrate as a non-animal sourced alternative diluent in high shear wet granulation tablet formulations. Drug Development and Industrial Pharmacy, 44(5), 817-828. https://doi.org/10.1080/03639045.2017.1414231
Mitra B, Wolfe C, Wu SJ. Dextrose Monohydrate as a Non-animal Sourced Alternative Diluent in High Shear Wet Granulation Tablet Formulations. Drug Dev Ind Pharm. 2018;44(5):817-828. PubMed PMID: 29300107.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dextrose monohydrate as a non-animal sourced alternative diluent in high shear wet granulation tablet formulations. AU - Mitra,Biplob, AU - Wolfe,Chad, AU - Wu,Sy-Juen, Y1 - 2018/01/08/ PY - 2018/1/5/pubmed PY - 2018/10/3/medline PY - 2018/1/5/entrez KW - Dextrose monohydrate KW - disintegration time KW - high shear wet granulation KW - in vitro dissolution KW - tensile strength SP - 817 EP - 828 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 44 IS - 5 N2 - The feasibility of dextrose monohydrate as a non-animal sourced diluent in high shear wet granulation (HSWG) tablet formulations was determined. Impacts of granulation solution amount and addition time, wet massing time, impeller speed, powder and solution binder, and dry milling speed and screen opening size on granule size, friability and density, and tablet solid fraction (SF) and tensile strength (TS) were evaluated. The stability of theophylline tablets TS, disintegration time (DT) and in vitro dissolution were also studied. Following post-granulation drying at 60 °C, dextrose monohydrate lost 9% water and converted into the anhydrate form. Higher granulation solution amounts and faster addition, faster impeller speeds, and solution binder produced larger, denser and stronger (less friable) granules. All granules were compressed into tablets with acceptable TS. Contrary to what is normally observed, denser and larger granules (at ≥21% water level) produced tablets with a higher TS. The TS of the weakest tablets increased the most after storage at both 25 °C/60% RH and 40 °C/75% RH. Tablet DT was higher for stronger granules and after storage. Tablet dissolution profiles for 21% or less water were comparable and did not change on stability. However, the dissolution profile for tablets prepared with 24% water was slower initially and continued to decrease on stability. The results indicate a granulation water amount of not more than 21% is required to achieve acceptable tablet properties. This study clearly demonstrated the utility of dextrose monohydrate as a non-animal sourced diluent in a HSWG tablet formulation. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/29300107/Dextrose_monohydrate_as_a_non_animal_sourced_alternative_diluent_in_high_shear_wet_granulation_tablet_formulations_ L2 - https://www.tandfonline.com/doi/full/10.1080/03639045.2017.1414231 DB - PRIME DP - Unbound Medicine ER -
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