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Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition.
Int J Pharm. 2020 Jul 30; 585:119466.IJ

Abstract

The effect of a wide variety of binders on the quality of granules produced via continuous twin screw wet granulation was studied. Anhydrous dicalcium phosphate was used as poorly soluble filler and was granulated applying dry or wet addition of binders. Furthermore, dry and wet binder characteristics were determined and linked to the binder effectiveness. PVA 4-88 and starch octenyl succinate exhibited the lowest granule friability at low liquid-to-solid ratios, i.e. the highest binder effectiveness, which was attributed to fast binder activation based on the fast wetting kinetics of the binder, to efficient wetting of DCP particles, and to good spreading in the powder bed. The performance of wettability measurements in an early formulation development stage is therefore considered highly important. Additionally, an increased stickiness of the binder surface caused by high binder viscosity and slow dissolution kinetics also positively influenced the binder effectiveness. In conclusion, this study revealed which binder attributes have a critical impact on the granulation process of dicalcium phosphate. Additionally, dry binder addition proved successful for creation of high quality granules.

Authors+Show Affiliations

Ghent University, Laboratory of Pharmaceutical Technology, Ottergemsesteenweg 460, 9000 Ghent, Belgium.Ghent University, Laboratory of Pharmaceutical Technology, Ottergemsesteenweg 460, 9000 Ghent, Belgium.Ghent University, Laboratory of Pharmaceutical Technology, Ottergemsesteenweg 460, 9000 Ghent, Belgium.Roquette Frères, Rue de la Haute Loge, 62136 Lestrem, France.Ghent University, Laboratory of Pharmaceutical Process Analytical Technology, Ottergemsesesteenweg 460, 9000 Ghent, Belgium.Ghent University, Laboratory of Pharmaceutical Technology, Ottergemsesteenweg 460, 9000 Ghent, Belgium.Ghent University, Laboratory of Pharmaceutical Technology, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: valerie.vanhoorne@ugent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32464227

Citation

Vandevivere, L, et al. "Influence of Binder Attributes On Binder Effectiveness in a Continuous Twin Screw Wet Granulation Process Via Wet and Dry Binder Addition." International Journal of Pharmaceutics, vol. 585, 2020, p. 119466.
Vandevivere L, Denduyver P, Portier C, et al. Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition. Int J Pharm. 2020;585:119466.
Vandevivere, L., Denduyver, P., Portier, C., Häusler, O., De Beer, T., Vervaet, C., & Vanhoorne, V. (2020). Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition. International Journal of Pharmaceutics, 585, 119466. https://doi.org/10.1016/j.ijpharm.2020.119466
Vandevivere L, et al. Influence of Binder Attributes On Binder Effectiveness in a Continuous Twin Screw Wet Granulation Process Via Wet and Dry Binder Addition. Int J Pharm. 2020 Jul 30;585:119466. PubMed PMID: 32464227.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition. AU - Vandevivere,L, AU - Denduyver,P, AU - Portier,C, AU - Häusler,O, AU - De Beer,T, AU - Vervaet,C, AU - Vanhoorne,V, Y1 - 2020/05/25/ PY - 2020/02/25/received PY - 2020/05/20/revised PY - 2020/05/21/accepted PY - 2020/5/29/pubmed PY - 2021/3/4/medline PY - 2020/5/29/entrez KW - Binder addition method KW - Binder attributes KW - Continuous manufacturing KW - Pharmaceutical binders KW - Twin screw granulation KW - Wet granulation SP - 119466 EP - 119466 JF - International journal of pharmaceutics JO - Int J Pharm VL - 585 N2 - The effect of a wide variety of binders on the quality of granules produced via continuous twin screw wet granulation was studied. Anhydrous dicalcium phosphate was used as poorly soluble filler and was granulated applying dry or wet addition of binders. Furthermore, dry and wet binder characteristics were determined and linked to the binder effectiveness. PVA 4-88 and starch octenyl succinate exhibited the lowest granule friability at low liquid-to-solid ratios, i.e. the highest binder effectiveness, which was attributed to fast binder activation based on the fast wetting kinetics of the binder, to efficient wetting of DCP particles, and to good spreading in the powder bed. The performance of wettability measurements in an early formulation development stage is therefore considered highly important. Additionally, an increased stickiness of the binder surface caused by high binder viscosity and slow dissolution kinetics also positively influenced the binder effectiveness. In conclusion, this study revealed which binder attributes have a critical impact on the granulation process of dicalcium phosphate. Additionally, dry binder addition proved successful for creation of high quality granules. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/32464227/Influence_of_binder_attributes_on_binder_effectiveness_in_a_continuous_twin_screw_wet_granulation_process_via_wet_and_dry_binder_addition_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(20)30450-6 DB - PRIME DP - Unbound Medicine ER -