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Comparative binder efficiency modeling of dry granulation binders using roller compaction.
Drug Dev Ind Pharm. 2017 Apr; 43(4):574-583.DD

Abstract

Roller compaction parameters' impact on granules and tableting properties of coprocessed Avicel® DG [ADG], a physical mixture of the two components at the same composition present in ADG [PADCP], and microcrystalline cellulose and Kollidon® VA-64 Fine physical mixture [KVA64] was quantified by analysis of variance (ANOVA) and multivariate methods. Roller force, roller gap, and roller speed levels were selected for evaluation. A 33 full-factorial experimental design with three center points for roller force, roller gap, and roller speed was used. The response parameters studied were granule-to-fines (GF) ratio, compressibility index (CI), tablet thickness (TT), tablet friability (TF), tablet breaking force (TBF) and disintegration time (DT). A model acetaminophen tablet formulation was roller granulated and tableted at 10 kg scale. Principal component analysis of ADG and PADCP formulations were separated from KVA64 formulations, indicating different granule and tableting properties were binder dependent. This difference in binder performance was also confirmed by ANOVA. The ANOVA also showed that there were no statistical performance differences between coprocessed ADG and its comparable physical blend with the exception of TT. Principal component regression (PCR) analyses of ADG and PADCP revealed that these excipients exhibited a statistically significant negative effect on granules-to-fine (GF) ratio, TT, TBF, and DT. KVA64 demonstrated a positive effect on these parameters. The KVA64 physical mixture demonstrated an overall better performance and binding capability. This study strongly suggests that there is no performance advantage of coprocessed Avicel® DG when compared to a physical mixture of the two components at the same composition.

Authors+Show Affiliations

a Mayne Pharma Inc , Greenville , NC , USA.a Mayne Pharma Inc , Greenville , NC , USA.b Campbell University College of Pharmacy & Health Sciences , Buies Creek , NC , USA.b Campbell University College of Pharmacy & Health Sciences , Buies Creek , NC , USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27977316

Citation

Gupte, Anshul, et al. "Comparative Binder Efficiency Modeling of Dry Granulation Binders Using Roller Compaction." Drug Development and Industrial Pharmacy, vol. 43, no. 4, 2017, pp. 574-583.
Gupte A, DeHart M, Stagner WC, et al. Comparative binder efficiency modeling of dry granulation binders using roller compaction. Drug Dev Ind Pharm. 2017;43(4):574-583.
Gupte, A., DeHart, M., Stagner, W. C., & Haware, R. V. (2017). Comparative binder efficiency modeling of dry granulation binders using roller compaction. Drug Development and Industrial Pharmacy, 43(4), 574-583. https://doi.org/10.1080/03639045.2016.1272118
Gupte A, et al. Comparative Binder Efficiency Modeling of Dry Granulation Binders Using Roller Compaction. Drug Dev Ind Pharm. 2017;43(4):574-583. PubMed PMID: 27977316.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative binder efficiency modeling of dry granulation binders using roller compaction. AU - Gupte,Anshul, AU - DeHart,Michael, AU - Stagner,William C, AU - Haware,Rahul V, Y1 - 2017/01/05/ PY - 2016/12/16/pubmed PY - 2017/6/9/medline PY - 2016/12/16/entrez KW - Avicel DG KW - Excipients KW - Kollidon VA-64 KW - analysis of variance KW - compression KW - continuous pharmaceutical processing KW - dry granulation KW - multivariate analysis KW - powder technology KW - principal component analysis KW - principal component regression KW - roller compaction KW - spray-dried and coprocessed excipients KW - tableting SP - 574 EP - 583 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 43 IS - 4 N2 - Roller compaction parameters' impact on granules and tableting properties of coprocessed Avicel® DG [ADG], a physical mixture of the two components at the same composition present in ADG [PADCP], and microcrystalline cellulose and Kollidon® VA-64 Fine physical mixture [KVA64] was quantified by analysis of variance (ANOVA) and multivariate methods. Roller force, roller gap, and roller speed levels were selected for evaluation. A 33 full-factorial experimental design with three center points for roller force, roller gap, and roller speed was used. The response parameters studied were granule-to-fines (GF) ratio, compressibility index (CI), tablet thickness (TT), tablet friability (TF), tablet breaking force (TBF) and disintegration time (DT). A model acetaminophen tablet formulation was roller granulated and tableted at 10 kg scale. Principal component analysis of ADG and PADCP formulations were separated from KVA64 formulations, indicating different granule and tableting properties were binder dependent. This difference in binder performance was also confirmed by ANOVA. The ANOVA also showed that there were no statistical performance differences between coprocessed ADG and its comparable physical blend with the exception of TT. Principal component regression (PCR) analyses of ADG and PADCP revealed that these excipients exhibited a statistically significant negative effect on granules-to-fine (GF) ratio, TT, TBF, and DT. KVA64 demonstrated a positive effect on these parameters. The KVA64 physical mixture demonstrated an overall better performance and binding capability. This study strongly suggests that there is no performance advantage of coprocessed Avicel® DG when compared to a physical mixture of the two components at the same composition. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/27977316/Comparative_binder_efficiency_modeling_of_dry_granulation_binders_using_roller_compaction_ L2 - https://www.tandfonline.com/doi/full/10.1080/03639045.2016.1272118 DB - PRIME DP - Unbound Medicine ER -