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A formulation strategy for solving the overgranulation problem in high shear wet granulation.
J Pharm Sci. 2014 Aug; 103(8):2434-40.JP

Abstract

Granules prepared by the high shear wet granulation (HSWG) process commonly exhibit the problem of overgranulation, a phenomenon characterized by a severe loss of the ability to form adequately strong tablet. We hypothesize that the incorporation of brittle excipients promotes brittle fracture of granules during compaction, thereby improving tablet mechanical strength by increasing bonding area. On this basis, we have examined the effectiveness of incorporating a brittle excipient into a plastic matrix in addressing the overgranulation problem. A complete loss of tabletability is observed for plastic microcrystalline cellulose (MCC) when ≥ 55% of granulating water was used. The incorporation of a brittle excipient, either lactose or dibasic calcium phosphate (Dical) into the MCC matrix leads to improved tabletability in a concentration-dependent manner, with higher amount of brittle excipient being more effective. For each mixture, tablet tensile strength goes through a minimum as the granulating water increases, for example, 1.4 MPa for the mixture containing 80% of lactose and 2.1 MPa for the mixture containing 80% Dical. These results, along with scanning electron microscope evidence, show that the addition of brittle excipients to an otherwise plastic powder is an effective formulation strategy to address the overgranulation problem in HSWG.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Osei-Yeboah F
Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, 55455.
Zhang M
No affiliation info available
Feng Y
No affiliation info available
Sun CC
No affiliation info available

MeSH

Calcium PhosphatesCelluloseDrug CompoundingExcipientsLactoseTabletsTensile Strength

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24985120

Citation

Osei-Yeboah, Frederick, et al. "A Formulation Strategy for Solving the Overgranulation Problem in High Shear Wet Granulation." Journal of Pharmaceutical Sciences, vol. 103, no. 8, 2014, pp. 2434-40.
Osei-Yeboah F, Zhang M, Feng Y, et al. A formulation strategy for solving the overgranulation problem in high shear wet granulation. J Pharm Sci. 2014;103(8):2434-40.
Osei-Yeboah, F., Zhang, M., Feng, Y., & Sun, C. C. (2014). A formulation strategy for solving the overgranulation problem in high shear wet granulation. Journal of Pharmaceutical Sciences, 103(8), 2434-40. https://doi.org/10.1002/jps.24066
Osei-Yeboah F, et al. A Formulation Strategy for Solving the Overgranulation Problem in High Shear Wet Granulation. J Pharm Sci. 2014;103(8):2434-40. PubMed PMID: 24985120.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A formulation strategy for solving the overgranulation problem in high shear wet granulation. AU - Osei-Yeboah,Frederick, AU - Zhang,Minglun, AU - Feng,Yushi, AU - Sun,Changquan Calvin, Y1 - 2014/07/01/ PY - 2014/03/31/received PY - 2014/05/13/revised PY - 2014/06/05/accepted PY - 2014/7/3/entrez PY - 2014/7/6/pubmed PY - 2015/3/31/medline KW - compaction KW - formulation KW - granulation KW - materials science KW - powder technology KW - tablet SP - 2434 EP - 40 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 103 IS - 8 N2 - Granules prepared by the high shear wet granulation (HSWG) process commonly exhibit the problem of overgranulation, a phenomenon characterized by a severe loss of the ability to form adequately strong tablet. We hypothesize that the incorporation of brittle excipients promotes brittle fracture of granules during compaction, thereby improving tablet mechanical strength by increasing bonding area. On this basis, we have examined the effectiveness of incorporating a brittle excipient into a plastic matrix in addressing the overgranulation problem. A complete loss of tabletability is observed for plastic microcrystalline cellulose (MCC) when ≥ 55% of granulating water was used. The incorporation of a brittle excipient, either lactose or dibasic calcium phosphate (Dical) into the MCC matrix leads to improved tabletability in a concentration-dependent manner, with higher amount of brittle excipient being more effective. For each mixture, tablet tensile strength goes through a minimum as the granulating water increases, for example, 1.4 MPa for the mixture containing 80% of lactose and 2.1 MPa for the mixture containing 80% Dical. These results, along with scanning electron microscope evidence, show that the addition of brittle excipients to an otherwise plastic powder is an effective formulation strategy to address the overgranulation problem in HSWG. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/24985120/A_formulation_strategy_for_solving_the_overgranulation_problem_in_high_shear_wet_granulation_ DB - PRIME DP - Unbound Medicine ER -