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Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets.
Pharm Dev Technol. 2020 Jun 11 [Online ahead of print]PD

Abstract

Diabetes is characterized by chronic hyperglycemia. Although metformin hydrochloride (MHCl)- and glyburide (GLB)-containing conventional tablets are available in the market and used to treat diabetes, orally disintegrating tablets (ODTs) containing the combination of these drugs are not commercially available. Therefore, the aim of this study was to prepare ODTs containing MHCl and GLB by direct-compression (DC-ODTs) and freeze-drying (FD-ODTs) methods. Physical properties of the powder mixture of DC-ODT formulation were determined (Angle of repose: 37.18 ± 1.27°; compressibility index: 20.31 ± 1.06%; Hausner ratio: 1.25 ± 0.03). Its moisture content was 0.3 ± 0.09%. The hardness values and the disintegration times for DC-ODTs and FD-ODTs were 221.60 ± 40.82 and 66.54 ± 2.68 N, and 80 and 30 s, respectively. Friability values were 0.24% for DC-ODTs and 0.38% for FD-ODTs. In uniformity-of-mass for single-dose-preparations test, the average weight was 684.38 ± 1.97 mg for DC-ODTs and 342.93 ± 2.4 mg for FD-ODTs, with less than 5% deviation for all 20 tablets. Water-absorption ratio for DC-ODTs was 1.30 ± 0.05. More than 90% of MHCl and GLB were dissolved within 5 min in both DC-ODTs and FD-ODTs. Although Caco-2 permeability of MHCl was influenced by the ODTs, GLB permeability was not. These results indicated that MHCl- and GLB-containing ODTs may be used as promising formulations for the treatment of diabetes.

Authors+Show Affiliations

Department of Pharmaceutical Technology, Hacettepe University, Ankara, Turkey.Department of Pharmaceutical Technology, Hacettepe University, Ankara, Turkey.Department of Pharmaceutical Technology, Hacettepe University, Ankara, Turkey.Department of Pharmaceutical Technology, Ataturk University, Erzurum, Turkey.Department of Pharmaceutical Technology, Hacettepe University, Ankara, Turkey.Department of Pharmaceutical Technology, Hacettepe University, Ankara, Turkey.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32431206

Citation

Gulsun, Tugba, et al. "Development and Characterization of Metformin Hydrochloride- and Glyburide-containing Orally Disintegrating Tablets." Pharmaceutical Development and Technology, 2020, pp. 1-11.
Gulsun T, Akdag Y, Izat N, et al. Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets. Pharm Dev Technol. 2020.
Gulsun, T., Akdag, Y., Izat, N., Cetin, M., Oner, L., & Sahin, S. (2020). Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets. Pharmaceutical Development and Technology, 1-11. https://doi.org/10.1080/10837450.2020.1772290
Gulsun T, et al. Development and Characterization of Metformin Hydrochloride- and Glyburide-containing Orally Disintegrating Tablets. Pharm Dev Technol. 2020 Jun 11;1-11. PubMed PMID: 32431206.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets. AU - Gulsun,Tugba, AU - Akdag,Yagmur, AU - Izat,Nihan, AU - Cetin,Meltem, AU - Oner,Levent, AU - Sahin,Selma, Y1 - 2020/06/11/ PY - 2020/5/21/pubmed PY - 2020/5/21/medline PY - 2020/5/21/entrez KW - Direct compression ODTs KW - freeze-dried ODTs KW - glyburide KW - metformin hydrochloride KW - permeability SP - 1 EP - 11 JF - Pharmaceutical development and technology JO - Pharm Dev Technol N2 - Diabetes is characterized by chronic hyperglycemia. Although metformin hydrochloride (MHCl)- and glyburide (GLB)-containing conventional tablets are available in the market and used to treat diabetes, orally disintegrating tablets (ODTs) containing the combination of these drugs are not commercially available. Therefore, the aim of this study was to prepare ODTs containing MHCl and GLB by direct-compression (DC-ODTs) and freeze-drying (FD-ODTs) methods. Physical properties of the powder mixture of DC-ODT formulation were determined (Angle of repose: 37.18 ± 1.27°; compressibility index: 20.31 ± 1.06%; Hausner ratio: 1.25 ± 0.03). Its moisture content was 0.3 ± 0.09%. The hardness values and the disintegration times for DC-ODTs and FD-ODTs were 221.60 ± 40.82 and 66.54 ± 2.68 N, and 80 and 30 s, respectively. Friability values were 0.24% for DC-ODTs and 0.38% for FD-ODTs. In uniformity-of-mass for single-dose-preparations test, the average weight was 684.38 ± 1.97 mg for DC-ODTs and 342.93 ± 2.4 mg for FD-ODTs, with less than 5% deviation for all 20 tablets. Water-absorption ratio for DC-ODTs was 1.30 ± 0.05. More than 90% of MHCl and GLB were dissolved within 5 min in both DC-ODTs and FD-ODTs. Although Caco-2 permeability of MHCl was influenced by the ODTs, GLB permeability was not. These results indicated that MHCl- and GLB-containing ODTs may be used as promising formulations for the treatment of diabetes. SN - 1097-9867 UR - https://www.unboundmedicine.com/medline/citation/32431206/Development_and_characterization_of_metformin_hydrochloride-_and_glyburide-containing_orally_disintegrating_tablets L2 - http://www.tandfonline.com/doi/full/10.1080/10837450.2020.1772290 DB - PRIME DP - Unbound Medicine ER -
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