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https://doi.org/10.5599/admet.4.4.338

Investigation of biopharmaceutical and physicochemical drug properties suitable for orally disintegrating tablets

Asami Ono ; Asahi Kasei Pharma, 632-1 Mifuku, Izunokuni, Shizuoka 410-2321, Japan.
Takumi Tomono ; Laboratory of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 60 Nakaorui Takasaki, Gunma 370-0033, Japan.
Takuo Ogihara ; Laboratory of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 60 Nakaorui Takasaki, Gunma 370-0033, Japan.
Katsuhide Terada ; Department of pharmaceutics, Faculty of pharmaceutical sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan.
Kiyohiko Sugano ; Department of pharmaceutics, Faculty of pharmaceutical sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan.


Puni tekst: engleski pdf 1.213 Kb

str. 335-360

preuzimanja: 14.404

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Sažetak

The purpose of this study was to evaluate the biopharmaceutical and physicochemical drug properties suitable for orally disintegrating tablets (ODTs). The molecular weight (MW), polar surface area (PSA), hydrogen bond donor (HBD) and acceptor (HBA) numbers, net charge at pH 7.4, log D6.5, the highest dose strength, solubility in water, dose number, and elimination t1/2 of 57 ODT drugs and 113 drugs of immediate-release (IR) formulations were compared. These drugs were classified according to the Biopharmaceutical Classification System (BCS). A lower dose strength and a longer elimination t1/2 have been observed as characteristic properties of ODTs. The proportion of basic drugs was higher in the ODTs than in the IR formulations. A significant difference was not observed between the ODT and the IR formulation for MW, PSA, HBD, HBA, log D6.5, solubility in water, and dose number. The distributions of the ODTs and IR formulations among each BCS class were similar, suggesting that an ODT can be developed regardless of the BCS class of a drug.

Ključne riječi

orally disintegrating tablet (ODT); bioequivalence; biopharmaceutics classification system (BCS)

Hrčak ID:

171426

URI

https://hrcak.srce.hr/171426

Datum izdavanja:

26.12.2016.

Posjeta: 15.635 *