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Stability and Bioavailability of diltiazem/polyethylene Oxide Matrix Tablets

Stability and Bioavailability of diltiazem/polyethylene Oxide Matrix Tablets

Laila H Emara, Ahmed A El-Ashmawy, Nesrin F Taha

Pharm Dev Technol. 2018 Dec;23(10):1057-1066.

PMID: 28604151

Abstract:

The aim of this study was to prepare and evaluate in vitro and in vivo; Diltiazem-Hydrochloride (DTZ) in sustained-release matrix tablets. Stability of DTZ tablets prepared with polyethylene oxide (MWs 900 000, 4 000 000, and 8 000 000) with or without addition of electrolytes was carried-out for 1-month, under short-term storage at 40 °C/75% RH. Stability was evaluated by DTZ content, DSC and drug release using the Flow-Through Cell (USP # IV). The majority of stored tablets were stable for 1-month under short-term storage with respect to DTZ content and drug release. DSC curves of stored samples showed appearance of new exothermic peak after 1-month storage at 40 °C/75% RH, which was not observed after 5 years storage at room temperature. A selected formula was tested in vivo against reference product on eight healthy human volunteers. DTZ-plasma profiles were different between the two formulae. However, no statistically significant differences were detected between Cmax, AUC0-48 and AUC0-∞. The two products were therapeutically in-equivalent, as 90% confidence intervals "T/R" were 88.82-205.76, 91.40-139.94, and 93.73-134.97 for Cmax, AUC0-48 and AUC0-∞, respectively. This study highlighted possible differences observed between the two regimes frequently applied for stability testing.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP25322683-M	Polyethylene oxide		25322-68-3	Price

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