Development of terfenadine-pseudoephedrine double-layer tablet dissolution-equivalent to core tablet

Drug Development and Industrial Pharmacy
H G ChoiC K Kim

Abstract

The terfenadine-pseudoephedrine dosage form discussed here is the sustained-release core tablet composed of outer (fast-release) and inner (sustained-release) layers. To develop the double-layer tablet dissolution-equivalent to a core tablet, the fast-release and sustained-release layers were prepared using various disintegrants and polymers, respectively. The layer composed of terfenadine/pseudoephedrine/lactose/cornstarch/sodium bicarbonate/hydroxypropylcellulose (HPC)/sodium lauryl sulfate/microcrystalline cellulose (60/10/90/30/20/1/40/1/293 mg), which gave the fast disintegration time and high dissolved amounts of drugs, was selected as the fast-release layer. The dissolved amounts of pseudoephedrine from sustained-release layers increased more with a smaller ratio of ethylcellulose and hydroxypropylmethylcellulose (HPMC). Dissolution mechanism analysis showed the release of pseudoephedrine was proportional to the square root of time, indicating that drug might be released from the layers by Fickian diffusion. The layer composed of pseudoephedrine/ethylcellulose/HPMC (110/30/155 mg), which had similar dissolution amounts of pseudoephedrine as the inner layer of a core tablet, was selected as the sustained-release layer. Fu...Continue Reading

References

Jan 1, 1989·Journal of Pharmaceutical Sciences·F ForniM T Bernabei
Jan 1, 1994·European Journal of Clinical Pharmacology·J G Ramaekers, J F O'Hanlon
Jan 1, 1993·International Archives of Allergy and Immunology·P H HowarthS Smith
Oct 28, 1999·International Journal of Pharmaceutics·M YunC Kim
Jan 1, 1986·Journal of Pharmaceutical and Biomedical Analysis·T M ChenC L Housmyer

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Citations

Jul 13, 2001·Drug Development and Industrial Pharmacy·C S YongH G Choi
Nov 8, 2015·International Journal of Pharmaceutics·Kitti PapósTamás Sovány

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