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KMID : 0369820130430030171
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Jorunal of Korean Pharmaceutical Sciences
2013 Volume.43 No. 3 p.171 ~ p.183
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Sustained-release diclofenac potassium orally disintegrating tablet incorporating eudragit ERL/ERS: possibility of specific diclofenac-polymer interaction
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Qandil Amjad M.
Assaf Shereen M.
Al Ani Enas A.
Yassin Alaa Eldeen
Obaidat Aiman A.
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Abstract
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Sustained-release diclofenac potassium orally disintegrating tablet (ODT) formulations have been prepared and investigated. The ODTs were prepared by incorporating diclofenac potassium (DP), as a model for negatively ionizable drugs, in microcapsules that were prepared by the solvent evaporation method from a mixture of DP and different ratios of Eudragit RS and Eudragit RL, which are positively ionized synthetic polymers. The ODTs were prepared by direct compression of mixtures containing microcapsule formula M4, crospovidone as a superdisintegrant and water soluble excipients (mannitol or lactose and sorbitol). Diclofenac potassium ODT F2, showed acceptable hardness (4.08 KP) slight friability (2.13 %) and disintegration time of 22.41 s with a sustained drug release profile. Microcapsule characterization (DSC and FT-IR) and dissolution behavior suggests the presence of specific interaction between the carboxylate group of diclofenac and the quaternary ammonium group in the polymers.
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KEYWORD
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Orally disintegrating tablet, Sustained-release, Eudragit RS, Eudragit RL, Diclofenac
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