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Formulation of a Novel Tianeptine Sodium Orodispersible Film

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An Erratum to this article was published on 07 October 2010

Abstract

The present investigation was undertaken with the objective of formulating orodispersible film(s) of the antidepressant drug tianeptine sodium to enhance the convenience and compliance by the elderly and pediatric patients. The novel film former, lycoat NG73 (granular hydroxypropyl starch), along with different film-forming agents (hydroxypropyl methyl cellulose, hydroxyethyl cellulose, and polyvinyl alcohol), in addition to three film modifiers; namely, maltodextrin, polyvinyl pyrrolidone K90 and lycoat RS780 (pregelatinized hydroxypropyl starch) were evaluated. Eight formulae were prepared by the solvent-casting method; and were evaluated for their in vitro dissolution characteristics, in vitro disintegration time, and their physico-mechanical properties. The promising orodispersible film based on lycoat NG73 (F1); showing the greatest drug dissolution, satisfactory in vitro disintegration time and physico-mechanical properties that are suitable for orodispersible films, was evaluated for its bioavailability compared with a reference marketed product (Stablon® tablets) in rabbits. Statistical analysis revealed no significant difference between the bioavailability parameters (C max (ng/ml), t max (h), AUC0–t (ng h ml−1), and AUC0–∞ (ng h ml−1)] of the test film (F1) and the reference product. The mean ratio values (test/reference) of C max (89.74%), AUC0–t (110.9%), and AUC0–∞ (109.21%) indicated that the two formulae exhibited comparable plasma level-time profiles. These findings suggest that the fast orodispersible film containing tianeptine is likely to become one of choices for acute treatment of depression.

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ACKNOWLEDGEMENT

The authors are grateful to Professor Dr. Samia Nour, Professor of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University for revising the manuscript.

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Authors and Affiliations

  1. Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo, 11562, Egypt

    Doaa Ahmed El-Setouhy & Nevine Shawky Abd El-Malak

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  1. Doaa Ahmed El-Setouhy
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  2. Nevine Shawky Abd El-Malak
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Correspondence to Doaa Ahmed El-Setouhy.

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An erratum to this article can be found at http://dx.doi.org/10.1208/s12249-010-9524-7

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El-Setouhy, D.A., El-Malak, N.S.A. Formulation of a Novel Tianeptine Sodium Orodispersible Film. AAPS PharmSciTech 11, 1018–1025 (2010). https://doi.org/10.1208/s12249-010-9464-2

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