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Formulation and Evaluation of Fast-Dissolving Oral Film of Rivaroxaban

1, 1★, 1, 1, 1, 1★ Corresponding author

  1. 1Department of Pharmaceutics, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur, Andhra Pradesh, INDIA.

CORRESPONDENCE

Rama Rao Nadendla

Department of Pharmaceutics, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur, Andhra Pradesh, INDIA.

nadendla2000@yahoo.co.in

Received: 31-05-2023; Revised: 29-06-2023; Accepted: 22-07-2023.

Volume 15, Issue 4 · pp. 687-695 · 2023 · DOI: 10.5530/jyp.2023.15.94

ABSTRACT

Background: Following the COVID-19 pandemic, microvascular and macrovascular thrombotic problems emerged that required anticoagulants. Rivaroxaban (RN) is a factor Xa inhibitor that treats deep vein thrombosis and the two forms of artery diseases (coronary artery disease and peripheral artery disease).Materials and Methods: The study objective was to create fast-disintegrating rivaroxaban Oral Thin Films (OTF) with the help of various super disintegrants to shorten disintegration time and enhance drug release in order to assist patients who have difficulty in swallowing conventional dosage forms and increase bioavailability. OTF was created using the solvent casting method. A 22 factorial design was employed in Design-Expert® software to develop an ideal formula.Results: The optimized film formula pH, drug content, disintegration time, folding endurance, and dissolution rate were estimated, and the film was subjected to a short-term stability study. The optimized formula exhibited a cumulative drug release of 93.47% in 60 sec.Conclusion: The drug's in vitro release pattern shows first-order kinetics and fickian diffusion was the mechanism of drug release. These findings supported that rivaroxaban OTFs offer a quick release of the medication from the administration site into the systemic circulation.

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    Kanna, S., Nadendla, R. R., Satyanarayana, J., Karthikeya, V., Sonu, M. V., & Bhargavi, P. N. (2023). Formulation and Evaluation of Fast-Dissolving Oral Film of Rivaroxaban. Journal of Young Pharmacists, 15(4), 687-695. https://doi.org/10.5530/jyp.2023.15.94

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    © 2023 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0