Formulation and Evaluation of Fast-Dissolving Oral Film of Rivaroxaban

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Formulation and Evaluation of Fast-Dissolving Oral Film of Rivaroxaban
J Young Pharm. Vol 15/Issue 4/2023 
Sandeep Kanna1, Rama Rao Nadendla1, Juluri Satyanarayana1, Vajrala Karthikeya1, Muthumula Venkata Sonu1 and Pusuluri Naga Bhargavi1
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1Department of Pharmaceutics, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur, Andhra Pradesh, INDIA

Corresponding author.

Correspondence: Prof. Rama Rao Nadendla Principal and Professor, Department of Pharmaceutics, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam-522034, Guntur, Andhra Pradesh, INDIA. Email: nadendla2000@yahoo.co.in
Received May 31, 2023; Revised June 29, 2023; Accepted July 22, 2023.
Copyright 2023 Authors
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Citation

1.Kanna S, Nadendla RR, Satyanarayana J, Karthikeya V, Sonu MV, Bhargavi PN. Formulation and Evaluation of Fast-Dissolving Oral Film of Rivaroxaban. Journal of Young Pharmacists [Internet]. 2023 Dec 22;15(4):687–95. Available from: http://dx.doi.org/10.5530/jyp.2023.15.94
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Published in: Journal of Young Pharmacists, 2023; 15(4): 687-695. Published online: 07 December 2023DOI: 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.

Keywords: Rivaroxaban, Oral thin films, Factorial design, Fickian diffusion