Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Fixed Combination of Rivaroxaban and Aspirin: Tablet For-Mulation and Analytical Method Development

Hani A Naseef
* ORCID logo ,
Mosab Afaneh
,
Moammal Salah Qurt
ORCID logo ,
Numan M Malkieh
,
Maher Kharouf
,
Ramzi Muqedi
,
Abdallah D. Abukhalil
ORCID logo ,
Abdullah K. Rabba
ORCID logo
Version 1 : Received: 9 June 2023 / Approved: 12 June 2023 / Online: 12 June 2023 (04:20:14 CEST)

How to cite: Naseef, H.A.; Afaneh, M.; Qurt, M.S.; Malkieh, N.M.; Kharouf, M.; Muqedi, R.; Abukhalil, A.D.; Rabba, A.K. Fixed Combination of Rivaroxaban and Aspirin: Tablet For-Mulation and Analytical Method Development. Preprints 2023, 2023060754. https://doi.org/10.20944/preprints202306.0754.v1 Naseef, H.A.; Afaneh, M.; Qurt, M.S.; Malkieh, N.M.; Kharouf, M.; Muqedi, R.; Abukhalil, A.D.; Rabba, A.K. Fixed Combination of Rivaroxaban and Aspirin: Tablet For-Mulation and Analytical Method Development. Preprints 2023, 2023060754. https://doi.org/10.20944/preprints202306.0754.v1

Abstract

Rivaroxaban and aspirin are commonly used antithrombotic agents that are used in combination for the prevention of coronary artery disease (CAD) and atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, or with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) in high-risk patients. The recommended dosage is 2.5 mg Rivaroxaban twice daily with 75–100 mg aspirin daily. This study aimed to develop a fixed-dose combination tablet of rivaroxaban (2.5 mg) and aspirin (50 mg) to decrease the patient's pill burden and enhance medication adherence. The product formula was developed based on compatibility studies among the active ingredients and the active ingredients' compatibility studies. The formula and the manufacturing procedure were chosen based on the risk assessment for each active substance, wet granulation with both actives intragranular was found to have faster dissolution than direct mix formulae. Furthermore, a validated reverse-phase HPLC stability indicator method was developed to detect APIs and their possible degradants in the formula.

Keywords

Rivaroxaban; Aspirin; fixed-dose combination; validation; RP HPLC method

Subject

Medicine and Pharmacology, Medicine and Pharmacology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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