Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Design

Editor-in-Chief

ISSN (Print): 1381-6128
ISSN (Online): 1873-4286

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Drug Release and Stability Study of Innovated Losartan Potassium and Rosuvastatin Calcium Fixed-dose Combination Tablet

Author(s): Mian Inaam Zeb, Salimullah Khan*, Farid S. Ataya, Gaber El-Saber Batiha, Hamdy Kashtoh, Ajmal Khan* and Ahmed Al-Harrasi*

Volume 30, Issue 26, 2024

Published on: 11 June, 2024

Page: [2075 - 2085] Pages: 11

DOI: 10.2174/0113816128285601240527090932

Price: $65

Abstract

Background: Patient adherence to therapy and compliance is always a challenge for care providers in the management of chronic disorders with multiple medications.

Objective: Our study focused on formulating concurrently prescribed ARB (Angiotensin Receptor Blocker), i.e., losartan potassium, and a cholesterol-lowering statin derivative, i.e., rosuvastatin calcium, in a fixed-dose combination tablet.

Methods: The drugs were selected based on the presence of synergism and variation in solubility characteristics. Trial batches with fixed concentrations of both active pharmaceutical ingredients (APIs) and varying quantities of different excipients were prepared by dry granulation technique and subjected to different quality control tests for tablets. Batch F5 was selected on the basis of in-process quality control data for the development of a drug release protocol. Experimental conditions were optimized. Based on the sink condition, phosphate buffer (pH 6.8) was selected as the dissolution medium. Simultaneous determination of both APIs in samples collected at predetermined time intervals was carried out using the RP-HPLC technique with acetonitrile, methanol, and water (20:25:55 v/v/v) as mobile phase.

Results: Complete dissolution of both APIs in the FDC tablet was achieved in 45 min in 900 mL of the selected medium. The in vitro drug release protocol was validated for accuracy and precision without interference with sample analysis.

Conclusion: In this study, a validated, accurate, and robust dissolution testing method was developed for the newly formulated FDC tablet.

« Previous Next »
[1]
Blomberg B, Fourie B. Fixed-dose combination drugs for tuberculosis: Application in standardised treatment regimens. Drugs 2003; 63(6): 535-53.
[http://dx.doi.org/10.2165/00003495-200363060-00002] [PMID: 12656652]
[2]
Braga JU, Trajman A. Effectiveness of RHZE-FDC (fixed-dose combination) compared to RH-FDC + Z for tuberculosis treatment in Brazil: A cohort study. BMC Infect Dis 2015; 15(1): 81.
[http://dx.doi.org/10.1186/s12879-015-0820-4] [PMID: 25879615]
[3]
Campbell NRC. A step in the global effort to control hypertension: Fixed dose combination antihypertensive drugs. J Clin Hypertens 2019; 21(9): 1426-8.
[http://dx.doi.org/10.1111/jch.13683] [PMID: 31441988]
[4]
Mahfoud F, Kieble M, Enners S, et al. Use of fixed-dose combination antihypertensives in Germany between 2016 and 2020: An example of guideline inertia. Clin Res Cardiol 2023; 112(2): 197-202.
[http://dx.doi.org/10.1007/s00392-022-01993-5] [PMID: 35220445]
[5]
Lauffenburger JC, Landon JE, Fischer MA. Effect of combination therapy on adherence among US patients initiating therapy for hypertension: A cohort study. J Gen Intern Med 2017; 32(6): 619-25.
[http://dx.doi.org/10.1007/s11606-016-3972-z] [PMID: 28050754]
[6]
Belsey JD. Optimizing adherence in hypertension: A comparison of outcomes and costs using single tablet regimens vs. individual component regimens. J Med Econ 2012; 15(5): 897-905.
[http://dx.doi.org/10.3111/13696998.2012.689792] [PMID: 22548677]
[7]
Verma AA, Khuu W, Tadrous M, Gomes T, Mamdani MM. Fixed-dose combination antihypertensive medications, adherence, and clinical outcomes: A population-based retrospective cohort study. PLoS Med 2018; 15(6): e1002584.
[http://dx.doi.org/10.1371/journal.pmed.1002584] [PMID: 29889841]
[8]
Shah J, Kotadiya R. A critical review on analytical methods for recently approved FDC drugs: Pregabalin and etoricoxib. Crit Rev Anal Chem 2022; 52(5): 1048-68.
[http://dx.doi.org/10.1080/10408347.2020.1855411] [PMID: 33307732]
[9]
World Health Organization Model List of Essential Medicines. World Health Organization model list of essential medicines: 21st list 2019. 2019. Available from: https://apps.who.int/iris/handle/10665/325771
[10]
Yi I, Lee JJ, Park JS, et al. Enhanced effect of losartan and rosuvastatin on neointima hyperplasia. Arch Pharm Res 2010; 33(4): 593-600.
[http://dx.doi.org/10.1007/s12272-010-0414-z] [PMID: 20422369]
[11]
Ashokraj Y, Daroi A. Discriminatory dissolution method development and validation of etoricoxib tablets. Diss tech 2016; 23: 30-4.
[12]
Rosuvastatin Tablets 2018. Available from: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/rosuvastatin-tabs-rb-notice.pdf (Accessed on: 2022 December).
[13]
Kumar P, Ankalgi AD, Kaushal P, Ashawat MS. Method development and validation for multicomponent analysis of rosuvastatin calcium and losartan potassium in bulk drug by RP-HPLC. J Drug Deliv Ther 2020; 10(5-s): 76-84.
[http://dx.doi.org/10.22270/jddt.v10i5-s.4341]
[14]
National Formulary USP 38-NF 33. Paper presented at the Rockville MD: The United States pharmacopeial convention. 2015. Available from: https://www.uspnf.com/official-text/proposal-statuscommentary/usp-38-nf-33
[15]
International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topic Q2 (R1) validation of analytical procedures: Text and methodology. 2005. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r1-validation-analytical-procedures-text-and-methodology-step-5-first-version_en.pdf
[16]
Mitrevska I, Achkoska T, Brezovska K, Toshev K, Dimitrovska A, Ugarkovic S. Development and validation of discriminative dissolution method for metformin immediate-release film-coated tablets. J Anal Methods Chem 2019; 2019: 1-8.
[http://dx.doi.org/10.1155/2019/4296321] [PMID: 31886020]
[17]
Vaghela B, Kayastha R, Bhatt N, Pathak N, Rathod D. Development and validation of dissolution procedures. J Appl Pharm Sci 2011; 01: 50-6.
[18]
Polli JE, Rekhi GS, Shah VP. Methods to compare dissolution profiles. Drug Inf J 1996; 30(4): 1113-20.
[http://dx.doi.org/10.1177/009286159603000428]
[19]
Seburg RA, Ballard JM, Hwang TL, Sullivan CM. Photosensitized degradation of losartan potassium in an extemporaneous suspension formulation. J Pharm Biomed Anal 2006; 42(4): 411-22.
[http://dx.doi.org/10.1016/j.jpba.2006.04.030] [PMID: 16787732]
[20]
Afkham S, Hanaee J, Zakariazadeh M, Fathi F, Shafiee S, Soltani S. Molecular mechanism and thermodynamic study of Rosuvastatin interaction with human serum albumin using a surface plasmon resonance method combined with a multi-spectroscopic, and molecular modeling approach. Eur J Pharm Sci 2022; 168: 106005.
[http://dx.doi.org/10.1016/j.ejps.2021.106005] [PMID: 34688823]
[21]
Kumar R, Kumar R, Khursheed R, et al. Development and validation of RP-HPLC method for estimation of fisetin in rat plasma. S Afr J Bot 2021; 140: 284-9.
[http://dx.doi.org/10.1016/j.sajb.2020.05.010]
[22]
Pawar HA, Joshi PR. Development and validation of a discriminating in vitro dissolution method for oral formulations containing satranidazole. Int J Spectrosc 2014; 2014(Spec): 1-7.
[http://dx.doi.org/10.1155/2014/624635]
[23]
Moghbel A, Abbaspour H. Study of compressibility properties of yogurt powder in order to prepare a complementary formulation. Iran J Pharm Res 2013; 12(3): 231-7.
[PMID: 24250628]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy