Comparative Dissolution Studies on Various Brands of Telmisartan Tablets
Abstract
Background: Telmisartan’s low solubility limits its bioavailability, leading to poor dissolution, reduced efficacy, and decreased patient compliance. This study assesses the dissolution and quality control of various commercially available 40 mg telmisartan IP tablets, all marketed as bioequivalent.
Methods: The study analyzed various marketed formulations containing Telmisartan. Both the marketed products and Tazloc were evaluated through dissolution studies (drug release), with drug quantification performed using ultraviolet visible spectroscopy (Jasco UV-730) at λmax values of 291 nm and 296 nm.
Results: Tazloc demonstrated a drug release of 65% in 60 minutes in pH 1.2 HCl, outperforming other commercial tablets. In comparison, Brand A, Brand B, and Brand C each showed less than 60% release within the same period. Additionally, Tazloc exhibited the highest release—over 10% more than the other brands—in pH 4.5. In vitro release studies in pH 6.8 revealed that Tazloc achieved 95% release in 60 minutes, while Brand A, Brand B, and Brand C reached 91%, 82%, and 62%, respectively. Similarly, in pH 7.5 phosphate buffer, the cumulative drug release after 60 minutes was 99% for Tazloc, followed by 96% for Brand A, 94% for Brand B, and 93% for Brand C.
Conclusion: Tazloc, utilising ODCA technology, exhibits superior dissolution and solubility compared to conventional brands, ensuring enhanced bioavailability and optimal blood pressure control, leading to improved patient outcomes.
Keywords: cumulative release, dissolution, ODCA, patient compliance, quality.
Keywords:
cumulative release, dissolution, ODCA, patient compliance, qualityDOI
https://doi.org/10.22270/jddt.v14i12.6904References
1. World health organization- Hypertension. Avaialable at: https://www.who.int/news-room/fact-sheets/detail/hypertension, Last accessed on 26 October 2024.
2. Lehane E, McCarthy G. An examination of the intentional and unintentional aspects of medication non-adherence in patients diagnosed with hypertension. J Clin Nurs. 2007;16(4):698-706. https://doi.org/10.1111/j.1365-2702.2005.01538.x PMid:17402951
3. Banegas JR, Lopez-Garcia E, Dallongeville J, Guallar E, Halcox JP, Borghi C, et al. Achievement of treatment goals for primary prevention of cardiovascular disease in clinical practice across Europe: the EURIKA study. Eur Heart J. 2011; 32:2143-52. https://doi.org/10.1093/eurheartj/ehr080 PMid:21471134 PMCid:PMC3164103
4. Neutel JM, Smith DH. Improving patient compliance: a major goal in the management of hypertension. J Clin Hypertens (Greenwich). 2003;5(2):127-132. https://doi.org/10.1111/j.1524-6175.2003.00495.x PMid:12671325 PMCid:PMC8101871
5. Burnier M. Drug adherence in hypertension. Pharmacol Res. 2017;125(Pt B):142-149. https://doi.org/10.1016/j.phrs.2017.08.015 PMid:28870498
6. Mallion J, Siche J, Lacourcière Y. ABPM comparison of the antihypertensive profiles of the selective angiotensin II receptor antagonists telmisartan and losartan in patients with mild-to-moderate hypertension. J Hum Hypertens. 1999;13(10):657-664. https://doi.org/10.1038/sj.jhh.1000925 PMid:10516734
7. Food Drug Administration- Telmisartan Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf, Last accessed on 26 October 2024.
8. Bloch MJ, Basile JN. Analysis of Recent Papers in Hypertension Jan N. Basile, MD, Senior Editor. The Journal of Clinical Hypertension. 2004; 6(6):342-6. 15. https://doi.org/10.1111/j.1524-6175.2004.02864.x PMCid:PMC8109420
9. Doggrell SA. Telmisartan-killing two birds with one stone. Expert opinion on pharmacotherapy. 20041; 5(11):2397-400. 16. https://doi.org/10.1517/14656566.5.11.2397 PMid:15500387
10. Takagi H, Yamamoto H, Iwata K, Goto SN, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Effects of telmisartan on proteinuria or albuminuria: a meta-analysis of randomized trials. Int J Cardiol. 2013;167(4):1443-1449. https://doi.org/10.1016/j.ijcard.2012.04.058 PMid:22560941
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Copyright (c) 2024 Arindam Pande , Viveka Kumar , D. Prabhakar, Rita R. Lala , Archana S. Gurjar , Puja Gianani , Sagar Patil , Shweta Ghatge

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