A review on current updates on drug dissolution eplerenone testing for immediate relese oraldosage forms
Abstract
Immediate-release oral dosage forms, also known as IR dosage forms, are widely favoured for medication delivery due to their rapid dissolution rate. This characteristic enables the medication to quickly enter the bloodstream, offering swift relief to patients. In formulation development, dissolution is a critical factor, providing essential insights for quality control. In vitro dissolution tests-a laboratory method simulating the medication's dissolution in the body—plays a key role across various stages of drug development. From a regulatory standpoint, validating dissolution enhances the review process for preclinical and clinical data. In certain situations, dissolution test results may also be utilized to assess the biopharmaceutical impact of product modifications. Such testing ensures that medications are not only effective but also safe and dependable for patients.
Keywords:
IR dosage forms, pre-clinical, Dissolution
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References
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23. Banakar UV. Pharmaceutical dissolution testing: CRC Press; 1991.
24. Rediguieri CF, Porta V, Nunes DS, Nunes TM, Junginger HE, Kopp S, et al. Biowaiver monographs for immediate release solid oral dosage forms: metronidazole. 2011;100(5):1618-27.
25. Buwade P, Jadiya S, Shukla T, Upmanyu DNJWJoPR. Advantages of immediate release tablets over the other tablet forms. 2015;4(11):757-80.
26. Rahul M, Patil S, Shetkar M, Chavan D, Bhagwat PJP. A review on immediate release drug delivery systems. 2014; 2(8):95-109.
27. Perrie Y, Rades T. FASTtrack Pharmaceutics: Drug Delivery and Targeting: Pharmaceutical press; 2012.
28. Gupta E, Barends D, Yamashita E, Lentz K, Harmsze A, Shah V, et al. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. 2006;29(3-4):315-24.
29. GL19 VJCfVM. Guidance for Industry; 2002.
30. Hermans A, Abend AM, Kesisoglou F, Flanagan T, Cohen MJ, Diaz DA, et al. Approaches for establishing clinically relevant dissolution specifications for immediate release solid oral dosage forms. 2017;19(6):1537-49.
31. Fortunato DJDT. Dissolution method development for immediate release solid oral dosage forms. 2005;12(3):11.
32. Bredael GM, Liang S, Hahn DJDT. A strategy for quality control dissolution method development for immediaterelease solid oral dosage forms. 2015;22:10-6.
33. Banakar UV. Pharmaceutical dissolution testing: CRC Press; 1991.
2. Moore T D, Nawarskas J J, Anderson J R. Eplerenone: a selective aldosterone receptor antagonist for hypertension and heart failure. Heart Dis, 5(5):354-63, 2003.
3. Fraccarollo D, Galuppo P, Hildemann S, Christ M, Ertl G, Bauersachs J: Additive improvement of left ventricular remodeling and neurohormonal activation by aldosterone receptor blockade with eplerenone and ACE inhibition in rats with myocardial infarction. J Am Coll Cardiol, 5; 42(9):1666- 73, 2003.
4. Flockhart D A. Drug Interactions: Cytochrome P450 Drug Interaction Table. Indiana University School of Medicine, 2007. 5. Thosar; Shilpa S. (Des Plaines, IL), Gokhale; Rajeev D
5. Nandi T. Importance of sufficient time points for efficient pharmacokinetic (PK) compartmental modeling. International Journal of Applied Pharmaceutics. 2023; 15(1):87-92.
6. Ghosh R, Nayan MIH, Mitu MM, Nandi T. Common Approaches of Cytochrome P450 (CYP) Induction Assays. International Blood Research & Reviews. 2023; 14(1): 6-14.
7. Nandi T. Time-dependent inactivation of intestinal cytochrome P450S and its impact on systemic bioavailability; 2022.
8. Nandi T, Korzekwa K, Nagar S, editors. Inclusion of intestinal metabolism in a continuous intestinal absorption model to predict clinical pharmacokinetics of oral midazolam 2022.
9. Nyol S, Gupta MJJoDD, Therapeutics. Immediate drug release dosage form: a review. 2013; 3(2).
10. Sharma N, Pahuja S, Sharma NJIJPSR. Immediate release tablets: A review. 2019; 11:3607-18
11. Neha D, Kamini KM, Neeraj P, Manmohan S, Kamal V, Neeraj SJWJoP, et al. Immediate release tablets: A review. 2017; 6(4):595-611.
12. Rediguieri CF, Porta V, Nunes DS, Nunes TM, Junginger HE, Kopp S, et al. Biowaiver monographs for immediate release solid oral dosage forms: metronidazole. 2011; 100(5):1618-27.
13. Buwade P, Jadiya S, Shukla T, Upmanyu DNJWJoPR. Advantages of immediate release tablets
14. for establishing clinically relevant dissolution specifications for immediate release solid oral dosage forms. 2017;19(6):1537-49.
15. Fortunato DJDT. Dissolution method development for immediate release solid oral dosage forms. 2005;12(3):11. 16. Bredael GM, Liang S, Hahn DJDT.
A strategy for quality over the other tablet forms. 2015; 4(11):757-80.
16. Rediguieri CF, Porta V, Nunes DS, Nunes TM, Junginger HE, Kopp S, et al. Biowaiver monographs for immediate release solid oral dosage forms: metronidazole. 2011;100(5):1618-27.
17. Buwade P, Jadiya S, Shukla T, Upmanyu DNJWJoPR. Advantages of immediate release tablets over the other tablet forms. 2015;4(11):757-80
18. Rahul M, Patil S, Shetkar M, Chavan D, Bhagwat PJP. A review on immediate release drug delivery systems. 2014; 2(8):95-109.
19. Perrie Y, Rades T. FASTtrack Pharmaceutics: Drug Delivery and Targeting: Pharmaceutical press; 2012.
20. Gupta E, Barends D, Yamashita E, Lentz K, Harmsze A, Shah V, et al. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. 2006;29(3-4):315-24.
21. GL19 VJCfVM. Guidance for Industry; 2002.
22. Hermans A, Abend AM, Kesisoglou F, Flanagan T, Cohen MJ, Diaz DA, et al. Approaches control dissolution method development for immediaterelease solid oral dosage forms. 2015;22:10-6.
23. Banakar UV. Pharmaceutical dissolution testing: CRC Press; 1991.
24. Rediguieri CF, Porta V, Nunes DS, Nunes TM, Junginger HE, Kopp S, et al. Biowaiver monographs for immediate release solid oral dosage forms: metronidazole. 2011;100(5):1618-27.
25. Buwade P, Jadiya S, Shukla T, Upmanyu DNJWJoPR. Advantages of immediate release tablets over the other tablet forms. 2015;4(11):757-80.
26. Rahul M, Patil S, Shetkar M, Chavan D, Bhagwat PJP. A review on immediate release drug delivery systems. 2014; 2(8):95-109.
27. Perrie Y, Rades T. FASTtrack Pharmaceutics: Drug Delivery and Targeting: Pharmaceutical press; 2012.
28. Gupta E, Barends D, Yamashita E, Lentz K, Harmsze A, Shah V, et al. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. 2006;29(3-4):315-24.
29. GL19 VJCfVM. Guidance for Industry; 2002.
30. Hermans A, Abend AM, Kesisoglou F, Flanagan T, Cohen MJ, Diaz DA, et al. Approaches for establishing clinically relevant dissolution specifications for immediate release solid oral dosage forms. 2017;19(6):1537-49.
31. Fortunato DJDT. Dissolution method development for immediate release solid oral dosage forms. 2005;12(3):11.
32. Bredael GM, Liang S, Hahn DJDT. A strategy for quality control dissolution method development for immediaterelease solid oral dosage forms. 2015;22:10-6.
33. Banakar UV. Pharmaceutical dissolution testing: CRC Press; 1991.
Published
31/12/2024
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Badri, S. (2024). A review on current updates on drug dissolution eplerenone testing for immediate relese oraldosage forms. Journal of Innovations in Applied Pharmaceutical Science (JIAPS), 9(3), 7-11. https://doi.org/10.37022/jiaps.v9i3.644
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