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

Development of Simple Dissolution Methods for Felodipine and Combined Amlodipine Besylate-Indapamide Extended Release Tablets without Stationary (Felodipine) Basket

Author(s): Arslan Javed, Ummarah Kanwal, Syed Ahmad Nazir Gilani, Farhan Akhtar, Rahat Shamim, Nasir Abbas and Nadeem Irfan Bukhari*

Volume 28, Issue 24, 2022

Published on: 18 July, 2022

Page: [2010 - 2021] Pages: 12

DOI: 10.2174/1381612828666220526122615

Price: $65

Abstract

Background: The dissolution method for certain drugs needs specialized conditions. Dissolution testing for felodipine extended release (ER) tablets (Plendil® 5 mg) and amlodipine-indapamide fixed dose (Natrilam®, 5/1.5 mg) ER tablets requires the use of a stationary (felodipine) basket in USP Apparatus II.

Objective: The study aimed to develop simple methods for Plendil® and Natrilam® without the use of a felodipine basket.

Methods: The dissolution profiles obtained from different media and paddle speeds were used to compute miscellaneous dissolution parameters and were compared to those obtained from standard (existing) methods using a felodipine basket.

Results: The f1, f2, and bootstrap f2 (5th % percentile) values for Plendil® 2.47, 88.17, and 54.62, respectively, and all other dissolution factors revealed similarity between standard and the selected test method with 1% Tween 20 at 50 rpm. For Natrilam®, f1 and f2 and bootstrap f2 5.13, 72.92, and 62.67, respectively, and all other dissolution parameters showed similarity of the standard and selected test method using 0.1N HCl media having 0.38 gm/L EDTA with a sinker at 100 rpm. Release of products assumed zero-order and Weibull model, respectively.

Conclusion: Test dissolution methods for Plendil® and Natrilam® tablets produced equivalent dissolution profiles compared to their respective standard methods with stationary basket USP Apparatus II.

Keywords: Felodipine basket, stationary hanging basket, dissolution, felodipine, indapamide, amlodipine besylate, similarity factor.

« Previous Next »
[1]
Shah VP, Konecny JJ, Everett RL, McCullough B, Noorizadeh AC, Skelly JP. In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants. Pharm Res 1989; 6(7): 612-8.
[http://dx.doi.org/10.1023/A:1015909716312] [PMID: 2798311]
[2]
Shiu GK. Dissolution methodology: Apparatus and conditions. Drug Inf J 1996; 30(4): 1045-54.
[http://dx.doi.org/10.1177/009286159603000421]
[3]
Dressman J, Krämer J, Brown CK, Brown WE, Diebold SM, Dobro S. Pharmaceutical Dissolution Testing. Taylor & Francis Group 2005.
[4]
Nep EI, Mahdi MH, Adebisi AO, et al. The influence of hydroalcoholic media on the performance of Grewia polysaccharide in sustained release tablets. Int J Pharm 2017; 532(1): 352-64.
[http://dx.doi.org/10.1016/j.ijpharm.2017.09.022] [PMID: 28903068]
[5]
Wang Y, Armenante PM. A novel off-center paddle impeller (OPI) dissolution testing system for reproducible dissolution testing of solid dosage forms. J Pharm Sci 2012; 101(2): 746-60.
[http://dx.doi.org/10.1002/jps.22783] [PMID: 22083630]
[6]
Karande AD, Yeole PG. Comparative assessment of different dissolution apparatus for floating drug delivery systems. Dissolut Technol 2006; 7: 9-12.
[7]
Parikh RK, Parikh DC, Delvadia RR, Patel SM. A novel multicompartment dissolution apparatus for evaluation of floating dosage form containing poorly soluble weakly basic drug. Dissolut Technol 2006; 13(1): 14-9.
[http://dx.doi.org/10.14227/DT130106P14]
[8]
Pillay V, Fassihi R. Evaluation and comparison of dissolution data derived from different modified release dosage forms: An alternative method. J Control Release 1998; 55(1): 45-55.
[http://dx.doi.org/10.1016/S0168-3659(98)00022-4] [PMID: 9795013]
[9]
Dressman JJ, Kramer J. Pharmaceutical Dissolution Testing 1st Ed Taylor & Francis, Boca Raton, CRC Press, 2005.
[http://dx.doi.org/10.1201/9780849359170]
[10]
Hassan M. Felodipine Tablets BP. In British Pharmacopoeia 2009. London: Stationery Office 2009; III: pp. 2574.
[11]
USP. Felodipine Extended-Release Tablets. In: USP 27, NF 22: The United States Pharmacopeia, the National Formulary, United States Pharmacopeial Convention. Rockville, MD 2004; I: pp. 779.
[12]
USP. United States Pharmacopeia : USP 30: The National Formulary : NF 25 : By authority of the United States Pharmacopeial Convention, Inc, meeting at Washington, DC, United States Pharmacopeial Convention.. 2007.
[13]
USP. USP 33 NF 28: United States Pharmacopeia [and] National Formulary. Reissue. Supplement 2.a. United States Pharmacopeial Convention.. 2010.
[14]
Hanon O, Caillard L, Chaussade E, Hernandorena I, Boully C. Blood pressure-lowering efficacy of indapamide SR/amlodipine combination in older patients with hypertension: A post hoc analysis of the NESTOR trial (Natrilix SR vs Enalapril in hypertensive type 2 diabetics with microalbuminuria). J Clin Hypertens 2017; 19(10): 965-72.
[http://dx.doi.org/10.1111/jch.13053] [PMID: 28721700]
[15]
Kobalava Z, Troitskaya E, Ezhova N. Fixed-Drug combination amlodipine, indapamide and perindopril: New horizons of antihypertensive therapy. Kardiologiia 2017; 57(4): 79-88.
[PMID: 28762910]
[16]
USP. Felodipine Extended-Release Tablets. USP 41 - NF 36 The United States Pharmacopeia and National Formulary. 2018; II: pp. 1690.
[17]
PharmaTest. Stationary Tablet (Felodipine) Baskets Operator Manual Version 1.0 PharmaTest Apparatebau AG 2013.
[18]
Wingstrand K, Abrahamsson B, Edgar B. Bioavailability from felodipine extended-release tablets with different dissolution properties. Int J Pharm 1990; 60(2): 151-6.
[http://dx.doi.org/10.1016/0378-5173(90)90301-J]
[19]
Zhang Y, Huo M, Zhou J, et al. DDSolver: An add-in program for modeling and comparison of drug dissolution profiles. AAPS J 2010; 12(3): 263-71.
[http://dx.doi.org/10.1208/s12248-010-9185-1] [PMID: 20373062]
[20]
Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001; 13(2): 123-33.
[http://dx.doi.org/10.1016/S0928-0987(01)00095-1] [PMID: 11297896]
[21]
Akaike H. A new look at the statistical model identification Selected Papers of Hirotugu Akaike. Springer 1974; pp. 215-22.
[http://dx.doi.org/10.1007/978-1-4612-1694-0_16]
[22]
Moore J. Mathematical comparison of dissolution profiles. Pharm Technol 1996; 20: 64-75.
[23]
FDA. Guidance for industry: Immediate release solid oral dosage forms. Scale-up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation [SUPAC-IR] 1995.
[24]
Tsong Y, Hammerstrom T, Sathe P, Shah VP. Statistical assessment of mean differences between two dissolution data sets. Drug Inf J 1996; 30(4): 1105-12.
[http://dx.doi.org/10.1177/009286159603000427]
[25]
Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison--statistics and analysis of the similarity factor, f2. Pharm Res 1998; 15(6): 889-96.
[http://dx.doi.org/10.1023/A:1011976615750] [PMID: 9647355]
[26]
Riegelman S, Collier P. The application of statistical moment theory to the evaluation of in vivo dissolution time and absorption time. J Pharmacokinet Biopharm 1980; 8(5): 509-34.
[http://dx.doi.org/10.1007/BF01059549] [PMID: 7252794]
[27]
Podczeck F. Comparison of in vitro dissolution profiles by calculating mean dissolution time (MDT) or mean residence time (MRT). Int J Pharm 1993; 97(1-3): 93-100.
[http://dx.doi.org/10.1016/0378-5173(93)90129-4]
[28]
Freitag G. Guidelines on dissolution profile comparison. Drug Inf J 2001; 35(3): 865-74.
[http://dx.doi.org/10.1177/009286150103500325]
[29]
O’hara T, Dunne A, Butler J, Devane J, Group ICW. A review of methods used to compare dissolution profile data. Pharm Sci Technol Today 1998; 1(5): 214-23.
[http://dx.doi.org/10.1016/S1461-5347(98)00053-4]
[30]
FDA. Guidance for Industry: Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances; U.S. Department of Health and Human Services; Food and Drug Admin istration; Center for Drug Evaluation and Research (CDER) Biopharmaceutics 2018. Docnet Number: FDA=2018-D-2614..
[31]
Missaghi S, Fassihi R. In Evaluation and comparison of dissolution profiles for a swelling and eroding dimenhydrinate tablet using USP apparatus I, II, and III Proceedings of the AAPS Annual Meeting and Exposition, Poster Presentation 2003.
[32]
USP. Amlodipine Tablets. In: The United States Pharmacopeia National Formulary USP 41 - NF 36. 2018; 1: pp. 262.
[33]
FDA. Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation 1997.
[34]
De Muth JE. In basic statistics and pharmaceutical statistical applications 3rd Ed CRC press Taylor and Francis Group Boca Raton 2014 pp. 638.
[35]
Islam M, Begum M. Bootstrap confidence intervals for dissolution similarity factor f2. Biom Biostat Int J 2018; 7(5): 397-403.
[http://dx.doi.org/10.15406/bbij.2018.07.00237]
[36]
Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol 1975; 27(1): 48-9.
[http://dx.doi.org/10.1111/j.2042-7158.1975.tb09378.x] [PMID: 235616]
[37]
Anderson NH, Bauer M, Boussac N, Khan-Malek R, Munden P, Sardaro M. An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J Pharm Biomed Anal 1998; 17(4-5): 811-22.
[http://dx.doi.org/10.1016/S0731-7085(98)00011-9] [PMID: 9682166]

Rights & Permissions Print Cite
Article Metrics
18
1
© 2024 Bentham Science Publishers | Privacy Policy