A A COMPARATIVE STUDY OF QUALITY CONTROL TESTING ON CANDESARTAN CILEXETIL CONVENTIONAL TABLETS IN IRAQ
Objective: The present study was performed to compare the quality of conventional tablets loaded with candesartan cilexetil. The selected candesartan cilexetil tablets were commercialized in the Iraq market and produced by different companies.
Methods: Different batches of candesartan cilexetil oral tablets (the concentration of candesartan was 8 mg) were subjected to quality control tests. Tests included weight variation, friability, hardness, drug content, disintegration time and in vitro release study. The protocols of these tests were performed according to USP pharmacopeia.
Results: The results, in this study, revealed that all the used batches of candesartan cilexetil oral tablets complied with the specification of USP pharmacopeia for weight uniformity, friability value (% loss) was<1. Hardness results of the tablets were 4.9-6.6 Kg/cm2, which was within the required limits (i.e. 4-8 Kg/cm2). Disintegration time was<15 min in both Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The percentage of drug content in all marketed tablets was found between 96.2 % and 99.8 %, reflecting compliance with the pharmacopeia limits (i.e. 85-115 %). An in vitro release study indicated that the release of all marketed tablets exceeds 80 % within 15 min.
Conclusion: All the studied tablets, loaded with candesartan cilexetil, were produced within the standard criteria of tablet production. The quality control analysis of the selected tablets, in this study, revealed satisfactory pharmaceutical properties (including safety and effectiveness) that comply within the limits of USP pharmacopeia.
2. Hendriksen C, Arciniega JL, Bruckner L, Chevalier M, Coppens E. The consistency approach for the quality control of vaccines. Biologicals 2008;36:73.
3. Shabana Md. A review on the quality control analysis of oral dosage form: tablets. Res Rev: J Pharm Pharm Sci 2016;5:108-14.
4. Al-Nuss Raghad, El-Zein Hind. Enhancement of the candesartan cilexetil dissolution rate by using different methods. Asian J Pharm Clin Res 2015;8:320-6.
5. Sunday O Awofisayo, Oladoja A Awofisayo. Comparative assessment of the quality control measurements of multisource ofloxacin tablets marketed in nigeria. Dissolution Technol 2010;6:20-5.
6. Bandyopadhyay S, Bhuria L, Lal D. An explicit review on quantitative estimation of candesartan cilexetil employing various analytical techniques. Pharma Anal Acta 2013;4:1–7.
7. Sandeep Lahoti, Sanjay Toshniwal. Development and validation of UV. Spectrophotometric method of nimodipine in bulk and tablet formulation. Asian J Biomed Pharm Sci 2012;2:8-10.
8. Mowafaq M Ghareeb, Abulfadhel J Neamah. Formulation and characterization of nimodipine nanoemulsion as ampoule for oral route. Int J Pharm Sci Res 2017;8:591-2.
9. Gupta MM, Gupta M. Comparative pharmaceutical quality control testing of different brands of paracetamol tablets available in the trinidad and tobago, West Indies. Int J Pharm Sci Res 2016;7:2830-6.
10. Ramakrishna S, Mihira V, Raja Vyshnavi K, Ranjith V. Design and evaluation of drug release kinetics of meloxicam sustained release matrix tablets. Int J Curr Pharm Res 2012;4:90–9.
11. Mazhar Rasool Shah, Muhammad Iqbal Nasiri, Sohail Anwer. Pharmaceutical quality assessment of different brands of moxifloxacin 400 mg tablets available in Pakistan. RADS J Pharm Pharm Sci 2019;7:2-8.
12. Shailaja T, Latha K, Alkabab AM. Formulation and evaluation of orodispersible tablets of metoprolol tartrate with natural and synthetic superdisintegrants. Int J Pharm Pharm Sci 2012;4:148-54.
13. Avinash Mahatme, Vijay R Mahajan, VR Gudsoorkar. Formulation and evaluation of immediate-release tablet of amlodipine. Literati J Pharm Drug Delivery Technol 2015;3:26-9.
14. Abulfadhel Jaber Neamah AL-Shaibani, Karrar Mohammed Hasan Al-Gburi, Karrar Talib Khudhair Albo Hamrah. Design and characterization of candesartan cilexetil oral nanoemulsion containing garlic oil. Int J Appl Pharm 2019; 6:116-24.
15. Shaimaa Nazar Abd Alhammid. Enhancement of the solubility and the dissolution rate of candesartan cilexetil using microsponge technology. Asian J Pharm Clin Res 2018;9:385-90.
16. GN Darwhekar, DK Jain, Jitendra Chouhan. Biopharmaceutical classification of candesartan and candesartan cilexetil. Asian J Pharm Life Sci 2012;2:295-302.
17. The United State Pharmacopeia. USP30-NF25. Convention Inc. Rockville MD. General tests and assays CD; 2007.
18. US Pharmacopoeia. United States Pharmacopoeial Convention, Thirty-Seventh Edition; 2014. p. 342-51, 1571-72.
19. Parrot EL, Saski W. Solid pharmaceuticals. In: Experimental pharmaceutical technology. 3rd ed. Burgess Publishing Co.: Minneapolis MN; 1971. p. 58-106.
20. Gupta MM, Patel Vishal. Formulation and evaluation of oral dispersible tablet of cinnarizine. J Drug Delivery Ther 2013;3:12-7.
21. Naik Prajakta Satish, Kurup Nalini Satish. Design and optimization of fast dissolving tablets containing metoprolol by sublimation method. Int Res J Pharm 2010;1:346-57.
This work is licensed under a Creative Commons Attribution 4.0 International License.