Author(s): Ayesha Siddika, Rashni Agarwala, Md. Nazmul Haque, Milon K. Ghosh

Email(s): milon@pharmacy.iu.ac.bd

DOI: 10.52711/0974-360X.2025.00297   

Address: Ayesha Siddika, Rashni Agarwala, Md. Nazmul Haque, Milon K. Ghosh*
Department of Pharmacy, Islamic University, Kushtia 7003, Bangladesh.
*Corresponding Author

Published In:   Volume - 18,      Issue - 5,     Year - 2025


ABSTRACT:
In developing countries, the use of generic medicine as a cost-saving measure in health care provision has been increasing daily. Alverine citrate (ALV), a smooth muscle relaxant, is Available in the form of Tablets from different pharmaceutical companies in the local market of Bangladesh. So, the quality control test is needed to check the pharmaceutical similarity through which one product might securely substitute another. Therefore, we designed this project to appraise the ALV 60mg Tablets’ excellence Available from various manufacturers in Bangladesh. Tablet form of ALV 60mg generic from 4 different manufacturers were assessed for quality control. All the studied variables, namely, weight variation, disintegration, friability, dissolution, and hardness tests were done based on USP and BP guidelines. Tests were performed in triplicates, and the mean value was considered for expressing results. The result revealed that weight variation ranged from 202.5mg to 314.5mg. In the hardness study, the maximum and minimum values found were 4.6kg/cm2 and 2.6kg/cm2, respectively. In contrast, the highest value of friability was 0.19%. In the disintegration test, all the products disintegrated fully within 186 sec. Whereas the dissolution study showed that all the tested ALV Tablets released 97.2% of the drug within 15 minutes. Finally, it can be assured that the studied brands presented unique quality within the pharmacopeial limit. Nevertheless, further in-vivo analysis would be desired to confirm their pharmacological equivalence.


Cite this article:
Ayesha Siddika, Rashni Agarwala, Md. Nazmul Haque, Milon K. Ghosh. In-vitro Comparative Quality Evaluation of Alverine citrate 60mg Tablets Available in Bangladesh. Research Journal of Pharmacy and Technology. 2025;18(5):2075-0. doi: 10.52711/0974-360X.2025.00297

Cite(Electronic):
Ayesha Siddika, Rashni Agarwala, Md. Nazmul Haque, Milon K. Ghosh. In-vitro Comparative Quality Evaluation of Alverine citrate 60mg Tablets Available in Bangladesh. Research Journal of Pharmacy and Technology. 2025;18(5):2075-0. doi: 10.52711/0974-360X.2025.00297   Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-5-20


REFERENCES:
1.    Rizea-Savu S. Duna SN. Sandulovici RC. Single dose study assessing the pharmacokinetic and metabolic profile of Alverine Citrate in healthy volunteers. Frontiers in Pharmacology. 2021; 11: 620451. doi: 10.3389/fphar.2020.620451
2.    Havaldar VD. Yadav AV.  Dias RJ., Mali KK.  Kale SS. Pujari PP. Rectal Suppository of Mucoadhesive Microspheres of Alverine Citrate for İrritable Bowel Disease: In vitro Evaluation. Research J. Pharm. and Tech. 2018; 11(7): 3091-3098. doi: 10.5958/0974-360X.2018.00568.1
3.    Ducrotté P. Grimaud JC. Dapoigny M. Personnic S. O'Mahony V.  Andro‐Delestrain M C.  On‐demand treatment with Alverine Citrate/Simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014; 68(2): 245-54. doi: 10.1111/ijcp.12333
4.    Oval N. Suresh AJ, Niraimathi V. IR Quantification of Alverine Citrate in Bulk and Oral Dosage Form. Research J. Pharm. and Tech. 2013; 6(4): 360-362.
5.    Shrank WH. Choudhry NK. Liberman JN. Brennan TA. The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money. Health Aff (Millwood). 2011;30(7):1351-7. doi: 10.1377/hlthaff.2010.0431
6.    Hellerstein JK. The importance of the physician in the generic versus trade-name prescription decision. Rand J Econ. 1998;29(1):108-36.
7.    Dunne SS. Dunne CP. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Med. 2015; 13:173. doi: 10.1186/s12916-015-0415-3
8.    Williams L. McKnight E. The real impact of counterfeit medications. US Pharm. 2014;39(6):44-46.
9.    Ali M. Ali FF. Rita NA. Bhuiyan MA. Comparative in-vitro evaluation of some commercial brands of valsartan Tablets marketed in Bangladesh. The Pharma Innovation Journal. 2018;7(4): 1068-72.
10.    Sacré P. Deconinck E. Beer TD. Courselle P. Vancauwenberghe R. Chiap P. Crommen J. Beer JOD. Comparison and combination of spectroscopic techniques for the detection of counterfeit medicines. J Pharm Biomed Anal. 2010; 53(3): 445-53. doi: 10.1016/j.jpba.2010.05.012
11.    Almuzaini T. Choonara I. Sammons H. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open. 2013; 3(8): e002923. doi: 10.1136/bmjopen-2013-002923
12.    Dégardin K. Roggo Y. Margot P. Understanding and fighting the medicine counterfeit market. J Pharm Biomed Anal. 2014; 87:167-75. doi: 10.1016/j.jpba.2013.01.009
13.    Khan AY. Ghilzai NMK. Counterfeit and substandard quality of drugs: the need for an effective and stringent regulatory control in India and other developing countries. Indian Journal of Pharmacology. 2007; 39(4):206-207. doi: 10.4103/0253-7613.36541.
14.    Hanif M. Mobarak MR. Ronan A. Rahman D. Donovan JJ. Bennish ML. Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ. 1995; 311(6997): 88-91. doi: 10.1136/bmj.311.6997.88
15.    Jackson G. Patel S. Khan S. Assessing the problem of counterfeit medications in the United Kingdom. Int J Clin Pract. 2012; 66(3): 241-50. doi: 10.1111/j.1742-1241.2011. 02826.x
16.    Ahmad K. WHO fights fake pharmaceuticals. Lancet Infect Dis. 2006; 6(4):195. doi: 10.1016/S1473-3099(06)70427-3
17.    Uddin MS. Mamun AA. Tasnu T. Asaduzzaman M. In‑process and finished products quality control tests for pharmaceutical Tablets according to pharmacopoeias. J Chem Pharm Res. 2015; 7(9): 180-5.
18.    Uddin MS. Mamun AA. Akter N. Sarwar MS. Rashid M. Amran MS. Pharmacopoeial standards and specifications for pharmaceutical oral liquid preparations. Archives of Current Research International. 2016; 3 (2): 1-12. doi.org/10.9734/ACRI/2016/22675
19.    Uddin MS. Mamun AA. Rashid M. Assaduzzaman M. In‑process and finished products quality control tests for pharmaceutical capsules according to pharmacopoeias. Journal of Pharmaceutical Research International. 2015;9(2):1-9. doi: 10.9734/BJPR/2016/22044
20.    Fahmy S. Abu‑Gharbieh E. In vitro dissolution and in-vivo bioavailability of six brands of Ciprofloxacin Tablets administered in rabbits and their pharmacokinetic modeling. Biomed Res Int. 2014; 2014:590848. doi: 10.1155/2014/590848
21.    Fadare JO. Adeoti AO. Desalu OO. Enwere OO. Makusidi AM. Ogunleye O. Godman B. The prescribing of generic medicines in Nigeria: knowledge, perceptions and attitudes of physicians. Expert Rev Pharmacoecon Outcomes Res. 2016; 16(5): 639-650. doi: 10.1586/14737167.2016.1120673
22.    Crawford P. Feely M. Guberman A. Kramer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure. 2006; 15(3): 165-76. doi: 10.1016/j.seizure.2005.12.010
23.    Shargel L. Wu‑Pong S. Yu AC. Applied biopharmaceutics and pharmacokinetics. 2012; 6th ed. New York: McGraw‑Hill.
24.    Mosaddek ASM. Islam Z. Rahman MF. Akter MS. Laizu J. Parvin R. Tabassum NE. Simbak NB. Haque M. A Pilot Study on Evaluation of Self-Medication among Undergraduate Medical Students in Dhaka, Bangladesh. Research J. Pharm. and Tech. 2014; 7(11): 1240-1245.
25.    Shah VP. Dissolution: a quality control test vs a bioequivalent test. Dissolution Technol. 2001; 8(4): 1-2. doi:10.14227/DT080401P6
26.    Hassali MA. Thambyappa J. Saleem F. Haq N. Aljadhey V. Generic substitution in Malaysia: recommendations from a systematic review. J App Pharm Sci. 2012; 2(8):159-60. doi: 10.7324/JAPS.2012.2827
27.    Sufian MA. Uddin MS. Islam MT. Zahan T. Hossain K. Uddin GMS. Mamun AA. Quality control parameters of parenteral pharmaceuticals based on pharmacopoeias. Indo Am JP Sci. 2016; 3(12): 1624-1638.
28.    Pujari AS. Gaikwad NA. Mane IV. Vambhurkar GB. Honmane PP. In-Vitro Evaluation of Different Marketed Brands of Paracetamol Tablets Using Quality Control Tests. Asian J. Pharm. Tech. 2018; 8 (3):119-122. doi: 10.5958/2231-5713.2018.00019.3
29.    Hasin F. Hossain MM. Ghosh MK. Paul S. Rahman M. Ahmad MF. Pharmaceutical quality evaluation of cefuroxime axetil Tablets Available in drug market of Bangladesh. WJPPS. 2017; 7(1):1589-1599.
30.    Havaldar VD. Yadav AV. Dias RJ. Mali KK. Kale SS. Pujari PP. Rectal suppository of mucoadhesive microspheres of Alverine Citrate for irritable bowel disease: in-vitro evaluation. Research J. of Pharm. and Tech. 2018; 11(7): 3091-3098. doi: 10.5958/0974-360X.2018.00568.1
31.    Habib B. Mittha J. Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets. Asian Journal of Pharmaceutical Analysis. 2021; 11(4):255-8. doi: 10.52711/2231-5675.2021.00043
32.    Hamrah KTKA. Al-shaibani AJN. Al-edresi SS. Al-gburi KMH. A comparative study of quality control testing on Candesartan cilexetil conventional Tablets in iraq. International Journal of Applied Pharmaceutics. 2020; 12(2): 103-108. doi.org/10.22159/ijap.2020v12i2.36220
33.    Mathew M. Ravikumar. Madathil S. Govind A. VB NS. Formulation and Evaluation of Cinitapride Controlled Release Tablets. Asian J. Pharm. Res. 2016; 6(2): 87-94. doi: 10.5958/2231-5691.2016.00015.0
34.    Vambhurkar GB. Jagtap AM. Gavade AS. Rajput MD. Kambale HV. Kengar MD. Evaluation of five Different Marketed Brands of Paracetamol Tablets using Quality Control Tests. Asian J. Pharm. Tech. 2018; 8 (4):227-230. doi: 10.5958/2231-5713.2018.00035.1
35.    Sarfaraz Md. Prasad Y. Reddy SR. Doddayya H. Udupi RH. Development and Evaluation of Press Coated Time-Release Tablet of Nifedipine. Asian J. Pharm. Res. 2011; 1(3): 58-63.
36.    Puri S. Dandagi PM. Patil S. Gada SG. Formulation and in vitro Evaluation of Taste-Masked Orodispersible Tablets of Levocetirizine Dihydrochloride. Asian Journal of Pharmaceutical Research. 2023; 13(1):1-0. doi: 10.52711/22315691.2023.00001
37.    Oishi TS. Nimmi I. Islam SA. Comparative in-vitro bioequivalence analysis of some generic Tablets of Atorvastatin, a BCS class II compound. Bangladesh Pharmaceutical Journal. 2011;14(1): 61-66.
38.    Khan F. Li M. Schlindwein W. Comparison of in-vitro dissolution tests for commercially Available Aspirin Tablets. Diss Technol. 2013; 20(1): 48-58. doi: 10.14227/DT200113P48
39.    Pooja. Sharma PK. Agrahari V. Design and evaluation of self-nano emulsifying drug delivery system of Alverine for enhancement of solubility. Int. Res. J. Pharm. 2021; 12 (7):25-31. doi: 10.7897/2230-8407.1207153
40.    Noor S. Salam FBA. Hima HN. Bhuiyan MSI. Chowdhury S. Comparative in-vitro quality evaluation of some brands of Metronidazole tablet Available in Bangladesh. Int J Appl Res. 2017; 3(7): 753-8.
41.    Girish PK. Vamshi KT. Kumar L. Reddy MS. Shreenidhi G. Reddy AP. Comparative evaluation of the physical parameters of uncoated Tablets of Amlodipine Besylate with different types of primary packaging materials. Asian J. Pharm. Res. 2013; 3(1):03-05.
42.    Shorna MJ. Kumar A. Hossain MM. Hasan MM. Rony SR. Ghosh MK. In-vitro comparative quality evaluation of marketed Bisoprolol 5mg Tablets in Bangladesh. Bangladesh J. Sci. Ind. Res. 2019;54 (Special Issue): 29.
43.    Vageesh NM. Sura RS. Begum KG. Swathi B. Formulation Development and In vitro Evaluation of Floating Tablets of Lafutidine by Employing Effervescent Technology. Asian J. Pharm. Res. 2017; 7(3): 189-197. doi: 10.5958/22315691.2017.00029.6
44.    Lovely Z. Abdul A. Sanjida H. Sabrin IK. Sharmeen A. Kanij ND. Comparative In Vitro Quality Evaluation of Some Clopidogrel Tablets, Commercially Available in Bangladesh Drug Market. Bioequiv and Bioavailab Int J. 2017; 1(3):000117.
45.    Gupta MM. Khoorban A. Ali A. Ramlogan O. Talukdar D. Comparative quality control study of different brands of Diclofenac Sodium tablet Available in Local and governmgent pharmacies by in-vitro testing. Cureus. 2020; 12(11): e11348. doi: 10.7759/cureus.11348
46.    Rahman M. Akter K. Sarker MS. Sharna JF. Wahed MII. In-vitro comparative quality evaluation of different brands of marketed Paracetamol Tablets Available in Bangladesh. Journal of Pharmaceutical Research International. 2021; 33(38A):26–32. doi: 10.9734/jpri/2021/v33i38A32056
47.    British Pharmacopoeia. UK London. Appendix IIB. 2007: 1678. US Pharmacopoeia. The Official Compendia of Standards. 2007; 2: 1269- 90.

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