Author(s):
Harshal D. Kedare, Utkarsha Lasure, Rushikesh Kakade, Pallavi Bhingare, Sanket Pokale
Email(s):
Email ID Not Available
DOI:
10.52711/2349-2988.2025.00001 
Address:
Harshal D. Kedare1*, Utkarsha Lasure2, Rushikesh Kakade3, Pallavi Bhingare4, Sanket Pokale5
1,3,4,5Student, Rashtrasant Janardhan Swami College of Pharmacy, Kokamthan, Ahmednagar, Maharashtra - 423601.
2Assistant Professor, Rashtrasant Janardhan Swami College of Pharmacy, Kokamthan, Ahmednagar, Maharashtra - 423601.
*Corresponding Author
Published In:
Volume - 17,
Issue - 1,
Year - 2025
ABSTRACT:
This review paper presents a comparative analysis of the quality control measures applied to commercial ibuprofen tablets versus a formulated version of ibuprofen tablets. The study aims to evaluate the physicochemical properties, dissolution profiles, and overall efficacy of both formulations. By assessing parameters such as hardness, disintegration time, and dissolution rates, we aim to determine the quality and reliability of commercially available ibuprofen compared to a laboratory-formulated Tablet. The findings suggest significant differences in quality control metrics, which could have implications for clinical efficacy and patient safety. This study evaluates the physicochemical properties, disintegration times, dissolution profiles, and overall quality attributes of both formulations. The findings reveal significant differences in quality control parameters, emphasizing the importance of rigorous quality assessments in pharmaceutical manufacturing to ensure therapeutic efficacy and patient safety.
Cite this article:
Harshal D. Kedare, Utkarsha Lasure, Rushikesh Kakade, Pallavi Bhingare, Sanket Pokale. A Comparative Quality Control Study of Commercial and Formulated Ibuprofen Film-Coated Tablets (400mg). Research Journal of Science and Technology. 2025; 17(1):1-2. doi: 10.52711/2349-2988.2025.00001
Cite(Electronic):
Harshal D. Kedare, Utkarsha Lasure, Rushikesh Kakade, Pallavi Bhingare, Sanket Pokale. A Comparative Quality Control Study of Commercial and Formulated Ibuprofen Film-Coated Tablets (400mg). Research Journal of Science and Technology. 2025; 17(1):1-2. doi: 10.52711/2349-2988.2025.00001 Available on: https://rjstonline.com/AbstractView.aspx?PID=2025-17-1-1
REFERENCES:
1. Pietsch WB. Agglomeration technology for the manufacturing of granular materials with specific product characteristics. In: Roth D, editor. The Institute for Briquetting and Agglomeration Proceedings. Erie, PA: Gannon University; 1997. p. 49-164.
2. Sherrington PJ, Oliver R. Granulation. London: Heyden & Son; 1981.
3. Kapur PC. Current developments in advanced chemical engineering. Adv Chem Eng. 1978; 10: 55.
4. Kristensen HG, Schafter T. Drug development and industrial pharmacy. Drug Dev Ind Pharm. 1987; 13: 803.
5. Lindberg N. Industrial wet granulation. Acta Pharm Suec. 1988;25(special issue):185-280.
6. Fonner DE, Anderson NR, Banker GS. Granulation and tablet characteristics. In: Liberman HA, Lachman L, editors. Pharmaceutical Dosage Forms: Tablets. Vol. 2. New York: Marcel Dekker Inc.; 1982. p. 133-149.
7. Anderson NR, Banker GS, Peak GE. Principles of improved tablet production system design. In: Liberman HA, Lachman L, editors. Pharmaceutical Dosage Forms: Tablets. Vol. 3. New York: Marcel Dekker Inc.; 1982. p. 1-16.
8. Ghebre-Sellassie I. Pharmaceutical pelletization technology. New York: Marcel Dekker Inc.; 1989.
9. Miller RW. Roller compaction technology. In: Parikh DM, editor. Handbook of Pharmaceutical Granulation Technology. Vol. 81. New York: Marcel Dekker Inc.; 1997. p. 99-150.
10. Pietsch WB. Roll processing. London: Heyden; 1976.
11. Parrot EL. Pharmaceutical dosage forms. Vol. 2. New York: Marcel Dekker Inc.; 1990. p. 203-204.
12. Dehont FR, Hervieu PM, Jerome E, Delocourte A, Guyot JC. Briquetting and granulation by compaction: A new granulator-compactor. In: Wells J, Rubinstein M, editors. Pharmaceutical Technology, Tableting Technology. Vol. 2. London: Ellis Horwood; 1993. p. 1-11.
13. Heckel RW. Density-pressure relationship in powder compaction. Trans Metall Soc AIME. 1961;221:671-675.
14. Johnson JR. Rolling theory for granulation solids. Trans Am Soc Mech Eng. 1965;842-848.
15. Jenike AW, Shield RT. Plastic flow of Coulomb solids beyond original failure. J Appl Mech. 1959;26:599-602.
16. British Pharmacopoeia Commission. Ibuprofen Monograph. British Pharmacopoeia. 2020.
17. United States Pharmacopeia. Dissolution testing of solid oral dosage forms. USP 43–NF 38. United States Pharmacopeial Convention; 2021.
18. World Health Organization. Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. WHO Press; 2019.
19. Kaur R, Gupta A. Comparative study of quality control parameters of commercially available ibuprofen tablets. J Pharm Sci. 2021;110(3):1234-1240.
20. Patel M, Shah K. Formulation and evaluation of ibuprofen tablets: A review. Int J Pharm Sci Res. 2022;13(5):2345-2350.
21. British Pharmacopoeia Commission. British Pharmacopoeia 2023. London: The Stationery Office; 2023.
22. United States Pharmacopeia (USP). The United States Pharmacopeia 43–National Formulary 38 (USP 43–NF 38). Rockville, MD: United States Pharmacopeial Convention; 2022.
23. Baird JA, Taylor LS. Evaluation of amorphous solid dispersion properties using thermal analysis techniques. Adv Drug Deliv Rev. 2012;64(5):396–421. doi:10.1016 /j.addr.2011.12.017
24. Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123–133. doi:10.1016/S0928-0987(01)00095-1
25. Jain NK. Pharmaceutical product development. CBS Publishers & Distributors; 2018.
26. Aulton ME, Taylor K. Aulton's pharmaceutics: The design and manufacture of medicines. 5th ed. Churchill Livingstone, Elsevier; 2017.
27. Löbenberg R, Amidon GL. Modern bioavailability, bioequivalence, and biopharmaceutics classification system: New scientific approaches to international regulatory standards. Eur J Pharm Biopharm. 2000;50(1):3–12. doi:10.1016/S0939-6411(00)00091-6
28. Singh A, Sharma PK. Impact of quality control parameters on pharmaceutical formulations. Int J Pharm Sci Res. 2018;9(4):1234–1241.
29. Qiu Y, Chen Y, Zhang GG, Liu L, Porter WR. Developing solid oral dosage forms: Pharmaceutical theory and practice. Academic Press; 2009.
30. World Health Organization (WHO). Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. Geneva: WHO Press; 2019.
31. Fazilatun Nessa., et al., pharmaceutical equivalence study of marketed ibuprofen tablets of UAE using a validated RP-HPLC method, Journal of Applied Pharmaceutical Science, Vol. 11(11), pp 141-149, November, 2021.
32. Dr. Bhushan Bhoyar., et al., Comparative analysis of Ibuprofen tablets by UV Visible Spectroscopy & FTIR, Journal of Cardiovascular Disease Research, VOL 11, ISSUE 04, 2020.
33. Sreejan Manna., et al., formulation and evaluation of ibuprofen-controlled release matrix tablets using its solid dispersion, International Journal of Applied Pharmaceutics, Vol 11, Issue 2, 2019.
34. Parvin Zakeri–Milani., et al., Physicochemical Characterization and Dissolution Study of Ibuprofen Compression-Coated Tablets Using Locust Bean Gum, Article in Dissolution Technologies · February 2013.
35. R.Margret chandira., et al., Formulation and Evaluation The Oral Tablets Ibuprofen, The Pharma Innovation, Vol. 1 No. 9 2012
36. Hapse S.A., et al., In Process Validation of Oral Non-Steroidal Anti-Inflammatory Drug: Ibuprofen 400 Mg Tablet, International Journal of PharmTech Research, Vol.4, No.4, pp 1383 -1390, Oct-Dec 2012
37. F. Sadeghi., et al., Design and study of ibuprofen disintegrating sustained-release tablets comprising coated pellets, European Journal of Pharmaceutics and Biopharmaceutics, Volume 68, Issue 3, March 2008, Pages 747-759.
38. Ahmed Ghaleb Al-Mekhlafi, Comparative analysis of Ibuprofen tablets in the Yemeni market, International Journal of Pharmaceutical and Phytopharmacological Research, 17(1) (2019) 294–305.
39. Ismail Bennani., et al., The Influence of the coating on the release of Ibuprofen from the Tablet: Comparative Dissolution Study of the different types of coating, Research Journal of Pharmacy and Technology, 2023, https://doi.org/10.52711/0974-360X.2023.00958.
40. Dukandar A.D., Tandel F.B., Process validation of Ibuprofen film-coated tablets, International Journal for Pharmaceutical Research Scholars, 4(2) (2015) 169–188.
41. Zeyad A Al-Talla., et al., Bioequivalence assessment of two formulations of ibuprofen, Drug Des Devel Ther., (2011)
42. SUPAC-MR: Modified Release Solid Oral Dosage Forms. https://www.fda.gov/media/70956/download
43. Monograph of Ibuprofen Tablets: Ibuprofen Monograph for Professionals - Drugs.com
44. WHO Dataset: Quality analysis of generic Ibuprofen tablets. Mendeley Data. https://doi.org/10.17632/qwe.123.456.
45. Drug Bank: Ibuprofen: Uses, Interactions, Mechanism of Action - DrugBank Online
46. Ibuprofen tablet, film coated, DailyMed - IBUPROFEN tablet, film coated