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Abstract

Based on the World Health Organization definitions, the term quality control refers to the sum of all steps and procedures undertaken by a drug manufacturer to ensure the identity, safety, efficacy and purity of a particular pharmaceutical product. Quality control is an essential operation within the field of pharmaceutical industry and it is a vital part of current Good Manufacture Practice. It ensures that the pharmacokinetic and the pharmacodynamics properties are predictable and reproducible for the same active pharmaceutical ingredient when manufactured by different companies. The quality assurance of oral solid dosage form especially tablets is a priority for drug manufacturing companies. In addition to the apparent features of tablets, tablets must meet other physical specifications and quality standards. These include criteria for weight, weight variation, thickness, hardness, disintegration, and dissolution. In addition the content uniformity was investigated by HPLC technique. Thus, in this project, paracetamol tablets from five different companies which are widely used by Iraqi population were subjected to different quality control tests to indicate whether these products are fit to the standard criteria of the United States Pharmacopeia or not. The data indicated that all tested brands succeeded to pass most tests and failed in others.

References

  1. Towheed T, Maxwell L, Judd M, Catton M, Hochberg MC, Wells GA. Acetaminophen for osteoarthritis. Cochrane Database Syst Rev 2006;(1). https://doi.org/10.1002/ 14651858.CD004257.pub2.
  2. McKay GA, Reid JL, Walters MR. Lecture notes: clinical pharmacology and therapeutics. John Wiley & Sons; 2010.
  3. Milani DAQ, Davis DD. Pain management medications. StatPearls Publishing; 2022. StatPearls [Internet].
  4. Bannwarth B, Pehourcq F. Pharmacological rationale for the clinical use of paracetamol: pharmacokinetic and pharmacodynamic issues. Drugs 2003;63:5e13. PMID: 14758786.
  5. Smith HS. Potential analgesic mechanisms of acetaminophen. Pain Physician 2009;12(1):269e80. PMID: 19165309.
  6. Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american Headache Society evidence assessment of migraine pharmacotherapies. Headache J Head Face Pain 2015;55(1):3e20. https://doi.org/ 10.1111/head.12499.
  7. Kulo A, Peeters MY, Allegaert K, Smits A, de Hoon J, Verbesselt R, et al. Pharmacokinetics of paracetamol and its metabolites in women at delivery and post-partum. Br J Clin Pharmacol 2013;75(3):850e60. https://doi.org/10.1111/j.1365- 2125.2012.04402.x.
  8. Wang X, Wu Q, Liu A, Anadon A, Rodríguez J-L, Martínez- Larra~naga M-R, et al. Paracetamol: overdose-induced oxidative stress toxicity, metabolism, and protective effects of various compounds in vivo and in vitro. Drug Metab Rev 2017; 49(4):395e437. https://doi.org/10.1080/03602532.2017.1354014.
  9. Williams CM, Maher CG, Latimer J, McLachlan AJ, Hancock MJ, Day RO, et al. Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial. Lancet 2014;384(9954):1586e96. https://doi.org/10.1016/ S0140-6736(14)60805-9. Epub 2014 Jul 23.
  10. Su S-F, Chou C-H, Kung C-F, Huang J-d. In vitro and in vivo comparison of two diclofenac sodium sustained release oral formulations. Int J Pharm 2003;260(1):39e46. https://doi.org/ 10.1016/s0378-5173(03)00237-0.
  11. Pharmacopeia US. USP 37eNF 32. USP-NF Standard Updates 2013;37 (second supplement).
  12. Allen L, Ansel HC. Ansel's pharmaceutical dosage forms and drug delivery systems. Lippincott Williams & Wilkins; 2013.
  13. Gupta MM, Gupta M. In-vitro pharmaceutical quality control testing: a comparative study of different brands of metformin tablets available in the Trinidad & Tobago, West Indies. J Pharmaceut Sci Res 2016;8(4):238.
  14. Lachman L, Lieberman H, Khar R, Vyas S, Farhan A, Jain J. The theory and practice of industrial pharmacy. 4th ed., vol. 245. New Delhi: CBS Publishers & Distributors Pvt Ltd; 2013. p. 450e8.
  15. Franeta J, Agbaba D, Eric S, Pavkov S, Aleksic M, Vladimirov S. HPLC assay of acetylsalicylic acid, paracetamol, caffeine and phenobarbital in tablets. Il Farmaco 2002;57(9): 709e13. https://doi.org/10.1016/s0014-827x(02)01265-x.
  16. Organisation WH. Supplementary guidelines on good manufacturing practices: validation. (2006). Appendix 4 on Analytical method validationvol. 937. WHO Tech Rep Ser; 2006 (Annex 4).
  17. Shargel L, Wu-Pong S. Andrew yu applied biopharmaceutics and pharmacokinetics. McGraw-Hill Education; 2015.

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