Quality Comparisons of Acetaminophen Tablets Commercially Available in Thailand

Authors

  • Areerat Suedee School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110
  • Nuansri Niwattisaiwong School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110
  • Thitiya Saelim School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110
  • Saksit Chaiwut School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110

Keywords:

Acetaminophen Tablet, Quality Control, Uniformity of Weight, Tablet Friability, Tablet Breaking Force, Dissolution Test, Assay, Uniformity of Dosage Unit

Abstract

Acetaminophen or paracetamol is one of the most widely used over-the-counter analgesic and antipyretic medications. Many different brands of acetaminophen tablets are available in Thailand market where people can easily access medicines. The aim of this present study was to compare the quality of three brands of acetaminophen tablets (500 mg/tablet) marketed in Thailand with various prices. The three brands of acetaminophen tablets were obtained from a retail pharmacy and their qualities were evaluated using criteria and methods according to USP 40 and BP 2017 together with CDER--Center for Drug Evaluation and Research guidance 1997. The quality of the acetaminophen tablets was compared based on uniformity of weight, tablet friability, tablet breaking force, dissolution test, assay procedure as well as uniformity of dosage unit. All brands conformed to USP and BP criteria. According to CDER guidance, dissolution profiles of two brands were considered to be equivalent, but they are slightly different from the other one. However, the overall quality of the three brands of acetaminophen tablets was satisfactory as they met the USP 40 and BP 2017 requirements.

Author Biographies

Nuansri Niwattisaiwong, School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110

Acetaminophen or paracetamol is one of the most widely used over-the-counter analgesic and antipyretic medication. Many different brands of acetaminophen tablets are available in Thailand market that people can easily access medicines. The aim of the present study was to compare the quality of three brands of acetaminophen tablets (500 mg/tablet) marketed in Thailand with various prices. The three brands of acetaminophen tablets were obtained from a retail pharmacy and their quality were evaluated using criteria and methods according to USP 40 and BP 2017 together with CDER guidance 1997. The quality of the acetaminophen tablets was compared based on uniformity of weight, tablet friability, tablet breaking force, dissolution test, assay as well as uniformity of dosage unit. All brands conformed to USP and BP criteria except the tablet breaking force which has no acceptance criteria available in any pharmacopoeia. According to CDER guidance, dissolution profiles of two brands were considered to be equivalent, but they are slightly different from the other one. However, the overall quality of the three brands of acetaminophen tablets was satisfactory as they met the USP 40 and BP 2017 requirements.

Thitiya Saelim, School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110

Acetaminophen or paracetamol is one of the most widely used over-the-counter analgesic and antipyretic medication. Many different brands of acetaminophen tablets are available in Thailand market that people can easily access medicines. The aim of the present study was to compare the quality of three brands of acetaminophen tablets (500 mg/tablet) marketed in Thailand with various prices. The three brands of acetaminophen tablets were obtained from a retail pharmacy and their quality were evaluated using criteria and methods according to USP 40 and BP 2017 together with CDER guidance 1997. The quality of the acetaminophen tablets was compared based on uniformity of weight, tablet friability, tablet breaking force, dissolution test, assay as well as uniformity of dosage unit. All brands conformed to USP and BP criteria except the tablet breaking force which has no acceptance criteria available in any pharmacopoeia. According to CDER guidance, dissolution profiles of two brands were considered to be equivalent, but they are slightly different from the other one. However, the overall quality of the three brands of acetaminophen tablets was satisfactory as they met the USP 40 and BP 2017 requirements.

Saksit Chaiwut, School of pharmacy, Eastern Asia University, 200 Rangsit-Nakhon Nayok Road, Thanyaburi, Pathum Thani, 12110

Acetaminophen or paracetamol is one of the most widely used over-the-counter analgesic and antipyretic medication. Many different brands of acetaminophen tablets are available in Thailand market that people can easily access medicines. The aim of the present study was to compare the quality of three brands of acetaminophen tablets (500 mg/tablet) marketed in Thailand with various prices. The three brands of acetaminophen tablets were obtained from a retail pharmacy and their quality were evaluated using criteria and methods according to USP 40 and BP 2017 together with CDER guidance 1997. The quality of the acetaminophen tablets was compared based on uniformity of weight, tablet friability, tablet breaking force, dissolution test, assay as well as uniformity of dosage unit. All brands conformed to USP and BP criteria except the tablet breaking force which has no acceptance criteria available in any pharmacopoeia. According to CDER guidance, dissolution profiles of two brands were considered to be equivalent, but they are slightly different from the other one. However, the overall quality of the three brands of acetaminophen tablets was satisfactory as they met the USP 40 and BP 2017 requirements.

References

References

American Chemical Society. (2014). Re: Molecule of the week archive “Acetaminophen”. Retrieved September 15, 2014, from https://www.acs.org/content/acs/en/molecule-of-theweek/archive/a/acetaminophen. html.

ASEAN Common Technical Requirements (ACTR). (2016). ASEAN Secretariat, Jakarta: Indonesia. British Pharmacopoeia 2017. (2016). London: The Stationary Office.

Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of curves with an emphasis on in vitro dissolution profiles. Pharmaceutical Technology. 20(6), 64-74.

Shah, V. P., Tsong, Y., & Sathe, P. (1988). In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharmaceutical Research. 15, 889-896.

Stippler, E. (2019). Re: Compendial dissolution: Theory and practice. Retrieved June 5, 2019, from https://www.academia.edu/7603260/Compendial_Dissolution_Theory_and_Practice.

The United States Pharmacopeia. (2016). The United States Pharmacopeia 40: National Formulary 35. (2016). Baltimore, USA.: United Book Press.

U.S. Department of Health and Human Services Food and Drug Administration. (1997). Guidance for industry: Dissolution testing of immediate release solid oral dosage forms, Center for Drug Evaluation Research, Rockville. MD, USA: Center for Drug Evaluation Research (CDER).

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Published

2020-04-19

How to Cite

Suedee, A. ., Niwattisaiwong, N. ., Saelim, T. ., & Chaiwut, S. . (2020). Quality Comparisons of Acetaminophen Tablets Commercially Available in Thailand. EAU Heritage Journal Science and Technology (Online), 14(1), 182–191. retrieved from https://he01.tci-thaijo.org/index.php/EAUHJSci/article/view/240031

Issue

Vol. 14 No. 1 (2020): January-April

Section

Research Articles

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