Post–market In vitro Equivalency Evaluation of Paracetamol Tablets in Kedah, Malaysia

DOI:

https://doi.org/10.37285/ijpsn.2011.4.2.5

Authors

  • Chandrasekaran A R
  • Chen Yi Han
  • Alex Chin Yang Chung
  • Lim Wei Cheang
  • Low Sing Ping

Abstract

 Six brands of paracetamol (acetaminophen) 500 mg tablets have been evaluated using specific quality control tests for uniformity of weight, hardness, friability, content, disintegration and dissolution with the aim to assess its bioequivalence. The results obtained have been discussed in details using monographs in United States Pharmacopeia and British Pharmacopoeia. In conclusion, despite some apparent minor differences in tablet hardness and disintegration time profiles, the dissolution characteristics of various paracetamol tablets appears to be similar and not significantly different from various manufacturers.

 

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Quality control tests, paracetamol, dissolution, dissolution efficiency, weight variation, disintegration

Downloads

Published

2011-08-31

How to Cite

1.
A R C, Han CY, Chung ACY, Cheang LW, Ping LS. Post–market In vitro Equivalency Evaluation of Paracetamol Tablets in Kedah, Malaysia. Scopus Indexed [Internet]. 2011 Aug. 31 [cited 2024 Dec. 21];4(2):1403-7. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/425

Issue

Section

Research Articles

References

pharmaceutical dosage forms and drug delivery systems, 8th Ed, Lippincott Williams & Wilkins, Philadelphia, 236.

Anderson NH, Bauer M, Boussac N, Khan MR, Munden P, and Sardaro M (1998). An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J. Pharm. Biomed. Anal. 17: 811-822.

British Pharmacopoeia, Vol. I & II. The Stationery Office, London, 1988.

Chen M, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang S, Hare D, Lesko L, Sporn D, and Williams R (2001). Bioavailability and Bioequivalence: An FDA Regulatory Overview. Pharm. Res. 18: 1645-1650.

Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ (2005). The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. PLoS Med. 2 (4): e100. Costa P (2001). An alternative method to the evaluation of similarity factor in dissolution testing. Int. J. Pharm. 220 (1-2): 77-83.

Costa P, Sousa LoboJ M (2001). Modeling and comparison of dissolution profiles. Eur. J. Pharm. Sci., 13(2): 123-133.

Gohel MC, Sarvaiya KG, Mehta NR., Soni CD, Vyas VU, Dave RK (2005). Assessment of Similarity Factor using Different Weighting Approaches. Dissolution Technologies, 12 (4): 22-27.

Gupta E, Barends DM, Yamashita E., Lentz KA, Harmsze AM, Shah VP, Dressman JB., Lipper RA (2006). Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. Eur. J. Pharm. Sci. 29 (3-4): 315-324.

FDA (1997). US Food and Drug Administration, Center for Drug Evaluation and Research (1997). Guidance for industry: Dissolution testing of immediate release solid oral dosage forms, Available at: http://www.fda.gov/cder/Guidance/ 1713bp1.pdf.

FDA (2008). US Food and Drug Administration, Center for Drug Evaluation and Research (2000). Guidance for Industry - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, Available at: http://www.fda.gov/cder/guidance/3618fnl.pdf Accessed 7th November (2008).

FDA (1995). US Food and Drug Administration, Center for Drug Evaluation and Research (2003). Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products—general considerations, Available at: http://www.fda.gov/cder/guidance/5356f nl.pdf. US Pharmacopeia National Formulary USP 23/NF 18 (1995). United States Pharmacopeial Convention. Inc., Rockville, MD. (2008a). Guidance for Industry - Waiver of In vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, Available at: http://www.fda.gov/cder/guidance/3618fnl.pdf Accessed 7th November, 2008.

FDA (2008b). Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products—general considerations, Available at: http://www.fda.gov/cder/ guidance /5356fnl.pdf Accessed 6th November, 2008.

FDA (2008c). Guidance for industry: Dissolution testing of immediate release solid oral dosage forms, Available at: http://www.fda.gov/cder/Guidance/ 1713bp1.pdf Accessed 14th November, 2008.

FDA (2008d). Guidance on the Investigation of Bioavailability and Bioequivalence. Available at http://www.emea.europa.eu/ pdfs/human/ewp/140198en.pdf Accessed 25, November, 2008.

Hennessy S (1998). Postmarketing drug surveillance: an epidemiologic approach. Clin. Ther. 20 (3): C32-C39.

Kasim NA, Whitehouse M, Ramachandran C., Bermejo M., Lennernas H, Hussain AS, Junginger HE, Stavchansky SA., Midha KK, Shah VP., Amidon GL (2004). Molecular Properties of WHO Essential Drugs and Provisional Biopharmaceutical Classification. Mol. Pharm. 1(1): 85-96.

Khan A, Ghilzai N (2003). Counterfeit and substandard quality of drugs: The need for an effective and stringent regulatory control in India and other developing countries. Indian J. Pharmacol. 39 (4): 206-207.

Meredith P (2003). Bioequivalence and other unresolved issues in generic drug substitution. Clin. Ther. 25 (11): 2875-2890.

Ngwuluka NC., Abubakar MS., Mustapha B., Adegoke OA (2006). An assessment of the compliance of some essential drugs in Nigeria to pharmacopoeial specifications. J. Pharm. Bioresour. 3(1): 7-11.

Ochekpe NA, Ngwuluka NC, Owolayo H, Fashedemi T (2006). Dissolution profiles of three brands of Lamivudine and Zidovudine combinations in the Nigerian market. Dissolution Tech., 13(4): 12-17.

Polli J (2008). In Vitro Studies are Sometimes Better than Conventional Human Pharmacokinetic In Vivo Studies in Assessing Bioequivalence of Immediate-Release Solid Oral Dosage Forms. The AAPS J., 10 (2): 289-299.

Polli JE, Rekhi SG, Augsburger LL, Shah VP (1997). Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J. Pharm. Sci. 86 (6): 690-700.

Rani S (2007). Bioequivalence: Issues and perspectives. Indian J. Pharmacol. 39(5): 218-225.

Raufu A (2003). India agrees to help Nigeria tackle the import of fake drugs. BMJ, 326 (7401): 1234.

Shah V (2001). Dissolution: A Quality Control test vs A Bioequivalenttest. Dissolution Technol. 8 (4): 1-2.

Shah VP, Tsong Y, Sathe P, Liu J (1998). In vitro Dissolution Profile Comparison-Statistics and Analysis of the Similarity Factor, f2.

EMEA (2001). The European Agency for the Evaluation of Medicinal Products (EMEA), (2001) Notes for Guidance on the Investigation of Bioavailability and Bioequivalence. Available at http://www.emea.europa.eu/ pdfs/human./ewp /140198en.pdf.

World Health Organization (2004). WHO medicines strategy; countries at the core 2004-2007. p. 68. Available at http://libdoc.who.int/hq/ 2004/WHO_EDM_2004.5.pdf.

Wu C, Benet LZ, (2005). Predicting Drug Disposition via Application of BCS: Transport/Absorption/ Elimination Interplay and Development of a Biopharmaceutics Drug Disposition Classification System. Pharm. Res. 22 (1): 11-23.

Yu LX, Amidon GL, Polli JE., Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen M, Lee VHL, Hussain AS (2002). Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions. Pharm. Res. 19 (7): 921-925.