A Quality Control Assessment of Five Brands of Chlorpheniramine Maleate Tablets Marketed In Nigeria
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Résumé
In vitro evaluations of five brands of Chlorpheniramine maleate marketed in Nigeria from companies designated A, B, C, D and E were carried out in order to determine the bioavailability of each brand. The uniformity, hardness, friability, disintegration time and dissolution test were conducted. The BP standard value of the deviation for weight uniformity is ±7.5%, hence all the samples passed the test based on specification as these respective values were obtained from each of the samples: (A = 1.48, B = 4.24, C = 3.69, D = 2.59 and E =2.50). The hardness test values of 2, 0.775, 1.493, 1.176, 1.122KgF and disintegration values of 2.2, 1.8, 3.8, 1.1 and 2.3 were obtained for A, B, C, D and E respectively. This means that, they all passed disintegration test
according to USP specification. Absolute drug content test results obtained were: A = 96.99, B = 96.57, C = 87.04, D = 74.76 and E = 92.13 showing that brands A, B and E passed the test (official acceptance range is 92.5 and 107.5%) while C and D failed it. The result obtained for dissolution test indicated that the drug content of each of the brand released with an initial increasing order and later declined as the time increased. In conclusion, this study revealed that formulation of the same dosage form of the drug varies among manufacturers.
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Références
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Lloyd V Allen, Jr., Nicholas G. Popovich, Howard C Ansel (2011) Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems.9th Edition. Lippincott Williams & Wilkins pp 205-251
Kalakuntla R, Veerlapati U, Chepuri M, Rapavla R (2010) Effect of various superdisintegrant on hardness, disintegration and
dissolution of drugs from forms. J Adv. Sci. Res. 2010. 1(1): 15-19
Aulton.M.E, (1988), Pharmaceutics: The Science of Dosage form Design. (Churchill Livingstone London). Pp 250 – 280.
Ofoefule, S I (2002). A textbook of Pharmaceutical technology and Industrial Pharmacy, Samakin Nigeria Enterprises, Lagos .pp 2 – 14, 60 – 65, 283 – 285.
Koch –Wesser, J.(1974). Bioavailability of drugs. New England, J. Med., 291: 233 –237
Olaniyi AA (2000).Principle of drug quality assurance and Pharmaceutical analysis, Mosuro Publishers Ibadan. pp 399 – 404.
The United State Pharmacopoeia. XXIII, 1995 and the National Formulary (18th Edition). The United States Pharmacopeia
Convention, Inc. Rockville, MD, pp 1790 – 1794.
Gilbert S. Banker, Christopher T Rhodes Ed. (2002) Modern Pharmaceutics. 4th Edition. Marcel Dekker USA. Pp 520-560
Lloyd V Allen, Jr., Nicholas G. Popovich, Howard C Ansel (2011) Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 9th Edition. Lippincott Williams & Wilkins pp 205-251
Kalakuntla R, Veerlapati U, Chepuri M, Rapavla R (2010) Effect of various superdisintegrant on hardness, disintegration and
dissolution of drugs from forms. J Adv. Sci. Res. 2010. 1(1): 15-19