Ai Adegbite1, O M Adegbolagun. 1. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan.
Abstract
BACKGROUND: The relatively little resistance to quinine globally has led to an increase in its use in P. falciparum malaria especially in multi-drug resistant strains. OBJECTIVE: To evaluate the physicochemical and equivalency of three brands of quinine sulphate tablets available in South Western region of Nigeria. METHODS: The pharmaceutical and chemical equivalence of three brands of quinine sulphate tablets were assessed through the evaluation of some biopharmaceutical parameters and active drug content. RESULTS: All the brands complied with the official specification for uniformity of weight. Two of the brands (A & B) gave similar crushing strengths while the third brand (C) gave a much lower value. Similarly all the brands complied with the official specification of disintegration test but the obtained values were statistically different (p<0.05). The T(70) obtained from the dissolution rate profile was less than 45 minutes for the three brands, although A and B were not statistically different but C was statistically from A and B. The quinine content of brands B and C are within the official specification however brand A with percentage content of 110±1.3%w/w, is above the specification while it is statistically different from the other brands. CONCLUSION: Brands B and C could be regarded as chemical equivalent, but they are not biopharmaceutical equivalents, on the other hand, brands A and B may be regarded as biopharmaceutical equivalents but not chemical equivalent.
BACKGROUND: The relatively little resistance to quinine globally has led to an increase in its use in P. falciparum malaria especially in multi-drug resistant strains. OBJECTIVE: To evaluate the physicochemical and equivalency of three brands of quinine sulphate tablets available in South Western region of Nigeria. METHODS: The pharmaceutical and chemical equivalence of three brands of quinine sulphate tablets were assessed through the evaluation of some biopharmaceutical parameters and active drug content. RESULTS: All the brands complied with the official specification for uniformity of weight. Two of the brands (A & B) gave similar crushing strengths while the third brand (C) gave a much lower value. Similarly all the brands complied with the official specification of disintegration test but the obtained values were statistically different (p<0.05). The T(70) obtained from the dissolution rate profile was less than 45 minutes for the three brands, although A and B were not statistically different but C was statistically from A and B. The quinine content of brands B and C are within the official specification however brand A with percentage content of 110±1.3%w/w, is above the specification while it is statistically different from the other brands. CONCLUSION: Brands B and C could be regarded as chemical equivalent, but they are not biopharmaceutical equivalents, on the other hand, brands A and B may be regarded as biopharmaceutical equivalents but not chemical equivalent.
Entities:
Keywords:
Quinine sulphate tablets; biopharmaceutical equivalence; chemical equivalence; non-aqueous titration
Authors: M Le Jouan; V Jullien; E Tetanye; A Tran; E Rey; J-M Tréluyer; M Tod; G Pons Journal: Antimicrob Agents Chemother Date: 2005-09 Impact factor: 5.191
Authors: Paul N Newton; Rose McGready; Facundo Fernandez; Michael D Green; Manuela Sunjio; Carinne Bruneton; Souly Phanouvong; Pascal Millet; Christopher J M Whitty; Ambrose O Talisuna; Stephane Proux; Eva Maria Christophel; Grace Malenga; Pratap Singhasivanon; Kalifa Bojang; Harparkash Kaur; Kevin Palmer; Nicholas P J Day; Brian M Greenwood; François Nosten; Nicholas J White Journal: PLoS Med Date: 2006-06 Impact factor: 11.069