A study of the pharmaceutical quality of chloroquine and paracetamol products sold in a major Nigerian “market”

Abstract

SUMMARYMalaria is a major public health problem in endemic countries, and the quality of antimalarial products is a concern in the therapeutic management of individual patient. In this study, we have evaluated the pharmaceutical quality of chloroquine and paracetamol oral products obtained from a major Nigerian drug "market" using a less elaborate sampling procedure. Results have shown that there are still some defects in the pharmaceutical quality of these drugs, despite the activities of the Nigeria's drug regulatory agency (National agency for Food and Drug Administration and Control, NAFDAC). 21% (7/34) of the drug products were not registered by NAFDAC. The pharmaceutical properties of the products indicated that 6, 15, 9, and 9% of them failed tests for disintegration, dissolution, crushing strength, and percentage of active content, respectively. 4 out of the 6 chloroquine liquid preparations evaluated had inadequate active content. These defects could have resulted from deliberate counterfeiting, poor quality control during manufacture or decomposition of the products. However, this could not be ascertained from the data available to us in this study. The implication of these findings, however, is that the newer anti-malarial drugs that have recently been introduced into the Nigerian market should be safeguarded, if their therapeutic usefulness must be sustained.

Quality of chloroquine tablets available in Africa

“…Previous studies in Southeast Nigeria and Sudan revealed that the poor-quality drugs are highly distributed and circulating intensively in the market (Alfadl et al, 2006;Onwujekwe et al, 2009). However, availability of substandard drugs is the most important challenge to the chemotherapy of malaria and other infectious diseases in the developing communities (Ofonaike et al, 2007).…”

<p>Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia</p>

“…Africa focused studies that intended to investigate the quality of chloroquine tablets found in African countries showed that percentage failures in dissolution ranged from 5% to 50%, in ingredient content from 20% to 67%, in disintegration was 20%, in crushing strength was 30%, and friability test was 21%. [19][20][21] Another commonly prescribed drug for malaria in Ethiopia is quinine. Quinine contains in its structure a quinoline nucleus and an amino alcohol side chain.…”

Is Chloroquine better than Artemisinin combination therapy as first line treatment in adult Nigerians with uncomplicated malaria? a cost effective analysis

“…One of the expected consequences of treatment failure in AN is a longer duration of malaria morbidity because, by adult age, herd immunity is usually well established and mortality is extremely rare ( Gavazzi et al, 2004 ). Other considerations that may guide decision is that while ACT has high rates of substandard preparations that contain between 74%and 77% ( Atemnkeng et al, 2007 , Raufu, 2002 ) of the value stated by the manufacturer and currently have treatment failures of about 1–18% ( Ittarat et al, 2003 ; Ajayi et al, 2008a ), CQ has substandard preparations that contain 0–87% ( Ofonaike et al, 2007 ) but those that contain above 50% (89% of substandard CQ) of the label value are still efficacious in non-resistant parasite because CQ concentrates within parasite vacuoles ( Shapiro and Goldberg, 2001 ). Two different strategies may therefore be considered to be available as potential first line treatments in adults with uncomplicated malaria namely-ACT or CQ plus ACT when needed (CQ plus as needed Artemisinin combination treatment-CANACT).…”