Preponderance of toxigenic Escherichia coli in stool pathogens correlates with toxin detection in accessible drinking-water sources.

Since early detection of pathogens and their virulence factors contribute to intervention and control strategies, we assessed the enteropathogens in diarrhoea disease and investigated the link between toxigenic strains of Escherichia coli from stool and drinking-water sources; and determined the expression of toxin genes by antibiotic-resistant E. coli in Lagos, Nigeria. This was compared with isolates from diarrhoeal stool and water from Wisconsin, USA. The new Luminex xTAG GPP (Gastroplex) technique and conventional real-time PCR were used to profile enteric pathogens and E. coli toxin gene isolates, respectively. Results showed the pathogen profile of stool and indicated a relationship between E. coli toxin genes in water and stool from Lagos which was absent in Wisconsin isolates. The Gastroplex technique was efficient for multiple enteric pathogens and toxin gene detection. The co-existence of antibiotic resistance with enteroinvasive E. coli toxin genes suggests an additional prognostic burden on patients.

Postmarketing in vitro/in vivo assessment of fixed dose combination products of first line antiretrovirals.

The purpose of this study was to evaluate the postmarket pharmaceutical equivalence, stability and bioequivalence of generic and innovator fixed dose combination products of lamivudine (3TC) and zidovudine (AZT) 150/300 mg tablets available in Nigeria. An isocratic HPLC-UV method was developed and validated for the quantitative determination of 3TC and AZT in human plasma and pharmaceutical samples. The model independent f(2) similarity factor was used to compare the dissolution profiles of the two products stored at accelerated and long-term stability conditions for 6 months. The f(2) values for 3TC and AZT in both products were found to be greater than 51. Also, the tablets were stable according to the USP potency and drug dissolution criteria with more than 80% of drug dissolution in 30 min indicating the pharmaceutical equivalence of the two products. The 90% confidence interval for the ratios of generic/innovator pharmacokinetic parameters for 3TC/AZT were 73.5-112.6/63.4-95.8 (C(max)); 68.5-105.6/68.0-114.8 (AUC(0-t)); and 64.2-106.2/80.1-120.3 (AUC(0-infinity)) respectively. The pharmacokinetic parameters failed to fully demonstrate bioequivalence between the products. The results underscored the importance of assessing the quality of the combination drug products that would ensure the safety and efficacy of the generic drug products available in the market.

Design of a fixed-dose paediatric combination of artesunate and amodiaquine hydrochloride.

Fixed-dose combinations of artesunate and amodiaquine hydrochloride provide challenges in product development due to the incompatibility of the two agents. This is particularly critical for paediatric preparations which can often be presented in liquid form. The studies reported in this article aimed to develop an understanding of the factors responsible for this incompatibility, whilst assessing the feasibility of developing a stable paediatric formulation. The stability characteristics of fast-disintegrating granular formulations containing intimate mixtures of both agents and single agent granules blended prior to production of unit doses were therefore studied under a range of storage conditions. The granular products remained stable over the 3-month period under stressed accelerated conditions, in contrast to control samples containing both drugs in combined granular form, which demonstrated reductions in artesunate content at elevated humidity. It was hypothesized that loss of active agent content for artesunate was accelerated by access to the water of crystallization of amodiaquine as demonstrated by the more facile dehydration of amodiaquine when a mixture of the two agents was analysed by differential scanning calorimetry (DSC). It was therefore concluded that a stable, versatile paediatric preparation of the two drugs could be prepared by blending pre-formulated granules containing the individual constituents rather than producing a combined granule comprising intimate mixtures of the two agents.

Prevalence of abnormal cervical smears among patients with HIV in Lagos, Nigeria.

BACKGROUND: There are over four million people living with HIV/AIDS in Nigeria. Cervical cancer is the most common genital cancer in Nigeria. There are many reports on the association of HIV with increased risk of cervical dysplasia. OBJECTIVE: To determine the prevalence of abormal cervical smears in Nigerian women who are HIV positive in Lagos. METHODS: Cervical smears were taken from 233 HIV positive women and 235 HIV negative women who attended the HIV clinic and the family planning clinic respectively of the Lagos University Teaching Hospital during the period January-April 2004. Proportions were compared with the X2 test. RESULTS: Data were complete for analysis in 227 of HIV positive and 228 of HIV negative women. Mean (SD) ages of HIV positive and HIV negative patients were respectively 35.2 (9.81) and 34.5 (7.37) years. Prevalence of squamous intraepithelial lesion (SIL) was higher in those who were HIV positive than in those who were HIV negative, 10.9% vs 4.3% (X2, 7.04; p=0.00798). Prevalence of high grade SIL was higher in HIV positive than HIV negative subjects, 7.9% vs 2.6% (X2, 6.38; p=0.0115). There was no significant difference in the prevalence of inflammatory smears, 15.7% in HIV positive vs 16.2% in HIV negative. CONCLUSION: Prevalence of cervical dysplasia is high in women who harbour HIV.

Community pharmacies as possible centres for routine immunization.

BACKGROUND: Nigeria has embraced the primary healthcare movement and has committed its resources to the provision of cost effective community based primary healthcare strategy which recognizes the need for effective partnership between public and private sector. Immunizations are important part of this effort, especially the provision of the vaccines incorporated into the national Expanded Programme on Immunization (EPI) which has now metamorphosis to National Programme on Immunization (NPI) due to decline in immunization coverage. Community pharmacies can be involved in immunization to improve coverage as has been shown in the United States of America (U.S.A) that this led to great improvement in immunization coverage. The need to find out if this can also be adopted in Nigeria is the objective of this work. OBJECTIVES: This study therefore aimed to have an insight into current interest of community pharmacists to be involved in routine immunization and assess their physical structures for possible adaptation for use in routine immunization. METHOD: Sixty (60) pre-tested questionnaires were randomly administered to community pharmacists. Forty-three (43) questionnaires were retrieved for analysis. RESULTS: The study revealed that the use of community pharmacies as places where routine immunization services can be provided is feasible as shown by 95.3% interest expressed by community pharmacists. Most of the required infrastructures to carry out these services are on the ground as shown by availability of adequate space (88.4%), stand-by generator (83.7%) and functional fridge/ freezer (95.3%). Community pharmacists (88.4%) expect to be remunerated for providing this service. CONCLUSION: This study has shown the willingness of community pharmacists to participate in immunization efforts and the possibility of using pharmacies in routine immunization.

A consideration of the range and strength of interparticle forces in coated lactose powder.

A study has been made of the range and strength of interparticle forces in lactose powder coated with increasing concentrations of paraffins at different temperatures. Marked changes occurred in these forces as the paraffin content was altered and the temperature increased from -10 degrees to +50 degrees C. The strength and range of interparticle forces depended on the mechanical properties of the coating materials and the surface free energy of the coated powders.

Dissolution mechanism of tablets produced from coated lactose powder.

The use of the equation of Kitazawa et al in the analysis of the dissolution process of tablets produced from lactose powder coated with paraffin has suggested either an initial breaking of the tablets into particles that subsequently break down into smaller particles or a progressive breaking of the tablet into smaller particles. The former produces a change in rate constant from k1 to k2.