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Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria.

ABSTRACT: Background:Pharmaceutical products need to be of good quality and it is even more critical when it comes to life saving medicaments like infusions. Objective:This research surveyed the quality fitness of some ciprofloxacin and metronidazole infusion samples marketed in South-eastern of Nigeria. Methods:Using Official Compendial methods, microbiological quality, active pharmaceutical ingredients quantitation, pH and particle count tests were evaluated on eighty infusion bottles (from eight pharmaceutical companies) of each of the two drugs. Results:Out of the sixteen brands tested, 2 metronidazole brands and 1 ciprofloxacin brand (representing 18.75% of the total 16 brands/makes) were contaminated while the remaining 13 brands (81.25%) were found sterile. The active pharmaceutical ingredients quantitative assay showed that all the brands of ciprofloxacin infusion were between the 95% and 105% limit of label claim while one metronidazole brand has <95-110% limit label claim. Six brands each of the two drugs evaluated fall below the acceptable pH range [ciprofloxacin (3.5-4.6) and metronidazole (4.8-5.2)], while the other two brands of both drugs passed the test. In the antibacterial study, Pseudomonas aeruginosa and Escherichia coli were susceptible to the ciprofloxacin (5 µg). However, Salmonella typhi recorded inhibition zone diameters within resistant and intermediate range. Peptostrepococcus spp was susceptible (at minimum inhibitory concentrations of 100 µg/mL) to all the brands of metronidazole, while none of the brands were effective on Lactobacillus spp. All the brands passed the test for particulate contamination. The particles size range was <10µm. Conclusion:About eighty-one percent (81.25%) of the infusions have acceptable good microbiological quality. However, 18.75% that failed the tests is a concern knowing that these are lifesaving products.

SUBMITTER: Oli AN

PROVIDER: S-EPMC7369296 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria.

Oli Angus Nnamdi AN Ibeabuchi MaryRose Ukamaka MU Enweani Ifeoma Bessie IB Emencheta Stephen Chijioke SC

Drug, healthcare and patient safety 20200714

<h4>Background</h4>Pharmaceutical products need to be of good quality and it is even more critical when it comes to life saving medicaments like infusions.<h4>Objective</h4>This research surveyed the quality fitness of some ciprofloxacin and metronidazole infusion samples marketed in South-eastern of Nigeria.<h4>Methods</h4>Using Official Compendial methods, microbiological quality, active pharmaceutical ingredients quantitation, pH and particle count tests were evaluated on eighty infusion bott ...[more]

PMID: 32765114

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Project description:IntroductionQuality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.MethodsA total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out.ResultsThe samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements.ConclusionThis study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.

Project description:IntroductionSignificant gap exists in knowledge about employee-centred human resources practices that address motivation and retention of local government tuberculosis control programme supervisors (LGTBS) in Nigeria. The study examined the role of quality of worklife (QWL) in motivating and retaining LGTBS.Materials and methodsThe study was conducted in south-eastern region of Nigeria comprising five states and 95 local government areas. The design was mixed-methods. We used cross-sectional survey to collect quantitative data on socio-demographic factors, QWL, motivation and retention from a total sample of LGTBS. The qualitative component involved focus group discussions (n = 3) with 26 LGTBS. Quantitative data were analysed using exploratory factor analysis, descriptive statistics, Spearman correlation, Mann-Whitney test, Kruskal-Wallis test and multiple linear regression. Qualitative data were analysed using a thematic framework approach.ResultsThe final 40-item QWL scale was found to be valid and reliable. The LGTBS had high QWL (M = 5.15, SD = 0.88) and motivation (M = 5.92, SD = 1.08), but low intention to leave their jobs (M = 2.68, SD = 1.59). Education significantly predicted satisfaction with overall QWL, work-family balance and work design; but tenure predicted satisfaction with work context. Work design and work-family balance significantly predicted motivation of LGTBS. Motivation mediated the relationship between QWL and intention to leave and accounted for 29% variance in intention to leave. Whereas LGTBS were motivated by responsibility, learning opportunities, achievement and recognition; they were dissatisfied with lack of flexible work schedules, involvement in non-TB tasks, long hours at work, limited opportunities for vacation, resource inadequacy, work-related stigma, lack of promotional opportunities, and pay disparity and delay.ConclusionAddressing work design, work-family balance and working conditions may increase the motivation and retention of LGTBS and improve human resources for TB at the district level and performance of the TB control programme.

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Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria.

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Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria.

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