In-vitro evaluation of the quality of Paracetamol and Co-trimoxazole tablets used in Malawi based on pharmacopoeial standards

Objectives This study was an in-vitro evaluation of different brands of paracetamol and cotrimoxazole tablets, used or found in Malawi, based on Pharmacopoeia standards, in order to ascertain the existence and extent of substandard medicines in Malawi and to give an overview of their distribution in the public and private sectors. Methodology A cross-sectional analytical study was conducted using 11 samples each of paracetamol and cotrimoxazole tablets. Stratified random sampling was used to collect samples. Samples were analyzed using HPLC and Spectrophometric methods as outlined in the BP-2007 and USP-32 at the National Drug Quality Control Laboratory (NDQCL)-Lilongwe (under Pharmacy Medicines and Poisons Board-PMPB) and Orient Pharma Co. Ltd of Taiwan. The results were analyzed using Epi Info. Results and discussion Fifty percent of samples (n=22) were not registered in the country by the PMPB as required by the PMP Act with the majority of those coming from public health facilities. All paracetamol and cotrimoxazole samples complied with identification tests using spectrophotometric and HPLC method. Overall, 27.3% of samples failed to meet the BP-2007 standards for Active Ingredient content, while 22.7% of the samples failed the Friability test. The results from Malawi are similar in magnitude to those within surrounding countries in Africa. Conclusion This pilot study provides objective evidence to show that substandard and unregistered paracetamol and cotrimoxazole are present and being used in Malawi, and thus posing a considerable hazard to public health in Malawi. PMPB, together with the Ministry of Health, must continue to develop a quality assurance system to ensure that medicines are randomly and routinely checked.

Clinical evaluation of two materials in the restoration of abfraction lesions

Aim: To evaluate the clinical performance of a composite resin (CR) and a resin-modified glassionomer cement (RMGIC) for the treatment of abfraction lesions. Methods: Thirty patients with abfraction lesions in at least two premolar teeth were selected and invited to participate in this study. All restorations were made within the same clinical time frame. One tooth was restored with CR Z100TM (3M, St. Paul, MN, USA), and the other was restored with RMGIC VitremerTM (3M). The restorations were assessed immediately and 1, 6 and 12 months after the restoration, using modified US Public Health Service (USPHS) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and hypersensitivity. The statistical analysis was based on Friedman ANOVA test and Mann-Whitney test, considering p<0.05 for statistical significance. Results: Both materials demonstrated satisfactory clinical performance after one year. In the individual analysis of each material, there was a significant difference (p<0.05) in the criteria marginal integrity and wear, for both CR and RMGIC. RMGIC exhibited more damage one year after the restoration. Comparing both materials, it was found a significant difference only for marginal discoloration, while the RMGIC restorations showed the worst prognosis after a year of evaluation. There was no significant difference in the number of retentions, caries or hypersensitivity between CR and RMGIC. Conclusions: It was concluded that CR exhibited the best clinical performance according to the cost-effectiveness and evaluation criteria used in this study.