scholarly journals Comparative Quality Evaluation of Selected Brands of Cefuroxime Axetil Tablets Marketed in the Greater Accra Region of Ghana

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Christina Osei-Asare ◽  
Esther Eshun Oppong ◽  
Frederick William Akuffo Owusu ◽  
John Antwi Apenteng ◽  
Yvonne Ochesinda Alatu ◽  
...  

The ever-growing commercialization of poor-quality and substandard medicines, especially anti-infectives characterized by inadequate postmarket surveillance by stakeholders remains a major global health challenge, particularly in developing countries, where antibiotic drug resistance and its repercussions on human health remain dominant. This research sought to evaluate the pharmaceutical quality of six randomly selected brands of cefuroxime axetil tablets (250 mg) marketed in the Greater Accra region of Ghana. The selected brands were coded and subjected to both compendial and noncompendial tests. Statistical analysis and model-independent parameter (similarity factor, f2) were employed in analyzing the dissolution profiles of all the brands. All brands including the reference brand conformed to the pharmacopeial specifications for both compendial and noncompendial tests, indicating that they were of good quality. However, there were significant variations ( p < 0.05 ) in the disintegration time amongst the various brands. All the brands had ƒ2 values > 50 indicating similarity of their drug release profiles with the innovator. Hence, all the sampled cefuroxime axetil brands can be considered as pharmaceutical equivalents to the innovator drug. These brands can, therefore, be used as a substitute for the innovator drug by physicians to patients in cases of unaffordability or unavailability of the innovator brand.

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 96 ◽  
Author(s):  
Md. Islam ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Chisana Uwatoko ◽  
Mohammad Rahman ◽  
...  

Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.


2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Grace Frimpong ◽  
Kwabena Ofori-Kwakye ◽  
Noble Kuntworbe ◽  
Kwame Ohene Buabeng ◽  
Yaa Asantewaa Osei ◽  
...  

The quality of 68 samples of 15 different essential children’s medicines sold in licensed medicine outlets in the Ashanti Region, Ghana, was evaluated. Thirty-two (47.1%) of the medicines were imported, mainly from India (65.6%) and the United Kingdom (28.1%), while 36 (52.9%) were locally manufactured. The quality of the medicines was assessed using content of active pharmaceutical ingredient (API), pH, and microbial limit tests, and the results were compared with pharmacopoeial standards. Twenty-six (38.2%) of the samples studied passed the official content of API test while 42 (61.8%) failed. Forty-nine (72.1%) of the samples were compliant with official specifications for pH while 19 (27.9%) were noncompliant. Sixty-six (97.1%) samples passed the microbial load and content test while 2 (2.9%) failed. Eighteen (26.5%) samples passed all the three quality evaluation tests, while one (1.5%) sample (CFX1) failed all the tests. All the amoxicillin suspensions tested passed the three evaluation tests. All the ciprofloxacin, cotrimoxazole, flucloxacillin, artemether-lumefantrine, multivitamin, and folic acid samples failed the content of API test and are substandard. The overall API failure rate for imported products (59.4%) was comparable to locally manufactured (63.9%) samples. The results highlight the poor quality of the children’s medicines studied and underscore the need for regular pharmacovigilance and surveillance systems to fight this menace.


2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi

Abstract Objective To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market. Results A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25–75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% weight loss, n = 20) were 97–103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were ≤ ±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and ≤ 0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n = 6) and dissolution profile (n = 8) were also determined. No formulation disintegrated or released ˃ 0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99–103%) of label ASC by 45 min in phosphate buffer (pH = 6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69–90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia.


2019 ◽  
Author(s):  
Selass Kebede ◽  
Habtamu Abuye ◽  
Woldemichael Abraham ◽  
Sultan Suleman ◽  
Sileshi Belew

AbstractThe safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines. Poor quality medicines do not meet official standards for strength, quality, purity, packaging and labelling. Hence, this study determines in-vitro quality attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to USP-38 drug monograph specifications. All tested brands meet the requirements for physical inspection & complied specification for friability and hardness. Besides, the tested brands met USP 38 specification for assay (99.96% to 108.85%) and for content uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met USP 38 requirements. However, significant difference with respect to dissolution profile among tested brands GL4 and GL6 were confirmed with comparator product through model independent approach. Moreover, DE values were studied and confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator product.


2020 ◽  
pp. 34-36
Author(s):  
M. A. Pokhaznikova ◽  
E. A. Andreeva ◽  
O. Yu. Kuznetsova

The article discusses the experience of teaching and conducting spirometry of general practitioners as part of the RESPECT study (RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related aetiology). A total of 33 trained in spirometry general practitioners performed a study of 3119 patients. Quality criteria met 84.1% of spirometric studies. The analysis of the most common mistakes made by doctors during the forced expiratory maneuver is included. The most frequent errors were expiration exhalation of less than 6s (54%), non-maximal effort throughout the test and lack of reproducibility (11.3%). Independent predictors of poor spirogram quality were male gender, obstruction (FEV1 /FVC<0.7), and the center where the study was performed. The number of good-quality spirograms ranged from 96.1% (95% CI 83.2–110.4) to 59.8% (95% CI 49.6–71.4) depending on the center. Subsequently, an analysis of the reasons behind the poor quality of research in individual centers was conducted and the identified shortcomings were eliminated. The poor quality of the spirograms was associated either with the errors of the doctors who undertook the study or with the technical malfunctions of the spirometer.


2019 ◽  
Vol 7 (3) ◽  
pp. 232-237
Author(s):  
Hana Larasati ◽  
Theresia Titin Marlina

Background: stroke is a disorder of nervous system function that occurs suddenly and is caused by brain bleeding disorders that can affect the quality of life physical dimensions, social dimensions, psychological dimensions, environmental dimensions. Based on the result of Lumbu study (2015) the number of samples were 71 people collected data using the (WHOQOL-BREF). There were 56 people (78,9%) had the poor quality of life of post stroke. The mean of post-stroke quality of life domain was physical domain (45,27%), psychological domain (49,87%), social relations domain (48,15%) and environmental domain (50.01%). Objective: the purpose of the study was know the quality of life of the stroke patients in Outpatient Polyclinic of Private Hospital in Yogyakarta. Methods: used descriptive quantitative by using questionnaire test of purposive sampling system based on patients who have been affected of ischemic or hemorrhagic stroke before, number 30 respondents. Result: quality of life of stroke patient of medium physical dimension (67%), psychological dimension (71%), social dimension (67%), dimension good environment (63%). Conclusion: the quality of life of stroke patients of physical dimension, psychological dimension, and moderate social dimension, while the quality of life of stroke patients were good environmental dimension.   Keywords: Hemorrhagic stroke, ischemic stroke, quality of life


2020 ◽  
pp. 3-53
Author(s):  
Yu.B. Vinslav

The article analyzes the main indicators of the evolution of the domestic economy and its industrial complex in the past year (in January — November 2019). It Identifies trends in this evolution, including negative trends that determine the preservation of reproductive threats in 2020: sluggishness, instability and low quality of economic growth. The main reasons for the fact that the objective resource capabilities of the macro level were clearly not used enough to effectively solve the urgent problems of technological modernization of the economy and increase people’s welfare are established. The main reason is the poor quality of public administration, including imperfect strategic planning and industrial policy; there is still no modern national innovation system in the country. Accordingly, recommendations for improving the quality of state regulation in its specified components are justified. The recommended measures, according to the author, will help the economy to move to a trajectory of rapid, sustainable and high-quality growth.


2020 ◽  
Vol 27 (1) ◽  
pp. 106-120 ◽  
Author(s):  
L. A. Rodionova ◽  
E. D. Kopnova

The relevance of the chosen topic is closely related to the development of a system for monitoring the implementation of the May Presidential Decree (2018) to increase life expectancy and improve the quality of life of the population. It has been stated that despite the positive dynamics of life expectancy over the past decade, Russia still has a huge regional differentiation (16,6 years for women, 18,2 years for men in 2016) and an average gender gap - 10,6 years. The choice of factors affecting the gender gap in life expectancy in Russian regions is supported by a conclusion most common in foreign studies that climatic conditions, living conditions, the quality of food and drinking water, alcohol consumption are essential components of public health and life expectancy.The article provides an overview of studies on assessment factors of life expectancy, presents the authors’ approach to identifying gender gaps in life expectancy, living conditions, and lifestyle affecting the indicator of life expectancy. The paper presents the results of a comparative analysis of gender gap in life expectancy in Russia and foreign countries. The paper studies the correlation between living conditions and lifestyle, and life expectancy.Classification of the regions by the life expectancy at birth for men and women is an important component of this study. The authors used Rosstat data for 2016 and the k-means method to select three clusters of Russian regions taking into account gender, living conditions and lifestyle. The paper identifies similar health problems of the regions that are associated with alcohol consumption, poor nutrition and poor quality of drinking water, poor housing and living conditions. The lowest life expectancy rates for men and women are recorded in regions of the 1st cluster (Jewish Autonomous Region, Republic of Tuva, Chukotka Autonomous Area). High mortality rates are a result of external causes. There is a poor quality of drinking water and poor nutrition, excessive alcohol consumption, and inadequate housing conditions.Based on the obtained results were determined possible reserves for reducing the gender and regional differentiation of life expectancy.


Sign in / Sign up

Export Citation Format

Share Document