scholarly journals Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Reem AlSwayeh ◽  
Rajaa F. Hussein
Keyword(s):  
Active Substance ◽  
Diclofenac Sodium ◽  
Quality Criteria ◽  
Immediate Release ◽  
United States Pharmacopoeia ◽  
Pharmaceutical Quality ◽  
Weight Variation ◽  
Variation Range ◽  
Enteric Coated

Abstract Objective We previously reported the pharmaceutical quality of eight brands of 50 mg enteric-coated diclofenac sodium tablet available on the Saudi market. Here, we assess the quality of reference (R1) and four generic (G1–G4) brands of 50 mg immediate-release diclofenac potassium tablet and of reference (R2) and generic (G5) brands of 100 mg sustained-release diclofenac sodium tablet. Results Weight variation (range as % difference from mean), active substance content (mean (SD) as % difference from label), breaking force [mean (SD)], and friability (as % weight loss) were 95–104% and 99–102%, 100.9% (3.4%) and 105.6 (4.2%), 12.2 (1.3) and 12.9 (1.8) kg, and 0.0014% and 0.0012%, for R1 and R2, respectively. For G1-G5, they were ≤ ± 2%, 98.8% (2.7%) to 109.2% (3.8%), 6.4 (0.6) to 13.3 (1.0) kg, and 0.0007% to 0.0261%, respectively. R1 and G1-G4 disintegrated within 04:50–17:20 min: seconds and released a mean of 89–100% of label active substance content by 60 min in buffer (pH 6.8). R2 and G5 did not disintegrate or dissolve in 0.1 N HCl for 2 h, disintegrated in buffer (pH 6.8) in 01:58–02:15 h: minutes, and fulfilled dissolution criteria (pH 7.5) for both United States Pharmacopoeia test-1 and test-2. Thus all seven brands met pre-specified quality criteria.

scholarly journals Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi
Keyword(s):  
Quality Evaluation ◽  
Diclofenac Sodium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
United States Pharmacopoeia ◽  
Weight Variation ◽  
Tablet Formulations ◽  
Enteric Coated

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.

scholarly journals Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Reem AlSwayeh ◽  
Syed N. Alvi ◽  
Muhammad M. Hammami
Keyword(s):  
Saudi Arabia ◽  
Active Substance ◽  
Immediate Release ◽  
Water Medium ◽  
Breaking Force ◽  
Weight Variation ◽  
Percent Difference ◽  
Stage 1

Abstract Objective To evaluate in-vitro quality of paracetamol 500 mg tablet brands marketed in Saudi Arabia. Results Two reference (R1 and R2) and seven generic (G1-G7) brands were commercially available. Four brands were single-drug, containing paracetamol only (R1, G1-G3) and five contained additional active ingredients (R2, G4-G7). All brands were immediate-release. Weight variation (n = 20, range as percent difference from mean), active substance content (n = 20, mean (SD) as percent difference from label), breaking force (n = 10, mean (SD)), and friability (n = 20, as percent weight loss) ranged from 97 to 102%, 96.1% (2.9%) to 99.8% (1.1%), 9.9 (0.4) to 21.0 (0.9) kg, and 0.017% to 0.809%, respectively. Disintegration (water medium) time (n = 6, minute: second) ranged from 02:35–03:09 to 12:49–13:10. Dissolution (phosphate buffer, pH 5.8) profile showed a mean release at 30 min of 87% to 97% of label content, with seven brands passing stage-1 (≥ 85% for each of 6 test units) and two passing stage-2 (mean of 12 test units ≥ 85%) criteria. Despite statistically significant differences between R1 and R2 and some of their corresponding generic brands in active substance content, breaking force, and amount dissolved at 30 min, all nine brands met the pre-specified quality standards.

scholarly journals Assessment of the pharmaceutical quality of marketed enteric coated pantoprazole sodium sesquihydrate products

2011 ◽  
Vol 19 (2) ◽  
pp. 123-127 ◽  
Author(s):  
Haitham F. Mostafa ◽  
Mohamed A. Ibrahim ◽  
Gamal M. Mahrous ◽  
Adel Sakr
Keyword(s):  
Pharmaceutical Quality ◽  
Enteric Coated

scholarly journals Comparative Evaluation of Some Commercial Clopidogrel Tablets Available in Yemen

2018 ◽  
Vol 13 (2) ◽  
pp. 79
Author(s):  
Bassam Abduh Ali ◽  
Mohammed Gameel Al-haddad ◽  
Abdullah Ahmed Areqi
Keyword(s):  
Quality Parameters ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Variation Range

Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.

Pharmaceutical quality of yarrow (Achillea millefolium L. s.l.) – Investigation of 40 commercial drug samples by means of the bioactive compounds

Planta Medica ◽  
2007 ◽  
Vol 73 (09) ◽  
Author(s):  
B Benedek ◽  
K Rothwangl-Wiltschnigg ◽  
E Rozema ◽  
N Gjoncaj ◽  
G Reznicek ◽  
...  
Keyword(s):  
Bioactive Compounds ◽  
Achillea Millefolium ◽  
Pharmaceutical Quality

An experience of performing spirometry by trained general practitioners

2020 ◽  
pp. 34-36
Author(s):  
M. A. Pokhaznikova ◽  
E. A. Andreeva ◽  
O. Yu. Kuznetsova
Keyword(s):  
General Practitioners ◽  
Quality Criteria ◽  
Poor Quality ◽  
Male Gender ◽  
Study Research ◽  
The Poor ◽  
Quality Of Research ◽  
Forced Expiratory Maneuver ◽  
Maximal Effort

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.

Knowledge, Perceptions and Practices on Modified Release Tablets among Prescribers: A Preliminary Study

2020 ◽  
Vol 01 (01) ◽  
pp. 05-14
Author(s):  
M.G.K.M. Fernando ◽  
K.I.J. Priyadarshi ◽  
L.G.T. Shanika ◽  
N.R. Samaranayake
Keyword(s):  
Online Survey ◽  
Product Information ◽  
Response Rate ◽  
Immediate Release ◽  
State Universities ◽  
Modified Release ◽  
Validated Questionnaire ◽  
Therapeutic Outcomes ◽  
Medical Faculties ◽  
Enteric Coated

Introduction: Modified release tablets (MRTs) are developed to achieve different therapeutic outcomes and are frequently prescribed. This study aims to evaluate the knowledge, perceptions and practices on using MRTs among a selected cohort of prescribers. Methods: A self administered online survey was conducted using a pre-validated questionnaire, prepared in-house to assess knowledge, perceptions and practices on using MRTs, among academics with an MBBS degree in medical faculties of State universities in Sri Lanka. Results: The response rate was 15.5% among 375 prescribers. Most were females (53.4%) and were 46-55 years (29.3%). Over 50% correctly expanded abbreviations related to MRTs. Most defined enteric coated (87.9%) and targeted release (77.6%) forms accurately. However, 87.0% mixed-up definitions of sustained release with controlled release. Most believed that inability to split tablets (70.7%) and high cost (70.7%), as disadvantages of MRTs. Nearly half did not identify the risk of dose dumping (53.5%) and inflexible dosing schedule (44.8%) as disadvantages. For frequency of administering MRTs, 86.2% referred the product information leaflet (PIL) while 29.0% depended on the frequency of the corresponding immediate release tablet. Most (79.3%) prescribed MRTs to increase patient compliance while 12.1% prescribed them to reduce cost. When problems regarding MRTs were encountered, most referred PILs (81.0%) and clarified with experts (75.9%). Conclusions: Although the response rate was low, a clear gap in knowledge, perceptions and practices on using MRTs were identified among prescribers who responded. Interventions are needed to improve the knowledge, perceptions, and practices on using MRTs among prescribers.

THE QUALITY OF PUBLIC HOSPITALS IN CAN THO CITY, 2016

2018 ◽  
Vol 8 (6) ◽  
pp. 76-81
Author(s):  
Chu Cao Minh ◽  
Thang Vo Van ◽  
Dat Nguyen Tan ◽  
Hung Vo Thanh
Keyword(s):  
Hospital Medicine ◽  
Secondary Data ◽  
Quality Criterion ◽  
Quality Criteria ◽  
Public Hospitals ◽  
Ministry Of Health ◽  
Cross Sectional ◽  
Significant Difference ◽  
Can Tho City

Background: The criteria set of assessing hospital quality in Vietnam in 2016 was revied from the criteria set in 2013 by the Ministry of Health in order to help hospitals to self-assess towards improvinge quality of hospitals in the international integration context. The study aimed to assess the quality of public hospitals in Can Tho City according to the revised criteria set of the Ministry of Health in 2016 and compare the quality among three hospital ranks (including grade I, grade II, and grade III) via to 5 groups of quality criteria. Methods: A cross-sectional study, using secondary data analysis was applied to assess the service quality of 7 general public hospitals in Can Tho City. Results: The average total score of 7 hospitals is 245 and the average for the criteria of 7 hospitals is 2.99, which is just satisfactory. In the criterion of quality, criterion D and E had the lowest scores compared to the other three groups. There was no statistically significant difference (p = 0.076) among the mean scores for the three hospital categories. Conclusion: The quality of public hospitals in Can Tho city in 2016 only reached moderately good level (2.99). Interventions should be developed to improve the quality of hospitals, with particular emphasis on improving the quality of criteria groups D and E. Key words: Quality, hospital, medicine, health, public, Can Tho

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