scholarly journals Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia

2020 ◽  
Author(s):  
Brhane Gebrehiwot Welegebrial ◽  
Getu Kahsay ◽  
Tadele Eticha ◽  
Hailekiros Gebretsadik
Keyword(s):  
Quality Evaluation ◽  
The United States ◽  
Pharmaceutical Products ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Drug Content ◽  
Significant Difference ◽  
Required Quality

Abstract Objective: Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed. Results: All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dissolution and amount of drug content among the tested samples. Thus, from this study we can conclude that all the products fulfilled the required quality evaluation parameters as stipulated in pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profile indicated that there may be a potential bio-in equivalence among the pharmaceutical products.

scholarly journals Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia

2020 ◽  
Author(s):  
Brhane Gebrehiwot Welegebrial ◽  
Getu Kahsay ◽  
Tadele Eticha ◽  
Hailekiros Gebretsadik
Keyword(s):  
Quality Evaluation ◽  
The United States ◽  
Pharmaceutical Products ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Drug Content ◽  
Significant Difference ◽  
Objective Quality

Abstract Objective Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed.Results All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dissolution and amount of drug content among the tested samples. Thus, from this study we can conclude that all the products fulfilled the required quality evaluation parameters as stipulated in pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profile indicated that there may be a potential bio-in equivalence among the pharmaceutical products.

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 Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

2019 ◽  
Author(s):  
Selass Kebede ◽  
Habtamu Abuye ◽  
Woldemichael Abraham ◽  
Sultan Suleman ◽  
Sileshi Belew
Keyword(s):  
Addis Ababa ◽  
Poor Quality ◽  
Content Uniformity ◽  
Dissolution Profile ◽  
Significant Difference ◽  
Physicochemical Evaluation ◽  
Model Independent ◽  
National Systems

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.

scholarly journals In vitro proportional investigation of different Pantoprazole sodium brands of gastro-resistant tablets

2020 ◽  
Vol 48 (1) ◽  
Author(s):  
Hindustan Abdul Ahad ◽  
◽  
Chinthaginjala Haranath ◽  
Rahul Raghav Dasari ◽  
Madana Gowthami ◽  
...  
Keyword(s):  
Weight Change ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Disintegration Time ◽  
Drug Content ◽  
Profile Study

The present work is a comparative exploration of some of the physicochemical possessions like weight change, thickness, diameter, hardness, disintegration time, in vitro drug discharge, and analysis studies of various commercially available Pantoprazole sodium tablets (PST) containing 40 mg of drug. The hardness, loss on friability, dissolution test, disintegration test, and uniformity of drug content were evaluated. All the brands meet the requirements as per the pharmacopoeial standards. The dissolution profile study revealed that PST-1 was faster, while PST-2 was slower. The dissolution information was kinetically treated.

scholarly journals Physicochemical Quality of Metformin Hydrochloride tablet Brands available in Jimma Town, South west, Ethiopia

2021 ◽  
Author(s):  
Yimer Mekonnen ◽  
Anbessa Bekele ◽  
Sultan Suleiman ◽  
Belachew Umeta Chali
Keyword(s):  
Single Point ◽  
The United States ◽  
Metformin Hydrochloride ◽  
Dissolution Test ◽  
Weight Variation ◽  
Significant Difference ◽  
Model Independent ◽  
Dissolution Efficiency ◽  
Jimma Town

Abstract Introduction: Metformin hydrochloride, classified under the class of biguanide, is an oral anti-diabetic agent used in type 2 diabetes mellitus patients. According to the biopharmaceutical classification system, metformin is classified as a Class III drug. This study aims to compare the quality of metformin hydrochloride 500 mg tablets available in Jimma town.Methods: The physical characteristic, packaging and labeling information of samples were evaluated according to the WHO guideline. In-vitro tests such as weight variation, friability, dissolution rate, and assay were performed on six brands of metformin hydrochloride tablets available in Jimma town following method outlined in USP. Experimental data were analyzed using SPSS- 20 and one-way ANOVA. To compare the dissolution profiles of the generic products with innovator product, a model-independent approach, similarity factor (f2), difference factor (f1) and dissolution efficiency (DE) were used.Results: All the tested brands were in line with the WHO specifications for physical characteristics, packaging and labeling of pharmaceuticals. Insumet had percent weight deviation more than 5% and failed to comply with the USP specification for uniformity of weight. Statistically, all brands had significant difference in their mean weight variation (P<0.001). The assay results range from 95.21% to 99.61% showing that all the brands met the USP requirement. Moreover, a single point dissolution test results of the brands ranged from 85.4% to 96.7% showing compliance to USP specification. Conclusion: No brand showed any sign of counterfeit and only Insumet failed to comply with the USP specification for weight variation test. All brands complied with the United States Pharmacopeia specification for the friability, assay and single point dissolution test. Furthermore, the model-independent approach and dissolution efficiency revealed that all the brands were interchangeable with the comparator product.

In vitro evaluation of the quality of essential drugs on the Tanzanian market

2020 ◽  
Author(s):  
Lungwani Muungo
Keyword(s):  
Acetylsalicylic Acid ◽  
The United States ◽  
Tolerance Limits ◽  
Drug Content ◽  
Essential Drugs ◽  
In Vitro Availability ◽  
Tropical Conditions ◽  
Sulphadoxine Pyrimethamine

We evaluated the in vitro availability and its stability under simulated tropical conditions of variousformulations of four essential drugs marketed in Tanzania. We obtained 22 formulations (containingparacetamol, acetylsalicylic acid, chloroquine or sulphadoxine/pyrimethamine) from wholesalepharmacies in Dar es Salaam and the Medical Stores Department (Tanzania). The drug content, in vitroavailability (dissolution) and its stability under simulated tropical conditions were determined usingmethods specified in the United States Pharmacopoeia (USP) 24 monograph of the respective drugs. Allformulations passed the pharmacopoeia requirements for the drug content. However, sevenformulations (three acetylsalicylic acid, two sulphadoxine/pyrimethamine and two paracetamol) failedto meet the USP 24 tolerance limits for dissolution. Another five formulations (three paracetamol andtwo chloroquine) failed to meet the dissolution tolerance limits after being subjected to an acceleratedstability test under simulated tropical conditions (75% RH/40 ?C) for 6 months. The study hasdemonstrated the presence on the Tanzanian market of essential drug formulations that met potencyrequirements and yet had unsatisfactory in vitro availability as they were not robust enough to withstandstorage under simulated tropical conditions.

scholarly journals Improved Antioxidant Capacity of Black Tea Waste Utilizing PlantCrystals

Molecules ◽  
2021 ◽  
Vol 26 (3) ◽  
pp. 592 ◽  
Author(s):  
Abraham M. Abraham ◽  
Reem M. Alnemari ◽  
Jana Brüßler ◽  
Cornelia M. Keck
Keyword(s):  
Antioxidant Capacity ◽  
Aqueous Media ◽  
Natural Antioxidants ◽  
Black Tea ◽  
Pharmaceutical Products ◽  
Small Scale ◽  
Alternative Source ◽  
Significant Difference ◽  
Plant Waste

Antioxidants are recommended to prevent and treat oxidative stress diseases. Plants are a balanced source of natural antioxidants, but the poor solubility of plant active molecules in aqueous media can be a problem for the formulation of pharmaceutical products. The potential of PlantCrystal technology is known to improve the extraction efficacy and antioxidant capacity (AOC) of different plants. However, it is not yet proved for plant waste. Black tea (BT) infusion is consumed worldwide and thus a huge amount of waste occurs as a result. Therefore, BT waste was recycled into PlantCrystals using small-scale bead milling. Their characteristics were compared with the bulk-materials and tea infusion, including particle size and antioxidant capacity (AOC) in-vitro. Waste PlantCrystals possessed a size of about 280 nm. Their AOC increased with decreasing size according to the DPPH (1,1-diphenyl-2-picrylhydrazyl) and ORAC (oxygen radical absorbance capacity) assays. The AOC of the waste increased about nine-fold upon nanonization, leading to a significantly higher AOC than the bulk-waste and showed no significant difference to the infusion and the used standard according to DPPH assay. Based on the results, it is confirmed that the PlantCrystal technology represents a natural, cost-effective plant-waste recycling method and presents an alternative source of antioxidant phenolic compounds.

scholarly journals Quality evaluation of minoxidil topical solutions obtained from magistral pharmacies

2019 ◽  
Vol 3 (2) ◽  
pp. 30-35
Author(s):  
Karen N. Dartora ◽  
Paula C. Bona ◽  
Francielli L. Dos Santos ◽  
Paula Bianchetti ◽  
Renata Vidor Contri
Keyword(s):  
Statistical Difference ◽  
Quality Evaluation ◽  
Quality Parameters ◽  
Centrifuge Test ◽  
Test Drug ◽  
Organoleptic Properties ◽  
Industrial Sample ◽  
Drug Content ◽  
Ph Values

The objective of this study was to evaluate quality parameters of magistral topical solutions containing minoxidil (A, B and C), comparing the results with the ones obtained for the industrial formulation. Organoleptic tests, evaluation of the pH and density, centrifuge test, drug content determination, comparison of indicated dosages and in vitro follicular penetration of minoxidil were performed. Regarding the organoleptic properties, differences in color and viscosity were observed between the magistral (composed of minoxidil sulfate) and the industrial formulations (composed of minoxidil base). For pH values, the magistral solutions presented considerably more acidic pH, compared to the industrial sample. For the density test, the samples with the highest ethanol percentages (B and C) presented lower density. In the centrifuge test, none of the samples showed changes. Considering the drug content test, only the industrial sample and the magistral sample C showed drug percentage within the expected (90-110%), indicating lack of correction factor determination by the magistral pharmacies. Furthermore, it was observed that the dosage indicated by the magistral pharmacies do not correspond to the dose indicated by the industry, being significantly lower. All topical solutions tested presented hair follicle penetration of minoxildil, without statistical difference. The results indicate that there is a failure in the magistral pharmacies regarding the production and the indication of dosage of minoxidil topical solutions.

scholarly journals FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLET OF LORNOXICAM BY DIRECT COMPRESSION METHOD

2021 ◽  
Vol 10 (5) ◽  
pp. 131-136
Author(s):  
Asim pasha ◽  
C N Somashekhar
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Matrix Tablets ◽  
In Vitro Dissolution ◽  
Prolonged Release ◽  
Matrix Tablet ◽  
Direct Compression ◽  
Dissolution Profile ◽  
Drug Content

The aim of the present work was to develop sustained release Lornoxicam matrix tablets with polymers like HPMC K15M, Ethyl cellulose, and Crospovidone as carriers in varying quantities. Direct compression was used to make matrix tablets. Various assessment parameters, such as hardness, friability, thickness, percent drug content, weight variation, and so on, were applied to the prepared formulations. In vitro dissolution studies were carried out for 24 hrs. The tablets were subjected to in-vitro drug release in (pH 1.2) for first 2 hrs. Then followed by (pH 6.8) phosphate buffer for next 22 hrs. And the results showed that among the six formulations FL3 showed good dissolution profile to control the drug release respectively. The drug and polymer compatibility were tested using FT-IR spectroscopy, which revealed that the drug was compatible with all polymers. It is also required to design an appropriate prolonged release formulation for Lornoxicam in order to maintain the drug's release. Hence by using the compatible polymers sustained release tablets were formulated and subjected for various types of evaluation parameters like friability, hardness, drug content and dissolution behaviour. Finally, the findings reveal that the prepared sustained release matrix tablets of lornoxicam have improved efficacy and patient compliance.

EFFECT OF DRUG TO B-CYCLODEXTRIN RATIO AND METHOD OF COMPLEXATION IN THE DEVELOPMENT OF B-CYCLODEXTRIN INCLUSION COMPLEX OF OFLOXACIN

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (12) ◽  
pp. 34-40
Author(s):  
M Panchpuri ◽  
◽  
D Singh ◽  
A Semalty ◽  
M. Semalty
Keyword(s):  
Inclusion Complex ◽  
In Vitro Dissolution ◽  
Molar Ratio ◽  
Dissolution Profile ◽  
Scanning Calorimetry ◽  
Dissolution Study ◽  
Drug Content ◽  
Kneading Method ◽  
Made In

Ofloxacin, a second generation fluoroquinolone, shows poor aqueous solubility and dissolution profile. Thus, ofloxacin–β-cyclodextrin complexes were prepared to improve its dissolution by imparting an environment of improved hydrophilicity. Ofloxacin was complexed with β-cyclodextrin (in 1:1 and 1:2 molar ratio) by two different methods namely, solvent evaporation and kneading method. These inclusion complexes were evaluated for solubility, drug content, scanning electron microscopy (SEM), differential scanning calorimetry (DSC), X ray powder diffraction (XRPD) and in vitro dissolution study. The highest drug content (35.45%) was found in complex made by kneading method (OK1:1) in 1:1 molar ratio. All the complexes OSE1:1, OSE1:2, OK1:1, OK1:2 were found to be showing rough and porous surface morphology in SEM. Solubility as well as the dissolution of the complexes was found to be improved. Complex prepared by kneading method in 1:1 molar ratio (OK1:1) showed a marked improvement in percent drug release (88.94%) than that of pure drug (54.22%) at the end of 1 hour in dissolution study. FTIR, DSC and XRPD data confirmed the formation of inclusion complex. It was concluded that the complex made in 1:1 molar ratio (irrespective of the method) showed better solubility and dissolution profile as compared to complex made in 1:2 molar ratio.

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