Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets

2021 ◽  
pp. 255-258
Author(s):  
Bhavana Habib ◽  
Jyoti Mittha
Keyword(s):  
Quality Control ◽  
Quality Evaluation ◽  
Indian Market ◽  
Disintegration Time ◽  
Innovator Product ◽  
Drug Content ◽  
Weight Variation ◽  
Generic Products

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

scholarly journals QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ

2022 ◽  
pp. 221-225
Author(s):  
MAZIN THAMIR ABDUL-HASAN ◽  
ABULFADHEL JABER NEAMAH Al-SHAIBANI ◽  
ALI N. WANNAS ◽  
KARRAR MOHAMMED HASAN AL-GBURI
Keyword(s):  
Quality Control ◽  
In Vitro Release ◽  
Gastric Fluid ◽  
Disintegration Time ◽  
Drug Content ◽  
Clopidogrel Bisulfate ◽  
Weight Variation ◽  
Release Study ◽  
Vitro Release

Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.

Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine

2015 ◽  
Vol 8 (2) ◽  
pp. 2881-2888
Author(s):  
Sudarshan Singh ◽  
S S Shyale ◽  
P Karade
Keyword(s):  
Drug Release ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Disintegration Time ◽  
Orally Disintegrating Tablet ◽  
Drug Content ◽  
Weight Variation ◽  
Wetting Time ◽  
Croscarmellose Sodium

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.

scholarly journals An Efficient Herbal Approach for Treating Fungal Infection in Cervical Cancer Patients by Developing and Optimizing a Vaginal Suppository

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Mohammed Ghazwani ◽  
Umme Hani ◽  
Riyaz Ali M. Osmani ◽  
Mohamed Rahamathulla ◽  
M. Yasmin Begum ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Side Effects ◽  
Drug Release ◽  
Cancer Patients ◽  
Poloxamer 407 ◽  
Vaginal Candidiasis ◽  
Disintegration Time ◽  
Drug Content ◽  
Vaginal Suppository ◽  
Weight Variation

Aim. The study is aimed at developing curcumin suppositories as a promising approach for natural antifungal management of vaginal candidiasis in cervical cancer patients to eradicate side effects produced by current antifungal drugs. The objective of the study was to optimize the suppositories using optimal (custom) design employing Design-Expert 13 software to recognize the concentration of polyethylene glycols (PEG) and Poloxamer 407 and obtain a stable suppository. Methodology. Combinations of PEG 1500 (10%–40%), PEG 6000 (40%–60%), and Poloxamer 407 (5%–30%) were entered as factors, and the responses evaluated were hardness, deformation time, and % drug release. In addition, the formulation was also evaluated for visual examination, weight variation, pH determination, drug content, hardness test, disintegration time, melting zone, deformation time, in vitro drug release, antifungal activity, and stability tests. Results. Suppositories were devoid of holes and cracks, with a characteristic odor and a dark yellowish-orange color. All formulations passed the weight variation test. Formulations exhibited pH ranging from 5.5 to 6.5. Drug content was observed to be 98.65 ± 0.041 % – 99.85 ± 0.041 % . The hardness of the formulation was between 2.9 and 4.2 kg/cm2. The disintegration time ranged from 11 ± 0.052   min to 20 ± 0.011   min . The melting point was between 41 ± 0 . 31 ° C and 58 ± 0 . 62 ° C . Deformation time ranged from 10 ± 0.45 to 35 ± 0.52   min . Most of the formulations resulted in 90% of drug release at 40 min, and the zone of inhibition noted was 19.6 ± 0.4   mm . All the selected factors have a significant effect on the response chosen for the study. Conclusion. The optimized curcumin vaginal suppository formulation can be an efficient herbal treatment devoid of side effects to treat vaginal candidiasis in cervical cancer patients.

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 In-vitro comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh

2012 ◽  
Vol 1 (5) ◽  
pp. 103-109 ◽  
Author(s):  
Palash Karmakar ◽  
Md Golam Kibria
Keyword(s):  
Quality Control ◽  
Pharmaceutical Journal ◽  
Dissolution Profile ◽  
Control Parameters ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Standard Quality ◽  
Tablet Hardness

Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile between the commercially available tablet brands of paraceta-mol and paracetamol/caffeine combination in Bangladesh. Tablets of five top level manufacturers those have both of the formulations were evaluated in two groups. Both similarities and dissimilarities were found between the groups. All tablets either paracetamol (1.07 to 2.14%) or paracetamol/caffeine (0.98 to 2.09%) showed acceptable weight variation and friability (below 1%). Formulations were somewhat different in their hardness, disintegration time and dissolution profile. All tablets of paracetamol/caffeine were found harder than paracetamol tablets of the same manufacturer. 1 out of 5 for paracetamol and 3 out of 5 for paracetamol/caffeine tablets exceeded the limit of tablet hardness or crushing strength. The disintegration time in 0.1N HCl of paracetamol tablet brands (24 seconds to 4 minutes 52 seconds) were less than the paracetamol/caffeine (6 minutes 33 seconds to 17 minutes 43 seconds) brands. On the other hand in phosphate buffer, pH 7.4, paracetamol/caffeine tablets dissolved quickly and showed better release profile than tablets containing only paracetamol. It can be concluded that standard quality control parameters always should be maintained not only for paracetamol or its combination but also for all kinds of medicine for getting better drug products.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10282International Current Pharmaceutical Journal 2012, 1(5): 103-109

scholarly journals Formulation design, optimization & in vitro evaluation of novel orodissolving tablets of efavirenz for hiv infections

2015 ◽  
Vol 49 (3) ◽  
pp. 173-180
Author(s):  
T Ayyappan ◽  
C Poojitha ◽  
T Vetrichelvan
Keyword(s):  
Drug Release ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Sodium Starch Glycolate ◽  
Weight Variation ◽  
Wetting Time

In the present work, orodissolving tablets of Efavirenz were prepared by direct compression method with a view to enhance patient compliance. A 23 full factorial design was applied to investigate the combined effect of three formulation variables. Amount of crospovidone, croscarmellose sodium and sodium starch glycolate were used as superdisintegrant material along with direct compressible mannitol to enhance mouth feel. The prepared batches of tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time, drug content and in-vitro dissolution studies. Based on wetting time, disintegration time, the formulation containing crospovidone (5% w/v), carscarmellose sodium (5% w/v) and sodium starch glycolate (8% w/v) was found to be promising and tested for in-vitro drug release pattern (in 0.1 N HCl), short term stability and drug- superdisintegrants interaction. Surface response plots are presented to graphically represent the effect of independent variables (conc. of superdisintegrants) on the in-vitro dissolution time. The validity of the generated mathematical model was tested by preparing extra-design check point formulation. The formulation showed nearly faster drug release compared to the conventional commercial tablet formulation. Stability studies on the optimized formulation indicated that there was no significant change found in physical appearance, hardness, disintegration time, drug content and in-vitro drug release. DOI: http://dx.doi.org/10.3329/bjsir.v49i3.22131 Bangladesh J. Sci. Ind. Res. 49(3), 173-180, 2014

scholarly journals DESIGN, DEVELOPMENT AND EVALUATION OF MOUTH DISSOLVING TABLETS OF TOFACITINIB CITRATE

2022 ◽  
pp. 238-245
Author(s):  
MEGHANA RAYKAR ◽  
MALARKODI VELRAJ
Keyword(s):  
Drug Release ◽  
Stability Study ◽  
In Vitro Dissolution ◽  
Design Development ◽  
Disintegration Time ◽  
Drug Content ◽  
Weight Variation ◽  
Wetting Time ◽  
Bulk Drug

Objective: This study aims to Formulate Mouth Dissolving Tablets (MDTs) of Tofacitinib Citrate with the increase in bioavailability and patient compliance. Methods: Mouth Dissolving Tablets (MDTs) of Tofacitinib Citrate were developed by full factorial design at 32levelsand prepared by direct compression method using super integrants like sodium starch glycolate, Ludiflash. The tablets were compressed into compacts on a 10 station tablet machine. The bulk drug was characterised by determining, MP, Solubility, pH and FTIR spectra. Results: The weight variation, hardness and diameter, thickness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies, and stability study, tablet thickness, weight variation and drug content post compression parameters remained consistent and reproducible. All the formulations showed, almost 100 percent of drug release within 75 min. Formulations F1, F2 and F3 were prepared with 5 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F1<F2<F3. Formulations F4, F5 and F6 were prepared with 10 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F4<F5<F6. Formulations F7, F8 and F9 were prepared with 15 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F7<F8<F9. Conclusion: It is concluded that the amount of superdisintegrants decreases disintegration time of tablets, decreases wetting time, increases the cumulative % drug release causes better absorption.

scholarly journals Quality Attributes Comparison of Selected Brands of Rosuvastatin Calcium Tablets Marketed in the US and Bangladesh

2021 ◽  
pp. 46-55
Author(s):  
Shahrin Tasnim Monisha ◽  
Kamrun Nahar Ela ◽  
Rabeya Islam ◽  
Sadia Afruz Ether ◽  
Fahad Imtiaz Rahman
Keyword(s):  
United States Pharmacopeia ◽  
Disintegration Time ◽  
Weight Variation ◽  
The Us ◽  
Generic Products ◽  
Chemical Attributes ◽  
Physical And Chemical ◽  
States Pharmacopeia ◽  
Rosuvastatin Calcium

Aims: This study investigated whether locally marketed rosuvastatin calcium tablets in Bangladesh have comparable physical and chemical attributes, including in vitro bioequivalence profiles, to the proprietary brand. Methodology: Nine generic products (G1-G9) containing 10 mg of rosuvastatin calcium were compared to the proprietary brand Crestor® (R1) and an FDA approved generic rosuvastatin calcium tablet (R2). Weight variation, diameter, thickness, friability, drug content, disintegration time and dissolution profiles were tested according to United States Pharmacopeia (USP) guidelines. In vitro bioequivalence requirements were assessed by calculating difference (f1) and similarity (f2) factors. Results: The generic products complied with the pharmacopeial requirements for weight variation, disintegration time and friability. All the tablets had drug ranging between 92%-105% and released more than 80% of rosuvastatin within first 15-30 minutes. However, for brands G5, G7 and G8 the f1 values were 15.7%, 15.82% and 25.21% respectively and their f2 values were 41.8, 41.6 and 32.6 respectively whereas for G9 the f2 value was 43.4. These brands have thus failed to meet in vitro bioequivalence requirements. Conclusion: We conclude that few substandard generics of rosuvastatin calcium has somehow found its way to the market and further studies are required to ascertain their noncompliance.

scholarly journals Formulation and Evaluation of Fast Dissolving Film of Losartan Potassium

2021 ◽  
Vol 68 (1) ◽  
Author(s):  
Bhageerathy A ◽  
Sandhya Murali ◽  
eny Sara Thomas ◽  
Sigi Vasanthkumar ◽  
Prasanth V V
Keyword(s):  
Drug Release ◽  
Physical Stability ◽  
Losartan Potassium ◽  
In Vivo Studies ◽  
Disintegration Time ◽  
Drug Content ◽  
Weight Variation ◽  
Significant Difference

A total of nine formulations of fast dissolving films of Losartan Potassium were developed by solvent casting method using film forming polymers such as HPMC E5, E15 and E50 and other film modifiers. The appearances of films were transparent, thin, flexible, elastic, smooth and transparent. The weight variation ranged between 16.14 ± 0.192 and 17.31 ± 0.313 and showed that there was no significant difference in the weight of individual formulations. All the formulations showed more than 150 of folding endurance. The drug content was found to be in an acceptable range for all the formulations which indicated uniform distribution of drug. A rapid dissolution of all the film was observed by the dissolution test, in which above 90% of Losartan Potassium was released within 5 min. The formulation F1 showed maximum drug release (98.73) within 5 minutes. Based on the in vitro drug release, drug content and in vitro disintegration time it is found that F1 was selected as the best formulation. The formulations showed satisfactory physical stability at 40°C at 75 % RH. Losartan Potassium (LOSAR-25) is shown in Figure 4. From the results of comparative studies of marketed product and it found that F1 showed 98.73% release within 5 min and LOSAR 25 showed 90.76% release in 30 min. In vitro studies indicate that this potential drug delivery system has considerably good stability and release profile. Nevertheless, further in vivo studies are warranted to confirm these results.

scholarly journals COMPARATIVE STUDY OF SEVEN BRANDS OF LEVOFLOXACIN 500 MG FILM-COATED TABLET MARKETED IN YEMEN

2021 ◽  
pp. 264-268
Author(s):  
GAMIL Q. OTHMAN ◽  
YASER M. AL-WORAFI ◽  
MOHAMMED M. BATTAH ◽  
ABDULSALAM M. HALBOUP ◽  
HASSAN M. HASSAN
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Hardness Test ◽  
The United States ◽  
Content Uniformity ◽  
Disintegration Time ◽  
Optimum Range ◽  
Weight Variation ◽  
Coated Tablet

Objective: The objective of the current study was to evaluate the quality control parameters of seven brands of levofloxacin 500 mg film-coated tablet available in the Yemeni market. Methods: Physicochemical parameters assay was performed for seven brands of levofloxacin 500 mg film-coated tablet. Each brand was subjected to official and unofficial in vitro quality control tests, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity assay by High-Performance Liquid Chromatography (HPLC). Results: Out of seven, six brands of levofloxacin 500 mg film-coated tablet passed official specified assay tests according to the United States Pharmacopeia (USP) specifications. They showed a similar profile of thickness ranged between±0.01 and 0.10%, friability ranged between 0.01% and 0.34%, disintegration time ranged between 3.00 and 15.00 min, dissolution percentage ranged between 90.650 and 103.05 and content uniformity ranged between 93.62 and 107.12%. Regarding weight variation and hardness, six brands passed the weight variation test and only three brands showed optimum range (10-20 kg) of hardness test. Only one brand failed to pass the weight variation test, and four brands failed to pass the optimum range (10-20 kg) of hardness. Conclusion: There are no remarkable differences between the seven brands regarding in vitro quality control tests of content uniformity, thickness, friability, disintegration, and dissolution. Even though four brands were above the optimum range of hardiness, they showed complete disintegration and dissolution within the acceptable limit. Regular assessment of marketed drugs is required to ensure bioequivalent to their innovators.

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