scholarly journals In vitro Comparative Quality Evaluation of Different Brands of Marketed Paracetamol Tablets Available in Bangladesh

2021 ◽  
pp. 26-32
Author(s):  
Mahfuza Rahman ◽  
Khurshida Akter ◽  
Md. Shahin Sarker ◽  
Jinat Fatema Sharna ◽  
Mir Imam Ibne Wahed
Keyword(s):  
Quality Parameters ◽  
Dissolution Time ◽  
Disintegration Time ◽  
Hardness Tester ◽  
Weight Variation ◽  
Retail Outlets ◽  
General Quality ◽  
Almost All

Aim: This study was performed to evaluate the quality of five brands of Paracetamol 500mg tablets from different manufacturers. Methods: The general quality parameters of these tablets like weight variation, hardness, thickness, diameter, friability, disintegration time and also dissolution time were evaluated according to the established protocols. For measuring weight variation, an electric analytical balance was used. The hardness, thickness and diameter were determined by an automated hardness tester. Friability was measured by a friabilator. Disintegration time and dissolution time were analyzed by disintegration apparatus and dissolution tester respectively. Results: In this study, all the five brands of the tablets passed the BP or USP standards for in vitro evaluation tests with a very slight deviation. All brands complied with the standards for weight variation (550.1±5.88 mg to 631.1±4.71 mg), hardness (121.60±6.6 N to 220.20±7.6), disintegration time (3 minutes 15 seconds to 5 minutes 30 seconds). However, in case of friability, although brand A showed slight deviation, the remaining had shown the satisfactory results with the standard. In addition, the drug release rate of different brands of paracetamol was satisfactory within 30 minutes and ranged from 90.88% to 103.75%. Conclusion: It can be concluded that almost all the tablets of paracetamol purchased from retail outlets in Bangladesh are manufactured and marketed according to GMP. Further work is recommended on bioequivalence of these tablets.

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.

Formulation and Evaluation of Orodispersible Tablets Containing Taste Masked Mirabegron Resinate

2021 ◽  
pp. 4736-4742
Author(s):  
Sarika S. Malode ◽  
Milind P. Wagh
Keyword(s):  
Overactive Bladder ◽  
Bitter Taste ◽  
In Vitro Release ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Disintegration Time ◽  
Orodispersible Tablets ◽  
Weight Variation

The objective of present work was to develop taste masked orodispersible tablets of mirabegron. Mirabegron is beta 3 adrenoceptor agonist used to treat overactive bladder. Overactive bladder (OAB) is defined as a symptom syndrome showing feeling of urgency to urinate, typically accompanied by frequent daytime and nocturnal urination, in the absence of proven infection or other obvious pathology. Over active bladders are generally common in geriatrics. Moreover, this drug has a very strong bitter taste. Frequent dosing requires frequent water intake, which further aggregates the condition of over active bladder and bitter taste of drug affects patient compliance. Hence a need arises to mask the bitter taste for development of an ODT which does not require consuming water with every dosage. In this work, the bitter taste of mirabegron was masked by forming a complex with an ion exchange resin tulsion 344. The drug resin complexation process was optimized for resin activation, drug: resin ratio, soaking time and stirring time. In –vitro release studies revealed complete drug elution from the complex within 10 minutes in pH 1.2 buffer. The taste-masked complex was then formulated into palatable orodispersible tablets using a direct compression approach by use of superdisintegrants to achieve a rapid disintegration. The tablets were evaluated for weight variation, hardness, friability, drug content, wetting time, In- vivo disintegration time and in-vitro dissolution time.

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 DEVELOPMENT, FORMULATION AND EVALUATION OF MECLOFENAMATE FAST DISSOLVING TABLETS

2021 ◽  
Vol 10 (1) ◽  
pp. 59-67
Author(s):  
Mahipal Shakkarwal ◽  
Dr. Mukesh Sharma ◽  
Dr. Ram Garg ◽  
Shankar Lal Soni ◽  
Gopal Kumar Paswan ◽  
...  
Keyword(s):  
Drug Release ◽  
Angle Of Repose ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Onset Of Action ◽  
Disintegration Time ◽  
Weight Variation ◽  
Suitable Treatment ◽  
The Stability

The demands for fast dissolving tablets have received ever increasing day by day during the last 10-15 years for the onset of action. In the present study, the effect of superdisintegrant was compared with synthetic super disintegrants and other conventional super disintegrants in the of fast dissolving tablet formulation of Meclofenamate. Meclofenamate is an antihypertensive drug and in case of hypertension immediate treatment is required so the proposed investigation is totally based to provide the suitable treatment for hypertension. In the present work 9 formulations of Fast dissolving tablets of Cilnidipine were prepared by using Synthesized Co-proceed was evaluated and compiles with the official standards, parameters and specifications. Various formulations were prepared using four different superdisintegrant namely- kyron T-304, sodium starch glycolate, cross carmelose sodium with three concentrations (2%, 4%, 6%) by direct compression method. The blend was evaluated for pre-compression parameters like Angle of repose , bulk density , tapped density , and then tablet  evaluated post-compression parameters like thickness , drug content , hardness , weight variation  , wetting time , friability , disintegration time , dissolution time, drug release study. Formulation A8 showed the lowest disintegration time and in-vitro dissolution studies recorded that formulation A8 showed 98.64% drug release at the end of 3 minutes. The best formulations were also found to be stable and optimized formulations were subjected to the stability studies as per ICH guideline and standards.

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 In-vitro study of quality control parameters of three different brands of azithromycin tablets

2017 ◽  
Vol 6 (7) ◽  
pp. 1572
Author(s):  
Rashmi Singh ◽  
Monika Saxena ◽  
Deeksha Sahay ◽  
Sujata Singh
Keyword(s):  
In Vitro Study ◽  
Quality Parameters ◽  
Pharmaceutical Companies ◽  
Dissolution Profile ◽  
Test Procedures ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Standard Value

Background: Azithromycin, being a very important antibiotic, is manufactured by different pharmaceutical companies and available in numerous brands. Therefore, it requires a quantitative evaluation and assessment of tablets chemical, physical and bioavailability properties.Methods: The physicochemical quality pararametrs like weight variation, size, hardness, friability, disintegration time and dissolution profile of three brands of azithromycin tablets were assessed by performing various test procedures according to established methods.Results: The different brands of tablets showed very slight variations in weight and size, not exceeding more than 5% of standard value. Similarly, hardness of all the brands was less than 5kg/f and friability ranged from 0.2 to 0.5%. All the brands tested disintegrated in <6 minutes and all the brands released >75% of the active ingredient within 45 minutes.Conclusions: All the physiochemical quality parameters of three brands of azithromycin tablets were found to be within the pharmacopeial specifications therefore all the brands were pharmaceutically and chemically equivalent and can be freely interchanged.

scholarly journals Formulation and Evaluation of Ketorolac Tromethamine Mouth Dissolving Tablets

2021 ◽  
Vol 11 (1) ◽  
pp. 60-64
Author(s):  
Rishabh Bindal ◽  
Arpna Indurkhya
Keyword(s):  
Ketorolac Tromethamine ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Solid Dosage ◽  
Sodium Starch Glycolate ◽  
Weight Variation ◽  
Croscarmellose Sodium ◽  
Fast Release

Due to more versatility and comfort, mouth dissolving tablets are the most advanced type of oral solid dosage forms. Compared to conventional tablets, it increases the effectiveness of APIs by dissolving within a minute in the oral cavity after contact with less saliva, without chewing and without the need for water for administration. Mouth Dissolving Tablets of Ketorolac tromethamine were prepared by direct compression method using various superdisintegrants like crospovidone, Croscarmellose sodium, and Sodium starch glycolate in different concentrations. Prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time and in vitro drug release. Results of pre-compression and post-compression studies of all formulations were found within the standard limits. The tablets of all the batches were found to release more than 80% of drug in 5 minutes, which is the desired quality of mouth dissolving tablets that helps in faster absorption of the drug and quick onset of therapeutic effect. The the order of dissolution of various disintegrants was found to be Crospovidone˃ SSG˃ CCS. There was no significant variation in drug content of drug during stability studies for selected batch F3 in accelerated conditions over three months. It was concluded from the study that fast release of Ketorolac tromethamine from formulation F3 may reduce onset of drug action with better patient compliance. Keywords: Crospovidone, Croscarmellose sodium, Ketorolac tromethamine, Mouth dissolving tablets, Sodium starch glycolate, superdisintegrants.

scholarly journals In vitro Comparative Quality Evaluation of Formulated and Marketed Losartan Potassium 25 Mg Tablets

2021 ◽  
pp. 239-245
Author(s):  
Md. Emran Hossain ◽  
Sukria Hossain ◽  
Md. Shahin Sarker ◽  
Mst. Mahfuza Rahman ◽  
Mir Imam Ibne Wahed
Keyword(s):  
Quality Control ◽  
Drug Product ◽  
Qualitative Evaluation ◽  
Quality Standard ◽  
Losartan Potassium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation

Background: The outcome of the drug therapy depends largely on the quality of the drug product. The lower quality of the drug product can be the reason for therapeutic failure. The present study was designed to evaluate the quality standard of Losartan Potassium tablet brands available in Bangladesh market to get an idea of quality standard of drug product people consuming in this country. Materials and methods: Three brands of losartan potassium were chosen randomly. Tablets of each brand were collected from individual retail outlets to gauge the qualitative evaluation and compare them by in-vitro drug release study. They were subjected to various quality control tests to measure the hardness, thickness, weight variation, friability, disintegration time, potency, stability, and dissolution profile. All these tests were performed according to the U.S. Pharmacopeia (USP) specification. Researchers further formulated a batch of tablet of Losartan Potassium and compared them with the existing brands. The formulation was prepared by optimizing the existing one available in the USP. Test results of the existing brands were taken into consideration during the optimization of the formulation. Results and discussion: Two brands passed the weight variation test, while one brand exceeded the range (±5%). The potency was determined instantly and 15 days after keeping the tablets in a stability chamber at 75% humidity and 60oC temperature. The potency of two brands degraded below the lower limit specified by the USP, while that of the remaining one was within the limits. Results of other tests were within the specified limits. Tablets prepared in the lab using an optimized formulation showed a better dissolution rate than the existing brands. Conclusion: Some of the brands failed to meet the desired quality, so the quality control system of that companies should be upgraded and a proper monitoring system should be developed by the drug administration.

scholarly journals Formulation development and characterization of fast dissolving tablets of oxcarbazepine

2015 ◽  
Vol 3 (01) ◽  
pp. 11-17
Author(s):  
Krishnamurthy A. Kamalapurkar ◽  
Mahesh P. Chitali ◽  
Revansidh R. Pujari
Keyword(s):  
Anticonvulsant Drug ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Stability Studies ◽  
Formulation Development ◽  
Disintegration Time ◽  
Hot Air ◽  
Weight Variation ◽  
The Stability

The objective of this study was formulation development and evaluation of Oxcarbazepine Fast Dissolving Tablets (FDTs) prepared by sublimation technique where different sublimating agents like camphor and menthol were used with L-HPC and crospovidone as a superdisintegrants. Oxcarbazepine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. Each sublimating agent was used in concentration of 10-20 mg per tablet. Tablets were first prepared and then kept in hot air oven for sublimation. The prepared FDTs were evaluated for weight variation, thickness, drug content, friability, hardness, wetting time, water absorption ratio, in-vitro dispersion time, in-vitro disintegration time and in-vitro dissolution time. All formulations showed disintegration time ranging from 8 to 332sec. Optimized batch (SA6) was selected for the stability studies. The results of stability studies revealed that there was no remarkable difference in the tested parameters of promising formulation after storage for 3 months at 400 c ± 20 c 75% ± 5%RH and at room temperature 65% ± 5%RH as compared to initial results All the prepared formulae complied with Pharmacopoeia requirements of drug contents.

scholarly journals In Vitro Quality Evaluation of Ciprofloxacin Tablets Marketed in Dessie, Ethiopia

2019 ◽  
Vol 9 (5-s) ◽  
pp. 7-10
Author(s):  
Haile Kassahun Desta ◽  
Tekleab Teka Tekelehaimanot
Keyword(s):  
Quality Control ◽  
Disintegration Time ◽  
Weight Variation ◽  
Post Marketing Surveillance ◽  
Quality Control Parameters ◽  
Post Marketing ◽  
Ensure Product Quality ◽  
Pharmacopoeial Specifications

Good quality medicines are a prerequisite for a successful treatment. Post marketing surveillance is very crucial to ensure product quality and eliminating substandard products to be distributed and, consequently, ensure better patient clinical outcome. Hence, this study assesses quality of six brands of ciprofloxacin tablets marketed in Dessie, Ethiopia using in vitro quality control tests. Weight variation test, disintegration test, dissolution test and assay for the content of active ingredients was done according to United sates Pharmacopoeia, 2007. The percentage content of ciprofloxacin tablets were within the range of 90-110% and the disintegration time was found between 2.375- 6.31 minutes. In addition, ciprofloxacin tablets released more than 80% of the drug after 30 minutes. Hence, all brands of ciprofloxacin tablets met the quality control parameters as per United States Pharmacopoeial specifications. Keywords: Ciprofloxacin; Quality; Substandard; Pharmacopoeial specifications

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