In-vitro Comparative Study of Different Brands of Metoclopramide Hydrochloride Tablets Marketed in Saudi Arabia

2020 ◽  
Vol 15 ◽  
Author(s):  
Umme Hani ◽  
Mohammed Rahmatulla ◽  
Ahaya Alhamhoom ◽  
Riyaz Osmani ◽  
Yasmeen Begum
Keyword(s):  
Quality Control ◽  
Saudi Arabia ◽  
Gastrointestinal Disorders ◽  
Gastric Stasis ◽  
Percentage Content ◽  
Weight Variation ◽  
Dissolution Tests ◽  
Metoclopramide Hydrochloride ◽  
Prevention Of Cancer

: Metoclopramide hydrochloride (MCP) a derivative of paraminobenzoic acid, freely soluble drug, rapidly absorbed from the gastrointestinal tract and is used in the management of gastrointestinal disorders such as gastric stasis, gastroesophageal reflux and for the prevention of cancer chemotherapy induced emesis. Many different brands of MCP are available in Saudi Arabia. Objectives: The objective of present study was to evaluate the four brands of MCP 10mg tablets (Premosan, Primperan, Maxolon and Metoclopramide) purchased from the retail pharmacy outlet in Abha, Riyadh and Jeddah, Saudi Arabia to choose the best brand. Methods: The study was done by quality control tests on branded tablets like; weight variation, hardness, friability, hardness, disintegration and dissolution. The results of all marketed products complied with the official specifications. The best brand was chosen depended on the quality control results. Results: The results showed that all parameters MCP tablets are in accordance with the USP limits. All the tested four brands were bioequivalent and complying with the official tests for weight variation, friability, disintegration and dissolution tests. The friability test was within the specified limit. All formulations were disintegrated within 2-6 min. The percentage content of active ingredient of four brands of MCP tablets showed values within the monograph specifications (95-105%). Conclusion: All the four brands evaluated in the present work could be considered bio pharmaceutically equivalent and therefore, patients can safely switch from one brand to another when there is unavailability of particular brand.

scholarly journals Automation of dissolution tests

2003 ◽  
Vol 25 (1) ◽  
pp. 7-15 ◽  
Author(s):  
Rolf Rolli
Keyword(s):  
Quality Control ◽  
In Vitro Dissolution ◽  
Pharmaceutical Companies ◽  
Dissolution Testing ◽  
Simultaneous Operation ◽  
Task Forces ◽  
The Core ◽  
Dissolution Tests ◽  
The 1960S

Dissolution testing of drug formulations was introduced in the 1960s and accepted by health regulatory authorities in the 1970s. Since then, the importance of dissolution has grown rapidly as have the number of tests and demands in quality-control laboratories. Recent research works lead to the development of in-vitro dissolution tests as replacements for human and animal bioequivalence studies. For many years, a lot of time and effort has been invested in automation of dissolution tests. There have been a number of in-house solutions from pharmaceutical companies and many have created task forces or even departments to develop automation. Robotic solutions with sequential operation were introduced as well as the simultaneous operation concept developed by SOTAX. Today, pharmaceutical companies focus their resources mainly on the core business and in-house engineering solutions that are very difficult to justify. Therefore, it is important to know the basic considerations in order to plan an automation concept and implement it together with a vendor.

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.

Fabrication and Evaluation of Mouth Dissolving Strips of Metoclopramide Hydrochloride by Using Novel Film Former

2021 ◽  
pp. 5515-5520
Author(s):  
Hemant A. Deokule ◽  
Smita S. Pimple ◽  
Praveen D. Chaudhari ◽  
Ajit S. Kulkarni
Keyword(s):  
Drug Release ◽  
Research Work ◽  
Systemic Circulation ◽  
In Vitro Dissolution ◽  
Disintegration Time ◽  
Visual Appearance ◽  
Dsc Studies ◽  
Weight Variation ◽  
Metoclopramide Hydrochloride

Fast dissolving strips are used as novel approaches, as it dissolves rapidly in mouth and directly reaches the systemic circulation. In present research work, an attempt has been made to prepare mouth dissolving strips of Metoclopramide hydrochloride by using a novel film former Pullulan by solvent casting method. A33 full factorial design was utilized for the optimization of the effect of independent variables such as the amount of Pullulan, amount of PEF 400, amount of SSG on mechanical properties, and % drug release of strips. The drug compatibility studies using FTIR and DSC studies formulated strips were characterized for their physicochemical parameter like weight variation, visual appearance, folding endurance, thickness, disintegration time, drug content, and in vitro dissolution studies. FTIR and DSC studies revealed that the polymer is compatible with the drug. It was found that the optimum levels of the responses for a fast release strip could be obtained at low levels of Pullulan, PEG400, and SSG. The prepared strip was clear transparent and had a smooth surface. The surface pH was found 4.8 to 5.2 be in the range of to which is close to salivary pH, which indicates that strips may have less potential to irritate the oral mucosa, thereby they are comfortable. The drug release was found to be between 90.94 to 100.5% in 2 min. The in-vitro disintegration time of strips prepared with Pullulan was in the range of 19 to 57 sec. As the concentration of SSG increases the decrease in the disintegration time of strips a decrease. The dissolution rate increased with an increase in the concentration of SSG. Hence, it can be inferred that the fast dissolving oral strips of Metoclopramide hydrochloride may produce rapid action thereby improving bioavailability and enhance the absorption by avoiding the first-pass effect.

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 In-Vitro Comparative Quality Evaluation of Marketed Cefuroxime 250 mg Tablets in Bangladesh

2020 ◽  
pp. 12-15
Keyword(s):  
Quality Control ◽  
Quality Evaluation ◽  
In Vitro Release ◽  
Control Parameters ◽  
Dissolution Tests ◽  
Quality Control Parameters ◽  
Retail Outlets ◽  
Release Study ◽  
Vitro Release

The study evaluated different quality control parameters of five brands of Cefuroxime 250mg tablets which are already marketed in Bangladesh. Five brands of the drug sourced from different retail outlets to assess the quality assessment and comparison of the tablets using the in-vitro release study. The brands were subjected to various official tests including uniformity of weight, thickness test, dissolution tests, and cumulative % of drug release and friability test. This research further focuses on the requirement of manufacturers to construct quality into their products during manufacture and also sustain the built-in quality from batch to batch in line with the principles of cGMP.

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.

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.

In vitro quality evaluation of generic ciprofloxacin tablets available in community pharmacies of Dessie town, Northeast Ethiopia

2020 ◽  
pp. 174113432092192
Author(s):  
Haile K Desta ◽  
Tekleab T Teklehaimanot
Keyword(s):  
United States ◽  
Quality Control ◽  
The United States ◽  
Disintegration Time ◽  
Ciprofloxacin Hydrochloride ◽  
Northeast Ethiopia ◽  
Weight Variation ◽  
Substandard Medicines ◽  
Post Marketing Surveillance

The introduction of generic drug products from multiple sources into the health care system of many developing countries may lead to spread of substandard medicines. Post marketing surveillance is very crucial to ensure product quality and eliminate substandard medicines and consequently, ensure better patient clinical outcome. Hence, the aim of the present work was to assess the quality of six generic ciprofloxacin hydrochloride 500 mg tablets available in Dessie town, Northeast Ethiopia using in vitro quality control tests. Weight variation test, disintegration test, dissolution test and assay for the content of active ingredients were done as per the United States pharmacopoeia. All generic ciprofloxacin hydrochloride tablets were evaluated for conformity with United States Pharmacopoeial standards.The results of weight variation test indicated that all samples were complied with United States Pharmacopoeial specifications.The percentage content of generic ciprofloxacin tablets was within the range of 90–110% and the disintegration time was found between 2.375 and 6.31 min. In addition, generic ciprofloxacin tablets released more than 80% of the drug in 30 min. Hence, all generic ciprofloxacin tablets met the quality control parameters as per the United States pharmacopoeial specifications.

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.

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

Sign in / Sign up

Export Citation Format

Share Document