scholarly journals QUALITY ASSESSMENT OF DIFFERENT BRANDS OF PARACETAMOL TABLETS IN YEMENI MARKET

2018 ◽  
Author(s):  
Abdulmajed Alsaifi ◽  
Ali Alyahawi
Keyword(s):  
Quality Control ◽  
Dosage Forms ◽  
In Vitro Tests ◽  
Dissolution Test ◽  
Active Metabolites ◽  
Disintegration Time ◽  
Over The Counter ◽  
Health Practitioners

Paracetamol or acetaminophen is active metabolites of phenacitin. It is a widely used over-the-counter analgesic and antipyretic. Chemically, it is 4-hydroxy acetanilide (acetaminophen). Paracetamol is approved for reducing fever in people of all ages. It is commonly used for the relief of headaches, other minor aches and pains, and is a major ingredient in numerous cold and flu remedies. Many different brands and dosage forms of paracetamol are available in Yemeni market that places health practitioners in a dilemma of drug substitution in case of non-availability of a particular brand. The aim of the present study was to evaluate the quality control of four brands of paracetamol tablets (500 mg) marketed and commonly prescribed in Yemeni market. The results and findings of the present study will be interpreted and discussed. Four brands of paracetamol tablets (500 mg) were purchased from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests according to USP and BP standards and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of uniformity of weight, hardens, friability, disintegration time, dissolution test as well as assay content by UV spectrophotometric method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but all  products were satisfactory for hardness. The results indicated that the overall quality of all tested paracetamol tablets brands was satisfactory as they met the requirements of the official and unofficial quality control tests.  

scholarly journals QUALITY CONTROL ASSESSMENT OF DIFFERENT BRANDS OF CIPROFLOXACIN 500 MG TABLETS IN YEMEN

2018 ◽  
Author(s):  
Ali Alyahawi ◽  
Abdulmajed Alsaifi
Keyword(s):  
Quality Control ◽  
In Vitro Tests ◽  
Disintegration Time ◽  
British Pharmacopoeia ◽  
Ciprofloxacin Hydrochloride ◽  
Wide Range ◽  
Health Practitioners ◽  
Systemic Infections

Ciprofloxacin is a fluorinated 4-quinolone or fluoroquinolone antibacterial with a wider spectrum of activity than nalidixic acid and more favorable pharmacokinetics allowing its use in systemic infections.  It  has  been  used  in  the  treatment  of  a  wide  range  of infections. Many  different  brands  and  dosage  forms  of  Ciprofloxacin hydrochloride are  available  in  the  Sana'a market  that  places  health practitioners  in  a  dilemma  of  drug  substitution  in case  of  non-availability  of  a  particular brand. The aim of the present study was to evaluate the quality control of five brands of Ciprofloxacin hydrochloride tablets marketed and commonly prescribed in Sana'a city. The results and findings of the present study will be interpreted and discussed. Five brands of Ciprofloxacin hydrochloride tablets (500 mg) were purchased from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests as per the British Pharmacopoeia (BP) and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of uniformity of weight, friability, hardens, disintegration time, dissolution test and assay content by UV spectrophotometric method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but the all products were satisfactory for hardness. The results indicated that the overall quality of all tested Ciprofloxacin hydrochloride tablets brands was satisfactory as they met the requirements of the official and unofficial quality control tests. 

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 The In-vitro studies and evaluation of telmisartan marketed tablets

2019 ◽  
Vol 9 (1) ◽  
pp. 74-78
Author(s):  
Jayendra Singh Bayas ◽  
Rameshwar Sanjabrao Cheke ◽  
Prachi Lokhande ◽  
Santosh Waghmare ◽  
Shivshankar Gunjegaonkar ◽  
...  
Keyword(s):  
Effective Means ◽  
Systemic Circulation ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Local Market ◽  
Dissolution Test ◽  
Disintegration Time ◽  
Weight Variation ◽  
Tablet Properties

Tablets or capsules taken orally remain one of the most effective means of treatment available. The effectiveness of such dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the systemic circulation. The present study reveals the evaluation of four marketed sample of Telmisartan tablets. The main aim of the study is to conduct dissolution test on the tablets to determine the compliance with a given official monograph. Four different marketed samples of Telmisartan were purchased from local market. The Telmisartan tablets were evaluated for the various in-vitro tablet properties such as thickness, hardness, friability, weight variation, drug content, disintegration time and dissolution rate. In-vitro dissolution test is conducted on four different brands of telmisartan tablets to assess their equivalency. All the four marketed samples of Telmisartan have shown good tablet properties and comply with the pharmacopoeial specification. The in- vitro dissolution showed the 80% drug release within one hour from all the four brands which complies with the specification of pharmacopoeia.

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

scholarly journals IN VITRO ASSESSMENT OF PHYSICOCHEMICAL PARAMETERS OF FIVE GENERICS AMLODIPINE BESYLATE TABLETS MARKETED IN YEMEN

2021 ◽  
pp. 15-19
Author(s):  
ARWA ALSHARGABI
Keyword(s):  
Physicochemical Parameters ◽  
Dissolution Test ◽  
Amlodipine Besylate ◽  
Disintegration Time ◽  
Physiochemical Parameters ◽  
Weight Variation ◽  
Label Claim ◽  
In Vitro Assessment

Objective: The present paper aims to evaluate the quality of five different brands (local and imported) of oral film-coated tablets of generic Amlodipine besylate 5 mg marketed in Sana`a-Yemen, through physiochemical parameters. Methods: Different physicochemical parameters, including the uniformity of tablet weight, hardness, thickness, disintegration time, and an assay of active ingredients, were conducted to validate the quality of generics Amlodipine Besylate 5 mg according to USP specification. Results: From the obtained results, it was observed that all the brands of Amlodipine Besylate 5 mg have passed the tests and met the specifications of USP. Results of weight variation, hardness, thickness, and disintegration time were ranged from-3.8 % to+5.13 % to-1.25 % to+3.25 %, 5.06±0.31 to 13.21±1.5, 2.682±0.04 to 3.676±0.01 and 25 s to 2 min: 30 s, respectively. The dissolution test and the assay results of all the brands are also ranged within the acceptable label claim 93.7±2.24 to 98.4±0.85 and 93.22±0.38 to 100.15±0.33, respectively. However, there is no relation was found between the disintegration time and the dissolution test. Conclusion: According to the finding, all the selected Amlodipine Besylate 5 mg brands are met pharmacopeia standards and USP specifications. Therefore, the local and imported Amlodipine Besylate 5 mg can be used safely to get the desired therapeutic efficiency.

Animal Models and Alternatives in the Quality Control of Vaccines: Are In Vitro Methods or In Vivo Methods the Scientific Equivalent of the Emperor's New Clothes?

1995 ◽  
Vol 23 (1) ◽  
pp. 61-73
Author(s):  
Coenraad Hendriksen ◽  
Johan van der Gun
Keyword(s):  
Quality Control ◽  
Test Methods ◽  
In Vitro Test ◽  
Large Numbers ◽  
Alternative Approach ◽  
Inactivated Vaccines ◽  
Vitro Test

In the quality control of vaccine batches, the potency testing of inactivated vaccines is one of the areas requiring very large numbers of animals, which usually suffer significant distress as a result of the experimental procedures employed. This article deals with the potency testing of diphtheria and tetanus toxoids, two vaccines which are used extensively throughout the world. The relevance of the potency test prescribed by the European Pharmacopoeia monographs is questioned. The validity of the potency test as a model for the human response, the ability of the test to be standardised, and the relevance of the test in relation to the quality of the product are discussed. It is concluded that the potency test has only limited predictive value for the antitoxin responses to be expected in recipients of these toxoids. An alternative approach for estimating the potency of toxoid batches is discussed, in which a distinction is made between estimation of the immunogenic potency of the first few batches obtained from a seed lot and monitoring the consistency of the quality of subsequent batches. The use of animals is limited to the first few batches. Monitoring the consistency of the quality of subsequent batches is based on in vitro test methods. Factors which hamper the introduction and acceptance of the alternative approach are considered. Finally, proposals are made for replacement, reduction and/or refinement (the Three Rs) in the use of animals in the routine potency testing of toxoids.

scholarly journals Perspectives approach to the assessment of the quality of the vaccine plague live in terms of immunogenicity. Epidemiology and Vaccinal Prevention

2019 ◽  
Vol 18 (1) ◽  
pp. 50-54
Author(s):  
S. E. Gostischeva ◽  
N. V. Abzaeva ◽  
E. L. Rakitina ◽  
D. G. Ponomarenko ◽  
M. V. Kostuchenko ◽  
...  
Keyword(s):  
Specific Antigen ◽  
Water Soluble ◽  
Control Group ◽  
In Vitro Tests ◽  
Laboratory Mice ◽  
Early Activation ◽  
High Degree ◽  
Stimulation Of

Research objective–studying of a possibility of application antigen – stimulated cellular in vitro tests and technology of the cytometric analysis for control of immunogene activity of batches of vaccine plague live.Materials and methods.As biomodels used white laboratory mice, immunized commercial medicine of vaccine of the plague NIIEG line, live from a strain of Yersinia pestis EV, in doses – 8 х 102, 4 х 103, 2 х 104 and 1 х 105 of living microbic cells. Blood for a research was taken from intact mice and on 7, 14 and 21 days after immunization. The intensity of an antigenreaktivnost of lymphocytes was defined in cellular in vitro tests, analyzing a marker of early activation (CD45+CD3+CD25+) of lymphocytes with use of the monoclonal antibodies conjugated from fluorokhroma. As specific antigen used a complex of water-soluble antigens of a plague microbe.Results.As a result of a research it is shown that at the animals vaccinated by doses 4 х 103 – 1 х 105 living microbic cells, the highest level of an expression activation marker lymphocytes at anti-gene stimulation of in vitro is registered on 14 days after immunization, at the same time the quantity of CD25 – positive lymphocytes are on average 6.8 times higher, than in control group. High degree of direct link (coefficient of correlation of r = 1,000) quantities of the survived animals with increase in level of lymphocytes, expressiruyushchy markers of early activation – CD25 is established.Conclusions.The offered technique can be used as the additional test when studying degree of immunogenicity of new (kandidatny) vaccines against plague.

scholarly journals Review on Standardization of Ayurvedic Medicine

2021 ◽  
pp. 194-199
Author(s):  
Janmejay Pant ◽  
. Ripudhaman
Keyword(s):  
Quality Control ◽  
Raw Materials ◽  
Dosage Forms ◽  
Classical Literature ◽  
Scientific Methods ◽  
Ayurvedic Drugs ◽  
Drug Manufacturing ◽  
And Storage ◽  
Current Guidelines

Standardization in Ayurvedic formulations ensures the establishment of standards for the quality and purity of raw materials, quality control during the drug manufacturing process, production of a good quality finished product, storage and distribution to maintain the quality of the final product. It is an essential tool for establishing quality control methods for Ayurvedic drugs. In Ayurveda, standardization has been well defined and documented in the classical and contemporary texts. Still, these have been written with an individualistic intent and not for industrial or commercial purposes.  Careful contemplation of the classical literature of Ayurveda was done, the current guidelines of WHO on standardization of herbal drugs, latest researches on the same via the internet were explored and examined in the purview of the newest standardization procedures.  In this article, an attempt has been made to bring to light the classical references related to standardization, the milestones in this on-going pursuit have been exhibited, with the use of the latest scientific methods being incorporated for a standardized Ayurvedic drug. It can be concluded from the review that standardization in Ayurveda is an on-going process where one needs to be strictly vigilant about the new scientific methods to study the fine chemical procedures and the intermediate compounds formed, but at the same time be aware of the classical. Ayurvedic methods concepts of the procedure. Asava-arista's medicinal characteristics of Ayurvedic classical dosage forms, liquid dosage forms based on self-generated alcohol with faster absorption, long shelf life, and increased market conformity have led to a continuous rise in demand. New fermentation methods and packaging innovations tend to have been embraced by many Ayurvedic processing units. The importance of standardization of such goods is underlined by these advances in manufacturing, distribution and storage. Therefore, it is of concern to examine the latest manufacturing situation and the standardization of the dosage type regarding the procedure and the consistency and effectiveness of the finished product. In addition to the effort to include criteria of consistency and standardization, the study consists of an overview and deliberates on the importance of improvements made to the conventional preparation processes, ingredients and material used in the process and the potential impact on its efficacy.

Lactobacillus plantarum ZJ316 improves the quality of Stachys sieboldii Miq. pickle by inhibiting harmful bacteria growth and degrading nitrite, promoting the gut microbiota health in vitro

2022 ◽  
Author(s):  
Shu Ting Hang ◽  
Ling zhou Zeng ◽  
Jia run Han ◽  
Zhong qin Zhang ◽  
Qingqing Zhou ◽  
...  
Keyword(s):  
Quality Control ◽  
Lactic Acid ◽  
Lactobacillus Plantarum ◽  
Microbial Contamination ◽  
Nitrite Accumulation ◽  
Bacteria Growth ◽  
Lactobacillus Plantarum Zj316 ◽  
Stachys Sieboldii

Microbial contamination and nitrite accumulation are two major concerns on the quality control of fermented vegetables. In the present study, a lactic acid bacteria strain Lactobacillus plantarum ZJ316 (ZJ316) was...

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