scholarly journals COMPARISON AND EVALUATION OF PHARMACOPOEIAL METHODS FOR THE ASSESSMENT OF POTENCY OF ANTIBIOTICS

Author(s):  
Gökhan CENGİZ ◽  
Evren ALGIN YAPAR ◽  
Bilge Ahsen KARA ◽  
Rakesh K. SINDHU

The detection and assessment of potency of antibiotics are crucial for the pharmaceutics. The valid methods for microbiological assays in pharmacopoeias are mainly based on statistical comparison of the data obtained by measuring the cidal activity resulting from the treatment of the antibiotic active ingredient in the composition of the pharmaceutics with the target microorganism. However, it was seen that there is no validated microbiological method for some active ingredients. Due to microbiological assays are indispensable methods for determining the potency of some active ingredient groups, the calculation of the potency is performed logarithmically. In either turbidimetric or chromatographic methods, the statistical evaluation of the sample is compared with the standard reference material. Analysis data obtained by chromatographic and chemical methods are linear peak areas and spectrophotometer readings. In microbiological methods, the data obtained from the analyzes performed to determine the potency of antibiotics are the inhibition zone diameters or turbidimetric turbidity data. In this study, above-mentioned microbiological assays are compared in the context of the main pharmacopoeias EP, USP, CP, IP and BP, and evaluated in terms of the chromatographic method and classical microbiological method. It has been observed that chromatographic and chemical methods are not available to determine the potency of some pharmaceutical products containing antibiotics. The examinations made reveal the difficulty of analyzing some active ingredient groups according to chemical and chromatographic methods. For this reason, the importance of method validation studies is increasing in order to analyze active substances that do not have alternative analysis methods with microbiological and chemical methods. In this study, all validated microbiological methods were investigated, and it was aimed to determine alternative methods to chromatographic and chemical methods. It was concluded that the realization of new microbiological methods to be validated by evaluating the methods in all differences would facilitate the study.                    Peer Review History: Received: 18 May 2021; Revised: 15 June; Accepted: 28 June, Available online: 15 July 2021 Academic Editor: Dr. Asia Selman Abdullah,  Al-Razi university, Department of Pharmacy, Yemen, [email protected] UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.  Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 6.5/10 Average Peer review marks at publication stage: 7.5/10 Reviewer(s) detail: Dr. Iman Muhammad Higazy, National Research Center, Egypt, [email protected] Dr. George Zhu, Tehran University of Medical Sciences, Tehran, Iran, [email protected] Similar Articles: AN OVERVIEW ON PHARMACOPOEIAS IN THE WORLD AND MONOGRAPH ELABORATION TECHNIQUES

Author(s):  
Priscila C. Viebrantz ◽  
Lauri L. Radunz ◽  
Rafael G. Dionello

ABSTRACT Due to the need to improve the quality and safety of foods, chemical methods used to control grain pests have been replaced by alternative methods. For example, modified atmosphere within the storage units has been used. Therefore, the objective was to evaluate maize grain quality and mortality of insects of the species Sitophilus zeamais and Tribolium castaneum in hermetic and non-hermetic environments for 50 days of storage. The hermetic units consisted of polyethylene "bags" with capacity for 60 kg. A cage with 20 adults of each species and 200 g of maize was placed inside each unit. The oxygen level was quantified every five days. Evaluations of insect mortality and survival occurred at 10, 20, 30, 40 and 50 days of storage. At 0, 30 and 50 days, density, moisture and fungal incidence analyses were conducted. The airtight system is efficient in the control of insects, with satisfactory mortality values for both species. Insects favor the development of fungi during the storage, regardless of the storage system.


Author(s):  
Gökhan CENGİZ ◽  
Evren ALGIN YAPAR

In the direction of microbiological quality control analysis in pharmaceutical products, determining the microbiological load of the product at the end-use stage is very important for human health. Quality control parameters in pharmaceutical products vary according to the structure of the type of product and administration route. In this context, according to the pharmacopoeias, parenteral products and eye drops are classified as sterile products and the other group of pharmaceuticals are classified as non-sterile products. However, non-sterile pharmaceuticals also must have a certain microbiological quality. For this reason, the pharmaceuticals should have a certain microbiological load and should not contain defined microorganisms specified to its type. Since the control of the microbiological quality of the products is important for safety, it should be determined by quality control analysis. In this study, standard methods used to detect specific microorganism in pharmaceutical products were compared. Application steps in standard methods and identification tests of specific microorganisms were examined. In addition, studies that are alternative to standard methods were evaluated. Peer Review History: Received: 5 September 2020; Revised: 20 October; Accepted: 28 October, Available online: 15 November 2020 UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file Average Peer review marks at initial stage: 6.0/10 Average Peer review marks at publication stage: 8.0/10 Reviewer(s) detail: Dr. Mujde Eryilmaz, Ankara University,Turkey, [email protected] Dr. Rawaa Souhil Al-Kayali, Aleppo University, Syria, [email protected]   Comments of reviewer(s): Similar Articles: CHEMICAL COMPOSITION AND ANTIMICROBIAL ACTIVITY OF THE ESSENTIAL OILS OF FOUR VARIETIES OF LIPPIA MULTIFLORA IN BENIN ANTIMICROBIAL ACTIVITIES FOR HADHRAMI HONEY ON GROWTH OF SOME PATHOGENIC BACTERIA


2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ruchika Mittal ◽  
Gauri Srivastava ◽  
Deepak Ganjewala

Abstract Monoterpenes, a class of isoprenoid compounds, are extensively used in flavor, fragrance, perfumery, and cosmetics. They display many astonishing bioactive properties of biological and pharmacological significance. All monoterpenes are derived from universal precursor geranyl diphosphate. The demand for new monoterpenoids has been increasing in flavor, fragrances, perfumery, and pharmaceuticals. Chemical methods, which are harmful for human and the environment, synthesize most of these products. Over the years, researchers have developed alternative methods for the production of newer monoterpenoids. Microbial biotransformation is one of them, which relied on microbes and their enzymes. It has produced many new desirable commercially important monoterpenoids. A growing number of reports reflect an ever-expanding scope of microbial biotransformation in food and aroma industries. Simultaneously, our knowledge of the enzymology of monoterpene biosynthetic pathways has been increasing, which facilitated the biotransformation of monoterpenes. In this article, we have covered the progress made on microbial biotransformation of commercial monoterpenes with a brief introduction to their biosynthesis. We have collected several reports from authentic web sources, including Google Scholar, Pubmed, Web of Science, and Scopus published in the past few years to extract information on the topic.


2014 ◽  
Vol 3 (3) ◽  
pp. 71
Author(s):  
Maria Encarnacion Tamayo Rodríguez ◽  
Francisco Miguel González Valverde ◽  
Manuel Madrigal de Torres ◽  
Pedro Pérez Fernández ◽  
Eduardo Osuna Carrillo de Albornoz

Objectives: The aim of this research has been to evaluate: (a) the frequency of the use of non-standard terms in medical prescriptions; (b) the proportion of “new drugs of irrelevant therapeutic value” or medication of low therapeutic utility (LTU); and (c) the use of Generic Pharmaceutical Specialties (GPS). Materials and methods: Descriptive transversal observational study with analytical components over the hospital discharge reports issued in a year. The main variables of the results were: a) the proportion of prescriptions with abbreviations, symbols or expressions of non-recommended doses in the discharge report, b) the frequency of prescriptions of pharmaceutical specialties without the relevant contribution (NRPS), c) the proportion of LTU medication in the hospital discharge reports, d) the frequency of GPS or, if they are not available, the Common International Denomination (CID) of the active ingredient in the discharge reports, and e) the mean cost per prescribed medication in the hospital discharge report. Results: A total of 854 discharge reports have been studied containing 4,055 medical prescriptions. A considerable number (38.8%) of the medical prescriptions in the discharge report have used abbreviations and non-recommended symbols for dose expression. The prescription of new drugs of irrelevant therapeutic value reached 2.8% while the prescription of pharmaceutical products of LTU was 2.1%. Only 13.8% of the prescriptions were carried out as an active ingredient. The mean cost per prescription was 17.3 euros (SD = 31.34). Conclusions: Appropriateness in the prescription of medication at hospital discharge is considered to be not satisfactory and our results are consistent with other previously published reports. However, there are frequent errors in the prescription of medication and given the demonstrated relationship between errors and possible adverse effects, it is necessary to introduce programs to raise awareness about the importance of the introduction of safe practices in the medical prescriptions of the hospital discharge report.


1975 ◽  
Vol 58 (4) ◽  
pp. 799-803
Author(s):  
Anthony F Gross

Abstract In a collaborative study, an automated method for the determination of niacin and niacinamide in cereal products was compared with the official final action microbiological (43.121–43.125) and chemical (43.044–43.046) methods. Ten samples of cereal products, including enriched flour, yeast-leavened baked products, fortified breakfast cereals, and baked pet food products, were submitted to 14 laboratories. Nine laboratories reported values by the automated method, 6 reported values by the microbiological method, and 7 reported values by the chemical method. The results from the microbiological method were not subjected to analysis of variance because of the unusually large between-laboratory variation. The between-laboratory coefficients of variation for the automated and chemical methods were 10.90 and 10.18%, on the basis of results from 7 and 4 laboratories, respectively. There was no significant (p>0.05) difference between methods when results from the 4 laboratories who used both methods were compared. The automated chemical method has been adopted as official first action.


2012 ◽  
Vol 107 (02) ◽  
pp. 302-314 ◽  
Author(s):  
Bianca Glauser ◽  
Bruno Vairo ◽  
Stephan-Nicollas Oliveira ◽  
Leonardo Cinelli ◽  
Mariana Pereira ◽  
...  

SummaryPatent protection for enoxaparin has expired. Generic preparations are developed and approved for clinical use in different countries. However, there is still skepticism about the possibility of making an exact copy of the original drug due to the complex processes involved in generating low-molecular-weight heparins. We have undertaken a careful analysis of generic versions of enoxaparin available for clinical use in Brazil. Thirty-three batches of active ingredient and 70 of the final pharmaceutical product were obtained from six different suppliers. They were analysed for their chemical composition, molecular size distribution, in vitro anticoagulant activity and pharmacological effects on animal models of experimental thrombosis and bleeding. Clearly, the generic versions of enoxaparin available for clinical use in Brazil are similar to the original drug. Only three out of 33 batches of active ingredient from one supplier showed differences in molecular size distribution, resulting from a low percentage of tetrasaccharide or the presence of a minor component eluted as monosaccharide. Three out of 70 batches of the final pharmaceutical products contained lower amounts of the active ingredient than that declared by the suppliers. Our results suggest that the generic versions of enoxaparin are a viable therapeutic option, but their use requires strict regulations to ensure accurate standards.


Author(s):  
Abdulrahman Humaid ◽  
Saeed M Alghalibi ◽  
Anes Al-Mahbashi ◽  
Aml AL-Arossi ◽  
Wadhah Hassan Edrees

Candida species are opportunistic yeasts affecting the genitourinary tract which causes the vulvovaginal candidiasis in the most female especially in developing countries. This study aims to determine the prevalence of vulvovaginal candidiasis caused by Candida species causing among pregnant women in Sana'a City, Yemen. This study was carried out at the department of microbiology of AL-Kuwait University Hospital. 250 vaginal swabs were collected and cultured on Sabouraud dextrose agar. Candida species identification and antifungal susceptibility testing were determined according to standard microbiological methods. The results showed that out of 250 samples, 63(25.2%) were positive for Candida species. It was found that the C. albicans (68.3%) was the most common species isolated followed by non-albicans species that are C. tropicalis (20.6%), C. glabrata (6.3%), and C. kefyr (4.8%). Also, it was recorded that the highest prevalence of Candida species was within group aged of 36-46 year. Susceptibility tests revealed that the most isolated species of C. andida were sensitive to nystatin (95%). miconazole was the next effective drug with 64% sensitive followed by amphotericin B (29%) and clotrimazole (24%). But only 6% of the isolates were sensitive to fluconazole. It can be concluded that the vulvovaginal candidiasis are quite common in Yemen country with a high prevalence. Also, the nystatin remains the effective agent against all isolated of Candida species. In contrast, the increase resistance of Candida species to fluconazole that commonly used antifungal is an alarming increase of vaginal candidiasis caused by antifungal-resistant Candida species. Peer Review History: UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file Average Peer review marks at initial stage: 5.0/10 Average Peer review marks at publication stage: 8.0/10 Reviewer(s) detail: Name: Dr. Hassan A.H. Al-Shamahy Affiliation: Sana'a University, Yemen E-mail: [email protected]   Name: Dr. Tamer Mohamed Ali El Habibi Affiliation: Suez Canal University, Egypt. E-mail: [email protected]   Name: Rola Jadallah Affiliation: Arab American University, Palestine E-mail: [email protected] Comments of reviewer(s): Similar Articles: AN EXHAUSTIVE STATISTIC ON CURRENT MUCOADHESIVE INTRAVAGINAL DRUG DELIVERY METHODOLOGIES TETANUS IMMUNIZATION AMONG PREGNANT WOMEN: COVERAGE RATE AND RATE OF PROTECTION AT TIME OF DELIVERY


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