scholarly journals Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria

2014 ◽  
Vol 50 (1) ◽  
pp. 1-24 ◽  
Author(s):  
Olímpia Maria Martins Santos ◽  
Maria Esther Dias Reis ◽  
Jennifer Tavares Jacon ◽  
Mônica Esselin de Sousa Lino ◽  
Juliana Savioli Simões ◽  
...  

Polymorphism in solids is a common phenomenon in drugs, which can lead to compromised quality due to changes in their physicochemical properties, particularly solubility, and, therefore, reduce bioavailability. Herein, a bibliographic survey was performed based on key issues and studies related to polymorphism in active pharmaceutical ingredient (APIs) present in medications from the Farmácia Popular Rede Própria. Polymorphism must be controlled to prevent possible ineffective therapy and/or improper dosage. Few mandatory tests for the identification and control of polymorphism in medications are currently available, which can result in serious public health concerns.

2017 ◽  
Vol 37 (1) ◽  
pp. 136-161 ◽  
Author(s):  
Thadiyam Puram Ramees ◽  
Kuldeep Dhama ◽  
Kumaragurubaran Karthik ◽  
Ramswaroop Singh Rathore ◽  
Ashok Kumar ◽  
...  

2017 ◽  
Vol 117 (3) ◽  
pp. 1379-1384 ◽  
Author(s):  
Kenichi Sekiya ◽  
Mariko Takahashi ◽  
Shingo Murakami ◽  
Ryusuke Kakigi ◽  
Hidehiko Okamoto

Tinnitus is a phantom auditory perception without an external sound source and is one of the most common public health concerns that impair the quality of life of many individuals. However, its neural mechanisms remain unclear. We herein examined population-level frequency tuning in the auditory cortex of unilateral tinnitus patients with similar hearing levels in both ears using magnetoencephalography. We compared auditory-evoked neural activities elicited by a stimulation to the tinnitus and nontinnitus ears. Objective magnetoencephalographic data suggested that population-level frequency tuning corresponding to the tinnitus ear was significantly broader than that corresponding to the nontinnitus ear in the human auditory cortex. The results obtained support the hypothesis that pathological alterations in inhibitory neural networks play an important role in the perception of subjective tinnitus. NEW & NOTEWORTHY Although subjective tinnitus is one of the most common public health concerns that impair the quality of life of many individuals, no standard treatment or objective diagnostic method currently exists. We herein revealed that population-level frequency tuning was significantly broader in the tinnitus ear than in the nontinnitus ear. The results of the present study provide an insight into the development of an objective diagnostic method for subjective tinnitus.


2017 ◽  
Vol 37 (1) ◽  
pp. 212-251 ◽  
Author(s):  
Rajendra Singh ◽  
Karam Pal Singh ◽  
Susan Cherian ◽  
Mani Saminathan ◽  
Sanjay Kapoor ◽  
...  

2019 ◽  
Vol 42 (3) ◽  
pp. 602-609
Author(s):  
Emily Phipps ◽  
Conall Watson ◽  
Rachel Mearkle ◽  
Sarah Lock

Abstract Background The European Centre for Disease Prevention and Control, National Institute for Health and Care Excellence and Public Health England have all endorsed the use of antivirals for the treatment and prophylaxis of influenza for care home residents. However, implementing these guidelines in practice is often challenging. This article aims to explore what factors impact the management of care home flu outbreaks in England according to national guidelines and highlight opportunities for change. Methods Qualitative data from notified outbreaks between September 2017 to April 2018 in the South East of England were analyzed, applying the Greenhalgh framework for barriers to guideline implementation. Summary statistics on outbreak characteristics were generated. Stakeholders were mapped out using Eden and Ackermann’s grid of interest and influence. A process map was developed to describe operational pathways. Results There was often a delay in notifying potential outbreaks to Public Health England. Clinicians cited a lack of robust evidence for the use of antivirals and the available guidelines being too unwieldy as reasons for not implementing prescribing guidance. Many high interests and high influence stakeholders are involved in the sometimes complex care pathway, requiring coordinated work and agreement before antivirals can be prescribed. Conclusions Our findings highlight points in the care pathway that stakeholders can target to improve quality of care and increase the likelihood of national guidance being implemented. The principles described in this article can also be applied to other challenges of translating evidence into practice and cross-organisational working.


2020 ◽  
Vol 24 (2) ◽  
pp. 323-328
Author(s):  
K.O. Yusuf ◽  
I.B. Sadiku ◽  
O.S. Abioye

This study was conducted to determine the quality of drinking well water near dumpsite at Ogidi-Oloje, Ilorin, Kwara State. Open wells near dumpsite could be polluted due to percolation of chemicals from the decomposition of refuse and scraps of electronic boards having potential of causing diseases to man. Most people at Ogidi-Oloje Ilorin depend on open wells near dumpsite for drinking water during dry season. Water samples were collected from seven open wells (W1 - W6) 9.2 - 18.2 m away from dumpsite and the control well W7 was 45.0 m away from the dumpsite. Physicochemical and bacteriological properties were determined from the water samples during dry season (March, 2019) and rainy season (July, 2019). Phosphate, Cadmium, Lead, Feacal coliform were not detected during dry season but only Feacal coliform was not detected in the water during rainy season. All the values of physicochemical properties of the water were within WHO permissible limits except Iron and Cadmium that above the limits which could cause diseases to mankind. Values of Iron during dry season for six well sources were 3.61, 4.02, 4.26, 3.25, 5.14 and 7.24 mg/L while values for rainy season and control were 0.715, 1.410, 0.650, 0.049, 0.780, 1.110 and 0.775 mg/L(control) but WHO limits is 0.03mg/L. Concentrations of Cadmium in the water during rainy season were 0.010, 0.015, 0.015, 0.020, 0.015, 0.015 and 0.02mg/L(control) but WHO limit is 0.003 mg/L. This study revealed that the water is suitable for consumption during dry season but unsuitable during rainy season. Keywords: well water quality, groundwater pollution, water diseases, dumpsite


Author(s):  
V. N. Okafor ◽  
U. B. Uche ◽  
R. C. Abailim

Aim: The aim is to investigate some physicochemical properties of beers and polycyclic aromatic hydrocarbons contaminants in beer brewed with isomerized hop extract and in comparison with beers brewed with extracts from four Nigerian potential hop substitutes. Study Design: Beers were brewed using isomerized hop extract and extracts from four Nigerian bitter vegetables. Analyses of physicochemical properties of the beers and for the presence of 16 specific target PAHs were carried out using their respective standard methods. Place and Duration of Study: Analysis of physicochemical properties of the beers was done at Nigerian Breweries PLC, Enugu while analysis for PAHs was conducted at Central Laboratory, Nigerian Institute for Oceanography and Marine Research, Lagos between July, 2018 and November, 2019. Methodology: Physicochemical properties of the beers (alcohol content, bitterness level, pH, specific gravity, colour) were determined using their respective standard methods. Gas chromatography/mass spectrometry was used in analyzing for PAHs [naphthalene, acenaphthylene, acenaphthene, phenanthrene, anthracene, fluoranthene, pyrene, benzo(a)anthracene, chrysene, benzo(b)fluoranthene, benzo(k)fluoranthene, benzo(a)pyrene, dibenzo(a,h)anthracene, indeno(1,2,3-cd)pyrene and benzo(g,h,i)perylene]. Four isotopically labelled PAHs (acenaphthene-d10, phenanthrene-d10, chrysene-d12 and perylene-d12) were used as internal standards. Results: Alcohol content (%v//v) in the beer samples is A(5.20); B(4.28); C(4.40); D(4.43) and E(4.54), bitterness level in International Bitterness Units (IBU) is A(0.54); B(0.80); C(1.46); D(1.46) and E(0.08), pH is A(4.36); B(3.08); C(3.88); D(3.90) and E(3.87), specific gravity is A(10.06); B(10.00); C(10.00); D(10.06) and E(10.06), and beer colour is A(5.80); B(7.70); C(6.60); D(8.00) and E(7.40). All 16 EPA PAHs were not found in all the beer samples except pyrene which was detected in sample B at a concentration of 0.00402 mg/kg. Conclusion: It is concluded that extracts from the four Nigerian bitter vegetables could be used as substitutes for isomerized hop extract and that consumption of beer produced using extract from G. kola poses great public health concerns.


2009 ◽  
Vol 37 (S1) ◽  
pp. 7-8
Author(s):  
George A. Mensah

Acommon theme throughout the greatest public health achievements of the 20th century is the importance of law. From the seminal successes in immunizations and motor vehicle safety to the recognition and control of tobacco as a health hazard, laws have been invaluable. More recently in this century, laws have been fundamental in public health preparedness to address environmental disasters and terrorist threats. In fact, the first National Summit on Legal Preparedness in 2007 focused on these “urgent threats.” It only seemed natural that the second summit would focus on the “urgent realities” posed by the continuing epidemic of obesity — an epidemic that directly attacks our children’s health and drains our nation’s wealth.Recognized worldwide as an energy imbalance resulting from excess caloric intake and reduced energy expenditure, obesity contributes to diabetes, heart disease, other multiple chronic diseases, impaired quality of life, and premature mortality.


2018 ◽  
Vol 24 (21) ◽  
pp. 2456-2472 ◽  
Author(s):  
Chandrakant R. Malwade ◽  
Haiyan Qu

Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities. Crystallization with its ability to engineer the final product to the desired qualities such as purity, polymorphic form, particle size and shape is one of the most important steps involved in the manufacturing of APIs. Therefore, development of crystallization processes with better understanding of process parameters and their impact on quality of APIs and subsequently the drug products assume great significance for the pharmaceutical industry. Methods: This review paper focuses on the application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design of crystallization processes in the manufacturing of APIs. Results: Firstly, various steps involved in the drug development process are introduced briefly with emphasis on crystallization as one of the most important steps in manufacturing of drug products. Secondly, Critical Quality Attributes (CQAs) of drug products, their dependence on material attributes of APIs and role of crystallization in manipulating material attributes of APIs has been discussed. Finally, application of PAT tools such as advanced process analyzers for continuous monitoring, chemometric methods for multivariate data analysis, and control strategy for APIs crystallization processes has been reviewed along with some examples. Conclusion: Application of PAT in crystallization of APIs facilitates development of robust processes that works within the design space to produce the drug products of consistent quality. Furthermore, it opens up the opportunities for continuous improvement of the process by generating knowledge base of existing processes.


2019 ◽  
Vol 2 (2) ◽  
pp. 36-46
Author(s):  
Jeancarlo Pereira dos Anjos ◽  
Samuel Sherratt ◽  
Josiane Dantas Viana ◽  
Valdir Gomes Barbosa Junior ◽  
R. Preston Manson ◽  
...  

Impurities found in generic medicinesmay contribute to loss of efficacy and adverse side effects when administered to patients suffering from various diseases. Methods of analysis of the quality of drug products are well advanced. Herein, we used Liquid Chromatography with Diode Array Detector coupled to Mass Spectrometry to detect the presence of organic impurities and determine the quantity of the Active Pharmaceutical Ingredient (API) present in representative Antibiotics (2) and Antifungals (2). Possible impurities were detected in some of the generic drugs in both classes of anti-infective drugs. No impurities were detected in the amoxicillin. The compounds 3’-N,N-Di(demethyl) azithromycin (azithromycin impurity E) and 3’-De(dimethylamino)-3’-keto azithromycin (azithromycin impurity N) were detected in generic azithromycin. For itraconazole, the compounds cis-[2-(2,4 dichlorophenyl)-2-(1H-1,2,4-triazol-4-yl-methyl)-1,3-dioxolan-4 yl] methylmethanesulfonate and trans-[2-(2,4-dichlorophenyl)-2-(1H 1,2,4-triazol-1-yl-methyl)-1,3-dioxolan-4-yl]methylmethanesulfonate, besides a third substance identified as 2- (2-Butyl) -4-{4-[4-(4-methyloxy-phenyl)-piperazin-1-yl]-phenyl}-2,4-dihydro-[1,2,4]-triazol-3-one were detected as possible impurities. Interestingly, an additional peak was noted in the chromatogram for the generic fluconazole, in addition to the peak of the API; however, none of known impurities of fluconazole were identified. We conclude that tests in addition to bioequivalence measurements may be required to assess post-market generic quality. Such surveillance of generic quality should be performed routinely.


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