Interchangeability and Comparative Effectiveness between Micronized and Non-micronized Products of Glibenclamide Tablets

Background: During the last few years there was wide debate about the interchangeability and effectiveness between circulated products containing Glibenclamide in the market.Objectives: This study aimed to compare the effectiveness of this product “non-micronized” to the originator’s product of Glibenclamide tablets “of micronized” sulfonylurea.Methods: 12 volunteers received a dose of 5mg of Glibenclamide (from test and standard products) under fasting conditions in two separate sessions using randomized crossover design. Blood glucose level for the volunteers was monitored to avoid the development of hypoglycemia. Plasma samples were collected over 24 hours and analyzed using HPLC.Results: The maximum concentration Cmax for the test and reference products were 2.508 ± 0.104 and 3.526 ± 0.118 (ìg/ml) respectively and the area under the curve AUC0-[ were 3.511 ± 0.153 4.572 ± 0.202 (ìg.h/ml) for these products respectively, with a difference of about 24% between the test and reference products in its AUC.Conclusions: The results indicate that the test product is not bioequivalent to reference product. The difference in formulation between micronized product and non-micronized product of Glibenclamide tablets has impact on clinical outcomes.Key words:sulfonylurea,Blood glucose,hypoglycemia

IN VITRO-IN VIVO BIO-EQUIVALENCE CORRELATION STUDY OF METRONIDAZOLE, AND ITS BRANDS OF IMMEDIATE RELEASE TABLET UNDER BIO-WAIVER CONDITIONS

Objective: The aim of present study is to examine the in-vitro in-vivo correlation (IVIVC) of immediate release product. Metronidazole 500mg and its brands of immediate release dosage forms. Metronidazole is clearly classified into BCS class I, and could be evaluated under bio waiver conditions. Methods: The in vitro parameters employed were hardness, weight uniformity, friability, disintegration time, absolute drug content, dissolution rate (in 0.1 N Hydrochloric acid, phosphate buffer and acetate buffer at 37ºC), and dissolution efficiencies were also analyzed. The in-vitro dissolution study was performed on the brands, according to FDA,USP dissolution profile in three different PH (1.2), (4.5), and (6.8) at37ºC, using the USP apparatus II, then f1, f2 were determined for the time intervals of 10, 15, 30, 45 and 60 minutes, and dissolution efficiencies were calculated. MINITAB 14 statistical program used for in vitro in vivo correlation, level A was done for reference product. Results: A non linear relation was established which is typical for immediate release formulation, of class 1. There was significant relationship between in vitro and in vivo data of reference metronidazole product, Correlation and distribution of data with correlation coefficient (r=0.724, 0.837, 0.707), nonlinear relationship with p-value (>0.05) =(0.167, 0.098, 0.182), there is no out lines, no lake of fits at P-Values=0.0040, 006, 0.026.Conclusion: Study concluded that there is no linear correlation between percent of drug released and percent of drug absorbed ,this may be due to uncontrollable gastric emptying rate for class one Metronidazole.                          Peer Review History: Received 2 January 2020;   Revised 1 February; Accepted 3 March, Available online 15 March 2020 Academic Editor: Ahmad Najib, Universitas Muslim Indonesia,  Indonesia, [email protected] Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 4.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewer(s) detail: Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, [email protected] Dr. Mohamed Ismail Nounou, Appalachian College of Pharmacy, Oakwood, Virginia, USA, [email protected] Similar Articles: IN VITRO-IN VIVO BIO-EQUIVALENCE CORRELATION STUDY OF ATENOLOL, AND ITS BRANDS OF IMMEDIATE RELEASE TABLET UNDER BIO-WAIVER CONDITION

Challenges in disclosure of adverse events and errors in surgery; perspectives from sub-Saharan Africa

Surgery in sub-Saharan Africa is widely known to be done against a background of poverty and illiteracy, late presentation with complicatedpathologies, and a desperate lack of infrastructure. In addition, patient autonomy and self determination are highly flavored by cultural practicesand religious beliefs. Any of these factors can influence the pattern and disclosure of adverse events and errors. The impact of these in therelationships between surgeons and patients, and between health institutions and patients must be considered as it may affect disclosure andresponse to errors. This article identifies the peculiar socioeconomic and cultural challenges that may hinder disclosure and proposes strategies forinstituting disclosure of errors and adverse events services in Sub-Saharan Africa.Key words: Challenges, errors, adverse events, surgery, sub-Saharan Afric

IN VITRO-IN VIVO BIO-EQUIVALENCE CORRELATION STUDY OF ATENOLOL, AND ITS BRANDS OF IMMEDIATE RELEASE TABLET UNDER BIO-WAIVER CONDITIONS

Objective: The aim of present study is to examine the in vitro-in vivo correlation (IVIVC) of immediate release product. Atenolol 100mg and its brands of immediate release dosage forms. Atenolol is clearly classified into BCS class III, and could be evaluated under bio waiver conditions. Methods: The in vitro parameters employed were hardness, weight uniformity, friability, disintegration time, absolute drug content, dissolution rate (in 0.1 N Hydrochloric acid, phosphate buffer and acetate buffer at 37ºC), and dissolution efficiencies were also analyzed. The in-vitro dissolution study was performed on the brands, according to FDA, USP  dissolution profile in three different PH (1.2), (4.5), and (6.8) at 37ºC, using the USP apparatus II. A non linear relation was established which is typical for immediate release formulation, of class III. Results: All Atenolol brands released about 90% drug in PH (6.8), where about 87% in PH (4.5), reference drug released about 91% and test drug released about 87% in pH (1.2). Dissolution efficiency of  the entire brands differed by less than 10% from the innovator brand. According to MINITAM 14 statistical program, there was significant relationship between in vitro and in vivo data of reference Atenolol product. Conclusion: By applying level A in vitro-in vivo correlation, study concluded that there is no linear correlation between percent of drug released and percent of drug absorbed, this may be due to uncontrollable permeability rate for class three Atenolol.                    Peer Review History: Received 20 September 2019;   Revised 16 December; Accepted 7 January, Available online 15 January 2020 Academic Editor: Dr. Amany Mohamed Alboghdadly, Princess Nourah bint abdulrahman university, Riyadh, [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: 3.0/10 Average Peer review marks at publication stage: 7.0/10 Reviewer(s) detail: Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, [email protected] Dr. Nicola Micale, University of Messina, Italy, [email protected] Similar Articles: FAST DISSOLVING DRUG DELIVERY SYSTEMS: FORMULATION, PREPARATION TECHNIQUES AND EVALUATION FAST DISSOLVING TABLETS: A PROMISING APPROACH FOR DRUG DELIVERY DEVELOPMENT AND EVALUATION OF FAST DISSOLVING THIN FILMS OF ARIPIPRAZOLE TABLET GRANULATION: CURRENT SCENARIO AND RECENT ADVANCE

Causes and Outcome of Acute Kidney Injury: Gezira Experience

Introduction: A precise operational definition of acute kidney injury remains elusive. Conceptually, acute kidney injury is defined as the loss of renal function, measured by decline in glomerular filtration rate, developing over a period of hours to days. Clinical manifestations of acute kidney injury (AKI) are highly variable; in some patients, the only manifestation may be biochemical abnormalities on routine blood sampling, while other patients will present with overt uremic signs or symptoms.Objectives: We evaluated the aetiology and the clinical outcome of all patients admitted to Gezira Hospital for Renal diseases and Surgery with AKI.Methods: Clinical data of patients admitted from January 2008 through December 2009 were reviewed and analysed.Results: Total number of patients included in this study was 122. Out of them 39.3% (48) were females. The mean age was 51.34 (SD 22.18) years. The most common causes of acute kidney injury are ischemic acute tubular necrosis, followed by sepsis and obstruction respectively. Mortality rate was 18.9%.Conclusion: Mortality rate of AKI in our set up was 18.9%.Key words: glomerular, tubular necrosis, creatinine

Is diffusion weighted imaging adding value in diagnosis of focal hepatic lesions? Experience in 50 patients

Introduction: Diffusion weighted imaging (DWI) offers molecular information that complements the morphologic information obtained with conventional magnetic resonance imaging (MRI) and can reflect the functions and structures of the body without trauma.Aim of the work: To assess the role of DWI as a routine sequence in a MRI study to help in differentiating liver lesions.Patients and methods: The study included 50 patients referred to do a MRI study to diagnose and/or to confirm the ultrasonographic or CT findings of focal hepatic lesions. The examination was done on 1.5T superconducting magnet MRI machines; Philips Gyroscan Intera version 12.1.1.2 (Best, The Netherlands) and Siemens Magnetom Avanto (Erlangen, Germany) machine.Results: All studied patients had a focal hepatic lesion either on top of cirrhotic liver or non cirrhotic liver. DWI was found to be helpful with the routine MRI sequences to reach the diagnosis. The final diagnosis was confirmed by histopathological examination or follow up. A cutoff value of ADC for benign lesions was found to be 1.25 x 103 mm2/s.Conclusions: DWI should be included as a basic sequence in the routine MRI study of the liver as it helps in diagnosis and so reaching a final diagnosis or at least trying to narrow the list of differential diagnosis.KEYWORDS MRI; DWI; Diffusion restriction; Hepatic focal lesio

IMPROVED HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY/MASS SPECTROSCOPY (HPLC/MS) METHOD FOR DETECTION OF ANTHRAQUINONES AND ANTIOXIDANT POTENTIAL DETERMINATION IN ALOE SINKATANA

Objectives:  Medicinal plants, either as an extract, pure compound or as a derivative, offer limitless opportunities for the discovery of new drugs. Sudan is a very rich source of medicinal plants which are used in the treatment of a wide range of diseases. Aloe sinkatana, has great potential to be developed as drug by pharmaceutical industries. The present study is undertaken to investigate the antioxidant potential of Aloe sinkatana by DPPH radical scavenging activity. In addition, the study also performed to explore the possibility of using HPLC-MS technique for the determination and analysis of Aloe sinkatana. Methods:  The extracts of Aloe sinkatana were analyzed for antioxidant activity by using DPPH free radical scavenging activity. The results indicated that the extracts showed a high effective free radical scavenging in the DPPH assay, also these extracts exhibited a noticeable antioxidant effect at low concentrations. Results:  During in vitro evaluation the antioxidant potential of methanolic extract was the highest, followed by aqueous extract  in DPPH radical scavenging activity. So the methanolic extract of the plant, exhibited a great antioxidant effect at 50 μg/ml which may be attributed to high phenolic content. Therefore, methanolic extract to be a more active radical scavenger than aqueous extract. The HPLC-MS analysis had shown the methanolic extract of Aloe sinkatana to be rich in the major anthraquinones and their glucosides, which revealed 9 compounds, and also UV spectroscopy detected the presence of two flavonoids. Conclusion:  The results indicated that the extracts of Aloe sinkatana  is a potential source of natural antioxidants or nutraceuticals with potential application to reduce oxidative stress with consequent health benefits. Due to stronger antioxidant potential and phytochemical composition, Aloe sinkatana could be proved as a valuable prospect in pharmaceutical formulations by taking part in the antioxidant defense system against generation of free radicals.                              Peer Review History: Received 26 March 2020; Revised 15 April; Accepted 4 May, Available online 15 May 2020 Academic Editor: Dr. Ali Abdullah Al-yahawi, 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: 4.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewer(s) detail: Prof Cyprian Ogbonna ONYEJI, Obafemi Awolowo University, Ile-Ife, Nigeria, [email protected] Dr. Gehan Fawzy Abdel Raoof Kandeel, Pharmacognosy Department, National Research Centre, Dokki, 12622,  Giza, Egypt, [email protected]  Dr. Nyunaï Nyemb, Ministry of Scientific Research and Innovation of Cameroon, [email protected]  Similar Articles: ANTIHYPERGLYCEMIC AND ANTI-OXIDANT POTENTIAL OF ETHANOL EXTRACT OF VITEX THYRSIFLORA LEAVES ON DIABETIC RAT

Binding to CSA receptor is associated with asymptomatic and mild malaria: a preliminary study using P.falciparum field isolates from Sudan

Malaria imposes great socio-economic burden on humanity, and afflicts approximately 90 countries and territories in the tropical and subtropical regions, almost one half of them are in Africa, South of Sahara. Sequestration of parasitized erythrocytes within the small vessels of vital organs is a key event in the pathogenesis of malaria and responsible of virulence of Plasmodium falciparum parasite. To find out whether the ability of infected red blood cells (IRBCs) to adhere to a specific receptor is a risk factor for developing severe clinical manifestation of the disease, in-vitro cytoadhesion and inhibition experiments were performed on field isolates obtained from five symptomatic and five asymptomatic patients inhabiting Gazira State, Central Sudan. The results showed significant lower levels (

Detection of Optimum pH of Momordica balsamina Seeds Lectin

Background: Lectins are carbohydrate binding proteins of non-immune origin that reversibly and non-enzymatically bind carbohydrates with high specificity for the chemical structure of the glycan array without changing their structure.Objectives: The present study aimed to detect the optimum pH of Momordica balsamina seeds lectin (MbSL).Materials and Methods:A season fresh of Momordica balsamina fruit seeds were brought from urban areas of Sudan (Gadarif and north Kurdofan states), then the lectin was isolated from saline extract by affinity chromatography on alpha agarose lactose matrix then the purified lectin activity was evaluated in different buffers to detect the optimum pH.Results: The activity of the lectin remained stable in the pH range 2-12.Conclusion: A lactose-binding lectin from seeds of Momordica balsamina medicinal plant shares a high degree of similarity with other Cucurbitaceae family lectins in term of their physicochemical features including sugar specificity, effect of pH on lectin stability.Keywords: Momordica balsamina; lectin; seeds; plant lectin; pH; protein

Inducible clindamycin resistance and nasal carriage rates of Staphylococcus aureus among healthcare workers and community members

Background: Nasal carriage of Staphylococcus aureus is becoming an increasing problem among  healthcare workers and community individualsObjectives: To determine the prevalence of methicillin-resistant S. aureus (MRSA) nasal colonization and inducible clindamycin resistance (ICR) of S. aureus among healthcare workers at Soba University Hospital and community members in Khartoum State, Sudan.Methods: Five hundred nasal swabs samples were collected during March 2009 to April 2010. Isolates were identified using conventional laboratory assays and MRSA determined by the disk diffusion method. The D-test was performed for detection of ICR isolates with Clinical Laboratory Standard Institute guidelines.Results: Of the 114 S. aureus isolated, 20.2% represented MRSA. The occurrence of MRSA was  significantly higher among healthcare worker than community individuals [32.7% (18/55) vs. 6.9% (5/59)] (p=0.001). Overall the 114 S. aureus isolates tested for ICR by D-test, 29 (25.4%) yielded inducible resistance. Significantly higher (p=0.026) ICR was detected among MRSA (43.5%) than methicillin-susceptible S. aureus (MSSA) (20.9%).Conclusion: MRSA nasal carriage among healthcare workers needs infection control practice in hospitals to prevent transmission of MRSA. The occurrence of ICR in S. aureus is of a great concern, D- test should be carried out routinely in our hospitals to avoid therapeutic failure.Keywords: S. aureus nasal carriage, healthcare workers, community members, inducible clindamycin resistanc