Application of Quality by Design Principles to Study the Effect of Coprocessed Materials in the Preparation of Mirtazapine Orodispersible Tablets.

The aim of this study was to determine the effect of two coprocessed materials in presence and absence of superdisintegrant (kyron T314) in the preparation of mirtazapine orodispersible tablets. Mirtazapine solubility was increased by complexation with kleptose forming an inclusion complex in a ratio 1:1. Quality by Design (QbD) was incorporated to determine the material attributes and the critical quality attributes (CQAs). Box behnken design was applied to study the effect of three independent variables X1: amount of lufiflash, X2: amount of pearlitol flash and X3: % of kyron T314 on two responses, Y1: dissolution after 1 minute and Y2: disintegration time. All formulated ODTs showed disintegration time less than 35 seconds and all formulations showed a notable increase in dissolution rate. Design space was determined from the overlay plot of different variables, X1 and X2 and X3 at two levels of the superdisintegrant. The one with maximum predicted dissolution rate and minimum predicted disintegration time was a formulation containing ludiflash (X1)= 9.25 mg, pearlitol flash (X2= 50 mg) and kyron T314= 3%. This formulation (Test ODT) was prepared and was subjected to in vivo study. Mirtazapine in human plasma was determined by LC-MS/MS and different pharmacokinetic parameters was determined for both test ODT and conventional oral tablet (Remeron). The pharmacokinetic parameters indicated that the two formulations are bioequivalence

Application of Quality by Design Principles to Study the Effect of Coprocessed Materials in the Preparation of Mirtazapine Orodispersible Tablets.

The aim of this study was to determine the effect of two coprocessed materials in presence and absence of superdisintegrant (kyron T314) in the preparation of mirtazapine orodispersible tablets. Mirtazapine solubility was increased by complexation with kleptose forming an inclusion complex in a ratio 1:1. Quality by Design (QbD) was incorporated to determine the material attributes and the critical quality attributes (CQAs). Box behnken design was applied to study the effect of three independent variables X1: amount of lufiflash, X2: amount of pearlitol flash and X3: % of kyron T314 on two responses, Y1: dissolution after 1 minute and Y2: disintegration time. All formulated ODTs showed disintegration time less than 35 seconds and all formulations showed a notable increase in dissolution rate. Design space was determined from the overlay plot of different variables, X1 and X2 and X3 at two levels of the superdisintegrant. The one with maximum predicted dissolution rate and minimum predicted disintegration time was a formulation containing ludiflash (X1)= 9.25 mg, pearlitol flash (X2= 50 mg) and kyron T314= 3%. This formulation (Test ODT) was prepared and was subjected to in vivo study. Mirtazapine in human plasma was determined by LC-MS/MS and different pharmacokinetic parameters was determined for both test ODT and conventional oral tablet (Remeron). The pharmacokinetic parameters indicated that the two formulations are bioequivalence

Surface architecture of the mouth cavity of Pagellus affinis (Boulenger, 1888)

The topological characteristics of the mouth cavity of the carnivorous fish Pagellus affinis was studied by using a light microscope. The results revealed that all the teeth of P. affinis are pointed and canine-like, papilliform teeth present on the premaxillae and the anterior regions of the dentaries are associated with seizing, grasping and holding of prey. The morphology and distribution of different taste buds of P. affinis were predominantly localized at the anterior and tongue regions of the mouth cavity. Two types of taste buds are elevated from the epithelium at different levels, which may be useful for ensuring full utilization of the gustatory ability of the fish, detection and analyzing of taste substances, as well as for assessing the quality and palatability of food, during its retention in the mouth cavity. Observations of the surface architecture of the mouth cavity of P. affinis are discussed within the context of feeding and habitat preferences as well as ecomorphological adaptation of the species

Evaluation of microalbuminuria in patients with systemic sclerosis as an indicator of early renal damage and increased morbidity

AbstractIntroductionRenal involvement and systemic vascular damage have been shown to be significantly affecting prognosis in systemic sclerosis.Aim of workMicroalbuminuria detection in SSc patients as an indicator of early renal involvement and its correlation with various SSc clinical, laboratory parameters and severity of organ systems’ damage assessed by Scleroderma Assessment Questionnaire.Patients and methodsForty SSc patients (33 females and 7 males) with mean age of 27.48±12.56years and mean disease duration of 6.2±4.14years were included. Twenty-four (60%) had lSSc; 13 (32.5%) had dSSc and 3 (7.5%) patients had SSc sine scleroderma.ResultsEight (20%) had microalbuminuria and 9 (22.5%) patients had decreased creatinine clearance. Albumin/creatinine ratio was significantly higher among dSSc patients compared to those with lSSc and SSc sine scleroderma (X2=9.077; p=0.01). Albumin/creatinine ratio showed significant positive correlations with telangiectasia (r=0.322; p=0.04) and mRodnan’s skin score (r=0.352; p=0.026) and negative correlations with inter-incisor distance (r=−0.525; p=0.001) and pleurisy (r=−0.446; p=0.004). Albumin/creatinine ratio correlated significantly and positively with IMSS and IDS indices of SAQ (r=0.378, 0.32; p=0.016, 0.044, respectively). SSc patients with microalbuminuria showed significantly higher mean IDS than those without (1.058 vs. 0.631, p=0.04). No statistically significant correlations were found between creatinine clearance and the different demographic, clinical features and the indices of SAQ.ConclusionMicroalbuminuria compared to creatinine clearance may be a more sensitive indicator of early renal affection and predictor of increased morbidity

A Qualitative Study on Factors Affecting the Clinical Learning of Nursing students in College of Nursing, Kuwait

The aims of the study were to identify the factors facilitating and hindering the clinical learning of nursing students in the College of Nursing, Kuwait. Clinical practice is a vital component of the nursing education. Nursing students encounter various problems during their clinical rotation. Identification of the factors that facilitate and hinder the clinical learning will provide a greater insight to develop an effective clinical teaching strategy in nursing education. A descriptive qualitative research design was used. The study included 120 nursing students selected through convenient sampling technique from level 2 to level 5, Associated Degree in Nursing Program.  Data was collected via focus group interviews with five students in each group. All interviews were recorded using an audio recorder and the transcripts of the interviews were coded. Data obtained were categorized under the factors affecting clinical learning of nursing students.  Content analysis was used to analyze the data. Two main themes were recognized through analyzing the data were facilitating factors and hindering factors. The various categories of facilitating factors included clinical practice, clinical supervision, clinical instructors, team factors, client related factors, students’ personal factors and laboratory practice. Excellent opportunities for learning, more hands on experiences, availability of equipment, continuous supervision as small working groups, educational behavior of clinical instructors, cooperative staff, effective communication with peer groups and clinical teachers, client cooperation and acceptance, personal motivation and effective laboratory practice  stimulated the clinical learning of students as perceived by the participants of the study. In contrast, the students identified hindering factors like clinical teachers’ incompetence, non-supportive staff, fewer opportunities to practice skills, patient refusal, language barrier, rejection, and blaming by the staff, teachers and clients. In addition, personal factors such as less English proficiency, family responsibilities, inadequate clinical hours, early clinical timings and standing for too long were the main hindering factors of clinical learning identified by the students. In conclusion, the research results provide an in depth understanding of nursing students’ clinical experiences in Kuwait. Deeper understanding of the factors affecting the clinical learning of the students help to draw the attention of various personnel involved in nursing education, practice and administration for the factors which facilitate or hinder the quality of learning experience among the nursing students. Keywords: Qualitative study, factors affecting, clinical learning, nursing student

Evaluation of serum hepcidin in assessment of iron status in renal transplant patients

Background: Hepcidin is a 25 aminoacid peptide that isproduced primarily by the liver in response to a varietyof stimuli known to modulate tissue iron stores and itsserum availability. It circulates in plasma, is filtered bythe kidney, and accumulates in urine. The presence ofhepcidin in the plasma negatively regulates the egress ofiron from the cells and macrophages, involved intransport of iron into the extracellular spaces. Hepcidinbinds to ferroportin 1 present on the cell surface leadingto the internalization of ferroportin 1 and subsequentdegradation. Hepcidin has also been shown to be anacute phase reactant increased by interleukin 6 (IL-6) andmarkedly induced by infection and inflammation.Documentation of the role of hepcidin in thedevelopment of anemia in chronic kidney disease andwhether it can be used as a marker of iron status inchronic kidney disease (CKD) has been sought in manystudies.The aim of this study was to detect the value of hepcidinas a marker of iron status in post renal transplantrecipients as compared with chronic renal failure (CRF)patients on hemodialysis.Results: In our study we found the level of serumprohepcidin in the renal transplant recipient group to becomparable to the control group. In the group with CKDthe serum prohepcidin was significantly lower thancontrols as well as the transplant recipients (p-value:0.00). There was no significant difference between theCKD group with higher hemoglobin and those withlower hemoglobin. From the correlation between theacute phase proteins and prohepcidin we found a positivecorrelation between serum ferritin, CRP and prohepcidinonly in the group with CKD on hemodialysis.Conclusion: We suggest that serum prohepcidin can be used as a routine measurement in transplant recipients as an indicator of the iron stores in the body. Further dedicated studies on large groups of patients need to be done to verify the usefulness of such a test

Knowledge, attitude and practice of in-home medication disposal in U.A.E.

Background: Medication disposal is one of the topics overlooked by the population in the United Arab Emirates. The present study aims at assessing the knowledge, attitude and practice of public to appropriate disposal of medications in Sharjah, UAE.Methods: A cross-sectional study on randomly selected subjects was conducted using a pre-piloted questionnaire written in Arabic and English and distributed to 250 subjects. The survey was designed with 22 questions to assess knowledge, attitude and practice on safe disposal of expired medication.Results: More than half (120, 54.8 %) of the participants were females of age 17-25 (100, 45.7%) and with a university or a higher degree (124, 56.6%). A total of 131 (59.8%) of the participants reported that they do not take any precautions when disposing hazardous products and they just throw them in the general waste. Regardless of their educational level, 90 (41.1%) of the respondents believed that throwing medications in the general waste is the safest way of disposal. The majority of participants (202, 92.3%) reported that they never received counselling from pharmacists on safe disposal of expired and unused medications.Conclusions: International guidelines on safe medication disposal need to be adopted by health authorities. Providing secure collection boxes in various residential areas and increasing public awareness of medication’s safe disposal are important steps that could be implemented in the UAE. Pharmacists should also play a major role in guiding and instructing patients on this topic

Malnutrition and its association with functional, cognitive and psychological status among Palestinian older adults in long-term care houses

Older adults often suffer from psychological, functional and health-related diseases. Literature has documented the relationship between, malnutrition with adverse health outcomes. This study aims to examine the relationship between malnutrition with the cognitive, functional and psychological status of older adults living in long-term care houses. The study employed a cross-sectional approach in which 99 participants were included from seven nursing homes in six different cities across the West Bank, Palestine. The nutritional status of older adults was assessed using anthropometric measurements and meal patterns. Malnutrition risk was assessed using Mini Nutritional Assessment; the cognitive function using Mini Mental Status Examination; the functional status using the Activity of Daily Living. Results: A total of 99 participants (45.5%) men and (54.5%) women were included in the final data analysis. The results revealed 47% of the participants were at risk of malnutrition, while 23% were malnourished. Variables that were significantly associated with malnutrition; male gender, higher score of depressive symptoms, and impaired cognitive function, p < .05 using chi square test. However, number of meals and hours of overnight fasting were not associated with being malnourished. Greater dependency level was associated with high risk of malnutrition, p < .05 using One Way ANOVA test. Conclusion: Risk of malnutrition was common among the study sample, and it was associated with impaired cognitive, psychological and functional status. Hence, there is a need to provide older adults living in long-term care houses with health programs to enhance their overall health and decrease the level of dependency. These findings are important to design educational programs targeting the stakeholders in the long-term care facilities to improve the residents' nutritional and functional status

Association of Neuregulin-4 levels and body mass index with hyperandrogenism in Polycystic Ovary Syndrome patients

Background: Polycystic Ovary Syndrome (PCOS) is a common endocrine and metabolic disease that affects approximately 15% of women of childbearing age worldwide. It is one of the causes of infertility and is characterized by hirsutism, acne, persistent or interrupted anovulation, and hyperandrogenemia. Neuregulin-4 (NRG-4) is an adipokine hormone from the protein neuregulin family. Its level is greater in PCOS than in control women, and Neuregulin-4 is linked to body fat percentage and liver fat, as well as insulin resistance (IR). Objectives: To estimate the serum NRG-4 levels in women diagnosed with (PCOS), to compare it with, non-PCOS healthy control and to explore the effect of hyperandrogenism on the obtained result. Patients and Methods: A case-control study was conducted in the Gynecology and the Infertility Clinics in Kut - Zahraa Hospital, Medical City, from September to December 2022. The study included 120 women aged (18-42) years, 60 of whom were diagnosed with polycystic ovaries, and the other 60 were in the control group. Results: Women with PCOS had a significantly higher NRG-4, LH, LH/FSH ratio, testosterone, free testosterone, and Dehydroepiandrosterone sulfate (DHEA-S) than the control groups. In this study, NRG-4 was significantly higher in obese and overweight PCOS women than in normal-weight women. Conclusion: The mean serum NGR-4 concentration is significantly increased in women with PCOS and could be a part of metabolic syndrome. NGR-4 levels were associated with obesity, hyperandrogenism (testosterone, free testosterone, and DHAES) and may have a role in the development of PCOS. Received: May,, 2022 Accepted: Oct, 2023 Published: Jan.202

Study of Thermal Analysis Behavior of Fenbendazole and Rafoxanide

Purpose: Thermal analysis techniques have been applied to study the thermal behavior of fenbendazole (Fen) and rafoxanide (Raf). Semi-empirical molecular orbital calculations were used to confirm these results. Methods: Thermogravimetric analysis, derivative thermogravimetry, differential thermal analysis and differential scanning calorimetry were used to determine the thermal behavior and purity of the drugs under investigation. Results: Thermal behavior of Fen and Raf were augmented using semi-empirical molecular orbital calculations. The purity values were found to be 99.17% and 99.60% for Fen and Raf, respectively. Conclusion: Thermal analysis techniques gave satisfactory results to obtain quality control parameters such as melting point and degree of purity at low cost, furthermore, its simplicity and sensitivity justifies its application in quality control laboratories