Syringe Research Articles

Development of a generic approach for monitoring leachable compounds in hospital pharmacy-prepared prefilled plastic packaging by ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry with postcolumn infusion

Prefilled plastic packaging is time- and cost-effective in hospital pharmacy because it prevents waste, preparation errors, dosage errors, microbial contamination and accidents. This packaging mostly includes prefilled syringes (PFS), intravenous (IV) bags and vials intended for long-term storage that can be used for immediate treatment. There is a rising availability in the market for prefilled drug products due to their practical approach. Leachable compounds could be evaluated in hospital pharmacy-prepared prefilled drug solutions. The Pharmacy Department at the Lausanne University Hospital has developed an innovative, highly sensitive, and generic method by postcolumn infusion based on ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry (LC-HRMS) for the analysis of plastic additives in hospital pharmacies. The postcolumn infusion solution was developed with 2% ammonium hydroxide in methanol on a representative set of 30 candidate compounds with different physical-chemical properties, such as log P and molecular structure, to represent the most important categories of additives. The LODs obtained for all compounds ranged from 0.03 to 7.91 ng/mL with linearity up to 250 ng/mL. Through this screening method, plastic additives can be rapidly identified due to the combined use of retention time, exact mass (including isotopic pattern) and MS/MS spectra. In addition, the users can screen for vast categories of plastic additives, including plasticizers, epoxy monomers, antioxidants, UV stabilizers, and others. The screening is facilitated by assessments of a complex in-house-built database for extractable and leachable trace assessment (DELTA), containing 205 compounds for unambiguous identification. Relative response factors were established for all analytes to obtain a semiquantitation of compounds. Moreover, the database also contains valuable estimative toxicology information, which was obtained through calculating their permissible dose exposure threshold; thus, estimative toxicology assessment can be performed for identified compounds in prefilled drug products. This method and the database were applied to a hospital pharmacy-prepared prefilled vancomycin syringe for paediatric use. Ultrasound-assisted dispersive liquid-liquid microextraction (UA-DLLME) was used to prepare the samples for leachable analysis. As a result, 17 plastic additives were formally identified, and their concentrations were estimated. A toxicology assessment was performed by comparing their concentrations with their theoretical PDE thresholds. In conclusion, the prefilled drug solution released a negligible amount of known leachables that appeared to be safe for use in neonates and children.

Impact of Prefilled Syringes and Masking on Postintravitreal Injection Endophthalmitis.

Purpose: To compare rates of endophthalmitis (1) following intravitreal injection of antivascular endothelial growth factor therapies with glass-vial preparation (GVP) vs prefilled syringes (PFS) and (2) before and after masking protocols were implemented. Methods: Medical records within a multicenter retina practice in Houston, Texas, from January 2015 to August 2021 were retrospectively reviewed. The primary outcome was rate of endophthalmitis after intravitreal injection. Results: A total of 307 349 injections were performed during the study period and 101 cases of endophthalmitis were identified (0.033%). PFS use was associated with a decreased risk of endophthalmitis (relative risk [RR], 0.320; 95% CI, 0.198-0.518, P < .001); 54 cases of endophthalmitis occurred in the GVP group of aflibercept and ranibizumab (0.052%) compared with 24 in the PFS group (0.017%). There was no difference in the endophthalmitis rates with or without universal masking (RR, 0.953; 95% CI 0.616-1.473, P = .91). Discussion: PFS use was associated with a significant reduction in the rate of endophthalmitis while the use of surgical face masks did not appear to significantly impact the rate of endophthalmitis.

Remineralization ability of different root canal sealers

AimsThis research was designed to contrast the biocompatibility and remineralization ability of different sealers (BioRoot, MTA-FillApex and GuttaFlow-Bioseal). MethodTwenty rabbits were used in this study, they were randomly divided into 4 groups equally depending on the observation time“3,7,14, and 28 days” post-implantation. Each rabbit was generally anesthetized,“7cm”long incision was made on the skin of the right and left sides of the ventral aspect of the mandible of each rabbit, 4 bony cavities of approximately“5mm”in depth and“2mm”in diameter (2 cavities on the left side and 2 cavities on the right side of mandible of each rabbit) were made in the cortical surface of the buccal alveolar bone. The sealers mixed depend on manufactural instructions and immediately insert into the prepared cavities (in the right side the BioRoot and MTA-FillApex were placed while on the left side, GuttaFlow-Bioseal was placed in one cavity and the other cavity was left unfilled as control).The same volume of each sealer was placed in the corresponding cavity using disposable syringes. After each observation period, the animals were sacrificed and bone biopsy from the tested area was taken and examined histologically using Olympus light microscopy at“400X”magnification. ResultsThe obtained data were analyzed through non-parametric statistical tests using SPSS software version“22”.Kruskal-Wallis test and Mann - Whitney test were utilized at“0.05”levels of significance to evaluate the results. GuttaFlow-Bioseal displayed excellent biocompatibility in comparison to other groups indicated by low inflammatory tissue reaction at all evaluation intervals. While the BioRoot group represented better osteo-conductivity although statistically not significant than GuttaFlow-Bioseal group. ConclusionBioRoot and GuttaFlow-Bioseal showed higher osteo-conductivity and biocompatibility than MTA-FillApex. However, all sealer used in this study were well tolerated by bone tissue and might accelerate bone repair.

Disposable Dosators Intended for Dry Powder Delivery to Mice.

Dry powder inhalers offer numerous advantages for delivering drugs to the lungs, including stable solid-state drug formulations, device portability, bolus metering and dosing, and a propellant-free dispersal mechanism. To develop pharmaceutical dry powder aerosol products, robust in vivo testing is essential. Typically, initial studies involve using a murine model for preliminary evaluation before conducting formal studies in larger animal species. However, a significant limitation in this approach is the lack of suitable device technology to accurately and reproducibly deliver dry powders to small animals, hindering such models' utility. To address these challenges, disposable syringe dosators were developed specifically for intrapulmonary delivery of dry powders in doses appropriate for mice. These dosators load and deliver a predetermined amount of powder obtained from a uniform bulk density powder bed. This discrete control is achieved by inserting a blunt needle to a fixed depth (tamping) into the powder bed, removing a fixed quantity each time. Notably, this dosing pattern has proven effective for a range of spray-dried powders. In experiments involving four different model spray-dried powders, the dosators demonstrated the ability to achieve doses within the range of 30 to 1100 µg. The achieved dose was influenced by factors such as the number of tamps, the size of the dosator needle, and the specific formulation used. One of the key benefits of these dosators is their ease of manufacturing, making them accessible and cost-effective for delivering dry powders to mice during initial proof-of-concept studies. The disposable nature of the dosators facilitates use in animal procedure rooms, where cleaning and refilling reusable systems and weighing materials is inconvenient. Thus, developing disposable syringe dosators has addressed a significant hurdle in murine dry powder delivery for proof-of-concept studies, enabling researchers to conduct more accurate and reproducible preliminary studies in small animal models for pulmonary drug delivery.

Relationship between blood components, inflammatory factors and bacterial spp that cause tonsillitis and dental caries in Iraqi children

Aims and Objectives: Study the correlation between Anti streptolysin O Titer (ASOT) and Reactive Protein (CRP)with other related factors and the correlation between bacterial species and related tested parameters. Materials and Methods: 120 patients were part of the study and were divided into 6 groups; each group had 20 patients aged 6–12 years. Blood Sample Collection About 10 ml was withdrawn from each patient via vein puncture using 10 ml disposable syringes, 5 ml for immunological study and 5 ml for hematological study. Results: The results of ASOT titer showed a highly significant positive correlation with Monocytes and a highly negative correlation with eosinophil. CRP was found to have a highly significant positive correlation with eosinophils and lymphocytes and a highly negative correlation with neutrophil and monocyte percentage. With a positive correlation with ESR. Conclusion: Our study shows that ASOT is still a useful diagnostic tool for tonsillitis. CRP levels in the tonsillitis patients group were significantly higher than in other groups. In contrast, ESR levels in the tonsillectomy patients group were significantly higher than in other groups. Keywords: blood components, inflammatory factors, bacterial spp, tonsillitis, dental caries

Assessing pyrolysis performance and product evolution of various medical wastes based on model-free and TG-FTIR-MS methods

The COVID-19 pandemic has caused a substantial rise in the amount of medical waste, posing additional hurdles in waste management. Disposing of this waste properly is essential to curb transmission of the diseases. The pyrolysis reaction kinetics, synergistic interactions, and pyrolysis gas release behavior of typical constituents of medical waste (MW): syringe (SY), medical gloves (MG), cotton swab sticks (CS), and their blends were examined by utilizing advanced analytical techniques including TG, TG-FTIR, TG-MS, and kinetic models (Friedman, KAS). The experiments were conducted using a wide range of heating rates, namely 10, 20, 30, and 40 °C⋅min−1. The pyrolysis reactions were mainly endothermic, with main stages ranging from 352.0–480.0 °C, from 381.0–511.0 °C, from 200.0–404.5 °C, 336.6–509.9 °C, 375.4–477.6 °C, 384.0–500.9 °C, for SY, MG, CS, SY5MG5, SY7CS3, and MG7CS3, respectively. According to the KAS method, the average activation energies for the mono-pyrolysis of SY, MG, and CS were determined as 240.8, 226.1, and 147.5 kJ⋅mol−1 respectively. Interestingly, during the pyrolysis of blends such as SY5MG5, SY7CS3, and MG7CS3, the activation energies decreased to 177.2, 159.9, and 149.1 kJ⋅mol−1 respectively. Notably, the experimental activation energy values (Eexp) obtained during the co-pyrolysis were significantly lower than the calculated values (Ecal), revealing an apparent synergistic effect during the pyrolysis of various MW blends. The pyrolysis process of MW blends resulted in the release of significant volatile components, including CH4, CO, C3H6, CO2, C2H5OH, C4H8, C5H8, C6H6, C6H14, C7H8, and C8H10. The specific composition of these volatile components varied depending on the types of waste present in the blends.

Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.

Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of self-injection devices of SB4 and SB5 compared with the reference product injectors. A systematic search was conducted in PubMed using the search string "(Imraldi OR Hadlima OR SB5 OR Benepali OR Brenzys OR SB4) AND (preference) AND (device)" covering the period from 28 January 2016 (first introduction of SB4) to 31 May 2022. Only articles and abstracts on usability or preference-rating of SB4 and SB5 autoinjectors (AI) written in English were selected. Additional papers identified via manual search supplemented the retrieved papers. A total of nine articles and one conference poster were selected (seven surveys, one observational study, and two phase II studies). Overall, participants of the studies included nurses and rheumatologists, as well as patients who were from three medical specialties where these medicines are most commonly used (rheumatology, gastroenterology, and dermatology). The majority of patients and healthcare professionals rated ease of use and ease of grip as the most important device attributes. SB4/Pen and SB5/Pen were mostly preferred over their prefilled syringes (PFS), Enbrel/Pen, and Humira/Pen. The analyzed data on usability and device preference indicate that SB4/Pen and SB5/Pen were preferred over the other reference product autoinjectors, thanks to their button-free design, auditory and visual injection feedback, and overall ease of use. Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices.

Evaluating Ease of Use and Patient Safety of Dasiglucagon Hypo Pal Autoinjector for the Management of Hypoglycemia.

Severe hypoglycemia is a medical emergency that must be treated promptly in order to prevent complications or death in a patient. Patients who have been diagnosed with Type 1 diabetes and treated with insulin have the potential to experience a severe hypoglycemia episode, or low blood sugar. When a patient is experiencing severe hypoglycemia, it is imperative for this patient to receive glucose quickly. However, patients who are experiencing low blood sugar may not be able to manage for themselves, take food or liquid orally or may be unconscious. Glucagon is a medication that reverses low blood sugar. Up until 2018, glucagon had to be reconstituted immediately before injection because of the medication's lack of stability after reconstitution. A medication recently approved for patients 6 years through adult is Dasiglucagon. This form of glucagon comes in a ready-to-administer, pre-filled syringe, making it easier for caretakers and bystanders to administer in an emergency situation due to the readiness of the medication. The purpose of the paper is to evaluate literature that pertains to the ease of use and patient safety of dasiglucagon HypoPal autoinjector for the management of severe hypoglycemia.

Estimation of Gingival Crevicular Blood as Noninvasive Method to Determine the Blood Glucose Level: A Comparative Study.

The current study's aim was to assess gingival crevicular blood as a noninvasive method to measure blood glucose levels. The current study comprised a total of 50 patients who had been diagnosed with chronic periodontitis and age was ≥30 years old. The study's procedures were carried out after receiving informed consent. For finger capillary blood collection method, a sterile lancet was used to prick the finger and a drop of blood was taken, for gingival crevicular blood collection method, blood was taken from the gingival margin of the chosen site, and for venous blood collection method with the aid of a disposable syringe, a venous blood sample was taken from the patient's antecubital fossa for determining blood glucose levels. One-way analysis of variance (ANOVA) was used to examine the differences between the three methodologies' significance, and Karl Pearson's correlation (r) was used to determine their correlation. The maximum glucose level was found in venous blood (187.78 ± 18.23), followed by finger capillary blood (181.88 ± 21.67) and gingival crevicular blood (169.04 ± 11.24). And there was no significant difference between the different blood collection methods (p > 0.05). The positive significant correlation was found between gingival crevicular blood and finger capillary blood (r = 0.912, p < 0.001). Correlation with gingival crevicular blood and venous blood showed a positive correlation (r = 0.898, p < 0.001). Correlation between venous blood and finger capillary blood also showed a strong positive correlation (r = 0.988, p < 0.001). In conclusion, the findings of the current study suggest that blood drawn from the gingival crevicular during a clinical examination may be a great source for glucometric analysis. The gingival crevicular blood may show to be a promising technique for routine dental office screening for diabetes mellitus in periodontal patients, even if capillary/venous blood samples used for diabetes mellitus screening are the gold standard. Oral health is crucial for the early detection of many systemic disorders. As a result, dentists are crucial in the screening for systemic disorders. One of the prevalent chronic disorders is diabetes. Any systemic disease that is detected early enough can avoid long-term problems.

The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment.

The importance of B cells in multiple sclerosis (MS) has been demonstrated through the advent of B-cell-depleting anti-CD20 antibody therapies. Ofatumumab is the first fully human anti-CD20 monoclonal antibody (mAb) developed and tested for subcutaneous (SC) self-administration at monthly doses of 20mg, and has been approved in the US, UK, EU, and other regions and countries worldwide for the treatment of relapsing MS. The development goal of ofatumumab was to obtain a highly efficacious anti-CD20 therapy, with a safety and tolerability profile that allows for self-administration by MS patients at home and a positive benefit-risk balance for use in the broad relapsing MS population. This development goal was enabled by the unique binding site, higher affinity to B cells, and higher potency of ofatumumab compared to previous anti-CD20 mAbs; these properties of ofatumumab facilitate rapid B-cell depletion and maintenance with a low dose at a low injection volume (20mg/0.4ml). The high potency in turn enables the selective targeting of B cells that reside in the lymphatic system via subcutaneous (SC) administration. Through a comprehensive dose-finding program in two phase 2 studies (one intravenous and one SC) and model simulations, it was found that safety and tolerability can be further improved, and the risk of systemic injection-related reactions (IRRs) minimized, by avoiding doses≥30mg, and by reaching initial and rapid B-cell depletion via stepwise weekly administration of ofatumumab at Weeks 0, 1, and 2 (instead of a single high dose). Once near-complete B-cell depletion is reached, it can be maintained by monthly doses of 20mg/0.4ml. Indeed, in phase 3 trials (ASCLEPIOS I/II), rapid and sustained near-complete B-cell depletion (largely independent of body weight, race and other factors) was observed with this dosing regimen, which resulted in superior efficacy of ofatumumab versus teriflunomide on relapse rates, disability worsening, neuronal injury (serum neurofilament light chain), and imaging outcomes. Likely due to its fully human nature, ofatumumab has a low immunogenic risk profile-only 2 of 914 patients receiving ofatumumab in ASCLEPIOS I/II developed anti-drug antibodies-and this may also underlie the infrequent IRRs (20% with ofatumumab vs. 15% with the placebo injection in the teriflunomide arm) that were mostly (99.8%) mild to moderate in severity. The overall rates of infections and serious infections in patients treated with ofatumumab were similar to those in patients treated with teriflunomide (51.6% vs. 52.7% and 2.5% vs. 1.8%, respectively). The benefit-risk profile of ofatumumab was favorable compared to teriflunomide in the broad RMS population, and also in the predefined subgroups of both recently diagnosed and/or treatment-naïve patients, as well as previously disease-modifying therapy-treated patients. Interim data from the ongoing extension study (ALITHIOS) have shown that long-term treatment with ofatumumab up to 4years is well-tolerated in RMS patients, with no new safety risks identified. In parallel to the phase 3 trials in which SC administration was carried out with a pre-filled syringe, an autoinjector pen for more convenient self-administration of the ofatumumab 20mg dose was developed and is available for use in clinical practice.

Prevalence of Anaemia among Antenatal Clinic Attendees at A Tertiary Hospital in South West, Nigeria

Introduction: Anaemia in pregnancy is a global public health problem causing both maternal and perinatal morbidities and mortalities. Prevalent rates vary from one geopolitical region to the other. Efforts have been made to reduce this condition during pregnancy through the use of haematinics and other interventions. However, despite all the efforts put in place, pregnant women still present with this condition. This study was carried out to find out its prevalence rate and the factors responsible for it. Materials and Methods: It was a cross-sectional institutional based study carried out at the antenatal clinic of the University of Medical Sciences Teaching Hospital Complex, Akure, Ondo State, South West, Nigeria. The study used a systematic sampling to recruit 400 antenatal clinic patients over a period of 16weeks starting from the 16th of August to 16th of December 2022.The women were interviewed with copies of a structured questionnaire administered by trained research doctors who also helped in the collection of the blood samples. About 3mls of venous blood was collected from the antecubital vein using plastic disposable syringes into sample bottles containing ethylene diamine-tetra acetic acid (EDTA) and the bottles labelled accordingly. Packed cell volume and red cell morphology were done for the women at the time of recruitment. Data obtained were analysed using the Statistical Package for Social Sciences (SPSS Version 22). Descriptive statistics were computed for all relevant variables, Chi Square test and Multivariate logistic regression were used to test for association and possible risk factors for anaemia. The level of significance was set at ???? &lt; 0.05. Results: Most of the women were within 30years- 39years (51.2%, 205) with a mean age of 31.61years±5.37years. Most of them were married (97.3%, 389), were Christians (94.5%, 378), were Yorubas (82.8%, 331), were traders (40.3%, 161), had tertiary level of education (68.8%, 275) and lived in the urban areas of Ondo State (89.5%,358). Most had their first menses between the ages of 10 to 15 years (79.2%, 317) with a mean age of 14.24 ± 2.12 years. Majority had inter- pregnancy interval of ≤ 2 years (53.7%, 215). There was no history of bleeding in most of the women (91.5%, 366), many of them were in the third trimester of their pregnancy (64.1%, 257) with a mean gestational age of 28.83 ± 6.91 weeks. The prevalence of anaemia among the study participants was 40.0% (160/400) while 60% (240/400) were not anaemic. Among the participants who were anaemic, 77.5% (124/160) had mild anaemia, 22.5% (36/160) had moderate anaemia while none had severe anaemia. The only risk factors identified to be responsible for anaemia among the women were high parity and being in the third trimester of pregnancy. Conclusion: This study showed that the prevalence of anaemia is still high among our women mostly occurring among women of high parity and in the third trimester of pregnancy. Efforts must be intensified to address this condition through the use of haematinics which can be started pre-conception and adequate counselling on the need to fully recover from the effects of one pregnancy before embarking on another.

Cone-Beam Computed Tomography Evaluation of Rotary MM Files vs Manual K Files in Primary Molars: An In Vitro Study.

Rotary instrumentation in pediatric dentistry is an emerging concept, thus this study was performed to evaluate the remaining dentine thickness (RDT), canal transportation, centering ability, quality of obturation using cone-beam computed tomography (CBCT), and the time efficiency of rotary versus manual instrumentation in mandibular second primary molars. Forty mandibular primary second molars (160 canals) were randomly and equally allocated to four groups. Instrumentation was done using K files in groups I and II; in each group, the obturation was done by two different obturation techniques; incremental technique and disposable syringe technique, respectively. MM rotary files (Innovative Material and Devices, Inc. [IMD], Shanghai, China) were used in groups III and IV; in each group, the obturation was done by incremental technique and disposable syringe technique. Preoperative and postoperative CBCT scans were performed and evaluated for the RDT, centering ability, canal transportation, and the canal filling quality, which was assessed as (underfill, optimal fill, and overfill). Instrumentation time was recorded for groups I and II collectively (manual instrumentation), and groups II and III collectively (rotary instrumentation). Statistical analysis was done using Chi-square, ANOVA, and post hoc Tukey tests, at p < 0.05). The MM rotary file removed a significantly less amount of dentine at all levels specifically at the middle section (p = 0.003). The canal transportation was significantly higher in the manual group at the cervical level (p = 0.022). In all sections, the rotary group had significantly higher values of centering ratio than the manual group (p < 0.05), which means a lower deviation of rotary instruments. For both types of files, there was no significant difference between different obturation techniques (p > 0.05). Instrumentation time was significantly lower in the rotary group (p < 0.001). Regarding the dentine removal and the shaping ability of MM files acceptable results were obtained; however, no significant difference between the different obturation techniques. Notable time efficiency was reported in the rotary files as well. The use of rotary files resulted in better conservation of tooth structure, better canal centering, and obturation quality as well as less canal transportation and less instrumentation time compared to manual K files.

WITHDRAWN: Novel machine learning models for flow imaging microscopy sub-visible particle classification in protein formulations

Understanding the particulate content of formulated drug products is essential for ensuring patient safety. In particular, it is critical to assess the presence of aggregated proteins or extraneous particles (e.g. fibres) that pose potential dangers. Additionally, it is useful to be able to distinguish non-proteinaceous particles, such as silicone oil droplets that commonly occur in formulations stored in pre-filled syringes. Standard particle counting methods (e.g. light obscuration) provide only total numbers of particles of a given size, but provide no mechanism for particle classification. Significant recent work has focused on the use of flow imaging microscopy to enable simultaneous classification and counting of particles using machine learning (ML) models including convolutional neural networks (CNN). In this paper we expand upon this theme by exploring techniques for achieving high prediction accuracy when the size of the labeled dataset used for model training is limited. We demonstrate that maximum performance can be achieved by combining multiple techniques such as data augmentation, transfer learning, and novel (to this field) models combining imaging and tabular data.

Diagnostic Accuracy of Ultrasonography-Guided Fine Needle Aspiration Cytology in Abdominopelvic Masses: A Prospective Study.

Introduction Accurate diagnosis of deep-seated abdominopelvic masses is crucial to distinguish malignant from non-malignant lesions for proper treatment and prognosis. Ultrasonography-guided fine needle aspiration cytology (USG-FNAC) is a cost-effective and straightforward procedure that offers rapid diagnosis, facilitating early initiation of treatment. This study aimed to determine the diagnostic accuracy of USG-FNAC in comparison to the biopsy diagnosis of various abdominopelvic masses in a resource-limited setting. Materials and methods This prospective study enrolled 208 patients with clinically and ultrasonographically confirmed abdominopelvic masses over two years. Of these, 64 cases were excluded from the study because of the non-availability of biopsy specimens. The remaining 144 cases comprised 88 males and 56 females, with a male-to-female ratio of 1.57:1. Patients' ages ranged from 1.5 to 65 years, with most male patients aged 51 to 60 years and female patients aged 41 to 50 years. USG-FNAC was performed on these patients using a 22G spinal needle and a 10cc disposable syringe, and no complications were reported during the procedure. The cytological findings were compared to histopathological results when available. Dry smears were stained with May-Grunwald-Giemsa stain, while fixed smears were stained with Papanicolaou stain for cytological investigation. Results A total of 144 cases had both cytological and histological specimens available for comparison. The overall diagnostic accuracy of USG-FNAC was 90.97%, with 91.8% sensitivity for malignant lesions, 83.33% for benign lesions, and 85.7% for inflammatory lesions. Conclusions USG-FNAC provides high diagnostic accuracy for abdominopelvic masses, making it a valuable diagnostic tool in resource-limited settings. The technique allows for rapid diagnosis, triaging specimens for ancillary immunohistochemical and molecular studies, and in many cases, obviates the need for more expensive and time-consuming procedures like laparotomy and open biopsy.

The role of IL-6, and IL-12+p40 in Ischemic heart disease patients

Background: Ischemic heart disease (IHD) is often termed coronary artery disease or coronary heart disease; because it is usually caused by atherosclerosis that occurs when fatty materials and a substance called a plaque are built up on the walls of coronary arteries. Such consequences lead to a narrowing of these arteries and then blood flow can slow down or stop, causing chest pain, shortness of breath, heart attack and other related symptoms.&#x0D; Objectives: To investigate the correlation between Ischemic heart disease and patient’s descriptive data such as gender, age, and to evaluate the role of two cytokines IL-6 and IL-12+p40 in the aetiology of IHD, as well as to observe the relationship of IL-6 , IL-12+p40 and two related diseases diabetes mellitus and hypertension in IHD patients.&#x0D; Methodology: A total of 70 (55 males and 15 females) patients with ischemic heart disease (IHD; stable angina) were included in the study. They were admitted to the Coronary Care Unit (CCU) at Ibn-Al-Betar Hospital (Baghdad) for a surgical operation during the period July 2022 - April 2023. The diagnosis was made by the consultant medical staff at the hospital. In addition to the patients, a total of 20 apparently healthy individuals (control group), with no history of cardiovascular diseases, were included in the study for the purpose of comparison with patients, they were age- and gender matched with patients. five ml of peripheral blood were obtained by venipuncture from each patient before surgical operation using 5 ml disposable syringe, the blood was drawn in a plain tube (without anti-coagulant). Serum levels of IL-6 and IL-12+p40 were quantitatively determined in patients and control subjects by means of indirect sandwich ELISA test.&#x0D; Results: Thirty patients from total IHD patients were observed to have diabetic mellitus, and the frequency in males was more than in females (73.3 vs. 26.7%), twenty two IHD patients were observed to have hypertension in percentage higher in males than in females (77.3 vs. 22.7%). The results obtained from this study about age group distributions of IHD patients with diabetic are higher in 60 and more age group in percentage (63.3%) , as well as in hypertensive patients in percentage (68.2%). Serum levels of IL-6 for total patients are (404.8 pg/ml), diabetic (480.3 pg/ml), non-diabetic (250.8 pg/ml), hypertensive (451.6 pg/ml) and non-hypertensive (322.2 pg/ml), patients showed a significant increased serum level of IL-6 as compared to controls (155.7 pg/ml). The diabetic patients also showed a significantly higher level than non-diabetic patients (480.3 vs. 250.8 pg/ml), as well as, hypertensive patients (451.6 pg/ml) versus non-hypertensive patients (322.2 pg/ml). Serum level of IL-12+p40 for total patients (410.2 pg/ml), diabetic (357.7 pg/ml), non-diabetic (458.1 pg/ml), hypertensive (270 pg/ml) and non-hypertensive (420.5 pg/ml) patients showed a significant decreased level of IL-12+p40 as compared to controls (649.3 pg/ml). In contrast, the non-diabetic patients showed a significantly higher level than diabetic patients (458.1 vs. 357.7 pg/ml), as well as, non-hypertensive patients (420.5 pg/ml) versus hypertensive patients (270.0 pg/ml).&#x0D; Conclusion: The prevalence of IHD according to age are increased in older aged patients, the male show high infected percentage than female. Chronic diseases like hypertension and diabetes mellitus were contributed to the pathogenesis of IHD, and proinflammatory cytokine cascades play crucial roles in the onset and progression of IHD.&#x0D; Recommendations: Targeting cytokines in an attempt to develop pharmacological activators of some interleukins, and inhibitors of other ones, and this may provide effective means to control atherosclerosis and associated diseases (i.e. diabetes mellitus and hypertension).&#x0D; Keywords: IL-6, IL-12+p40, IHD

The Efficacy of Therapeutic Needling with Narrow-Band UVB in Patients of Stable Vitiligo

Objective: To determine the efficacy of therapeutic needling with narrow-band UVB in patients of stable vitiligo with type IV skin, which is the most common depigmenting skin disorder, characterized by clearly demarcated discolored patches of various shapes and sizes.Methodology: This descriptive case series was conducted on one hundred dermal skin patches of stable vitiligo in 20 patients presenting to the outdoor of Dermatology Department, Services Hospital Lahore from January- June 2019. They were subjected to therapeutic needling using 30 G disposable insulin syringe followed immediately by Narrow-Band UVB exposure thrice weekly for 6 months. The efficacy was determined by re-pigmentation of patches using "Five Grade Scale System." Patients were clinically assessed during and after completion of therapy. All the detailed information was collected through a specially designed proforma. Procedures and follow up of all the patients were conducted and SPSS version 23 was used to analyze the collected data. Descriptive and inferential statistics were used for present the results.Results: Out of 100 dermal patches of stable vitiligo in 20 patients, 58% patches showed grade 4 response i.e 75% or more re-pigmentation, which is therapeutically the first major step of depigmentation in this process, followed by reduction of pigmentation with further therapies.Conclusion: Therapeutic needling with Narrow-Band UVB is an effective therapy in the treatment of stable vitiligo in patients with type IV skin.

Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes

Investigate the incidence and mechanisms of sharps injuries (SI) to staff using Lovenox and generic enoxaparin prefilled syringes. Four national adverse event databases were examined over a 12-year period for incidence and brands involved with injury events to staff using enoxaparin prefilled syringes. The search revealed 581 adverse events (including 20 sharps injuries) associated with device malfunction in 8 of 16 brands, with one brand mentioned significantly more frequently than others. No national alert had been issued. Use of certain brands of enoxaparin prefilled syringes poses a small but serious risk of injury to staff. Conducting root cause analyses on all SI is essential, as is the need for regularly evaluating safer devices, reporting all device incidents, enabling simpler reporting of adverse events, and establishing more effective intervention by FDA and manufacturers.

A Novel Method for Administering Epinephrine during Neonatal Resuscitation.

This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation. Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone. For other emergency use drugs, prefilled medication syringes have decreased error and administration time. Twenty-one neonatal intensive care unit nurses were enrolled. Each subject engaged in four simulated neonatal resuscitation scenarios involving term or preterm manikins using conventional epinephrine or novel prefilled epinephrine syringes specified for patient weight and administration route. All scenarios were video-recorded. Two investigators analyzed video recordings for time to epinephrine preparation and administration. Differences between conventional and novel techniques were evaluated using the Wilcoxon Signed Rank Tests. Twenty-one subjects completed 42 scenarios with conventional epinephrine and 42 scenarios with novel prefilled syringes. Epinephrine preparation was faster using novel prefilled epinephrine syringes (median = 17.0 s, interquartile range [IQR] = 13.3-22.8) compared with conventional epinephrine (median = 48.0 s, IQR = 40.5-54.9, n = 42, z = 5.64, p < 0.001). Epinephrine administration was also faster using novel prefilled epinephrine syringes (median = 26.9 s, IQR = 22.1-33.2) compared with conventional epinephrine (median = 57.6 s, IQR = 48.8-66.8, n = 42, z = 5.63, p < 0.001). In a poststudy survey, all subjects supported the clinical adoption of prefilled epinephrine syringes. During simulated neonatal resuscitation, epinephrine preparation and administration are faster using novel prefilled epinephrine syringes, which may hasten return of spontaneous circulation and be lifesaving for bradycardic neonates in clinical practice. · Currently, epinephrine administration in neonatal resuscitation is inefficient and error prone.. · Prefilled epinephrine syringes hasten medication administration in simulated neonatal resuscitation.. · Clinical use of prefilled epinephrine syringes may be lifesaving for bradycardic neonates..

Variables Impacting Silicone Oil Migration and Biologics in Prefilled Syringes

Prefilled syringes (PFS) as a primary container for parenteral drug products offer significant advantages, such as fast delivery time, ease of self-administration and fewer dosing errors. Despite the benefits that PFS can provide to patients, the silicone oil pre-coated on the glass barrels has shown migration into the drug product, which can impact particle formation and syringe functionality. Health authorities have urged product developers to better understand the susceptibility of drug products to particle formation in PFS due to silicone oil. In the market, there are multiple syringe sources provided by various PFS suppliers. Due to current supply chain shortages and procurement preferences for commercial products, the PFS source may change in the middle of development. Additionally, health authorities require establishing source duality. Therefore, it is crucial to understand how different syringe sources and formulation compositions impact the drug product quality. Here, several design of experiments (DOE) are executed that focus on the risk of silicone oil migration induced by syringe sources, surfactants, protein types, stress, etc. We utilized Resonant Mass Measurement (RMM) and Micro Flow Imaging (MFI) to characterize silicone oil and proteinaceous particle distribution in both micron and submicron size ranges, as well as ICP-MS to quantify silicon content. The protein aggregation and PFS functionality were also monitored in the stability study. The results show that silicone oil migration is impacted more by syringe source, siliconization process and surfactant (type & concentration). The break loose force and extrusion force across all syringe sources increase significantly as protein concentration and storage temperature increase. Protein stability is found to be impacted by its molecular properties and is less impacted by the presence of silicone oil, which is the same inference drawn in other literatures. A detailed evaluation described in this paper enables a thorough and optimal selection of primary container closure and de-risks the impact of silicone oil on drug product stability.

Fine Needle Aspiration Cytology of Lymphnodes: A Hospital Based study in a Tertiary Health Care Center in Southern Odisha

Introduction: FNAC is widely accepted the most accurate sensitive, specific, cost-effective minimally invasive OPD technique to establish the basic diagnostic information not only to relieve the anxiety of the patients but also to provide materials for microbial culture, and decrease unnecessary surgery from the visibly accessible superficial masses. It also distinguishes a benign from a malignant entity that can obtain tissue for immuno-phenotyping &amp; molecular studies and obtain cellular &amp; genetic material for storage also useful for staging and follow up including response to treatment in patients with known malignancies. Our study was conducted on 796 Outpatients including all age groups &amp; sexes presenting with palpable enlarged lymph nodes not only for early diagnosis &amp; treatment but also to reveal the burden of various categories of diseases in tribal areas where our institution is situated. Material &amp; methods: FNAC was performed under aseptic precaution using a 22 to 24 Gauge needle attached to a 20CC disposable syringe. The aspirated material after smearing was treated with 95% ethyl alcohol for fixation and stained with H&amp; E and Papanicolaou stain &amp; air-dried smears are stained with Leishman stain. Modified Z-N stain was done wherever necessary followed by diagnosis based on clinic cytomorphological features. Result: Out of 796 cases the most common cause of lymphadenopathy in our study was found to be Tubercular lymphadenitis with 360 (45.22%) cases, the second most frequent entity was reactive lymphadenitis in 277(34.79%) cases followed by metastatic lesions in 47 (5.90%) cases and lymphoma 17 (2.13%) cases. Conclusion: FNAC is a simple, safe, reliable, and inexpensive method for early detection of various non-neoplastic (lymphadenitis) &amp; neoplastic lesions (lymphoma &amp; metastatic carcinoma) of enlarged lymph nodes which helped diagnose approximately 99% of cases.