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1.
Artículo en Inglés | MEDLINE | ID: mdl-38870528

RESUMEN

OBJECTIVES: To evaluate magnetic susceptibility artefacts produced by orthodontic wires on MRI and the influence of wire properties and MRI image sequences on the magnitude of the artefact. METHODS: Arch form orthodontic wires [four stainless steels (SS), one cobalt chromium (CC) alloy, 13 titanium (Ti) alloys] were embedded in a polyester phantom, and scanned using a 1.5-T superconducting magnet scanner with an eight-channel phased-array coil. All wires were scanned with T1-weighted spin echo (SE) and gradient echo (GRE) sequences according to the American Society for Testing and Materials (ASTM) F2119-07 standard. The phantom was also scanned other eight sequences. Artefacts were measured using the ASTM F2119-07 definition and OsiriX software. Artefact volume was analyzed according to metal composition, wire length, number of wires, wire thickness, and imaging sequence as factors. RESULTS: With SE/GRE, black/white artefacts volumes from all SS wires were significantly larger than those produced by CC and Ti wires (P < 0.01). With the GRE, the black artefacts volume was highest with the SS wires. With the SE, the black artefacts volume was small, whereas white artefacts were noticeable. The cranio-caudal extent of the artefacts was significantly longer with SS wires (P < 0.01). Although a direct relationship of wire length, number of wires and wire thickness with artefact volume was noted, these factors did not influence artefact extension in the cranio-caudal direction. CONCLUSIONS: Ferromagnetic/paramagnetic orthodontic wires create artefacts due to local alteration of magnetic field homogeneity. The SS-type wires produced the largest artefacts followed by CC and Ti.

2.
Cureus ; 16(5): e60291, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38872701

RESUMEN

Emphysematous pyelonephritis (EPN) represents a severe and acute infection localized in the renal parenchyma and surrounding perirenal area, typically observed in individuals with predisposing factors such as urinary tract obstruction, diabetes mellitus, or compromised immune function. Here, we present a unique case involving a 23-year-old female patient presenting to the emergency department with complaints of discomfort localized to the right side of her abdomen. Despite the absence of diabetes mellitus, the patient was diagnosed with EPN based on clinical presentation and imaging findings. Prompt and effective management was initiated under the care of the urology department, highlighting the importance of early recognition and intervention in mitigating the potential complications associated with this severe infectious process.

3.
Cureus ; 16(5): e59865, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38864065

RESUMEN

Cholangiocarcinoma of the common bile duct (CBD) presenting as empyema of the gallbladder is a rare entity that poses a risk of septicemia, septic shock, peritonitis, and abscess formation. This case report describes an elderly female presenting with pain in the right hypochondrium, a positive Murphy's sign, and a history of regurgitation and constipation. It highlights the value of imaging in the early diagnosis of this rare presentation of underlying malignancy. The most common cause of empyema of the gallbladder is acute cholecystitis, followed by gallbladder neck obstruction by a calculus. This report discusses the important role of imaging supported by clinical history, examination, laboratory tests, and histopathological findings to diagnose this rare presentation of empyema of the gallbladder as a complication of underlying cholangiocarcinoma. Additionally, it briefly discusses the change in the management line for cholangiocarcinoma patients with complications such as gallbladder perforation and septicemia. The study concludes that the possibility of underlying bile duct malignancy cannot be overlooked in patients with similar symptoms, particularly among the elderly.

4.
Cureus ; 16(5): e60081, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38860080

RESUMEN

Hemifacial spasm (HFS) arises from involuntary, recurrent, irregular tonic-clonic-like contractions of the muscles innervated by the facial nerve. Typically, compression of the facial nerve root exit on the same side is attributed to either a vascular loop or a mass located in the cerebellopontine (CP) angle. Dolichoectasia, alternatively termed dilated arteriopathy, is characterized by arterial dilatation, elongation, and tortuosity. Here, we present a case involving vertebrobasilar dolichoectasia (VBD) as the cause of HFS, alongside relevant imaging findings.

5.
Cureus ; 16(5): e60072, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38860105

RESUMEN

An uncommon congenital hamartomatous disorder called Proteus syndrome is characterized by multifocal tissue expansion originating from all three germinal layers. Diagnosis mainly relies on clinical and radiological criteria. Here, we present a case of a 13-year-old female child exhibiting bony, soft tissue, and vascular abnormalities, along with developmental delay. We conclude by highlighting the importance of imaging studies in conjunction with physical examination, which are characterized by general and specific criteria to diagnose this rare condition until a specific gene test becomes available.

7.
Seizure ; 119: 44-51, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38776617

RESUMEN

PURPOSE: P-glycoprotein (P-gp) has been hypothesized to be involved in drug-resistance of epilepsy by actively extruding antiseizure medications (ASMs) from the brain. The P-gp inhibitor tariquidar (TQD) has been shown to effectively inhibit P-gp at the human blood-brain barrier, improving brain entry of several ASMs. A potential strategy to overcome drug-resistance is the co-administration of P-gp inhibitors such as TQD to ASMs. Here we present data on the tolerability of single-dose TQD as a potential add-on medication to ASMs. METHODS: We performed a multi-centre cohort study including drug-resistant epilepsy patients and healthy controls from the United Kingdom and Austria. TQD was administered intravenously at five different doses (2 mg/kg or 3 mg/kg of TQD were given to drug-resistant epilepsy patients and healthy controls, higher doses of TQD at 4 mg/kg, 6 mg/kg and 8 mg/kg as well as a prolonged infusion aiming at a dose of 6 mg/kg were only given to healthy controls). Adverse events were recorded and graded using the Common Terminology Criteria (CTCAE) scale. Additionally, TQD plasma concentration levels were measured and compared between drug-resistant patients and healthy controls. RESULTS: In total, 108 participants received TQD once at variable doses and it was overall well tolerated. At doses of 2 or 3 mg/kg TQD, only two of the 19 drug-resistant epilepsy patients and a third of the healthy controls (n = 14/42) reported adverse events probably related to TQD. The majority of those adverse events (96 %) were reported as mild. One drug-resistant epilepsy patient reported adverse events 24-hours after TQD administration possibly related to TQD-induced increased ASMs levels in the brain. CONCLUSIONS: TQD is an effective and well tolerated P-gp inhibitor as a single dose and could potentially be used intermittently in conjunction with ASMs to improve efficacy. This promising strategy to overcome drug-resistance in epilepsy should be investigated further in clinical randomised controlled trials.


Asunto(s)
Miembro 1 de la Subfamilia B de Casetes de Unión a ATP , Anticonvulsivantes , Epilepsia Refractaria , Humanos , Epilepsia Refractaria/tratamiento farmacológico , Anticonvulsivantes/administración & dosificación , Anticonvulsivantes/efectos adversos , Masculino , Femenino , Adulto , Miembro 1 de la Subfamilia B de Casetes de Unión a ATP/antagonistas & inhibidores , Persona de Mediana Edad , Adulto Joven , Quimioterapia Combinada , Adolescente , Estudios de Cohortes , Quinolinas
8.
Int J Biol Macromol ; 270(Pt 1): 132392, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38754681

RESUMEN

The most likely materials for use in packaging are plastics. A lot of synthetic polymers are harming the environment. A plasticizer is required for all polymers to improve their characteristics and workability. The plasticizers come in liquid form and are also derived from fossil fuels, which are harmful to the environment. Producing functional and affordable biopolymer for packaging applications is a difficult task nowadays. The preparation of biofilm for packaging using biopolymer and bioplasticizer is the main aim of this work. The biopolymer poly L-lactic acid (PLA) is used, and the bio plasticizer is extracted from Pedalium murex plant. Chemical and mechanical methods are used to extract the plasticizer. Plasticization of polylactic acid biopolymer was done using the extracted plasticizer at additions of 1 %, 2 %, 3 %, 4 %, and 5 %. FT-IR spectroscopy, X-ray diffraction spectroscopy, and surface roughness values are used to characterise the prepared biofilms. Scanning electron spectroscopy pictures are utilised to evaluate the morphological orientation of the biofilms. Strawberries packed with biofilms are used to evaluate the barrier properties of biofilms using UV spectroscopy analysis. Thermal degradation behaviour is investigated using thermo gravimetric analysis. We examined the mechanical characteristics, such as tensile strength, elongation modulus, and elongation break percentage. The plasticizing effect of the plasticizer raises the elongation break percentage while decreasing the tensile strength and modulus. For 2 % plasticizer addition the elongation break increases and the tensile not much affected. To demonstrate biodegradability and microbial resistance, the soil degradation behaviour and antimicrobial activities were examined.


Asunto(s)
Biopelículas , Embalaje de Alimentos , Plastificantes , Poliésteres , Poliésteres/química , Plastificantes/química , Embalaje de Alimentos/métodos , Biopelículas/efectos de los fármacos , Frutas/química , Biopolímeros/química , Biopolímeros/farmacología , Resistencia a la Tracción , Espectroscopía Infrarroja por Transformada de Fourier
9.
Neurol Clin Pract ; 14(3): e200288, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38737515

RESUMEN

Background and Objectives: Dravet syndrome (DS) is one of the most common monogenic epilepsies. Alongside the core seizure and developmental phenotypes, problems with appetite, swallowing, and weight loss are frequently reported, necessitating gastrostomy in some. We explored the burden of feeding difficulties and need for gastrostomy across 3 DS populations in the United Kingdom. We document caregiver opinion and postgastrostomy outcomes, and provide guidance regarding feeding issues and gastrostomy in DS. Methods: A retrospective, observational study was conducted; data were collected from medical records of 124 individuals with DS attending clinics at the National Hospital for Neurology and Neurosurgery, and Great Ormond Street Hospital, and from 65 DS caregiver responses to a UK-wide survey. Results: In total, 64 of 124 (52%) had at least 1 feeding difficulty; 21 of 124 (17%) had a gastrostomy, and gastrostomy was being considered in 5%; the most common reasons for gastrostomy were poor appetite (81%) and weight loss/failure to gain weight (71%). Median age at gastrostomy was 17 years (range 2.5-59). Multivariate analyses identified several factors that in combination contributed to risk of feeding difficulties and gastrostomy, including treatment with several antiseizure medications (ASMs), of which stiripentol made a unique contribution to risk of gastrostomy (p = 0.048, odds ratio 3.20, 95% CI 1.01-10.16). Preinsertion, 88% of caregivers were worried about the gastrostomy, with concerns across a range of issues. Postgastrostomy, 88% of caregivers were happy that their child had the gastrostomy, and >90% agreed that the gastrostomy ensured medication compliance, that their child's overall health was better, and that quality of life improved. Discussion: Feeding difficulties are common in DS, and 17% require a gastrostomy to address these. Risk factors for feeding difficulties in DS are unknown, but ASMs may play a role. There is a high level of caregiver concern regarding gastrostomy preprocedure; however, postgastrostomy caregiver opinion is positive. Feeding difficulties should be proactively sought during review of people with DS, and the potential need for gastrostomy should be discussed.

10.
Lancet Neurol ; 23(6): 636-648, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38760101

RESUMEN

Anthropogenic climate change is affecting people's health, including those with neurological and psychiatric diseases. Currently, making inferences about the effect of climate change on neurological and psychiatric diseases is challenging because of an overall sparsity of data, differing study methods, paucity of detail regarding disease subtypes, little consideration of the effect of individual and population genetics, and widely differing geographical locations with the potential for regional influences. However, evidence suggests that the incidence, prevalence, and severity of many nervous system conditions (eg, stroke, neurological infections, and some mental health disorders) can be affected by climate change. The data show broad and complex adverse effects, especially of temperature extremes to which people are unaccustomed and wide diurnal temperature fluctuations. Protective measures might be possible through local forecasting. Few studies project the future effects of climate change on brain health, hindering policy developments. Robust studies on the threats from changing climate for people who have, or are at risk of developing, disorders of the nervous system are urgently needed.


Asunto(s)
Cambio Climático , Enfermedades del Sistema Nervioso , Humanos , Enfermedades del Sistema Nervioso/epidemiología
11.
Epilepsia Open ; 9(3): 1059-1066, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38593277

RESUMEN

OBJECTIVE: To assess asymptomatic rates and severity of SARS-CoV-2 infection in people with epilepsy and their healthcare workers in a long-term care facility which had implemented weekly surveillance testing between April 2020 and June 2022. METHODS: Questionnaires focused on objective and subjective COVID-19 symptoms for people with epilepsy residing in and their healthcare workers at the Chalfont Centre for Epilepsy in June 2022. Demographic information, comorbidities, and seizure frequency were gathered from medical records. We also collected responses on objective and subjective COVID-19 symptoms from healthcare workers who participated in a prospective study assessing the reaction to COVID-19 vaccinations (SAFER). RESULTS: Fifty-five out of 89 (62%) residents tested positive at least once on weekly PCR testing for SARS-CoV-2 during the period of interest; 20 of those (37%) were asymptomatic. In comparison, of those 63 healthcare workers who tested positive at least once on weekly testing during the same period, only four (6%) were asymptomatic. Of the 159 healthcare workers who also participated in the SAFER study, 41 tested positive at least once, and seven (17%) were completely asymptomatic during infection with SARS-CoV-2. SIGNIFICANCE: People with epilepsy living in a long-term care facility were more likely to present with asymptomatic SARS-CoV-2 infections than healthcare workers at the same facility. Despite possible bias in the reporting of subjective symptoms due to management-by-proxy, there is no evidence that vulnerable people living in an epilepsy long-term care facility showed reduced resilience towards infections. PLAIN LANGUAGE SUMMARY: People with epilepsy living in care home facilities had a surprisingly high degree of asymptomatic infections with SARS-CoV-2. Very few residents had severe or fatal outcomes. This is in stark contrast to the widely reported bad outcomes for people without epilepsy in other care homes. People with epilepsy reported significantly less symptoms than their healthcare workers. No changes in seizure frequency during or after infection were observed.


Asunto(s)
COVID-19 , Epilepsia , Personal de Salud , Cuidados a Largo Plazo , Humanos , COVID-19/epidemiología , Femenino , Masculino , Persona de Mediana Edad , Adulto , Anciano , SARS-CoV-2 , Estudios Prospectivos , Encuestas y Cuestionarios , Vacunas contra la COVID-19/administración & dosificación , Infecciones Asintomáticas/epidemiología
12.
Indian J Pharmacol ; 56(2): 120-128, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-38687316

RESUMEN

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of topical nanoemulsion (NE)-loaded cream and gel formulations of Hippophae rhamnoides L. (sea buckthorn [SBT]) fruit oil for wound healing. MATERIALS AND METHODS: The NE-loaded cream and gel formulations of H. rhamnoides L. (SBT) fruit oil (IPHRFH) were prepared and evaluated for their wound-healing activity on female Sprague-Dawley (SD) rats. They were further divided into groups (seven) and the wound-healing activity was determined by measuring the area of the wound on the wounding day and on the 0th, 4th, 8th, and 10th days. The acute dermal toxicity of the formulations was assessed by observing the erythema, edema, and body weight (BW) of the rats. RESULTS: The topical NE cream and gel formulations of H. rhamnoides L. (SBT) fruit oil showed significant wound-healing activity in female SD rats. The cream formulation of IPHRFH showed 78.96%, the gel showed 72.59% wound contraction on the 8th day, whereas the positive control soframycin (1% w/w framycetin) had 62.29% wound contraction on the 8th day. The formulations also showed a good acute dermal toxicity profile with no changes significantly affecting BW and dermal alterations. CONCLUSIONS: The results of this study indicate that topical NE-loaded cream and gel formulation of H. rhamnoides L. (SBT) fruit oil are safe and effective for wound healing. The formulations showed no signs of acute dermal toxicity in female SD rats.


Asunto(s)
Emulsiones , Geles , Hippophae , Aceites de Plantas , Ratas Sprague-Dawley , Cicatrización de Heridas , Animales , Femenino , Hippophae/química , Hippophae/toxicidad , Cicatrización de Heridas/efectos de los fármacos , Ratas , Aceites de Plantas/toxicidad , Aceites de Plantas/administración & dosificación , Frutas , Piel/efectos de los fármacos , Administración Cutánea , Administración Tópica , Nanopartículas/toxicidad
13.
Heliyon ; 10(8): e29438, 2024 Apr 30.
Artículo en Inglés | MEDLINE | ID: mdl-38655338

RESUMEN

With an emphasis on classifying diseases of sugarcane leaves, this research suggests an attention-based multilevel deep learning architecture for reliably classifying plant diseases. The suggested architecture comprises spatial and channel attention for saliency detection and blends features from lower to higher levels. On a self-created database, the model outperformed cutting-edge models like VGG19, ResNet50, XceptionNet, and EfficientNet_B7 with an accuracy of 86.53%. The findings show how essential all-level characteristics are for categorizing images and how they can improve efficiency even with tiny databases. The suggested architecture has the potential to support the early detection and diagnosis of plant diseases, enabling fast crop damage mitigation. Additionally, the implementation of the proposed AMRCNN model in the Android phone-based application gives an opportunity for the widespread use of mobile phones in the classification of sugarcane diseases.

14.
Cureus ; 16(3): e57231, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38686252

RESUMEN

Liposarcoma presenting within an inguinal hernia is rare. It may manifest as either primary spermatic cord liposarcoma or as an extension of retroperitoneal liposarcoma into the inguinoscrotal region. Tumors originating in the retroperitoneum can extend toward the inguinal region through the gonadal vein pathway. Utilizing imaging modalities is crucial for differentiating between a retroperitoneal component and a fat-containing inguinal mass. Identification of non-lipomatous components within a fat-containing tumor provides diagnostic clues on radiological imaging.

15.
PLoS One ; 19(3): e0297385, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38551928

RESUMEN

BACKGROUND: In alignment with the Measles and Rubella (MR) Strategic Elimination plan, India conducted a mass measles and rubella vaccination campaign across the country between 2017 and 2020 to provide a dose of MR containing vaccine to all children aged 9 months to 15 years. We estimated campaign vaccination coverage in five districts in India and assessed campaign awareness and factors associated with vaccination during the campaign to better understand reasons for not receiving the dose. METHODS AND FINDINGS: Community-based cross-sectional serosurveys were conducted in five districts of India among children aged 9 months to 15 years after the vaccination campaign. Campaign coverage was estimated based on home-based immunization record or caregiver recall. Campaign coverage was stratified by child- and household-level risk factors and descriptive analyses were performed to assess reasons for not receiving the campaign dose. Three thousand three hundred and fifty-seven children aged 9 months to 15 years at the time of the campaign were enrolled. Campaign coverage among children aged 9 months to 5 years documented or by recall ranged from 74.2% in Kanpur Nagar District to 90.4% in Dibrugarh District, Assam. Similar coverage was observed for older children. Caregiver awareness of the campaign varied from 88.3% in Hoshiarpur District, Punjab to 97.6% in Dibrugarh District, Assam, although 8% of children whose caregivers were aware of the campaign were not vaccinated during the campaign. Failure to receive the campaign dose was associated with urban settings, low maternal education, and lack of school attendance although the associations varied by district. CONCLUSION: Awareness of the MR vaccination campaign was high; however, campaign coverage varied by district and did not reach the elimination target of 95% coverage in any of the districts studied. Areas with lower coverage among younger children must be prioritized by strengthening the routine immunization programme and implementing strategies to identify and reach under-vaccinated children.


Asunto(s)
Sarampión , Rubéola (Sarampión Alemán) , Humanos , Lactante , Niño , Adolescente , Estudios Transversales , Sarampión/prevención & control , Rubéola (Sarampión Alemán)/prevención & control , Vacuna Antisarampión/uso terapéutico , Vacunación , Vacuna contra la Rubéola/uso terapéutico , India/epidemiología , Programas de Inmunización
16.
Am J Hum Genet ; 111(4): 761-777, 2024 Apr 04.
Artículo en Inglés | MEDLINE | ID: mdl-38503299

RESUMEN

Ion channels mediate voltage fluxes or action potentials that are central to the functioning of excitable cells such as neurons. The KCNB family of voltage-gated potassium channels (Kv) consists of two members (KCNB1 and KCNB2) encoded by KCNB1 and KCNB2, respectively. These channels are major contributors to delayed rectifier potassium currents arising from the neuronal soma which modulate overall excitability of neurons. In this study, we identified several mono-allelic pathogenic missense variants in KCNB2, in individuals with a neurodevelopmental syndrome with epilepsy and autism in some individuals. Recurrent dysmorphisms included a broad forehead, synophrys, and digital anomalies. Additionally, we selected three variants where genetic transmission has not been assessed, from two epilepsy studies, for inclusion in our experiments. We characterized channel properties of these variants by expressing them in oocytes of Xenopus laevis and conducting cut-open oocyte voltage clamp electrophysiology. Our datasets indicate no significant change in absolute conductance and conductance-voltage relationships of most disease variants as compared to wild type (WT), when expressed either alone or co-expressed with WT-KCNB2. However, variants c.1141A>G (p.Thr381Ala) and c.641C>T (p.Thr214Met) show complete abrogation of currents when expressed alone with the former exhibiting a left shift in activation midpoint when expressed alone or with WT-KCNB2. The variants we studied, nevertheless, show collective features of increased inactivation shifted to hyperpolarized potentials. We suggest that the effects of the variants on channel inactivation result in hyper-excitability of neurons, which contributes to disease manifestations.


Asunto(s)
Epilepsia , Mutación Missense , Trastornos del Neurodesarrollo , Canales de Potasio Shab , Animales , Humanos , Potenciales de Acción , Epilepsia/genética , Neuronas , Oocitos , Xenopus laevis , Canales de Potasio Shab/genética , Canales de Potasio Shab/metabolismo , Trastornos del Neurodesarrollo/genética
17.
3 Biotech ; 14(4): 110, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38486820

RESUMEN

The current growing environmental awareness has forced the use of biodegradable plasticizers, which are sustainable and abundant in plant resources. Rose petal plasticizers (RPP) act as an actual substitute for chemical plasticizers in this situation as they are biocompatible and biodegradable. Chemical procedures like amination, alkalization, and surface catalysis are used to extract the natural emollients from rose petals. XRD, FT-IR, and UV studies were used to understand the characteristics of the rose petal plasticizer. Based on the XRD data, the RPP's crystallinity size (CS) and crystallinity index (CI) values were determined to be 9.36 nm and 23.87%, respectively. The surface morphology of the isolated plasticizer is investigated using SEM, EDAX analysis and AFM. RPP surface pores with rough surfaces are visible in SEM images, which make them appropriate for plasticizing novel bioplastics with superior mechanical qualities. The plasticizer's heat degradation behaviour is investigated using thermogravimetric and differential thermogram analysis curves. Following the characterization of the synthesised molecules, the plasticization effect was examined using a biodegradable polymer matrix called poly (butylene adipate-co-terephthalate) (PBAT). The reinforcement interface was also examined using scanning electron microscopy analysis. RPP-reinforced films demonstrated greater flexibility and superior surface compatibility at a 5% loading compared to PBAT-only films. Based on a number of reported features, RPP could be a great plasticizer to address future environmental problems.

19.
Sci Rep ; 14(1): 4224, 2024 02 20.
Artículo en Inglés | MEDLINE | ID: mdl-38378730

RESUMEN

Biosimilar insulin analogues are increasing market access for diabetic patients globally. Scientific establishment of biosimilarity is cornerstone of this key change in the medical landscape. BGL-ASP is a biosimilar insulin aspart developed by BioGenomics Limited, India. BioGenomics has considered a stepwise approach in generating the totality of evidence required to establish similarity with reference product. Insulin aspart is a recombinant rapid-acting human insulin analogue utilised in the treatment of type-1 and type-2 diabetes mellitus. The single amino acid substitution at position B28 where proline is replaced with aspartic acid results in a decreased propensity to form hexamers, thus increasing the absorption rate on subcutaneous administration compared to native insulin. In order to establish the safety and efficacy of BGL-ASP, the critical quality attributes (CQAs) of BGL-ASP are identified based on the impact created on biological activity, pharmacokinetic/pharmacodynamic (PK/PD), immunogenicity and safety. The CQAs of insulin aspart are related to product structure, purity and functionality and are characterised using a series of state-of-the-art orthogonal analytical tools. The primary protein sequence, the secondary, tertiary and quaternary structure are found to be highly similar for BGL-ASP and reference product. The product related impurities of insulin aspart and the assay content are determined using high performance liquid chromatography (HPLC) based analysis and is similar for BGL-ASP and reference insulin aspart sourced from United States of America (US), Europe Union (EU) and India. The safety, efficacy and immunogenicity of BGL-ASP is also found to be comparable with reference product and is confirmed through the clinical trials conducted as recommended by International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and European Medicines Agency (EMA) guidelines. The data encompassed in this study demonstrates that reference insulin aspart and BGL-ASP are highly similar in terms of structural, physicochemical, and biological properties, thus confirming its safety and efficacy for usage as potential alternative economical medicinal treatment for diabetes mellitus.


Asunto(s)
Biosimilares Farmacéuticos , Diabetes Mellitus Tipo 2 , Humanos , Biosimilares Farmacéuticos/uso terapéutico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/farmacología , Hipoglucemiantes/uso terapéutico , India , Insulina/uso terapéutico , Insulina Aspart/uso terapéutico , Estados Unidos
20.
Int J Biol Macromol ; 261(Pt 2): 129771, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38286386

RESUMEN

Plasticizers are active ingredients added to the polymer to increase its workability. Since synthetic plasticizer is not ecofriendly and toxic in nature, it is a real cause for concern. On this basis, our study focuses on plasticizer extraction from plant-based resources. In this research work, Thespesia populnea leaves are utilized for the isolation of biological macromolecules with a plasticizing effect for biofilm applications. This extraction process is done through solvent extraction, amination, slow pyrolysis, and surface catalysis process. The physico-chemical and microstructural characterization of novel plasticizer particles were studied for the first time. The lower crystallinity index and crystalline size obtained from X-ray diffraction is 50.08 % and 20.45 nm respectively. Energy dispersive spectroscopy, particle sizer analysis, atomic force microscopy, and scanning electron microscopy are used to assess surface morphology of this plasticizer. The thermogram and differential thermal analysis curves give the information about degradation behavior of plasticizers and their thermal stability. The glass transition temperature of the extracted plasticizer is 60.56 °C. The plasticizing effect of the plasticizer is studied through film fabrication of polylactic acid which was blended with the extracted plasticizer. The mechanical property of biofilm was improved with the addition of plasticizer. The elongation break percentage (for 5 % plasticizer 46.12 %) was increased compared to others with moderate tensile strength. However, the tensile and elongation modulus decreases with the increase of plasticizer content. The crystallinity of the PLA film was improved after the plasticization. The thermal stability also increased with 3 % addition of the plasticizer. The isolated plasticizer was soluble in water and its molecular weight ≈380.


Asunto(s)
Plastificantes , Poliésteres , Plastificantes/química , Poliésteres/química , Polímeros/química , Agua/química
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