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1.
AAPS PharmSciTech ; 25(7): 202, 2024 Sep 05.
Artículo en Inglés | MEDLINE | ID: mdl-39237685

RESUMEN

The focus of the present work was to develop amorphous solid dispersion (ASD) formulation of aprepitant (APT) using sucrose acetate isobutyrate (SAIB) excipient, evaluate for physicochemical attributes, stability, and bioavailability, and compared with hydroxypropyl methylcellulose (HPMC) based formulation. Various formulations of APT were prepared by solvent evaporation method and characterized for physiochemical and in-vivo performance attributes such as dissolution, drug phase, stability, and bioavailability. X-ray powder diffraction indicated crystalline drug conversion into amorphous phase. Dissolution varied as a function of drug:SAIB:excipient proportion. The dissolution was more than 80% in the optimized formulation (F10) and comparable to HPMC based formulation (F13). Stability of F10 and F13 formulations stored at 25 C/60% and 40°C/75% RH for three months were comparable. Both ASD formulations (F10 and F13) were bioequivalent as indicated by the pharmacokinetic parameters Cmax and AUC0-∞. Cmax and AUC0-∞ of F10 and F13 formulations were 2.52 ± 0.39, and 2.74 ± 0.32 µg/ml, and 26.59 ± 0.39, and 24.79 ± 6.02 µg/ml.h, respectively. Furthermore, the bioavailability of ASD formulation was more than twofold of the formulation containing crystalline phase of the drug. In conclusion, stability and oral bioavailability of SAIB based ASD formulation is comparable to HPMC-based formulation of poorly soluble drugs.


Asunto(s)
Disponibilidad Biológica , Excipientes , Solubilidad , Sacarosa , Sacarosa/análogos & derivados , Sacarosa/química , Administración Oral , Animales , Excipientes/química , Masculino , Derivados de la Hipromelosa/química , Química Farmacéutica/métodos , Estabilidad de Medicamentos , Difracción de Rayos X/métodos
2.
Surg Today ; 2024 Aug 10.
Artículo en Inglés | MEDLINE | ID: mdl-39126494

RESUMEN

PURPOSE: The study aims to present a specialized educational program using a 3D printed model for managing Grade IV and V liver injuries. Hepatic packing, a common technique, may not always achieve sufficient hemostasis in these cases, warranting alternative solutions such as mesh liver wrapping. However, mastering this procedure is challenging due to limited teaching resources and the need for repeated practice. METHODS: A computer-based model was created from an abdominal CT scan to produce a real-sized injured liver model using thermoplastic elastomer TPU-95. Trainees received systematic instruction from an instructor, allowing them to perform the procedure under supervision and independently. RESULTS: Eight surgical residents at Hillel Yaffe Medical Center participated in the program, with the majority successfully completing the procedure under supervision. Furthermore, trainees demonstrated reduced procedure times when performing independently, indicating improved proficiency. CONCLUSION: This educational approach offers a simple and repeatable method for continuous training in managing high-grade liver injuries, holding potential for enhanced patient outcomes.

3.
PLoS One ; 19(8): e0307217, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39197064

RESUMEN

Motion Estimation (ME) and the two-dimensional (2D) discrete cosine transform (2D-DCT) are both computationally expensive parts of HEVC standard, therefore real-time performance of the HEVC may not be free from glitches. To address this issue, this study deploys the graphics processing units (GPUs) to perform the ME and 2D-DCT tasks. In this concern, authors probed into four levels of parallelism (i.e., frame, macroblock, search area, and sum of the absolute difference (SAD) levels) existing in ME. For comparative analysis, authors involved full search (FS), test zone search (TZS) of HEVC, and hierarchical diamond search (EHDS) ME algorithms. Similarly, two levels of parallelism (i.e., macroblock and sub-macroblock) are also explored in 2D-DCT. Notably, the least computationally complex multithreaded Loeffler DCT algorithm is utilized for computing 2D-DCT. Experimental results show that ME processing task corresponding to 25 frames, with each frame of size (3840×2160) pixels, is accomplished in 0.15 seconds on the NVIDIA GeForce GTX 1080, whereas the 2D-DCT task along with the image reconstruction and differencing corresponding to 25 frames took 0.1 seconds. Collectively, both ME and 2D-DCT tasks are processed in 0.25 seconds, which still leaves enough room for the encoder's remaining parts to be executed within one second. Due to this enhancement, the resultant encoder can safely be used in real-time applications.


Asunto(s)
Algoritmos , Gráficos por Computador , Movimiento (Física) , Procesamiento de Imagen Asistido por Computador/métodos
4.
J Plast Reconstr Aesthet Surg ; 97: 41-49, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39137523

RESUMEN

BACKGROUND: Standardization of surgical protocols is an evolving issue owing to the low incidence of rare craniofacial clefts. In this article, we present our surgical management technique for repair of rare craniofacial clefts and evaluate the postoperative results. METHODS: This study was conducted from 2013 to 2022 and included patients who presented with craniofacial clefts. The results were assessed based on parents' satisfaction and objective evaluations by two independent observers. RESULTS: A total of 3679 patients presented with cleft anomalies; of these, 61 patients with 89 rare craniofacial clefts were observed with a prevalence of 2.42/100. The male to female ratio was 1:1.35. Craniofacial cleft "4" and "5" were the most common, with 17 (19.1%) and 16 (17.98%) patients, respectively. Multiple craniofacial clefts were observed in 37.7% of the patients. Associated craniofacial anomalies were found in 39.34% of the patients. The parents of 71.6% of the patients were very satisfied with the results. Based on the scores of two independent observers, 70.27% of the patients showed good results. CONCLUSION: The rare nature of craniofacial clefts and involvement of various structures make the standardization of surgical procedures very challenging. Our experience with these clefts will help new surgeons both in didactics and in technical aspects of patient management. KEY POINTS: 1. We share our experience with rare craniofacial clefts. 2. Each cleft presents with its own unique reconstructive challenges. The literature describes many techniques for each type of cleft, all with multiple permutations. We present a simplified technique that has worked for us over the years for all Tessier clefts.


Asunto(s)
Labio Leporino , Fisura del Paladar , Procedimientos de Cirugía Plástica , Humanos , Masculino , Femenino , Fisura del Paladar/cirugía , Procedimientos de Cirugía Plástica/métodos , Labio Leporino/cirugía , Preescolar , Lactante , Niño , Satisfacción del Paciente , Protocolos Clínicos , Adolescente , Resultado del Tratamiento , Anomalías Craneofaciales/cirugía
5.
Bone Joint J ; 106-B(8): 871-878, 2024 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-39084633

RESUMEN

Aims: The gold standard for percutaneous Achilles tendon tenotomy during the Ponseti treatment for idiopathic clubfoot is a tenotomy with a No. 15 blade. This trial aims to establish the technique where the tenotomy is performed with a large-bore needle as noninferior to the gold standard. Methods: We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively. Results: The blade group had more dorsiflexion at both follow-up consultations: 18.36° versus 18.03° (p = 0.115) at three weeks and 18.96° versus 18.26° (p = 0.001) at three months. The difference of the mean at three months 0.7° is well below the noninferiority margin of 4°. There was no significant difference in Pirani scores. The blade group had more extensive scar marks at three months than the needle group (8 vs 2). No major complications were recorded. Conclusion: The needle tenotomy is noninferior to the blade tenotomy for usage in Ponseti treatment for idiopathic clubfoot in children aged below 36 months.


Asunto(s)
Tendón Calcáneo , Pie Equinovaro , Agujas , Tenotomía , Humanos , Tendón Calcáneo/cirugía , Pie Equinovaro/cirugía , Pie Equinovaro/terapia , Tenotomía/métodos , Tenotomía/instrumentación , Femenino , Masculino , Lactante , Preescolar , Resultado del Tratamiento , Rango del Movimiento Articular , Estudios de Seguimiento
6.
Int J Biol Macromol ; 276(Pt 1): 133789, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38992556

RESUMEN

Human-machine interactions, monitoring of health equipment, and gentle robots all depend considerably on flexible strain sensors. However, making strain sensors have better mechanical behavior and an extensive sensing range remains an urgent difficulty. In this study, poly acrylamide-co-butyl acrylate with gellan gum (poly(AAm-co-BA)@GG) hydrophobic association networks and intermolecular hydrogen bonding interactions are used to fabricate dual cross-linked hydrogels for wearable resistive-type strain sensors. This could be an acceptable way to minimize the limitations in hydrogels previously identified. The robust fracture strength (870 kPa) and exceptional stretchability (1297 %) of the hydrogel arise from the collaborative action of intermolecular hydrogen bonding and hydrophobic associations. It also demonstrates exceptional resilience to repeated cycles of uninterrupted stretching and relaxation, retaining its structural integrity. The response and restoration times are 110 and 120 ms respectively. Furthermore, a wide sensing range (0-900 %), notable sensitivity across various strain levels, and an impressive gauge factor (GF) of 31.51 with high durability were observed by the dual cross-linked (DC) hydrogel-based strain sensors. The measured conductivity of the hydrogel was 0.32 S/m which is due to the incorporation of NaCl. Therefore, the hydrogels can be tailored to function as wearable strain sensors that can detect subtle human gestures like speech patterns, distinguish between distinct words, and recognize vibrations of the larynx during drinking, as well as large joint motions like wrist, finger, and elbow. Furthermore, these hydrogels are capable of reliably distinguishing and reproducing various printed text. These findings imply that any electronic device that demands strain-sensing functionality might make use of these developed materials.


Asunto(s)
Conductividad Eléctrica , Hidrogeles , Polisacáridos Bacterianos , Dispositivos Electrónicos Vestibles , Hidrogeles/química , Polisacáridos Bacterianos/química , Humanos , Monitoreo Fisiológico/instrumentación , Monitoreo Fisiológico/métodos , Biopolímeros/química
7.
Cureus ; 16(6): e63115, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38947136

RESUMEN

As the age increases particularly above the age of 50 years, there is a significantly higher risk of developing gallstone-related complications especially cholecystitis and common bile duct stones with its associated consequences. Complications that arise after surgical operations for cholecystitis have been reported to have negative impacts on senior patients. These effects include a higher rate of complications, a longer hospital stay, higher expenditures, and decreased patient satisfaction. Therefore, finding the most effective treatment for cholecystitis in older patients is still a challenge. The aim of the study was carried out in order to identify many approaches that can be taken in the treatment of cholecystitis and stones in the common bile duct in older patients. A search was conducted through Medline (PubMed), EMBASE, ProQuest, and Cochrane using relevant Medical Subject Heading (MeSH) terms and keywords (elderly, age over 50, cholecystitis, bile duct stones, cholecystectomy, ERCP, surgical, conservative management, and open). The searches were limited to studies on elderly individuals over 50 who had cholecystectomy and endoscopic retrograde cholangiopancreatography between January 2000 and December 2022. The meta-analysis used the Mantel-Haenszel odds ratio (MHOR) and 95% confidence interval (CI). Aries Systems Corporation's Editorial Manager® (Aries Systems Corporation, North Andover, USA) and ProduXion Manager® (Aries Systems Corporation, North Andover, USA) facilitated the study. Out of 102 citations, 39 studies were selected for further study. After that, 18 studies were eliminated, leaving 21 for meta-analysis. The study found a protective risk of cholecystitis in cholecystectomy patients (MHOR = 0.16; 95%, CI = 0.10 to 0.25; p 0.001). Developing cholecystitis was substantially lower in early cholecystectomy patients (MHOR = 0.16; 95%, CI = 0.10 to 0.25; p 0.001). There was no significant difference in cholecystitis risk between open and laparoscopic surgery (MHOR = 0.65; 95%, CI = 0.41 to 1.04; p 0.07). Cholecystectomy performed at an earlier stage protects elderly patients from developing recurrent cholecystitis. In contrast to late cholecystitis, in which the patient would experience several attacks of cholecystitis, early cholecystectomy protects against the recurrence of the condition.

8.
BJS Open ; 8(1)2024 Jan 03.
Artículo en Inglés | MEDLINE | ID: mdl-38949628

RESUMEN

BACKGROUND: Textbook outcomes are composite outcome measures that reflect the ideal overall experience for patients. There are many of these in the elective surgery literature but no textbook outcomes have been proposed for patients following emergency laparotomy. The aim was to achieve international consensus amongst experts and patients for the best Textbook Outcomes for non-trauma and trauma emergency laparotomy. METHODS: A modified Delphi exercise was undertaken with three planned rounds to achieve consensus regarding the best Textbook Outcomes based on the category, number and importance (Likert scale of 1-5) of individual outcome measures. There were separate questions for non-trauma and trauma. A patient engagement exercise was undertaken after round 2 to inform the final round. RESULTS: A total of 337 participants from 53 countries participated in all three rounds of the exercise. The final Textbook Outcomes were divided into 'early' and 'longer-term'. For non-trauma patients the proposed early Textbook Outcome was 'Discharged from hospital without serious postoperative complications (Clavien-Dindo ≥ grade III; including intra-abdominal sepsis, organ failure, unplanned re-operation or death). For trauma patients it was 'Discharged from hospital without unexpected transfusion after haemostasis, and no serious postoperative complications (adapted Clavien-Dindo for trauma ≥ grade III; including intra-abdominal sepsis, organ failure, unplanned re-operation on or death)'. The longer-term Textbook Outcome for both non-trauma and trauma was 'Achieved the early Textbook Outcome, and restoration of baseline quality of life at 1 year'. CONCLUSION: Early and longer-term Textbook Outcomes have been agreed by an international consensus of experts for non-trauma and trauma emergency laparotomy. These now require clinical validation with patient data.


Asunto(s)
Técnica Delphi , Laparotomía , Humanos , Laparotomía/efectos adversos , Complicaciones Posoperatorias/etiología , Consenso , Urgencias Médicas , Evaluación de Resultado en la Atención de Salud
9.
Int J Biol Macromol ; 277(Pt 1): 133697, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-38996882

RESUMEN

In this study, hydrogel beads were fabricated using alginate (Algt) polymer containing dispersed nickel phthalocyanine (NTC) nanomaterial. The viscous solution of Algt and NTC was poured dropwise into a divalent Ca2+ ions, resulting in the formation of hydrogel beads known as NTC@Algt-BDs. The surface of the NTC@Algt-BDs was further modified by coating them with different types of metal ions, yielding metal-coated M+/NTC@Algt-BDs. The adsorbed metal ions i.e., Cu+2, Ag+, Ni+2, Co+2, and Fe+3 were subsequently reduced to zero-valent metal nanoparticles (M0) by NaBH4. The prepared beads were characterized using scanning electron microscopy (SEM), energy-dispersive X-ray spectroscopy (EDS), X-ray diffraction (XRD) and X-ray photoelectron spectroscopy (XPS). Initially, M0/NTC@Algt-BDs were examined for the catalytic reduction of 4-nitrophenol (4-NP) to 4-aminophenol (4-AP). Among them, Cu0/NTC@Algt-BDs catalyst exhibited the highest reduction rate and therefore, investigated for reduction of different nitrophenols (NPs) and dyes, including 2-nitrophenol (2-NP), 2,6-dinitrophenol (2,6-DNP), methyl orange (MO), potassium ferrocyanide (PFC), congo red (CR), and acridine orange (ArO). The highest reduction rates of 2.019 and 1.394 min-1 were observed for MO and 2-NP, respectively. Furthermore, the fabricated catalysts were employed for the efficient production of H2 gas by NaBH4 methanolysis. Among which the Ag0/NTC@Algt-BDs catalyst showed excellent catalytic production of H2 gas, exhibiting the lowest activation energy (Ea) of 25.169 kJ/mol at ambient temperature. Furthermore, the impact of NaBH4 amount, and catalyst dosage on the reduction of 2-NP and H2 gas production was conducted whereas the effect of temperature on methanolysis of NaBH4 for evolution of H2 gas was studied. The amount of H2 gas was confirmed by GC-TCD system. Additionally, the recyclability of the catalyst was investigated, as it garnered significant research interest.


Asunto(s)
Alginatos , Hidrógeno , Alginatos/química , Catálisis , Hidrógeno/química , Contaminantes Ambientales/química , Indoles/química , Propiedades de Superficie , Nitrofenoles/química , Microesferas , Hidrogeles/química , Adsorción
11.
J Mater Chem B ; 12(25): 6190-6202, 2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-38832839

RESUMEN

Metal organic frameworks (MOFs) have garnered significant attention in the development of stretchable and wearable conductive hydrogels for flexible transducers. However, MOFs used in hydrogel networks have been hampered by low mechanical performance and poor dispersibility in aqueous solutions, which affect the performance of hydrogels, including low toughness, limited self-recovery, short working ranges, low conductivity, and prolonged response-recovery times. To address these shortcomings, a novel approach was adopted in which micelle co-polymerization was used for the ex situ synthesis of Zn-MOF-based hydrogels with exceptional stretchability, robust toughness, anti-fatigue properties, and commendable conductivity. This breakthrough involved the ex situ integration of Zn-MOFs into hydrophobically cross-linked polymer chains. Here the micelles of EHDDAB had two functions, first they uniformly dispersed the Zn-MOFs and secondly they dynamically cross-linked the polymer chains, profoundly influencing the mechanical characteristics of the hydrogels. The non-covalent synergistic interactions introduced by Zn-MOFs endowed the hydrogels with the capacity for high stretchability, high stress, rapid self-recovery, anti-fatigue properties, and conductivity, all achieved without external stimuli. Furthermore, hydrogels based on Zn-MOFs can serve as durable and highly sensitive flexible transducers, adept at detecting diverse mechanical deformations with swift response-recovery times and high gauge factor values. Consequently, these hydrogels can be tailored to function as wearable strain sensors capable of sensing significant human joint movements, such as wrist bending, and motions involving the wrist, fingers, and elbows. Similarly, they excel at monitoring subtle human motions, such as speech pronunciation, distinguishing between different words, as well as detecting swallowing and larynx vibrations during various activities. Beyond these applications, the hydrogels exhibit proficiency in distinguishing and reproducing various written words with reliability. The Zn-MOF-based hydrogels hold promising potential for development in electronic skin, medical monitoring, soft robotics, and flexible touch panels.


Asunto(s)
Conductividad Eléctrica , Hidrogeles , Estructuras Metalorgánicas , Dispositivos Electrónicos Vestibles , Hidrogeles/química , Humanos , Estructuras Metalorgánicas/química , Zinc/química , Transductores
12.
Heliyon ; 10(9): e30466, 2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38756608

RESUMEN

Integrating wind power with energy storage technologies is crucial for frequency regulation in modern power systems, ensuring the reliable and cost-effective operation of power systems while promoting the widespread adoption of renewable energy sources. Power systems are changing rapidly, with increased renewable energy integration and evolving system architectures. These transformations bring forth challenges like low inertia and unpredictable behavior of generation and load components. As a result, frequency regulation (FR) becomes increasingly important to ensure grid stability. Energy Storage Systems (ESS) with their adaptable capabilities offer valuable solutions to enhance the adaptability and controllability of power systems, especially within wind farms. This research provides an updated analysis of critical frequency stability challenges, examines state-of-the-art control techniques, and investigates the barriers that hinder wind power integration. Moreover, it introduces emerging ESS technologies and explores their potential applications in supporting wind power integration. Furthermore, this paper offers suggestions and future research directions for scientists exploring the utilization of storage technologies in frequency regulation within power systems characterized by significant penetration of wind power.

14.
Pharm Res ; 41(5): 1007-1020, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38561579

RESUMEN

PURPOSE: Products formulated for intramammary (IMM) infusion are intended for the delivery of therapeutic moieties directly into the udder through the teat canal to maximize drug exposure at the targeted clinical site, the mammary gland, with little to no systemic drug exposure. Currently, to our knowledge, there has been no in-vitro matrix system available to differentiate between IMM formulations. Our goal is to develop A custom tailored in-vitro "Matrix of Chemistry, Manufacturing and Control" (MoCMC) System to be a promising future tool for identifying inequivalent IMM formulations. MoCMC can detect inter and intra batch variabilities, thereby identifying potential generics versus brand product similarities or differences with a single numeric value and a specific & distinctive fingerprint. METHODS: The FDA-approved IMM formulation, SPECTRAMASTⓇ LC, was selected as the reference product for the MoCMC. Twelve in-house test formulations containing ceftiofur hydrochloride were formulated and characterized. The MoCMC was developed to include six input parameters and three output parameters. The MoCMC system was used to evaluate and compare SPECTRAMASTⓇ LC with its in-house formulations. RESULTS: Based on the MoCMC generated parameters, the distinctive fingerprints of MoCMC for each IMM formulations, and the statistical analyses of MCI and PPI values, in-house formulations, F-01 and F-02 showed consistency while the rest of in-house formulations (F-03-F-12) were significantly different as compared to SPECTRAMASTⓇ LC. CONCLUSION: This research showed that the MoCMC approach can be used as a tool for intra batch variabilities, generics versus brand products comparisons, post-approval formulations changes, manufacturing changes, and formulation variabilities.


Asunto(s)
Química Farmacéutica , Animales , Química Farmacéutica/métodos , Composición de Medicamentos/métodos , Femenino , Glándulas Mamarias Animales/metabolismo , Antibacterianos/análisis , Antibacterianos/administración & dosificación , Medicamentos Genéricos
15.
J Oncol Pharm Pract ; : 10781552241246119, 2024 Apr 24.
Artículo en Inglés | MEDLINE | ID: mdl-38656201

RESUMEN

INTRODUCTION: The incidence of invasive fungal diseases (IFDs) has risen in hematologic malignancy patients due to neutropenia. While posaconazole is recommended as the first-line antifungal prophylaxis in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients and voriconazole is an alternative, there is currently no direct comparison data available to assess their relative effectiveness. METHOD: We retrospectively reviewed eligible patient charts from January 2017 to February 2019 to identify breakthrough IFD rates, drug adverse event frequency, and drug acquisition cost in AML/MDS patients. RESULTS: Forty-eight patients received 130 chemo cycles, with 50 (38%) cycles prescribed posaconazole and 80 (62%) prescribed voriconazole as primary IFD prophylaxis. The incidence rates of IFD in the posaconazole group were 8% (4 out of 50), of which two were probable and two were possible infections, while 6.26% (5 out of 80) of patients in the voriconazole group developed IFD, with four possible infections and one probable infection (p = 0.73). A higher percentage of patients in the voriconazole group discontinued prophylaxis due to adverse events, with six patients compared to two patients in the posaconazole group (p = 0.15). The drug acquisition cost of posaconazole is 5.62 times more expensive than voriconazole. CONCLUSION: The use of voriconazole instead of posaconazole for 130 chemo cycles would save $166,584.6. Posaconazole and voriconazole have comparable efficacy and safety in preventing IFD in AML and MDS patients receiving chemotherapy. However, posaconazole is more costly than voriconazole.

16.
Biomed Chromatogr ; 38(5): e5845, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38412513

RESUMEN

A brompheniramine taste-masked pediatric formulation was developed as part of the National Institutes of Health Pediatric Formulation Initiative to help address low patient compliance caused by the bitter taste of many adult formulations. To confirm that the taste-masked formulation can provide a similar pharmacological effect to the previous marketed adult formulations, a juvenile porcine model was used to screen the model pediatric formulation to compare the bioavailability between the marketed brompheniramine maleate and the taste-masked maleate/tannate formulation. Pigs were dosed orally with both formulations and blood samples were obtained from 0 to 48 h. Plasma samples were prepared and extracted using solid-phase extraction. The mass spectrometer was operated under selected ion monitoring mode. The selected ion monitoring channels were set to m/z 319.1 for brompheniramine and m/z 275.2 for the internal standard chlorpheniramine. Calibration curves were linear over the analytical range 0.2-20 ng/ml (r2 > 0.995) for brompheniramine in plasma. The intra- and inter-day accuracies were between 98.0 and 105% with 5.73% RSD precision. The bioanalytical method was successfully applied to a preclinical bioavailability study. The bioavailability profiles were not significantly different between the two formulations, which demonstrates that taste-masking with tannic acid is a promising approach for formulation modification for pediatric patients.


Asunto(s)
Disponibilidad Biológica , Bromofeniramina , Animales , Porcinos , Bromofeniramina/farmacocinética , Bromofeniramina/química , Bromofeniramina/sangre , Reproducibilidad de los Resultados , Gusto , Modelos Lineales , Extracción en Fase Sólida/métodos
17.
AAPS PharmSciTech ; 25(1): 19, 2024 Jan 24.
Artículo en Inglés | MEDLINE | ID: mdl-38267707

RESUMEN

Between February 2020 and January 2022, the Food and Drug Administration (FDA) recalled 281 metformin extended-release products due to the presence of N-nitrosodimethylamine (NDMA) above the acceptable daily intake (ADI, 96 ng/day). Our previous studies indicated presence of NDMA levels above ADI in both metformin immediate and extended-release products. When metformin products have NDMA impurities, it is indispensable to check for the same impurities in metformin combination products. Therefore, the objective of the present study was to evaluate in-use stability of commercial metformin combination products for NDMA. For this purpose, metformin products in combination with glyburide (GB1-GB12), glipizide (GP1-GP8), pioglitazone (P1-P3), alogliptin (A1, A2), and linagliptin (L1, L2) were repacked in pharmacy vials, stored at 30°C/75% RH for 3 months, and monitored for NDMA impurity. The NDMA level varied from 0 to 156.8 ± 32.8 ng/tablet initially and increased to 25.4 ± 5.1 to 455.0 ± 28.4 ng/tablet after 3 months of exposure to in-use condition. Initially, 18 products have NDMA level below ADI limit before exposure which decreased to 7 products (GB5, GP3, GP5, A1, A2, L1, and L2) meeting specification. In conclusion, in-use stability study provides quality and safety risk assessment of drug products where nitroso impurities are detected in the probable condition of use.


Asunto(s)
Metformina , Nitrosaminas , Estados Unidos , Humanos , United States Food and Drug Administration , Dimetilnitrosamina , Comprimidos
18.
AAPS PharmSciTech ; 25(1): 20, 2024 Jan 24.
Artículo en Inglés | MEDLINE | ID: mdl-38267637

RESUMEN

The aim of this paper was to investigate the effects of formulation parameters on the physicochemical and pharmacokinetic (PK) behavior of amorphous printlets of lopinavir (LPV) manufactured by selective laser sintering 3D printing method (SLS). The formulation variables investigated were disintegrants (magnesium aluminum silicate at 5-10%, microcrystalline cellulose at 10-20%) and the polymer (Kollicoat® IR at 42-57%), while keeping printing parameters constant. Differential scanning calorimetry, X-ray powder diffraction, and Fourier-transform infrared analysis confirmed the transformation of the crystalline drug into an amorphous form. A direct correlation was found between the disintegrant concentration and dissolution. The dissolved drug ranged from 71.1 ± 5.7% to 99.3 ± 2.7% within 120 min. A comparative PK study in rabbits showed significant differences in the rate and extent of absorption between printlets and compressed tablets. The values for Tmax, Cmax, and AUC were 4 times faster, and 2.5 and 1.7 times higher in the printlets compared to the compressed tablets, respectively. In conclusion, the SLS printing method can be used to create an amorphous delivery system through a single continuous process.


Asunto(s)
Excipientes , Rayos Láser , Animales , Conejos , Preparaciones Farmacéuticas , Disponibilidad Biológica , Lopinavir , Impresión Tridimensional
19.
BMJ Open Qual ; 13(1)2024 01 29.
Artículo en Inglés | MEDLINE | ID: mdl-38286564

RESUMEN

INTRODUCTION: The extensive resources needed to train surgeons and maintain skill levels in low-income and middle-income countries (LMICs) are limited and confined to urban settings. Surgical education of remote/rural doctors is, therefore, paramount. Virtual reality (VR) has the potential to disseminate surgical knowledge and skill development at low costs. This study presents the outcomes of the first VR-enhanced surgical training course, 'Global Virtual Reality in Medicine and Surgery', developed through UK-Ugandan collaborations. METHODS: A mixed-method approach (survey and semistructured interviews) evaluated the clinical impact and barriers of VR-enhanced training. Course content focused on essential skills relevant to Uganda (general surgery, obstetrics, trauma); delivered through: (1) hands-on cadaveric training in Brighton (scholarships for LMIC doctors) filmed in 360°; (2) virtual training in Kampala (live-stream via low-cost headsets combined with smartphones) and (3) remote virtual training (live-stream via smartphone/laptop/headset). RESULTS: High numbers of scholarship applicants (n=130); registrants (Kampala n=80; remote n=1680); and attendees (Kampala n=79; remote n=556, 25 countries), demonstrates widespread appetite for VR-enhanced surgical education. Qualitative analysis identified three key themes: clinical education and skill development limitations in East Africa; the potential of VR to address some of these via 360° visualisation enabling a 'knowing as seeing' mechanism; unresolved challenges regarding accessibility and acceptability. CONCLUSION: Outcomes from our first global VR-enhanced essential surgical training course demonstrating dissemination of surgical skills resources in an LMIC context where such opportunities are scarce. The benefits identified included environmental improvements, cross-cultural knowledge sharing, scalability and connectivity. Our process of programme design demonstrates that collaboration across high-income and LMICs is vital to provide locally relevant training. Our data add to growing evidence of extended reality technologies transforming surgery, although several barriers remain. We have successfully demonstrated that VR can be used to upscale postgraduate surgical education, affirming its potential in healthcare capacity building throughout Africa, Europe and beyond.


Asunto(s)
Realidad Virtual , Humanos , Uganda , Aprendizaje , Países en Desarrollo , Reino Unido
20.
Pak J Med Sci ; 40(1Part-I): 36-40, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38196456

RESUMEN

Background and Objective: A thorough insight into the management of hand injuries can shape the approach of a surgeon in order to achieve optimal outcomes for the patients. The aim of this study was to share our experience in reconstruction of the hand and establishing an algorithm for classification and treatment of hand injuries. Methods: This is a descriptive cross sectional study and was conducted from January 2020 to August 2022 at Burns and Plastic Surgery center, Peshawar. Data was collected from medical records about the patient demographics, mechanism of injury and type of procedures done. Defect size was classified into small (<5cm), medium (5cm to 10 cm) and large (>10cm). The defect site and size was cross tabulated against the method of soft tissue reconstruction in order to make the algorithm for reconstruction of hand injuries. Data was analyzed using SPSS. Results: The study population included 41 (75.9%) male and 13 (24.1%) female patients, mean age 31.56±14.1. Machine injuries (33.3%) and electric burns (24.1%) were the most common cause of hand soft tissue defects. The most commonly performed flap was Posterior introsseous artery (PIA) flap, followed by First dorsal metacarpal artery (FDMA) flap. Flap necrosis was observed in three cases (5.6%). Conclusion: This treatment algorithm for coverage of soft tissue defects in hand injuries will help with the decision making process of hand reconstruction and has didactic value for novice surgeons. It will also form the foundation for further work on this aspect of hand injuries.

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