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Evaluation of starch granules based on hydroxypropylcellulose as a substitute for excipient lactose.Journal of Pharmaceutical Health Care... Jun 2024The improvement in flowability and adhesion of starch powder (SP) is essential for using starch as an excipient for lactose intolerant patients. In this study, we...
BACKGROUND
The improvement in flowability and adhesion of starch powder (SP) is essential for using starch as an excipient for lactose intolerant patients. In this study, we attempted to evaluate the usefulness of hydroxypropylcellulose with molecular weight 80,000 (HPC-80) in the preparation of the starch granules (SG) as a substitute for excipient lactose.
METHODS
Hydroxypropylcellulose with molecular weight 30,000 (HPC-30) and HPC-80 were used as binders to prepare the SG, and defined as HPC-30-SG and HPC-80-SG, respectively. Mean particle size (D50) was measured according to the Method, Optical Microscopy of Particle Size Determination in Japanese Pharmacopoeia, Eighteenth Edition, and storage stability were evaluated by measuring of the physical properties after vortexing the granules for 180 s (physical impact). The product loss rate was calculated from the weight change of the various excipients before and after the one dose packaging (ODP).
RESULTS
The D50 of SP (30 µm) was smaller than that of the lactose powder (115 µm). The granulation with 0.75-3% HPC-30 and HPC-80 increased the particle size of SP, and the D50 in 1.5% HPC-30-SG (255 µm) and HPC-80-SG (220 µm) were higher than that of lactose. The excipient was removed from the heat seal of the ODP, and upon visual inspection, a large amount of starchy material was observed to be adhering to the paper in the SP. On the other hand, the low recovery rate in SP was attenuated by the granulation with HPC-30 and HPC-80. In the both HPC-30 and HPC-80, the improvement in recovery rate reached a plateau at 1.5%, and the levels of recovery rate was similar to that of lactose. The recovery rate in the 0.75-3% HPC-30-SG and 0.75% HPC-80-SG were decreased by the physical impact, however, the recovery rate and amount of 1.5% and 3% HPC-80-SG were not affected by the physical impact, and these levels were similar to that of lactose.
CONCLUSIONS
The use of HPC-80 as a binder of SG was found to produce a higher quality granule product than conventional HPC-based SG. This finding is useful in streamlining the preparation of starch-based powdered medicine in clinical applications.
PubMed: 38907305
DOI: 10.1186/s40780-024-00354-w -
BMC Plant Biology Jun 2024Drought stress poses a significant threat to agricultural productivity, especially in areas susceptible to water scarcity. Sunflower (Helianthus annuus L.) is a widely...
Mitigation of drought-induced stress in sunflower (Helianthus annuus L.) via foliar application of Jasmonic acid through the augmentation of growth, physiological, and biochemical attributes.
Drought stress poses a significant threat to agricultural productivity, especially in areas susceptible to water scarcity. Sunflower (Helianthus annuus L.) is a widely cultivated oilseed crop with considerable potential globally. Jasmonic acid, a plant growth regulator, plays a crucial role in alleviating the adverse impacts of drought stress on the morphological, biochemical, and physiological characteristics of crops. Experimental detail includes sunflower varieties (Armani Gold, KQS-HSF-1, Parsun, and ESFH-3391), four drought stress levels (0, 25%, 50%, and 75% drought stress), and three levels (0, 40ppm, 80ppm) of jasmonic acid. The 0% drought stress and 0ppm jasmonic acid were considered as control treatments. The experimental design was a completely randomized design with three replicates. Drought stress significantly reduced the growth in all varieties. However, the exogenous application of jasmonic acid at concentrations of 40ppm and 80ppm enhanced growth parameters, shoot and root length (1.93%, 19%), shoot and root fresh weight (18.5%, 25%), chlorophyll content (36%), photosynthetic rate (22%), transpiration rate (40%), WUE (20%), MDA (6.5%), Phenolics (19%), hydrogen peroxide (7%) proline (28%) and glycine betaine (15-30%) under water-stressed conditions, which was closely linked to the increase in stomatal activity stimulated by jasmonic acid. Furthermore, JA 80 ppm was found to be the most appropriate dose to reduce the effect of water stress in all sunflower varieties. It was concluded that the foliar application of JA has the potential to enhance drought tolerance by improving the morphological, biochemical, and physiological of sunflower.
Topics: Oxylipins; Cyclopentanes; Helianthus; Droughts; Plant Growth Regulators; Stress, Physiological; Plant Leaves; Photosynthesis; Chlorophyll
PubMed: 38907232
DOI: 10.1186/s12870-024-05273-4 -
BMC Cancer Jun 2024Diffuse midline glioma (DMG), H3 K27M-mutant is a type of diffuse high-grade glioma that occurs in the brain midline carrying an extremely poor prognosis under the best...
PURPOSE
Diffuse midline glioma (DMG), H3 K27M-mutant is a type of diffuse high-grade glioma that occurs in the brain midline carrying an extremely poor prognosis under the best efforts of surgery, radiation, and other therapies. For better therapy, we explored the efficacy and toxicity of a novel therapy that combines apatinib and temozolomide in DMG.
METHODS
A retrospective analysis of 32 patients with DMG who underwent apatinib plus temozolomide treatment was performed. Apatinib was given 500 mg in adults, 250 mg in pediatric patients once daily. Temozolomide was administered at 200 mg/m/d according to the standard 5/28 days regimen. The main clinical data included basic information of patients, radiological and pathological characteristics of tumors, treatment, adverse reactions, prognosis.
RESULTS
The objective response rate was 24.1%, and the disease control rate was 79.3%. The median PFS of all patients was 5.8 months, and median OS was 10.3 months. A total of 236 cycles of treatment were available for safety assessment and the toxicity of the combination therapy was relatively well tolerated. The most common grade 3 toxicities were myelosuppression including leukopenia (5.08%), neutropenia (4.24%), lymphopenia (2.12%), thrombocytopenia (1.69%) and anemia (1.27%). Grade 4 toxicities included neutropenia (2.12%), thrombocytopenia (2.12%) and proteinuria (1.69%). All the adverse events were relieved after symptomatic treatment or dose reduction.
CONCLUSIONS
Apatinib plus temozolomide could be an effective regimen with manageable toxicities and favorable efficacy and may outperform temozolomide monotherapy, particularly in newly diagnosed adults with tumors located outside the pons. The novel therapy deserves further investigation in adult DMG patients.
Topics: Humans; Temozolomide; Female; Male; Adult; Pyridines; Glioma; Adolescent; Retrospective Studies; Child; Brain Neoplasms; Young Adult; Antineoplastic Combined Chemotherapy Protocols; Child, Preschool; Middle Aged; Treatment Outcome
PubMed: 38907215
DOI: 10.1186/s12885-024-12373-9 -
Scientific Reports Jun 2024To assess the effects of warm-up music and low dose (3 mg·kg) of caffeine (CAF) on female taekwondo athlete's activity profile and psychophysiological responses during... (Randomized Controlled Trial)
Randomized Controlled Trial
To assess the effects of warm-up music and low dose (3 mg·kg) of caffeine (CAF) on female taekwondo athlete's activity profile and psychophysiological responses during simulated combat. In a double-blinded, randomized, crossover study, 16 female athletes participated in simulated combats under one control and 5 experimental conditions [i.e., CAF alone (CAF), placebo alone (PL), CAF with music (CAF + M), PL with music (PL + M), and no supplement with music (M)]. After warming-up, athletes rated their felt arousal (FAS). Mean (HR) and peak (HR) heart rate values were determined for each combat. After fighting, athletes rated their perceived exertion (RPE), feeling scale (FS), FAS, and physical enjoyment (PACES). Time-motion and technical-tactical variables were analyzed. CAF + M induced shorter skip and pause time, while attack time increased compared to other conditions (p < 0.05). Moreover, CAF + M increased single attacks, combined attacks, counter-attacks (p < 0.001), and defensive actions (p < 0.05) than other conditions. HR and HR were lower under CAF + M than other conditions (p < 0.05). Additionally, higher FAS post-combat, FS, and PACES were observed under CAF + M, while RPE was lower (except CAF condition) compared to the other conditions (p < 0.05.Using CAF with warm-up music may increase combat cadence and improve the psychological state in female athletes more effectively than either strategy alone.
Topics: Humans; Female; Caffeine; Music; Athletes; Martial Arts; Young Adult; Cross-Over Studies; Double-Blind Method; Heart Rate; Warm-Up Exercise; Adult; Athletic Performance; Arousal
PubMed: 38906894
DOI: 10.1038/s41598-024-64880-1 -
Allergology International : Official... Jun 2024To avoid complete elimination of hen eggs (HE) from diet, we introduced a very-low-dose (VLD) oral food challenge (OFC) in patients with severe HE allergy in 2019....
BACKGROUND
To avoid complete elimination of hen eggs (HE) from diet, we introduced a very-low-dose (VLD) oral food challenge (OFC) in patients with severe HE allergy in 2019. Herein, we investigated the efficacy of VLD HE OFC for achieving the full dose OFC.
METHODS
Patients with an overt allergic reaction to LD (1/32 HE [≤100 mg]) or less, egg white (EW) protein within 6 months were included. In the VLD group, patients not achieving full-dose OFC (1/2 HE: 1600 mg EW protein) within 2 years were excluded. We retrospectively compared the rate of passing a full-dose OFC between patients who underwent a LD OFC before 2019 (LD group) and those who underwent a VLD OFC (1/100 HE: 32 mg EW protein) after 2019 (VLD group). The period for passing the full-dose OFC was evaluated using Kaplan-Meier survival analysis.
RESULTS
We enrolled 411 and 111 patients in the LD and VLD groups, respectively. The median age at OFC initiation was 2.2 [1.5-3.6] and 2.1 [1.4-3.2] years in the LD and VLD groups, respectively. EW- and ovomucoid-specific IgE levels were 38.3 (12.5-72.9) and 21.0 (8.3-46.2) kU/L in the LD group and 49.8 [18.8-83.9] and 32.1 [15.6-67.8] kU/L in the VLD group, respectively. Over 4 years, the LD and VLD groups passed the full-dose OFC at rates of 70 and 95%, respectively, with significant differences (log-rank test, P < 0.001).
CONCLUSIONS
VLD HE OFC may contribute to passing a full-dose OFC in patients with severe HE allergies.
PubMed: 38906734
DOI: 10.1016/j.alit.2024.05.006 -
Journal of the Formosan Medical... Jun 2024Rituximab (RTX),an anti-CD20 monoclonal antibody can effectively treat minimal change disease (MCD),with low toxicity and a reduced steroid dosage. The optimal dosage of...
BACKGROUND PURPOSE
Rituximab (RTX),an anti-CD20 monoclonal antibody can effectively treat minimal change disease (MCD),with low toxicity and a reduced steroid dosage. The optimal dosage of RTX for treating MCD remains unclear. This study aimed to investigate the efficacy of an ultra-low-dose regimen of RTX (100 mg per week for 4 weeks) for treating MCD.
METHODS
We retrospectively analyzed clinical data from 31 patients with MCD who received RTX. Seventeen patients received ultra-low-dose RTX (ULD-RTX) therapy, and 14 patients received standard-dose RTX (SD-RTX) therapy (500 mg weekly for 4 weeks). All patients were followed up for at least 6 months.
RESULTS
Both groups showed significant increases in the serum albumin levels and notable decreases in the urinary protein levels in the 1st and 6th months after RTX therapy. There were no significant differences in the plasma albumin or urinary protein levels between the groups (p > 0.05). B-cell depletion was observed in all patients after 1 month of RTX administration. At 6 months after RTX treatment, the remission rate was 93% in the SD-RTX group and 88% in the ULD-RTX group (p > 0.05). The ULD-RTX therapy incurred lower costs than did the SD-RTX therapy. One patient in the SD-RTX group developed community-acquired pneumonia.
CONCLUSION
Ultra-low-dose RTX is effective at inducing remission in patients with MCD at a lower cost.
PubMed: 38906733
DOI: 10.1016/j.jfma.2024.06.013 -
Revista Portuguesa de Cardiologia :... Jun 2024The use of loop diuretics is central in managing congestion in heart failure (HF), but their impact on prognosis remains unclear. In euvolemic patients, dose reduction...
INTRODUCTION AND OBJECTIVES
The use of loop diuretics is central in managing congestion in heart failure (HF), but their impact on prognosis remains unclear. In euvolemic patients, dose reduction is recommended, but there is no recommendation on their discontinuation. This study aims to assess the impact of loop diuretic discontinuation on the prognosis of outpatients with HF with reduced ejection fraction.
METHODS
This retrospective cohort study collected data from medical records of patients followed in an outpatient HF clinic at a university hospital center. Patients were included if they had been on loop diuretics and these were discontinued. Demographic, clinical and laboratory data were collected, and number and type of congestive events during the one-year period after discontinuation were recorded.
RESULTS
Among 265 patients on loop diuretics, almost half (129) discontinued them at some point. Patients had optimized medical therapy, low median age, low New York Heart Association class, low B-type natriuretic peptide values, normal blood pressure, controlled heart rate and kidney function within normal limits. Among 122 patients with one year of follow-up, 18 (14.8%) had a congestive event. Fifteen events (83.3%) were low-dose diuretic reinitiation at a scheduled visit. There were only three worsening heart failure events (2.5%) during the one-year period. A significant improvement in kidney function from discontinuation to the one-year follow-up appointment was also observed.
CONCLUSIONS
In our cohort, loop diuretic discontinuation was possible and safe in a large proportion of patients. The results should be interpreted with caution and cannot be extrapolated to a broader population of HF patients.
PubMed: 38906521
DOI: 10.1016/j.repc.2024.02.012 -
Journal of Infection and Chemotherapy :... Jun 2024This Phase III, multicenter, open-label, single-arm study evaluated the safety and immunogenicity of the measles-mumps-rubella (MMR) combined vaccine, JVC-001, as a...
Phase III, open-label, single-arm study of a new MMR vaccine (JVC-001); measles AIK-C, mumps RIT 4385, rubella Takahashi, as a second vaccine dose in healthy Japanese children aged 5-6 years.
PURPOSE
This Phase III, multicenter, open-label, single-arm study evaluated the safety and immunogenicity of the measles-mumps-rubella (MMR) combined vaccine, JVC-001, as a second MMR vaccination.
METHODS
Healthy Japanese children aged 5-6 years received a single dose of JVC-001 following a first measles, mumps, and rubella vaccination (measles-rubella bivalent and mumps monovalent vaccine [Hoshino or Torii strain] or JVC-001) or the MMR vaccine received between ages 1 to <4 years. Immunogenicity was evaluated using antibody titers before and after vaccination (Day 1/Day 43). The primary endpoint was the seroprotection rate of antibody titers against each virus; geometric mean titer (GMT) was also evaluated. Adverse events (AEs) and adverse drug reactions (ADRs) were monitored.
RESULTS
One-hundred participants completed the study. The seroprotection rate of antibody titers against measles, rubella, and mumps virus (genotype D) were 100.0% (95% confidence interval [CI] 96.4%, 100.0%), 100.0% (95% CI 96.4%, 100.0%), and 100.0% (95% CI 96.3%, 100.0%), respectively. GMT (fold) increases (Day 1 to Day 43) were 16.0 to 55.7 for measles virus, 35.5 to 99.0 for rubella virus, and 25.7 to 89.5 for mumps virus (genotype D). Solicited ADRs occurred in 40.0% of participants (injection site, 34.0%; systemic, 13.0%).
CONCLUSIONS
The second MMR vaccination with JVC-001 demonstrated sufficient antibody coverage against all three viruses; the safety profile was tolerable.
CLINICAL TRIAL REGISTRATION
jRCT2080225022.
PubMed: 38906375
DOI: 10.1016/j.jiac.2024.06.011 -
The Science of the Total Environment Jun 2024The global health implications of fine particulate matter (PM) underscore the imperative need for research into its toxicity and chemical composition. In this study,...
Prediction of developmental toxic effects of fine particulate matter (PM) water-soluble components via machine learning through observation of PM from diverse urban areas.
The global health implications of fine particulate matter (PM) underscore the imperative need for research into its toxicity and chemical composition. In this study, zebrafish embryos exposed to the water-soluble components of PM from two cities (Harbin and Hangzhou) with differences in air quality, underwent microscopic examination to identify primary target organs. The Harbin PM induced dose-dependent organ malformation in zebrafish, indicating a higher level of toxicity than that of the Hangzhou sample. Harbin PM led to severe deformities such as pericardial edema and a high mortality rate, while the Hangzhou sample exhibited hepatotoxicity, causing delayed yolk sac absorption. The experimental determination of PM constituents was followed by the application of four algorithms for predictive toxicological assessment. The random forest algorithm correctly predicted each of the effect classes and showed the best performance, suggesting that zebrafish malformation rates were strongly correlated with water-soluble components of PM. Feature selection identified the water-soluble ions F and Cl and metallic elements Al, K, Mn, and Be as potential key components affecting zebrafish development. This study provides new insights into the developmental toxicity of PM and offers a new approach for predicting and exploring the health effects of PM.
PubMed: 38906297
DOI: 10.1016/j.scitotenv.2024.174027 -
Alternative Therapies in Health and... Jun 2024To compare the effectiveness and safety of intravenous thrombolysis via the subpatellar vein versus the conventional popliteal vein approach in patients with early acute...
OBJECTIVE
To compare the effectiveness and safety of intravenous thrombolysis via the subpatellar vein versus the conventional popliteal vein approach in patients with early acute deep venous thrombosis (DVT) of the lower extremities.
METHODS
This study included 160 early-stage acute lower extremity DVT patients at our hospital from January 2020 to October 2023, randomly assigned to two groups using sealed envelopes. The control group underwent catheter-directed thrombolysis via the popliteal vein, while the study group received thrombolysis via the subpatellar vein. Surgical parameters, limb circumferences, blood parameters, vein patency, and adverse reactions were evaluated.
RESULTS
The study group had longer surgery and X-ray times, as well as a lower urokinase dose compared to the control group (P < .05), with no significant difference in thrombolysis time (P > .05). Thigh and calf circumferences and edema rates didn't significantly change before and after thrombolysis in both groups (P > .05). Hematological parameters, including PT, INR, APTT, FIB, TT, and D-D levels, remained similar between the two groups before and after thrombolysis (P > .05). However, after thrombolysis, both groups showed increased PT, INR, APTT, and TT levels and decreased FIB and D-D levels compared to before thrombolysis (P < .05). Porter scores showed no significant differences between the two groups before thrombolysis (P > .05), but after thrombolysis, both groups had reduced Porter scores, with the study group showing a more pronounced decrease (P < .05). Additionally, the study group had a higher vein patency rate and GCQ score than the control group (P < .05). Adverse reactions occurred at a similar rate in both groups (P > .05).
CONCLUSION
Subpatellar vein catheter-directed thrombolysis offers a safe and more effective alternative to traditional popliteal vein approaches for early acute DVT of the lower extremities, improving outcomes such as vein patency and reducing the need for urokinase.
PubMed: 38904617
DOI: No ID Found