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[Separation and purification of phospholipids from Antarctic krill oil by hydrophilic interaction liquid chromatography].

Antarctic krill has the largest biomass of any wild animal species on Earth. Krill oil extracted from Antarctic krill is rich in phospholipids， and is a major natural source of marine phospholipids. In marine phospholipids， eicosapentaenoic acid （EPA） and docosahexaenoic acid （DHA） are esterified at the sn-2 position of glycerol. This unique structural configuration endows them with the dual physiological functions of both phospholipids and Ω-3 polyunsaturated fatty acids. Compared with terrestrial phospholipids， marine phospholipids exhibit superior bioactivity in several key aspects， includi

Randomized single-dose crossover comparative bioavailability study of two novel oral cannabidiol (CBD) formulations in healthy volunteers under fed conditions, compared to a standard CBD isolate capsule.

BACKGROUND: This study aimed to compare the pharmacokinetics and relative bioavailability of two novel cannabidiol (CBD) formulations including bioavailability-enhanced capsule (CBDNEXT Supra capsule) and a bioavailability-enhanced liquid (CBDNEXT Supra liquid)- against a standard high-purity CBD isolate capsule in healthy volunteers under fed (low-fat) conditions. METHODS: A single-dose, open-label, randomized, three-period, three-sequence crossover trial was conducted in 12 healthy male volunteers (18-50 years). Of the 12 enrolled subjects, 9 completed all three treatment periods per protoc

Safety and tolerability of losartan to treat recessive dystrophic epidermolysis bullosa in children (REFLECT): an open-label, single-arm, phase 1/2 trial.

BACKGROUND: Recessive dystrophic epidermolysis bullosa (RDEB) is a skin fragility disorder characterised by life-long mechanically induced s … urbances; history of cancer or chronic viral infections; hypersensitivity to losartan or any of the excipients and known or persistent abuse of medication, drugs, or alcohol. Treatment duration with losartan comprised 10 months, encompassing 16 weeks up-dosing of losartan, 24 weeks full dose losartan (final target dose of 1.4 mg/kg), and 4 weeks losartan tap …

Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.

IntroductionRice bran arabinoxylan compound (RBAC) is a nutraceutical for enhancing a depleted immune system during and after cancer treatment. This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire. Other outcome measures include changes in inflammatory and nutritional status, cytokine profile, and gut microbiota.Methods/designThe study will recruit 50 participants from a regional cancer center in Australia. Patients aged 18-70, diagnosed with solid organ cancers stage

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… As shown in Table 3 , each RBAC sachet contains 1 g of the active ingredient with 1 g of excipients (Total = 2 g). The placebo powder contains 1.26 g of inert corn starch and 0.74 g of other excipients (Total = 2 g). … The placebo has a slight difference in excipient contents to achieve acceptable melt in the mouth, as well as a negligible amount of caramel, which is for binding and color matching. The placebo is similar in color, odor, and taste compared to the active compound. …

Влияние эндотелиальных клеток в костном мозге на выживание пациентов с многократным исследованием миеломы-единоцентра.

Это исследование было направлено на анализ выживаемости пациентов с множественной миеломой с точки зрения ценности эндотелиальных клеток, вовлеченных в процесс опухоли неонангиогенез. Методы: В этом неслучайном исследовании наблюдений мы в перспективе оценили когорту 74 Взрослые пациенты с множественной миеломой, которые прошли базовую оценку количества эндотелиальных клеток в их костном мозге и получили VCD или VTD антимиеломную терапию, за которой последовали автоPBSCT. Затем они оценивались на предмет их выживания с помощью долгосрочных последующих мер. Результаты: Был проанализирован вопро

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… for treatment in accordance with the guidelines of multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up [ 1 ]; (5) no contraindications to drug use in accordance with the current summary of product characteristics; (6) no hypersensitivity to any of the drugs or excipients … The exclusion criteria were as follows: (1) the occurrence of hypersensitivity symptoms to any of the drugs used or the excipients of the drugs; (2) pregnancy or breastfeeding; and (3) the occurrence of diseases or conditions that, in the opinion of the attending physician, prevent treatment continuation …

Role of Cannabidiol for Improvement of the Quality of Life in Cancer Patients: Potential and Challenges.

There is currently a growing interest in the use of cannabidiol (CBD) to alleviate the symptoms caused by cancer, including pain, sleep disruption, and anxiety. CBD is often self-administered as an over-the-counter supplement, and patients have reported benefits from its use. However, despite the progress made, the mechanisms underlying CBD's anti-cancer activity remain divergent and unclear. Herein, we provide a comprehensive review of molecular mechanisms to determine convergent anti-cancer actions of CBD from pre-clinical and clinical studies. In vitro studies have begun to elucidate the mo

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… Placebo contained colorants and excipients. | -Change from baseline in mean pain NRS score was statistically significant for Sativex, but not GW-1000-02. -Patients with a reduction of more than 30% from baseline pain NRS score. … Nabiximols contained: THC 27 mg/mL CBD 25 mg/mL With excipients Each 100 μL actuation delivered: 2.7 mg THC + 2.5 mg CBD Placebo was self-administered by participants as a 100 μL oromucosal spray up to a maximum of 10 sprays per day for 5 weeks. …

Surfactant-Enabled Nanocarriers in Breast Cancer Therapy: Targeted Delivery and Multidrug Resistance Reversal.

Breast cancer remains a leading cause of cancer-related morbidity and mortality among women worldwide. Its treatment is complicated by molecular heterogeneity and the frequent development of multidrug resistance (MDR). Conventional drug delivery approaches are often limited by poor aqueous solubility, rapid systemic clearance, non-specific biodistribution, and off-target toxicity. This review will critically explore the possibility of surfactant-based drug delivery systems (DDSs) in addressing the constraints of standard breast cancer treatments. It focuses on the mechanisms by which surfactan

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… Furthermore, regulatory avenues are uncertain, considering that TPGS is both an active ingredient with an effect on pharmacokinetics and a functional excipient. … Such dual functionality makes classification based on current FDA or EMA guidelines challenging, and the outcome is that it might have to be characterized and controlled with more stringent standards than typical excipients. …

Enhancing the Safety of Nanoparticles in Medicine: Highlights of Progress and Critical Objectives.

Nanoparticles have transformed drug delivery, imaging, vaccination, and precision therapeutics, but their clinical translation remains constrained by safety profiles that are inseparable from material design, biological identity, host factors, and manufacturing. This review critically evaluates recent progress, persistent limitations, and priority objectives for safer nanomedicine. Unlike reviews organized primarily by material class or isolated toxicology endpoints, we integrate physicochemical determinants, protein corona formation, immune recognition, organ disposition, preclinical models,

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… The relevant hazard profile is a system-level property of the entire nanoscale construct, including its excipients, degradation products, adsorbed biomolecular corona, process-related impurities, storage-dependent transformations, and dose- and route-specific biological interactions. 6 , 9–11 This principle … It illustrates that excipients once considered largely inert may become critical determinants of clinical performance and safety when deployed repeatedly, at scale, and in immunologically diverse populations. …

Clinical study of Shengxuening tablet combined with rHuEPO for the treatment of renal anemia of maintenance hemodialysis patients.

The aim of the present study was to investigate the clinical effects of Shengxuening tablet (silkworm excrement) combined with recombinant human erythropoietin (rHuEPO) for the treatment of renal anemia of maintenance hemodialysis (MHD) patients. Seventy-two MHD patients with renal anemia were included in the study and randomly divided into the control (n=34) and observation (n=38) groups. Patients in the control group were treated by hypodermic injection of 100-150 U/(kg·w) rHuEPO and patients in the observation group were treated by rHuEPO + 1.0 g t.i.d. p.o. Shengxuening tablet. The two gro

A new curcuma extract (flexofytol®) in osteoarthritis: results from a belgian real-life experience.

This retrospective observational study summarizes the experiences of 820 patients treated with a new Curcuma extract (Flexofytol®, 4-6 capsules per day), for more than 6 months for various forms of painful osteoarthritis. These experiences were reported by 110 Belgian general practitioners via a questionnaire that included quality-of-life parameters for assessing patient experience. Data were submitted to an independent statistician for analysis. Within the first 6 weeks, Flexofytol® improved patient pain, articular mobility, and quality of life. Excellent tolerance was reported, and more than

Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial.

CD38-targeting immunotherapy is approved in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma (NDMM) that are transplant ineligible (TI) and is considered the best standard of care (SOC). To improve current SOC, we evaluated the added value of weekly bortezomib (V) to isatuximab plus lenalidomide and dexamethasone (IsaRd versus Isa-VRd). This Intergroupe Francophone of Myeloma phase 3 study randomized 270 patients with NDMM that were TI, aged 65-79 years, to IsaRd versus Isa-VRd arms. The primary endpoint was a minimal residual disease (MRD) nega

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… and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents, monoclonal antibodies or human proteins, or their excipients … Subject has known hypersensitivity, allergy to one of the study product (isatuximab, lenalidomide, bortezomib), dexamethasone or to one of the excipients. Subject has acute diffuse infiltrative pneumopathy, pericardial disease. …

[Neoadjuvant chemoradiotherapy combined with surgery versus direct surgery in the treatment of Siewert type II and III adenocarcinomas of the esophagogastric junction: long-term prognostic analysis of a prospective randomized controlled trial].

Objective: To investigate the effectiveness, safety, and prognosis of neoadjuvant chemoradiotherapy (nCRT) for Siewert type II and III adeno … dney, cardiovascular system and other vital organs; allergy to capecitabine or oxaliplatin drugs or excipients; receiving any form of chemotherapy or other research drugs; pregnant or lactating women; patients with diseases resulting in difficulty to take capecitabine or with concurrent tumors. Based on sample size estimation, a total of 150 AEG patients wer …

Nanoparticle-Based Therapeutic Strategies in Respiratory Diseases: Current Approaches and Future Perspectives.

INTRODUCTION: Respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung cancer, tuberculosis, and acute respiratory distress syndrome (ARDS) remain major global health challenges, causing significant morbidity and mortality worldwide.1,2 Despite the availability of pharmacological treatments such as bronchodilators, corticosteroids, antibiotics, and chemotherapeutics, most conventional drug administration routes (oral or intravenous) are often associated with critical limitations. These systemic delivery methods lead to the widespread distribution of drugs through

Micro and nanotechnologies: The little formulations that could.

The first publication of micro- and nanotechnology in medicine was in 1798 with the use of the Cowpox virus by Edward Jenner as an attenuated vaccine against Smallpox. Since then, there has been an explosion of micro- and nanotechnologies for medical applications. The breadth of these micro- and nanotechnologies is discussed in this piece, presenting the date of their first report and their latest progression (e.g., clinical trials, FDA approval). This includes successes such as the recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines from Pfizer, Moderna, and Janssen (

Rosmarinic Acid and Related Dietary Supplements: Potential Applications in the Prevention and Treatment of Cancer.

Cancer constitutes a severe threat to human health and quality of life and is one of the most significant causes of morbidity and mortality worldwide. Natural dietary products have drawn substantial attention in cancer treatment and prevention due to their availability and absence of toxicity. Rosmarinic acid (RA) is known for its excellent antioxidant properties and is safe and effective in preventing and inhibiting tumors. This review summarizes recent publications on culture techniques, extraction processes, and anti-tumor applications of RA-enriched dietary supplements. We discuss techniqu

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… Veras et al. tested excipients for RA. Microcrystalline cellulose and polyvinylpyrrolidone have compatibility against physical interactions, chemical incompatibilities, high temperatures, and water [ 65 ]. … To improve the oral bioavailability of RA, modification of excipients, encapsulation using cyclodextrins, drug delivery systems, and derivatives of RA are promising candidates. This review provides a theoretical basis for the use of RA in the prevention and treatment of cancer. …

Does Therapeutic Repurposing in Cancer Meet the Expectations of Having Drugs at a Lower Price?

Therapeutic repurposing emerged as an alternative to the traditional drug discovery and development model (DDD) of new molecular entities (NMEs). It was anticipated that by being faster, safer, and cheaper, the development would result in lower-cost drugs. As defined in this work, a repurposed cancer drug is one approved by a health regulatory authority against a non-cancer indication that then gains new approval for cancer. With this definition, only three drugs are repurposed for cancer: Bacillus Calmette-Guerin (BCG) vaccine (superficial bladder cancer, thalidomide [multiple myeloma], and p

Advances in Drug Delivery and Biomaterials: Facts and Vision.

Drug delivery and biomaterials are different fields of science but, at the same time, are tightly related and intertwined. The 2018 CRS Italy Chapter Annual Workshop aims to explore recent advances in design and development in these areas. Many colleagues from Europe participated to the Workshop, stimulating the discussion. To foster the discussion on recent research and networking opportunities, especially among younger attendees, all poster-presenting authors were asked to provide a short talk. The very friendly and stimulating atmosphere allowed the attendees to explore new frontiers and ta

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… Excipients already used in ophthalmic preparation were preferred. The stability of rhNGF formulated solutions at different concentrations was investigated in the range of temperature −20 °C–+25 °C. … This solid-phase transition contributed, together with the wetting effect of the hydrophilic excipients, to the enhancement of solubility and dissolution behavior. …

Безопасность и эффективность добавки корма, состоящей из Enterococcus lactisNICIMB 10415 (Cylactin) для всей птицы, предназначенной для жирения или выращивания для слоения/бридинга и декоративных птиц, для всех суидов, телят и других видов червей, предназначенных для сжижения или выращивания (DSM Dutal Products Ltd).

По просьбе Европейской комиссии ЕФСА было предложено представить научное заключение по оценке Цилактин в качестве зоотехнической добавки. Активным агентом присадки является Enterococcus lactis NCIMB 10415, и three Разрешенные в настоящее время составы присадок: Cylactin (LBC G35), Cylactin (LBC ME10) и Cylactin (LBC ME20) плюс. В настоящее время эта добавка разрешена в ЕС для использования в птице (цыплятах и мелких видах птицы для жиров, цыплят и мелких видов, выращиваемых для стирания), телятах и детях для выращивания и жирения, свиней, кормовых и откормленных поросят и свиней для откорма. В

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… The formulations Cylactin® LBC G35 and LBC ME10 of the additive do not contain excipients of concern. The formulation of Cylactin® LBC ME20 plus includes ■■■■■ shellac as a coating agent, which is not currently authorised as a feed additive. … Based on the data assessed, the FEEDAP Panel concludes that the use of this excipient as a coating agent in one of the formulations of the additive under assessment (Cylactin® LBC ME20 plus) does not raise safety concerns for the target species, consumers and environment. …

Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The main aim of the study is to evaluate the efficacy of a single dose of sarilumab, in subcutaneous administration, in hospital … r SARS-CoV-2 infection. m. Patients with known hypersensitivity or contraindication to sarilumab or excipients. INTERVENTION AND COMPARATOR: The intervention group, sarilumab plus standard of care, will receive 400 mg single dose treatment with Sarilumab (Kevzara), 2 subcutaneous injections 200mg each in a pre-filled syringe. Treatment with drugs or procedu …

MUKnine OPTIMUM protocol: a screening study to identify high-risk patients with multiple myeloma suitable for novel treatment approaches combined with a phase II study evaluating optimised combination of biological therapy in newly diagnosed high-risk multiple myeloma and plasma cell leukaemia.

INTRODUCTION: Multiple myeloma (MM) is a plasma cell tumour with over 5800 new cases each year in the UK. The introduction of biological therapies has improved outcomes for the majority of patients with MM, but in approximately 20% of patients the tumour is characterised by genetic changes which confer a significantly poorer prognosis, generally termed high-risk (HR) MM. It is important to diagnose these genetic changes early and identify more effective first-line treatment options for these patients. METHODS AND ANALYSIS: The Myeloma UK nine OPTIMUM trial (MUKnine) evaluates novel treatment

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… Any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products. … Any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products. …