Background: The present study aimed to determine the pharmacokinetic parameters and bioequivalence of the test medicinal product, apixaban 5 mg tablet, and its reference product, Eliquis, in healthy male and female subjects under a fasted state.
Methods: Before in vivo evaluation, the quality control parameters of the products were evaluated and compared. This study was a single-dose, double-blind, 2-sequence, crossover, 2-period, randomized bioequivalence and pharmacokinetic study in 24 healthy individuals with a two-week washout period between doses.
J Biomed Mater Res B Appl Biomater
July 2025
Oral mucositis occurs after chemo/radiotherapy and can significantly impact patients' quality of life. The objective of this study was to develop and characterize mucoadhesive in situ gels (ISGs) using chitosan (CS) in conjunction with polymers like poloxamer (PLX) and beta-glycerophosphate (βGP) to deliver benzydamine hydrochloride (BNZ) locally. CS/PLX (2.
View Article and Find Full Text PDFLiposomal drug delivery systems have shown promising potential to improve drug delivery in several aspects. Precise characterization of formulated liposomes is vital to achieve proper function. In particular, release testing of liposomes offers crucial insights for predicting drug release behavior, guiding the development of more effective liposomal formulations.
View Article and Find Full Text PDFRecurrent aphthous stomatitis (RAS) is a common condition that manifests as ulcerative lesions in the oral mucosa. In this study, bilayer, mucoadhesive nanofibers loaded with pomegranate flower extract (PFE) were prepared using thiolated gelatin (TGel) and thiolated chitosan (TCS) as the active layer and drug-free polycaprolactone (PCL) as the backing layer. Gelatin (Gel) and chitosan (CS) were successfully thiolated (proven by Ellman's assay, solubility, H NMR, FTIR, Raman spectroscopy, and XRD) and electrospun into active nanofibrous layers with a diameter of 356.
View Article and Find Full Text PDFBiofilm-mediated osteomyelitis presents significant therapeutic challenges. Given the limitations of existing osteomyelitis treatment approaches, there is a distinct need to develop a localized drug delivery system that is biocompatible, biodegradable, and capable of controlled antibiotic release. Multivesicular liposomes (MVLs), characterized by their non-concentric vesicular structure, distinct composition, and enhanced stability, serve as the system for a robust sustained-release drug delivery platform.
View Article and Find Full Text PDFCerasomes are a modified form of liposomes containing both inorganic and organic parts and due to their strong polyorganosiloxane surface have remarkably high morphological stability and provide easier functionalization compared with conventional liposomes. To investigate the potential of these nanocarriers for oral delivery, bile salt integrated cerasomes (named bilocerasomes) encapsulating idarubicin hydrochloride (IDA) were prepared and characterized. The optimum formulation showed excellent stability in the simulated gastrointestinal fluids as well as under storage conditions.
View Article and Find Full Text PDFDoxorubicin (DOX) is a chemotherapeutic with considerable efficacy, but its application is limited due to cardiotoxicity. Nanoparticles can improve DOX efficacy and prevent its adverse effects. Herein, DOX-loaded extracellular vesicles (DOX-EVs) were prepared using different loading methods including incubation, electroporation, and sonication in different hydration buffers to permeabilize nanostructures or desalinize DOX for improved entrapment.
View Article and Find Full Text PDFRecombinant human epidermal growth factor (rhEGF) is widely utilized as an antiaging compound in wound-healing therapies and cosmetic purposes. However, topical administration of rhEGF has limited treatment outcomes because of its poor percutaneous penetration and rapid proteinase degradation. To overcome these obstacles, this study aims to develop and characterize rhEGF-containing conventional liposomes (rhEGF-CLs) and transferosomes (rhEGF-TFs) as efficient dermal carriers.
View Article and Find Full Text PDFBackground: Batch cultures used for various purposes, such as expression screening and recombinant protein production in laboratories, usually have some drawbacks due to the bolus addition of carbon sources, such as glucose and buffers, that lead to overflow metabolism, decreased pH, high osmolality, low biomass yield, and low protein production.
Objectives: This study aimed to overcome the problems of batch culture using the controlled release concept by a controlled porosity osmotic pump (CPOP) system.
Methods: The CPOP was formulated with glucose as a carbon source feeding and sodium carbonate as a pH modifier in the core of the tablet that was coated with a semipermeable membrane containing cellulose acetate and polyethylene glycol (PEG) 400.
Background: Crocin is a water-soluble carotenoid compound present in saffron ( L.), known for its wide range of pharmacological activities, including cardioprotective, hepatoprotective, anti-tumorigenic, anti-atherosclerosis, and anti-inflammatory effects.
Objectives: The instability of crocin, its low miscibility with oils, and poor bioavailability pose challenges for its pharmaceutical applications.
Iran J Basic Med Sci
January 2024
Objectives: Currently, the most important treatment approach for hemophilia type A is recombinant Factor VIII. However, due to its low retention time in the blood, the patients usually need successive injections. In addition, neutralization of injected proteins by antibodies complicates treatment.
View Article and Find Full Text PDFConventional cancer chemotherapy regimens, albeit successful to some extent, suffer from some significant drawbacks, such as high-dose requirements, limited bioavailability, low therapeutic indices, emergence of multiple drug resistance, off-target distribution, and adverse effects. The main goal of developing implantable drug delivery systems (IDDS) is to address these challenges and maintain anti-cancer drugs directly at the intended sites of therapeutic action while minimizing inevitable side effects. IDDS possess numerous advantages over conventional drug delivery, including controlled drug release patterns, one-time drug administration, as well as loading and stabilizing poorly water-soluble chemotherapy drugs.
View Article and Find Full Text PDFBile salts were first used in the preparation of nanoparticles due to their stabilizing effects. As time went by, they attracted much attention and were increasingly employed in fabricating nanoparticles. It is well accepted that the physicochemical properties of nanoparticles are influential factors in their permeation, distribution, elimination and degree of effectiveness as well as toxicity.
View Article and Find Full Text PDFPhospholipid-based nanosystems show promising potentials for oral administration of hydrophobic drugs. The study introduced a novel approach to optimize posaconazole-loaded phospholipid-based nanoformulation using the design of experiments, machine learning, and Technique for Order of Preference by Similarity to the Ideal Solution. These approaches were used to investigate the impact of various variables on the encapsulation efficiency (EE), particle size, and polydispersity index (PDI).
View Article and Find Full Text PDFThis study aimed to develop nanoaggregates of berberine-phospholipid complex incorporated into thiolated chitosan (TCS) hydrogel for the treatment of aphthous stomatitis. The berberine-phospholipid complex was formulated through the solvent evaporation technique and assembled into nanoaggregates. TCS was synthesized through the attachment of thioglycolic acid to chitosan (CS).
View Article and Find Full Text PDFDrug Deliv Transl Res
January 2024
Restenosis remains the main reason for treatment failure of arterial disease. Sirolimus (SIR) as a potent anti-proliferative agent is believed to prevent the phenomenon. The application of exosomes provides an extended-release delivery platform for SIR intramural administration.
View Article and Find Full Text PDFAphthous stomatitis is a common inflammatory oral disease with challenging management. Crocin is a natural carotenoid that has shown great anti-inflammatory properties. The aim of this study was to develop thiolated chitosan (TCS)-based hydrogels containing niosomes to serve as a mucoadhesive crocin delivery system for aphthous stomatitis.
View Article and Find Full Text PDFOver the last few years, among controlled-release delivery systems, multivesicular liposomes (MVLs) have attracted attention due to their unique benefits as a loco-regional drug delivery system. Considering the clinical limitations of the current treatment strategies for osteomyelitis, MVLs can be a suitable carrier for the local delivery of effective antibiotics. This study aimed to prepare vancomycin hydrochloride (VAN HL) loaded MVLs using the active loading method which to the best of our knowledge has not been previously reported.
View Article and Find Full Text PDFExosomes are cell-derived nanovesicles, circulating in different body fluids, and acting as an intercellular mechanism. They can be purified from culture media of different cell types and carry an enriched content of various protein and nucleic acid molecules originating from their parental cells. It was indicated that the exosomal cargo can mediate immune responses via many signaling pathways.
View Article and Find Full Text PDFTo develop quercetin nanocrystals by a simple approach and to evaluate their antifibrotic efficacy. Nanosuspensions were fabricated by a thin-film hydration technique and ultrasonication. The influence of process variables on the average diameter of quercetin nanoparticles was investigated.
View Article and Find Full Text PDFThis study aimed to prepare piperine (PIP) loaded liposomes in hyaluronic acid (HA) hydrogel to provide a hybrid superstructure for postoperative adhesion prevention. Liposomes were prepared using thin-film hydration method. The optimised formulation was characterised by size, SEM, TEM, FTIR, encapsulation efficiency (EE)% (w/w), and release pattern.
View Article and Find Full Text PDFBackground: A large number of new substances have insufficient biopharmaceutical properties for oral administration caused by their slow dissolution rate and poor solubility.
Objective: The purpose of our experiment was to improve the physicochemical properties of a hydrophobic drug, quercetin, by the nanomilling approach.
Methods: Quercetin nanosuspensions were prepared using a wet-milling method followed by lyophilization.
Background: Despite the advantages of direct intratumoral (IT) injection, the relatively rapid withdrawal of most anti-cancer drugs from the tumor due to their small molecular size limits the effectiveness of this method of administration. To address these limitations, recently, increasing attention has been directed to using slow-release biodegradable delivery systems for IT injection.
Objectives: This study aimed to develop and characterize a doxorubicin-loaded DepoFoam system as an efficient controlled-release carrier to be employed for locoregional drug delivery in cancer treatment.
Background: Postoperative peritoneal adhesions are among common challenging problems in surgery. The availability of limited efficient strategies to prevent intra-abdominal adhesion reinforces the need to explore new methods. Given the favorable prolonged drug release characteristics of polycaprolactone (PCL) films and their ability to act as a biodegradable physical barrier implant, along with the anti-inflammatory and anti-adhesion properties of indomethacin and phospholipids, this study hypothesized that indomethacin sustained-release membrane composed of phosphatidylcholine (PC) and PCL blend could efficiently prevent abdominal adhesion formation.
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