Nanoparticles (NPs) offer significant advantages over conventional drug formulations, including enhanced bioavailability, reduced toxicity, and controlled release. Human serum albumin (HSA) is a biocompatible material widely used for NP fabrication, exemplified by Abraxane, an HSA-based NP formulation that improves chemotherapy delivery. Despite these benefits, HSA-NPs predominantly rely on passive tumor targeting through enhanced permeability and retention effect. Attempts to enhance active targeting via surface modifications often trigger immune responses, while scalable production remains limited by inconsistencies in size, drug loading, and stability. Here, we introduce a variant HSA (VA) as a building block for a novel nanocarrier, VA-NPs. Engineered with an α-helical domain that pairs with a complementary α-helical counterpart, VA enables VA-NPs to self-decorate their surface with diverse payload proteins through spontaneous and specific coiled-coil interactions. Unlike traditional approaches, this strategy eliminates the need for chemical conjugation or genetic fusion, establishing VA-NPs as a modular platform for multifunctional nanomedicines. This programmable protein display method offers a scalable and clinically relevant solution to current limitations in nanoparticle-based drug delivery, paving the way for next-generation nanomedicines with enhanced specificity, functional versatility, and therapeutic efficacy.

Nanodrug impact on female reproductive health and fetal development: From translation approaches to long-term safety concern.

Targeted therapeutics for IBD unraveling the potential of stimulus-responsive nanoparticles.

Role of carriers and pre-dissolved polymers in drug-rich nanodroplet formation during dissolution of amorphous drug formulations.

Encapsulation-based enhancements in modern drug delivery systems.

Formulating drugs for pediatric patients is more complex than for adults due to the diversity within this group. Solubility of active pharmaceutical ingredients (APIs) presents specific challenges, since children have unique physiological traits—smaller stomach volume and immature digestive systems—that affect absorption, metabolism, and overall drug effectiveness. ‏Oral formulations must consider drug sensitivity, swallowing difficulties, and compliance. Taste, ease of administration, and patient acceptance strongly influence therapeutic outcomes and safety. Ensuring children take medication as directed is often as important as the formulation itself. ‏To address these issues, solubility enhancement technologies have advanced

Background:For large language models (LLMs) to reach their potential as information technology tools that make medication use safer, clinically relevant benchmarks capable of automated grading and designed specifically to measure the performance of LLMs for medication tasks are required. The purpose of this study was to design a suite of benchmarking tests reflective of Comprehensive Medication Management (CMM; the standard of care for medication optimization) and quantify the baseline performance of the latest LLMs.Methods:We established six benchmarks representing critical stages of the CMM process: drug formulation matching, drug order (sig) generation, drug route matching, drug-drug interaction identification, renal dose identification, and drug-indication matching. For each benchmark, we curated a clinician-annotated dataset comprising 250 standardized input-output pairs including both inpatient and outpatient medications. We evaluated the clinical knowledge retrieval capabilities of three LLMs: GPT-4o-mini, MedGemma-27B, and LLaMA3–70B. We employed a zero-shot prompting strategy, excluding in-context examples, to assess the models’ internal clinical knowledge rather than their few-shot learning potential. To check reliability, each model was run three times using a temperature of 0.7 (a mid-range value of an LLM setting controlling text generation randomness). Performance was assessed using task-specific evaluation metrics including precision (positive predictive value), recall (sensitivity), F1-score, accuracy, and correctness consistency across trials.Results:Across six benchmarks, LLaMA3–70B demonstrated the highest performance in four tasks: drug-formulation matching (F1, 54.0% [95 CI: 50.1–58]), drug-order generation (accuracy, 88.0%), drug-route identification (F1, 74.3% [95 CI: 71–78]), and drug-indication identification (accuracy, 97.6% [95 CI: 95.6–99.2]). In the drug–drug interaction task, GPT-4o-mini achieved the highest overall accuracy (70.4% [95 CI: 64.8–75.7]). For renal dose–adjustment identification, GPT-4o-mini demonstrated the highest F1 score (83.3% [95 CI: 77.6–88]). Correctness-consistency scores ranged from 8.0% to 97.6% across benchmarks, with no model exhibiting uniformly superior consistency.Conclusions:Model performance varied substantially across medication-related tasks. LLaMA3–70B demonstrated promising baseline performance in tasks involving formulation, ordering, route, and indication. GPT-4o-mini showed potential advantages in drug–drug interaction detection and renal dose adjustment. These findings underscore the need for task-specific evaluation when deploying models for medication-focused clinical decision support.

Background: Chronic insomnia is associated with elevated cardiovascular disease risk, and current therapeutic options for this condition remain inadequate. Melatonin (MT) combined with cannabidiol (CBD) may exert synergistic effects on improving sleep; the underlying pharmacological drug–drug interactions (DDI) and interspecies differences in their combined actions remain unknown. Purpose: This study aimed to evaluate the pharmacokinetic characteristics of combined drug formulations by utilizing DDI-based approaches so as to underpin the efficacy and safety of the formulation. Methods: Overexpressing hPEPT1 in MDCK cells, multiple species liver microsomes, equilibrium dialysis, and a static DDI model were employed to assess CBD’s effects on MT’s cellular uptake, inhibitory effect, enzymatic phenotype, protein binding, and human AUC changes. Results: CBD significantly increased MT exposure in dogs but caused dose-dependent biphasic changes in rats. MT negligibly affected CBD PK. In vitro, CBD inhibited MT metabolism with species differences: potent competitive inhibition in dogs (IC50 = 3.42 ± 1.30 μM), weaker inhibition in rats/humans (IC50 = 13.54 ± 1.15/16.47 ± 4.23 μM). CBD also demonstrated mechanism-based inhibition (KI = 25.63 μM, Kinact = 0.063 min−1) against human CYP1A2-mediated MT metabolism. Acidic conditions revealed that CBD inhibited PEPT1-mediated MT uptake. CBD exhibits high and MT moderate protein binding. Static model predictions aligned with in vivo dog/rat data project a worst-case human MT AUC increase up to 12-fold. Conclusions: This study identifies the critical role of PEPT1 in MT absorption and elucidates the dual mechanisms of CBD; namely, absorption inhibition and metabolic delay in regulating MT pharmacokinetics, which exhibits interspecies differences.

Lymphatic transport of drugs after oral administration is an important physiological process in highly lipophilic compounds, such as cannabidiol (CBD). The majority of lymphatic transport studies have been historically conducted in anesthetized rats. However, this animal model differs significantly from the humans regarding both anatomical and physiological features. The aim of this study was therefore to develop a novel animal model using pigs and to provide an interspecies comparison for the lymphatic transport of CBD. The thoracic lymph duct was cannulated via thoracotomy in three pigs and lymph and blood were sampled from conscious animals to assess the lymphatic transport parameters and basic pharmacokinetic parameters of CBD administered in two distinct drug formulations (sesame oil-based solution and nanoemulsion) using a two-period cross-over study design. The mean ± SD oral bioavailability (F) was 6.1 ± 0.9% for the oil solution and 9.2 ± 6.6% for the nanoemulsion. The relative bioavailability via lymph (FRL), i.e. the percentage of the systemically available drug that has been transported through the mesenteric lymph, was 20 ± 10% and 11 ± 13%, respectively. Whereas the FRL for the oil solution was 2.3-fold lower in pigs compared to rats, the FRL for the nanoemulsion was almost identical for both species. In conclusion, the lymphatic transport of CBD plays an important role after its oral administration. The particular parameters differed significantly between the rodent and higher non-rodent species. The use of higher species models is therefore warranted for the lymphatic transport assessment in settings close to humans.

Coccidiosis, caused by Eimeria species, is a major parasitic disease affecting livestock and poultry, leading to significant economic losses. Conventional treatments are increasingly limited due to drug resistance and concerns over chemical in the livestock products. This review aims to identify and evaluate novel medicinal plants with established ethnobotanical relevance as potential alternatives for the treatment of coccidiosis. Drawing from traditional medicinal practices, plant species historically used for various are explored and assessed their phytochemical constituents, efficacy and safety profiles based on modern scientific evidence. Additionally, recent advances in drug delivery and formulation to improve bioavailability and therapeutic outcomes of plant-based are examined in the present review. The present study also addresses key challenges including standardization, formulation, validation method, mode of action and integration into current veterinary practices. The objective of this review is to provide a comprehensive, evidence-based assessment of plant-derived therapeutics for sustainable and effective coccidiosis management, bridging traditional knowledge with modern veterinary science.

Good Compounding Practice (GCP) is a guideline for proper drug compounding, providing detailed instructions on applying good compounding practices to prepare drug formulations intended for human use. Poor compounding can compromise quality, including issues with uniformity of content/potency and weight, physical, chemical, and biological stability, as well as the risk of drug interactions and side effects. The compounding process involves several steps, including preparation, mixing, assembly, packaging, and labeling according to the physician's prescription. This study aims to assess the level of pharmacists' knowledge about GCP, the implementation of GCP, and the relationship between pharmacists' knowledge of GCP and its implementation. This research is non-experimental with a cross-sectional design. The study subjects are pharmacists in Samarinda City, focusing on their knowledge of GCP, the implementation of GCP, and the relationship between the level of knowledge and its implementation. The sampling technique used is total sampling, and data analysis to determine the correlation between knowledge and implementation uses chi-square analysis. The results indicate that the level of pharmacists' knowledge about Good Compounding Practice (GCP) and its implementation in Puskesmas is categorized as "Good." The average knowledge score is 83.26, while the implementation score is 82

The present review intends to offer a comprehensive insight into recent advancements in inhalation - based nanotherapeutics for lung cancer therapy, focusing on formulation approaches, biological hurdles and translational inroads, which underpin their increa sing significance in contemporary oncology .A comprehensive review of literatures was performed using the included characteristic including: PubMed, Scopus, Science direct and Web of science between 2010 and 2019. Highlights were focused on preclinical evi dence, results of clinical trials, and novel formulation strategies with lipid - based carriers, polymeric nanoparticles, and dry powder or nebulized administration systems .In preclinical models, liposomes, solid/lipid nanoparticles, as well as PLGA - based s ystems show greater therapeutic efficacy, reduced systemic toxicity and improved targeting in tumor after inhalation as nanocarriers. Clinical studies with aerosolized tonic formulations of cytotoxic drugs, such as cisplatin and gemcitabine, have demonstra ted acceptable pulmonary deposition and tolerability. However, physical barriers such as mucociliary clearance, alveolar macrophage clearance, and tumor penetration are still the major obstacles. Another significant improvement lies in technological advanc ements in particle engineering and device technology, which might in the future help to circumvent these issues.Inhaled nanotherapeutics is emerging as a promising strategy for lung cancer therapy that will help provide localized, sustained, and tumor - targ eted delivery of drug. Though there is ongoing clinical translation, additional exploration of nanoparticle design, long - term safety, and regulatory harmonization is critical to make these systems a mainstream therapeutic modality in pulmonary oncology lon gitudinally .

Berberine, an isoquinoline alkaloid that is naturally derived from Berberis species, owing to its broad spectrum of pharmacological activities, has been of significant interest due to its high potency for the treatment of metabolic, cardiovascular, neurological, and inflammatory diseases by modulation of cellular signaling pathways, antimicrobial action, and cytoprotection. Its therapeutic use, however, is still marred by poor oral bioavailability. This review aims to assess the therapeutic potential of berberine, highlight its pharmacological and structural characteristics, and discuss formulation advancements that optimize its bioavailability, with specific focus on its application in the control of chronic disease. Recent developments in structure-activity relationships, particularly at positions carbon-8 and carbon-13, are discussed in addition to nanocarrier drug delivery systems (such as phytosomes, nanoemulsions, solid dispersions, and inclusion complexes). Analytical methods and information from randomized controlled trials were also taken into account for compound isolation/quantification and therapeutic activity, respectively. The findings demonstrate that improved berberine drug formulations have better absorption, stability, and extended pharmacologic effects, supported by clinical evidence confirming its application in the management of type 2 diabetes, polycystic ovary syndrome, non-alcoholic fatty liver disease, and hyperlipidemia. In summary, berberine offers an exciting, multipurpose drug, and further formulation innovation and more rigorous clinical establishment are required to realize its benefits as broad biomedical and nutritional applications. © 2025 Society of Chemical Industry.

HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin and Linagliptin in Bulk Drug and Pharmaceutical Formulation

Physiologically based pharmacokinetic (PBPK) modelling can be utilized in dermal drug development and to support regulatory assessments by integrating information related to the active pharmaceutical ingredient (API), drug product, and skin physiology into a mechanistic simulation framework. The purpose of this study was to develop a mechanistic skin absorption model to predict the absorption of lidocaine and prilocaine following topical application of EMLA cream (lidocaine/prilocaine topical cream, 2.5%/2.5%) in virtual subjects. The multi-phase multi-layer mechanistic dermal absorption (MPML MechDermA™) model was used to simulate in vitro permeation of both APIs. Changes in formulation pH post application were studied experimentally, and these dynamic changes were captured in the model when simulating finite dose studies using ex vivo human skin. A dermal in vivo PBPK model for the EMLA cream (lidocaine/prilocaine topical cream, 2.5%/2.5%) was developed and validated. The model was able to consider the formulation and trial design differences of in vivo studies and adequately simulated the observed data. Further model validation was performed against a manufactured cream with microstructural characteristics that were different compared to the EMLA cream. Through virtual bioequivalence assessments, the in vivo model demonstrated that it may be used to predict the impact of differences in drug product quality attributes on the in vivo performance of a topically applied drug product and inform decisions related to product development.

Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental condition characterized by inattention, hyperactivity, and impulsivity, affecting both children and adults. While stimulant medications remain the first-line treatment due to their rapid and robust symptom control, they often fall short in addressing functional impairments related to executive functioning, emotional regulation, and social skills. This review explores a comprehensive spectrum of interventions for ADHD management, encompassing pharmacological, formulation-based, psychosocial, neurocognitive, digital, and lifestyle approaches. Pharmacological therapies, including both stimulants and nonstimulants, have strong short-term efficacy, and advances in drug formulations such as extended-release, transdermal, and prodrug preparations have improved adherence, reduced abuse potential, and enabled time-specific symptom control. Psychosocial and behavioral therapies, such as Cognitive Behavioural Therapy (CBT), parent training, and mindfulness-based interventions, address emotional and executive challenges and enhance overall functioning. Neurocognitive and digital interventions, including neurofeedback, cognitive training, and FDA-approved digital therapeutics like EndeavorRx, offer scalable and engaging options targeting attention and cognitive control. Lifestyle strategies such as aerobic exercise, diet quality, micronutrient supplementation, and gut microbiome modulation serve as supportive or adjunctive tools with growing empirical support. The integration of these strategies into personalized, multimodal treatment plans has shown superior outcomes compared to monotherapies. This review underscores the importance of tailoring interventions based on individual needs, preferences, and developmental context, and highlights the need for ongoing research to optimize long-term care in ADHD.

Medicinal plants have gained global attention as important sources of bioactive compounds with therapeutic and health-promoting potential. Acacia nilotica, a plant widely used in traditional medicine, was selected for this study due to its reported pharmacological properties. This study evaluated the phytochemical profile and antioxidant activity of the ethanolic leaf extract of Acacia nilotica. Fresh leaves of Acacia nilotica were collected, authenticated and extracted in ethanol using the cold maceration method. Qualitative and quantitative phytochemical analyses were performed using standard methods to detect the presence and concentration of phenols, flavonoids, tannins, alkaloids, saponins, glycosides, carbohydrates, reducing sugars, steroids, terpenoids, and cardiac glycosides while the antioxidant activity was assessed using the DPPH (2,2-diphenyl-1-picrylhydrazyl) radical scavenging assay. The crude ethanolic leaf extract contained high concentration of phenols (16.3 ± 0.02 mg/g), carbohydrates (16.5 ± 0.05 mg/g), flavonoids (10.4 ± 0.02 mg/g), tannins (10.1 ± 0.02 mg/g), and reducing sugars (10.7 ± 0.01 mg/g), while alkaloids (4.9±0.01 mg/g), saponins (5.3±0.01 mg/g), and glycosides (4.1±0.02mg/g) were present in moderate amounts. Steroids and terpenoids were not detected. The antioxidant assay revealed a concentration-dependent activity, with maximum inhibition of 88.6 ± 0.64% at 500 µg/mL, compared to 96.0 ± 0.06% for ascorbic acid. These findings show that the ethanolic leaf extract of Acacia nilotica is a rich and promising source of natural antioxidants and bioactive phytochemicals that may be responsible for pharmacological effects. The works provide bridges between traditional knowledge and modern science to validate ethnomedicinal claims with laboratory-based evidence. For further research, it can inspire isolation of specific compounds, in vivo testing, or formulation of herbal drugs supporting its traditional use and potential for pharmaceutical applications.

The stability of Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) remains a significant challenge in oral drug formulation, as liquid SNEDDS often suffer from leakage and chemical instability during storage. Transforming these systems into solid SNEDDS (S-SNEDDS) has emerged as a promising approach to combine the enhanced solubility and bioavailability of nanoemulsified systems with the physical and chemical stability of solid dosage forms. This review comprehensively examines the stability profiles of S-SNEDDS formulations produced using various solidifying agents and manufacturing methods. The discussion focuses on adsorption to solid carriers, spray drying, and freeze-drying techniques while comparing the effects of different adsorbents, such as amorphous silica derivatives Aerosil, Sylysia, and Neusilin, on the stability outcomes. Literature was systematically gathered from databases including PubMed, ScienceDirect, and Google Scholar, covering original studies published between 2011 and 2023 that reported short- and long-term stability. The synthesis of the reviewed data indicates that adsorption onto solid carriers, particularly silica-based excipients, provides the most stable S-SNEDDS formulations. These preparations maintained consistent globule size, drug content, dissolution profile, and absence of phase separation under accelerated and long-term storage conditions. Factors such as high oil absorption capacity and porosity of the adsorbent were key determinants of the flowability and stability of the resulting powder. In conclusion, this review highlights that silica-based adsorbents, especially Sylysia and Neusilin, confer superior stability to S-SNEDDS compared with other materials ...

Molecular characterization of two O-methyltransferases involved in benzylisoquinoline alkaloid biosynthesis in Aristolochia debilis.

It is estimated that more than 50% of marketed pharmaceuticals are derived from natural products. Structural characterization of natural products and their drug formulations is essential for the pharmaceutical industry. The use of microcrystal electron diffraction (MicroED) is reported to identify two polymorphic crystal structures of oxyacanthine dihydrochloride monohydrate from obfuscated samples that are mislabeled as "berbamine dihydrochloride". The two polymorphs display primary conformational differences in one of the tetrahydroisoquinoline rings: one polymorph exhibits an intermediate conformation between half-chair and half-boat, while the other adopts a distinct half-boat conformation. Analysis of their structures, energies, and crystal packing diagrams indicates a thermodynamic preference for a transformation into the latter. This study highlights the value of integrating MicroED into pharmaceutical pipelines as an efficient tool for structural analysis and quality control.