Living drug delivery systems including probiotics, engineered microbial therapeutics, and live biotherapeutic products represent a rapidly emerging therapeutic modality whose behavior fundamentally diverges from the assumptions underlying classical pharmacokinetics and pharmacodynamics (PK/PD). Unlike chemically defined, non-replicating drugs, living therapeutics persist, replicate, adapt, and generate bioactive molecules in situ, such that therapeutic exposure is not externally imposed but biologically generated over time. As a result, administered dose functions only as an initiating condition, while realized exposure emerges from population dynamics, ecological establishment, spatial localization, and regulated functional output. These properties render concentration-based PK/PD frameworks insufficient for predicting efficacy, safety, and controllability of living drug carriers. We introduce pharmaco-microdynamics (PMD) as a quantitative delivery-science framework designed to define, measure, and control exposure for living therapeutics. PMD is operationalized through a set of formal metrics including the functional exposure integral (F-AUC), colonization efficiency (CE), residence-time-weighted activity (RTWA), effective functional concentration (EFC50), and the genetic stability index (GSI) that serve as living-system analogues of AUC, bioavailability, mean residence time, EC50, and product-identity specifications. PMD reconceptualizes exposure as a time-integrated biological process governed by four interdependent axes: population kinetics, functional output kinetics, spatial pharmacology, and evolutionary dynamics. By integrating principles from pharmacology, microbial ecology, synthetic biology, biomaterials science, and systems modeling, PMD provides an operational vocabulary for translating adaptive biological agents into predictable and engineerable delivery systems. We further delineate PMD from adjacent frameworks such as quantitative systems pharmacology (QSP) and ecological microbiome modeling, and critically discuss boundary conditions under which classical PK/PD remains applicable to non-replicating or transient microbial interventions. This review critically examines the limitations of classical PK/PD in modeling living drug carriers, formalizes the core principles of PMD, and illustrates them through three quantitative case studies: SYNB1618 for phenylketonuria, synchronized-lysis bacterial tumor therapies, and fecal microbiota transplantation for recurrent Clostridioides difficile infection. Regulatory and clinical implications are addressed, emphasizing the need to shift from dose- and concentration-centric evaluation toward functional biomarkers, persistence metrics, and model-informed assessment of biological activity. Collectively, pharmaco-microdynamics establishes a unifying conceptual and quantitative foundation for the rational development of living medicines.
Parallel importation (PI) is a TRIPS-recognized flexibility intended to improve access to medicines through price competition. In low- and middle-income countries, however, concerns persist regarding regulatory oversight, product quality, and patient safety. Empirical evidence on the real-world implementation of PI in Kenya remains limited. This study aimed to assess the regulatory compliance of selected parallel imported medicines marketed in Nairobi County, identify predictors of compliance, evaluate their market prevalence, and examine whether PI delivers the intended economic benefits for patients. Twenty-two medicines identified as parallel imports were evaluated against Kenyan regulatory requirements, including Pharmacy and Poisons Board (PPB) guidelines on labeling, packaging, patient information leaflets, storage conditions, and the Parallel Imported Medicinal Substances Rules (2019). A mystery-shopper survey covering 2348 retail pharmaceutical outlets across all 85 Nairobi wards estimated the prevalence of non-compliant PI products. Logistic regression was used to identify predictors of compliance, and independent t-tests compared retail prices of PI products with those supplied through authorized channels. Regulatory non-compliance was widespread. Ninety percent of PI products failed to meet labeling and package insert requirements, primarily due to foreign-language packaging that precluded verification of critical safety information. Forty-five percent displayed storage instructions inconsistent with Kenya's ICH climatic Zone IV requirements, indicating supply chains not adapted to tropical conditions. Overall, 90% of products violated key provisions of the PPB PI Rules. Nearly all PI medicines were off-patent and already had multiple generic alternatives registered in Kenya, undermining the TRIPS-based public health rationale for PI. Unauthorized PI products were identified in approximately 90% of surveyed outlets. Price analysis showed significant differences in 53% of comparisons, but nearly half of PI products offered no economic advantage over authorized equivalents. Parallel importation of medicines in Nairobi is characterized by extensive regulatory non-compliance, limited or absent price benefits, and significant risks to medicine quality and patient safety. In its current implementation, PI in Kenya operates largely outside its intended TRIPS scope and fails to deliver meaningful public health value. Strengthened regulatory enforcement, climate-appropriate packaging, mandatory language compliance, and a reassessment of PI policy are urgently required to protect patients and preserve trust in the pharmaceutical system.
Atorvastatin calcium is an effective lipid-lowering drug, however, it has a low solubility in aqueous solutions and the oral absorption rate varies. Methods of solubilization have problems of thermodynamic instability and use of toxic organic solvents. This article sought to enhance solubility and biopharmaceutical properties of atorvastatin calcium through hydrotropism, the sodium citrate, is a strongly soluble and eco-friendly hydrotropic solution. Equilibrium solubility was determined in aqueous distilled water and sodium citrate solutions (10%, 20%, 30% w/v) at room temperature by validated UV-Vis spectrophotometry at λmax=240nm. Solvilating power (p), hydrotropic Efficiency Index (HEI) and Gibbs free energy change (DGo) were determined. FTIR compatibility solid-state compatibility FTIR spectroscopy (4000-400cm-1). Physiological dose number (Do) was used in the assessment of biopharmaceutical risk. Statistical procedures were one-way ANOVA and Tukey HSD test (a=0.05). Atorvastatin solubility in water was 0.00112mg/mL. A salting-in effect was gained by addition of 30% w/v sodium citrate with an increase in solubility to 0.01012mg/mL (ninefold, P<0.0001). DGo was -5.45kJ/mol, which is a spontaneous process. The dose number of dose 40mg reduced to 142.86 (high risk) to 15.81 (low-moderate risk). FTIR spectra were used to verify that there were no covalent reactions and that the drug was not damaged. Hydrotropism caused by sodium citrate is a thermodynamically favorable, and predictable. The ninefold solubility enhancement significantly lowers the biopharmaceutical risk of atorvastatin and offers a scalable solution to the enhancement of oral solid dosage forms.
The rise of viral infections has been accompanied by an increased incidence of secondary opportunistic infections, such as mucormycosis, highlighting the urgent need for broad-spectrum therapeutics capable of targeting multiple pathological pathways. This study evaluates the antiviral, antioxidant, anti-inflammatory, and antifungal potential of a polyherbal extract (PHE) and its optimized self-nanoemulsifying intravenous formulation (PH-SNEDDS). PHE displayed strong free-radical-scavenging activity (DPPH, IC50: 21.99μg/mL; ABTS, IC50: 58.97μg/mL) and significantly downregulated pro-inflammatory mediators in LPS-stimulated THP-1 and RAW 264.7 cells, reducing TNF-α and iNOS gene expression by 4.04-fold and 4.91-fold, respectively. The extract also exhibited potent antifungal activity against Apophysomyces elegans (MIC: 1μg/mL) and Rhizopus oryzae (MIC: 0.5μg/mL). In A549 lung epithelial cells, PHE effectively inhibited HCoV-229E replication with minimal cytotoxicity. The PH-SNEDDS formulation demonstrated optimal physicochemical properties, including a particle size of 146±2.9nm and zeta potential of -41.1±2.7mV. In HCoV-229E-infected BALB/c mice, PH-SNEDDS significantly reduced pulmonary viral load, mitigated histopathological damage, and suppressed viral RNA and protein expression. Immunological profiling revealed a shift toward protective immune responses, with an increased Th1/Th2 ratio (1.37±0.06), decreased Th17/Treg ratio (1.97±0.08), and elevated B cell (3.31±0.18) and NK cell (2.57±0.08) populations, along with markedly lower serum levels of IL-6 (59.62±5.03pg/mL) and TNF-α (121.75±5.83pg/mL). Collectively, these findings demonstrate the strong antiviral, anti-inflammatory, and antifungal efficacy of PH-SNEDDS, supporting its potential as a promising multifunctional therapeutic candidate for coronavirus infections and their associated inflammatory or fungal complications.
The drug development pipeline remains extraordinarily complex, costly, and time-intensive, typically requiring 10-15years and $2-3 billion per approved drug. This review presents a translational perspective on how artificial intelligence (AI) and machine learning (ML) are renovating pharmaceutical R&D across the entire value chain while maintaining rigorous safety and efficacy standards. In drug discovery, deep learning platforms enable virtual screening of billion-compounds, reducing target identification from years to months while improving hit rates by 30-50%. Preclinical development benefits from AI-powered toxicity prediction, potentially eliminating 40% of animal testing through accurate in silico models. Clinical trials are optimized through digital twin technology, reducing patient cohorts by 25-30% without compromising statistical power. Post-marketing surveillance is accelerated 100-fold through AI-driven real-world evidence analysis. Across the development lifecycle, AI delivers 30-60% time savings and 25-40% cost reductions while increasing success rates through enhanced predictive capabilities. Formulation development benefits from ML algorithms that optimize drug compositions and stability, reducing trial-and-error experimentation. However, challenges persist in data quality, algorithmic bias, and regulatory acceptance of AI-derived evidence. This review provides a balanced perspective on AI's transformative potential in drug discovery and various formulation developments, along with its limitations, offering a roadmap for successful implementation in pharmaceutical R&D.
Qiancao is a common medicinal herb worldwide, whose roots and rhizomes exhibit properties of cooling blood, arresting bleeding, activating meridians, and promoting blood circulation, colloquially known as "Bloodstanch" (Xue Jian Chou). Since its 1963 edition, the Pharmacopoeia of the People's Republic of China has stipulated Rubia cordifolia L. as the sole botanical origin for the medicinal herb Qiancao. However, the morphological similarities among various medicinal Rubia species pose a significant challenge for accurate identification, commonly resulting in their substitution or adulteration, some of which are documented in local standards. This review systematically summarizes the traditional uses, morphological characteristics, phytochemical composition, pharmacological effects and toxicology of Rubia cordifolia L. and two widely studied medicinal Rubia species (Rubia yunnanensis Diels and Rubia tinctorum L.), providing insights into the feasibility of these common alternatives. A total of 166, 130, and 143 compounds have been isolated from them, respectively. Extensive studies have demonstrated that extracts and isolated compounds from Rubia plants exhibit diverse pharmacological activities, including anti-inflammatory, antitumor, antioxidant, antibacterial, antiplatelet aggregation, and neuroprotective effects. However, chronic use of Rubia tinctorum induces hepatorenal tumors in mice, with identified carcinogens including lucidin, rubiadin, and alizarin. Currently, the phytochemical profiles of these three herbs have been extensively studied, which reveal that they possess only a limited set of common constituents, casting doubt on their clinical interchangeability. Future research should compare the levels of common compounds and the distinct profiles of components with marked bioactivity among these three herbs to further substantiate their potential substitutability.
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Advanced therapy medicinal products (ATMPs) are complex biological medicines associated with specific constraints related to handling, storage and pharmaceutical circuit security. This study aims to describe the current organization of the hospital pharmaceutical circuit for ATMPs in France and to analyse the human, organizational and capacity-related determinants conditioning its sustainability in a context of rapidly expanding activity. A national observational survey based on a questionnaire was conducted among hospital pharmacists involved in ATMP management. Data collected concerned the types of ATMPs handled, the organization of the pharmaceutical circuit, mobilized human resources, storage modalities, information systems, relationships with manufacturers, and institutional governance. Forty-four pharmacists responded, mainly from university hospitals. ATMPs are predominantly managed within clinical trials, with a predominance of gene therapies. Activity is rapidly expanding and characterized by marked organizational heterogeneity. The number of preparations per patient varies according to ATMP type, demonstrating that pharmaceutical workload cannot be assessed solely on the basis of patient volume. Organizational thresholds linking patient volumes and dedicated human resources were identified. Cryogenic storage remains a major bottleneck. Inadequate information systems, industrial constraints and insufficient institutional governance were identified as major barriers. The pharmaceutical circuit for ATMPs in France has reached a mature phase requiring organizational scale-up based on a structured capacity-based approach and dedicated governance.
Over a million people die each year from hepatitis B virus (HBV) infections, which are a serious global public health problem. More than seventy percent of adults in highly endemic areas, mainly in Africa and Southeast Asia, have signs of prior infection, and 7-20% of individuals are chronically infected. In Mauritania, hepatitis B is endemic, with infection rates ranging from 10 to 20%. A descriptive cross-sectional study was conducted between January 2019 and May 2020. Participants were recruited at Cheikh Zayed Hospital in Nouakchott. All patients presenting to the Cheikh Zaid Hospital laboratory for medical tests were recruited. Patients were referred by physicians from various hospital departments and provided informed consent prior to serological testing (HBsAg) for the detection of the hepatitis B virus surface antigen. During the research period, from 1st January 2019 to 30th May 2020, 10,735 people were examined, and 1223 people (472 men and 751 women) were determined to be HBsAg positive, resulting in an overall seroprevalence of 11.4 percent. It is greater in males (12.9%) than in women (10.6%). Following the introduction of hepatitis B vaccination and the strengthening of viral hepatitis control activities, a decrease in HBsAg seroprevalence was observed in this hospital population; however, this trend is probably multifactorial.
The full reimbursement of drugs listed on the "out of diagnosis-related groups" list and coded as off-label use, which has shown continuous growth, is being reconsidered. The objective of this study was to provide a nationwide overview of this practice and to identify the determinants of its dynamics. The percentage of dispensing units coded as off-label use, calculated from the Scan Santé database between 2020 and 2024, was stratified by year, region (metropolitan France), and type of healthcare institution (university hospital, general hospital, cancer center, private non-profit hospital, private for-profit hospital). The explanatory variables included: consumption volume, number of indications, duration of listing on the out of diagnosis related groups list, therapeutic class, and early access status. A descriptive analysis and a variance analysis were performed using R software. Over the study period, the percentage of off-label use ranged from 10.4% to 17.5% depending on the year (median 14.3%). Median values of off-label use differed by region (9.9% to 19.4%) and by type of healthcare institution (7.3% to 32.8%). The type of institution, the international nonproprietary names, and the region had a significant impact on this use (P<0.001). By contrast, the duration of listing on the out-of-DRG list had no impact. This prescribing freedom is granted by exception and by default. It raises the question of revising reimbursement modalities and of the risk of financial losses for hospital, in a context of hospital expenditure control.
Paclitaxel, a chemotherapeutic agent from the taxane family, is widely used in the treatment of breast, ovarian, and lung cancers. However, it is known to cause hypersensitivity reactions (HSRs) in about 10% of patients, which can range from mild to severe. These reactions often necessitate allergological testing and may impact the therapeutic regimen. While the management of HSRs is critical, no data is available on the physicochemical stability of paclitaxel at very low concentrations in polypropylene syringes, which are often used in allergological tests. A stability indicating ultra-performance liquid chromatography coupled to a Photodiode Array Detector (UPLC-DAD) method was developed and validated according to the ICH guidelines. The study aimed to evaluate the stability of paclitaxel at three different concentrations 0.6mg/mL, 0.06mg/mL, and 0.006mg/mL, diluted in sodium chloride 0.9% solution and stored in polypropylene syringes under various conditions: -20°C, 5°C, 25°C, and 40°C. The stability was assessed over 28days using UPLC to measure paclitaxel concentration and observe potential degradation products. The physical stability was also evaluated by monitoring pH, color, and turbidity. Paclitaxel remained chemically stable for 28days when stored at 5°C and 25°C at all concentrations, with degradation observed at 40°C. At -20°C, both physical and chemical stability was maintained for the full 28-day period. However, physical instability, evidenced by the appearance of precipitates and increased turbidity, was observed at 40°C by day 6 and at 4°C and 25°C by day 21, particularly in the more dilute solutions. The study highlights that paclitaxel can be pre-prepared and stored at low concentrations in polypropylene syringes for allergological use, particularly under refrigerated conditions, improving hospital workflow efficiency. However, the findings emphasize the necessity of adhering to strict storage guidelines to prevent both chemical and physical degradation, especially at higher temperatures. These results have significant implications for clinical practice, particularly in managing HSRs in oncology settings.
The Eurasian Economic Union aims in harmonizing the pharmaceutical regulations among the member States while aligning with the international standards. The transition to harmonized regulation in the Eurasian Economic Union faces unique challenges, including ambiguity in regulatory pathways and alignment with international benchmarks. The objective of this study is to compare and analyze the gaps between the regulatory frameworks for medicinal products within the Eurasian Economic Union and European Union. Thus, this study explores similarities and differences in both the regulatory frameworks and provides suggestions to address these gaps. The study follows a descriptive and comparative analysis of the regulatory frameworks for medicinal products of Eurasian Economic Union and European Union. The data regarding the regulations were collected from the official documents, regulations and guidelines published on their official websites (EudraLex and legal portal of Eurasian Economic Union) by the Eurasian Economic Commission and European Commission. The findings suggest that while the Eurasian Economic Union's regulatory framework for medicinal products shares similarities with the European Union's system, particularly in adopting mutual recognition and decentralized procedure, significant gaps remain in timelines, labelling requirements, clinical trial process, pharmacovigilance, dossier requirements and other aspects. While the European Union has a well-established system, the Eurasian Economic Union is still navigating the operational complexities and adapting to the challenges. By aligning with the European Union's framework, the Eurasian Economic Union can increase its credibility at the global level. This study underscores the importance of the Eurasian Economic Union's ongoing harmonization effort as a major step towards strengthening its position in the global market.
This review highlights the pharmaceutical and galenic potential of medical cannabis and the opportunities it offers for the development of Morocco's pharmaceutical industry. Following the enactment of Law 13-21 authorizing the medical, pharmaceutical, and industrial use of cannabis, Morocco has made major progress, including the launch of its first locally produced cannabidiol-based medicine and the signing of a partnership between Mohammed VI Polytechnic University and the National Agency for the Regulation of Cannabis-Related Activities. Therapeutically, cannabinoids show promising applications in pain management, neurological, psychiatric, oncological, and ophthalmic disorders. From a formulation perspective, cannabis can be developed into various dosage forms such as oral solutions, soft capsules, sprays, transdermal patches, buccal films, medicated chewing gums, and inhalation devices. With its strong local manufacturing capacity and high generic drug penetration, Morocco's pharmaceutical ecosystem provides a favorable environment for integrating medical cannabis. Altogether, these factors position Morocco as a strategic regional hub for research, production, and pharmaceutical valorization of medical cannabis.
Chronic kidney disease (CKD) is a major public health issue, affecting nearly 10% of the adult population, with a significant proportion of diagnoses occurring at advanced stages, often requiring renal replacement therapy. Given the high morbidity and mortality associated with CKD, particularly due to cardiovascular and metabolic complications, there is a critical need to optimize prevention and management at every stage of the disease. CKD patients are particularly complex, owing to multiple comorbidities and frequent polypharmacy, positioning the pharmacist at the center of collaboration between general practitioners and nephrologists. This narrative review explores this collaboration from three perspectives: first, in primary care, where general practitioners play a key role in the early detection of CKD and referral to nephrologists, while community pharmacists play a key role in medication safety, optimization, and patient education. The pharmacist, beyond his participation in the dissemination of knowledge about CKD, could also participate in CKD screening campaigns, in close coordination with medical biologists responsible for generating and interpreting the laboratory data required for diagnosis and follow-up. Second, within dialysis centers, nephrologists oversee the comprehensive management of patients and work in synergy with hospital pharmacists, who are responsible for water quality, management of dialysis-related medical devices, and medication safety in a technically complex environment. Finally, the review highlights the contribution of pharmacoepidemiology, a field where nephrologists and pharmacologists combine their expertise to analyze drug utilization and safety in a population often excluded from clinical trials, with the goal of tailoring prescriptions to real-world practice. This multidisciplinary cooperation appears essential to ensure a safe continuum of care for patients with CKD.
This study reports the experience of a French university hospital transitioning from Luer connectors to the secure NRFIT standard for neuraxial applications, with the aim to prevent serious drug administration errors. The objective was to describe the project approach, to share feedback, and to provide a preliminary evaluation of the economic impact. A multidisciplinary project group involving pharmacy and anesthesiology-critical care departments was established. The process included an exhaustive inventory and rationalisation of Luer medical devices (MD), followed by identification and validation of equivalent NRFIT devices through technical reviews and bench testing. The deployment was carefully planned using a Gantt chart, supported by an internal communication and training plan, and included a temporary three-month buffer stock of NRFIT devices. A post-transition analysis assessed the costs of withdrawn Luer stock and compared procurement costs between NRFIT and Luer systems. Of a total of 65 preexisting references of MDs, 44 were retained then converted to a NRFIT equivalent reference during a two-phase rollout in July and August 2025, driven by supplier availability. Multidisciplinary coordination and detailed planning were key success factors. Challenges included supply delays and the management of patients transferred from other hospitals equipped with Luer devices, requiring specific protocols. The transition resulted in a net loss of €7,873 from withdrawn Luer stock and a provisional annual cost increase of €11,224. The transition to NRFIT connectors was feasible and safe despite organisational and financial constraints. Strong multidisciplinary leadership, careful planning, effective communication, and training were essential. Wider adoption of NRFIT devices across hospitals may help reduce additional purchasing costs.
Pharmacy practice has evolved considerably over time. Pharmacy education programs rely in particular on practical training placements in professional settings. The primary objective was to describe and compare internship opportunities in hospital pharmacy offered as part of undergraduate and postgraduate pharmacy training between countries in the Global North and the Global South. The secondary objective was to describe perceptions regarding pharmacy internships in these two regions. Descriptive study. The study focused on the activities of the Groupe d'intérêt francophone de pharmacie clinique (GIF clinique) from September 1, 2024, to June 30, 2025. It targeted the ten member countries of the GIF clinique (France, Belgium, Switzerland, Canada, Morocco, Madagascar, Mali, Tunisia, Burkina Faso, and Benin). This was a convenience sample. GIF members answered questions representing their geographic environment for their countries. Data were collected using a 23-item questionnaire covering demographic variables and perceptions of clinical pharmacy internship programs according to eight variables measured on a four-point Likert scale. Nine of the ten GIF clinique members provided usable data. The number of pharmacists was heterogeneous, with a much higher average in Northern countries (3.86±3.50) than in Southern countries (0.96±0.19). Among the nine institutions surveyed, only one of the four in the North and four of the five in the South offered internships to technical staff. In contrast, all respondents offered internships to pharmacy students (9/9) and a majority to pharmacy residents (7/9). Only three institutions in the North offered internships to international pharmacy students, compared with none in the South. The ratio of the average number of students to the average number of full-time pharmacy staff was 1 in the North versus 14 in the South. Supervision modalities for trainees were broadly similar between hemispheres. However, the supervision of internship sites remained relatively limited in both regions. Respondents recognized the importance of experiential training in pharmacy. This exploratory study described and compared hospital pharmacy internship opportunities offered as part of undergraduate and postgraduate training between countries in the Global North and South. Among the 23 variables analyzed, several similarities and differences were identified. The study also described perceptions regarding pharmacy internships: respondents strongly valued the importance of experiential training in pharmacy. We recognize that the Francophonie is what connects and unites us, despite economic, political, and cultural differences. May the work of the GIF de pharmacie clinique inspire other pharmacy communities of practice.
Good practices for the medication use system is a complex process, particularly prone to medication errors. Reinforcing best practices among healthcare professionals is essential for improving the quality and safety of patient care. A training approach based on an escape room was chosen for this purpose. This paper describes the design and implementation of an original, educational Escape Game centered on this theme. The design of the escape room "The Mysteries of Room 651" required the establishment of a multidisciplinary working group. It incorporates three key activities of the medication management process: prescribing, storage, and preparation/administration of medications. Knowledge was assessed before and after the training session using a ten-questions quiz, and a satisfaction survey was conducted at the end of each session. An initial version of the game was developed by the working group, followed by a crucial phase of "testing and modifications" to obtain the final version. Over the course of one year, nearly 40 sessions were conducted, training 258 healthcare professionals, primarily registered nurses. The overall satisfaction rate among participants was over 98.1%. The average score on the assessment quiz increased from 7.51/10 before training to 8.38/10 (P<0.001) after training. This training program has proven to be an effective and valued tool for the continuing education of healthcare staff, serving to reinforce best practices for medication management in clinical care units.
Irinotecan (CPT-11; IRN) is used as a potent chemotherapeutic agent for CRC. Co-loaded self-nanoemulsifying drug delivery system (SNEDDS) of IRN with cyclosporine A (CSP), a P-gp inhibitor, was designed and developed. A novel liquid chromatography-triple quadrupole mass spectrometry (LC-QqQ MS/MS) method was developed and validated. The analysis was performed on a TSQ Quantis Plus triple quadrupole mass spectrometer, coupled with a Thermo Vanquish UHPLC system, using an Agilent Eclipse Plus C18 column and a gradient elution using 10mM ammonium acetate (0.1% formic acid) and methanol. Retention times were 6.2min for IRN and 10.17min for CSP. Linearity was achieved over the ranges of 10-10,000 ng/mL for IRN and 10-5,000 ng/mL for CSP, with R2 values of 0.9999 and 0.9998, respectively. Inter- and intra-day precision values were within acceptable limits, and recoveries were consistently 99-100%. The analytical method was applied for bioanalytical estimation using protein precipitation in MDCK cell permeability studies, and HCT-116 colorectal cancer cell internalization. The method demonstrates high sensitivity, reproducibility, and applicability for evaluating co-loaded SNEDDS formulations of IRN and CSP along with quantitation of IRN in MDCK and HCT-116 colorectal cell lines.
The growing demand for home-based cancer therapy calls for efficient and patient-centred delivery models. This study evaluates time savings and user satisfaction in patients receiving 5-fluorouracil (5-FU)-based chemotherapy who have been trained to disconnect their elastomeric pump at home. In this six-month pilot, nine patients with colorectal or pancreatic cancer deemed capable by their oncologist or nurse were trained to self-disconnect their 5-FU pump and perform basic line care, with initial support from home care nurses. Satisfaction was assessed using questionnaires completed by patients, hospital oncology nurses and home care nurses. A total of 81 completed surveys were collected. Patients and home care nurses reported, respectively, time savings of 102 and 64mins per treatment cycle. Satisfaction rates remained stable when comparing disconnection by a nurse to self-disconnection. Self-disconnection of 5-FU elastomeric pumps by patients at home seems feasible and may reduce the burden on oncology staff while increasing patient autonomy.
Morin (MOR), a multidimensional flavonoid, has poor solubility and oral absorption. The present study aims to prepare MOR immediate (IR) and sustained release (SR) multi-particulate dosage forms (pellets) and evaluate their oral pharmacokinetics in rats. MOR oral pellets were formulated via extrusion-spheronization technique using microcrystalline cellulose as spheronization aid and HPMC-K4M and Pluronic-F127 as SR polymers. The ATR-FTIR data indicated compatibility of MOR with the excipients used in pellets. The SEM data demonstrated the spherical shape of pellets, whereas the DSC results indicated reduced crystallinity of MOR. Based on in vitro drug release of MOR pellets, MOR-03 batch exhibited IR (98.49±0.17%, 1h), whereas MOR-06 showed SR (96.45±1.89%, 24h). The pharmacokinetic study illustrated a 2.64-fold and 2.77-fold enhanced maximum drug plasma concentration (Cmax) for MOR-IR and MOR-SR pellets whereas 2-fold (MOR-IR pellets) and 8-fold (MOR-SR pellets) improved area under the curve (AUC) compared to MOR-API group. IR and SR pellets could enhance oral absorption of MOR and offer cost-effective, scalable alternative for oral delivery of MOR.