Drug Development and Industrial Pharmacy最新文献

{"title":"Intranasal nanoemulsion-based <i>in-situ</i> gel containing dexlansoprazole: formulation development, <i>in-vitro</i> and <i>ex-vivo</i> evaluation.","authors":"Gyati Shilakari, Sai Kumar Uppala, Meghamala Ganti, Srilatha Bhukya, Abhay Asthana","doi":"10.1080/03639045.2026.2657498","DOIUrl":"10.1080/03639045.2026.2657498","url":null,"abstract":"<p><strong>Aim: </strong>Dexlansoprazole (DXL) is clinically effective in gastroesophageal reflux and ulcer healing, yet its oral bioavailability is compromised by acid instability, poor aqueous solubility, and extensive first-pass metabolism. To address these limitations, an intranasal nanoemulsion-based <i>in situ</i> gel was developed to bypass gastrointestinal and hepatic metabolism and enable rapid systemic absorption <i>via</i> the highly vascularized nasal mucosa. Owing to the BCS Class II nature of DXL, this approach was designed to enhance solubility, prolong nasal residence time, and provide sustained drug release.</p><p><strong>Methods: </strong>DXL-loaded nanoemulsions (NEs) were prepared using Capmul MCM EP as the oil phase, Cremophor EL as the surfactant, and PEG 300 as the co-surfactant by sonication. The NEs were evaluated for various <i>in vitro</i> parameters, <i>in vitro</i> drug release, and <i>ex vivo</i> permeation.</p><p><strong>Results: </strong>Among all NEs, F3 exhibited optimal characteristics, with a mean droplet size of 40.55 nm, a PDI of 0.374, a zeta potential of -17.70 mV, spherical globules under TEM and the highest cumulative release of 90.02% at 24 h. All NEs displayed significantly enhanced drug release as compared to the drug suspension. Cumulative drug permeation of 90.02 ± 0.565% for F3 and 80.69 ± 0.057% for its <i>in situ</i> gel (F3NEG4) was recorded, with 5.54- and 5.18-fold higher J_ss than the drug suspension, respectively. Additionally, F3 remained physically stable for 3 months at 2-8 °C and 25 ± 5 °C.</p><p><strong>Conclusion: </strong>The developed DXL-loaded NE improved <i>in vitro</i> dissolution, indicating potential enhancement of bioavailability, which requires confirmation through comprehensive <i>in vivo</i> studies.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1251-1272"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147662412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Orodispersible tablets in psychiatric and mood disorder management: clinical value, pharmacokinetics, and patient-centric formulation strategies.","authors":"Govind Kumar, Ishu Garg, Rohit Raj, Balajee Soni, Nargis Saifi, Madhu Verma, Iti Chauhan","doi":"10.1080/03639045.2026.2673053","DOIUrl":"10.1080/03639045.2026.2673053","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the extensive literature underlying the concept of using and formulating Orodispersible tablets (ODTs) for managing psychiatric and mood disorders.</p><p><strong>Significance: </strong>Psychiatric and mood disorders represent a major global health burden across all age groups, significantly impairing quality of life and daily functioning. Emotional distress associated with these conditions often leads to poor medication adherence and difficulty swallowing, particularly in vulnerable populations. Thus, an increased emergency intervention is required during acute panic or agitation states. ODTs have emerged as a patient-oriented, rapidly disintegrating oral drug delivery system. It enhances treatment adherence and facilitates faster therapeutic action, especially during acute psychiatric episodes. ODTs offer distinct advantages for antipsychotics, antidepressants, anxiolytics, and mood stabilizers by modulating pharmacokinetic and pharmacodynamic profiles based on the drug's Biopharmaceutics Classification System (BCS).</p><p><strong>Key findings: </strong>Recent advances in three-dimensional (3D) printing, nanotechnology, and smart polymer systems have expanded the potential of ODTs. These technologies can effectively address key formulation challenges such as dose loading, poor solubility, moisture sensitivity, and taste masking, and ensure personalized dosing strategies. In parallel, the application of Quality by Design (QbD) and systematic optimization approaches allows the development of robust ODT formulations with adequate mechanical strength, rapid disintegration, and consistent performance.</p><p><strong>Conclusion: </strong>The rational development and clinical translation of tailored psychiatric ODTs for patients require adherence to established regulatory frameworks to ensure product quality, safety, efficacy, and patient acceptability.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1204-1219"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147873626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polyherbal green-synthesised silver nanoparticle gel: in vitro antimicrobial activity and <i>in vivo</i> wound healing efficacy using mimosa pudica and tribulus terrestris extracts.","authors":"Purushotham C M, Mallamma T, Parimala Hanumesh, Jeevan Gowda, Rohith S, Prasiddhi Naik, Prakash Goudanavar","doi":"10.1080/03639045.2026.2668052","DOIUrl":"10.1080/03639045.2026.2668052","url":null,"abstract":"<p><strong>Objective: </strong>To synthesize and evaluate a polyherbal silver nanoparticle (PH-AgNPs) gel using <i>Mimosa pudica</i> and <i>Tribulus terrestris</i> extracts for enhanced antimicrobial activity and wound-healing efficacy.</p><p><strong>Significance: </strong>Wound infections remain a major clinical challenge due to rising antimicrobial resistance and cytotoxic limitations of conventional silver therapies. Green-synthesized PH-AgNPs offer a biocompatible and sustainable approach integrating antimicrobial and regenerative effects.</p><p><strong>Methods: </strong>PH-AgNPs were synthesized <i>via</i> green methods and characterized using UV-Vis, DLS, FTIR, XRD, and SEM-EDX. Nanoparticles were incorporated into Carbopol gels (0.1% and 0.2% w/w). Antioxidant activity was assessed by DPPH assay, antibacterial activity by agar well diffusion, and <i>in vivo</i> wound healing was evaluated using a full-thickness excision model in Wistar rats. Biochemical (CAT, glutathione peroxidase, lipid peroxidation) and histopathological analyses were performed, with AgNO₃ gel as standard.</p><p><strong>Results: </strong>The synthesized Silver Nanoparticles (AgNPs) exhibited a hydrodynamic diameter of 87 nm and a zeta potential of -25.4 mV. The polyherbal extract (PE) demonstrated 77.23% inhibition of DPPH radicals. Antibacterial testing showed inhibition zones of 14-15 mm against <i>Escherichia coli (E. Coli)</i> and <i>Staphylococcus aureus (S. aureus)</i>. Biochemical analysis showed differences in antioxidant enzyme activities, including CAT and glutathione peroxidase, between the treatment groups and the control. The 0.2% w/w AgNPs gel achieved 94.25% wound contraction by day 15 compared with 48.35% in untreated controls.</p><p><strong>Conclusion: </strong>PH-AgNPs gel exhibited effective antimicrobial activity and accelerated wound healing, suggesting potential as a safer alternative to conventional silver-based wound therapies.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1338-1356"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147812407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Paclitaxel permeation and anticancer efficacy through Soluplus-based solid dispersion with Piperine.","authors":"Riyad F Alzhrani, Syed Sarim Imam, Sultan Alshehri, Wael A Mahdi, Rawan A Fitaihi, Saad Alobid, Gamaleldin I Harisa","doi":"10.1080/03639045.2026.2675437","DOIUrl":"10.1080/03639045.2026.2675437","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to develop and optimize a Soluplus-based Paclitaxel-Piperine (PTX-PPN) solid dispersion to enhance PTX solubility, intestinal permeation, and anticancer efficacy in metastatic breast cancer cells.</p><p><strong>Significance: </strong>PTX suffers from extremely poor aqueous solubility and dose-limiting toxicity associated with Cremophor^® EL-based formulations. PPN is a well-documented bioenhancer and P-glycoprotein inhibitor that may modulate PTX permeation and cytotoxicity.</p><p><strong>Methods: </strong>PTX-PPN solid dispersions were prepared <i>via</i> freeze-drying using different PTX-PPN-Soluplus ratios (1:1:1, 1:1:1.5, and 1:1:2 w/w). The formulations were evaluated for drug content, saturation solubility, dissolution and solid-state characterization (FTIR, DSC, XRD, and microscopy). Intestinal permeation was assessed using an <i>ex vivo</i> model of intestinal permeation. Cytotoxicity and apoptosis were evaluated in 4T1 metastatic breast cancer cells.</p><p><strong>Results: </strong>The optimized PTX-PPN-Soluplus (1:1:1.5) formulation significantly enhanced solubility (PTX: 413.7 ± 36.7 µg/mL; PPN: 827.7 ± 38.7 µg/mL) compared to pure drugs. Solid-state analyses supported the conversion of pure PTX and PPN into an amorphous form. The incorporation of PPN into the PTX-Soluplus formulation significantly improved PTX permeation, resulting in 6-fold enhancement in flux compared with PTX alone. In 4T1 metastatic breast cancer cells, the co-loaded PTX-PPN-Soluplus solid dispersion (16 µM) displayed significantly higher cytotoxicity than PTX alone, reducing cell viability by 1.6-fold. Moreover, the PTX-PPN-Soluplus formulation induced apoptosis almost threefold higher than PTX-PPN alone.</p><p><strong>Conclusion: </strong>The developed PTX-PPN-Soluplus solid dispersion system represents a promising strategy to overcome PTX solubility limitations and support its broader clinical application in breast cancer therapy.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1391-1403"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147980893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent advancements and clinical translation of cinnamaldehyde derivatives in therapeutics.","authors":"Shakir Ullah Shakir, Saeed Ahmad Khan, Majeed Ullah, Amjad Khan, Nauman Rahim Khan, Iftikhar Khan","doi":"10.1080/03639045.2026.2678494","DOIUrl":"10.1080/03639045.2026.2678494","url":null,"abstract":"<p><strong>Objective: </strong>This review systematically evaluates why CA derivatives have failed to transition from bench to bedside despite superior preclinical performance.</p><p><strong>Significance: </strong>Cinnamaldehyde (CA) clinical translation is stymied by a biopharmaceutical paradox: promising <i>in vitro</i> efficacy is negated by poor aqueous solubility (≈1 mg/mL), rapid first-pass metabolism, and a short plasma half-life (≈1.7 h). Also, the reactive <i>α</i>,<i>β</i>-unsaturated aldehyde moiety often triggers Pan-Assay Interference (PAINS) behavior.</p><p><strong>Key findings: </strong>We identify three primary chemical strategies that circumvent native CA's limitations: (1) Aldehyde masking (e.g. N-oxide conversion in PX5-9), which improves aqueous solubility by >2000-fold; (2) <i>α</i>-substitution (e.g. <i>α</i>-bromo-4-chloro CA), which modulates Michael acceptor reactivity to achieve an 87-fold higher selectivity index than the parent compound; and (3) Stimuli-responsive polymer conjugation (e.g. ROS-labile thioacetals), which enables tumor-microenvironment-triggered CA release and reduces cytotoxicity to IC₅₀ ≫ 1600 µM in normal cells. While these derivatives show compelling <i>in vivo</i> efficacy in oncological, antiviral, and anti-inflammatory models, progress is halted by a lack of human pharmacokinetic profiling and 'safety bridging' toxicology.</p><p><strong>Conclusion: </strong>The science of CA derivatives is more mature and future development must shift from broad scaffold exploration to targeted translational consortia focused on four priority leads (Compound 5, HCAG, PX5-9, and Compound 6f). Addressing the '<i>in vitro</i>-<i>in vivo</i> disconnection' through chemoproteomic target validation and IND-enabling PK studies is the essential next step for advancing this reactive scaffold into clinical trials.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1187-1203"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148004996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical evaluation of <i>Asparagus stipularis</i> in a rat model of metabolic syndrome and development of its nanoencapsulated form.","authors":"Khaoula Adouni, Olfa Zouaoui, Pedro Brandão, Patrícia Rijo, Sofia A Costa Lima, Salette Reis, Lotfi Achour, Pedro Fonte","doi":"10.1080/03639045.2026.2674218","DOIUrl":"10.1080/03639045.2026.2674218","url":null,"abstract":"<p><strong>Context: </strong>Asparagus stipularis Forssk decoction (ASD) has shown potential metabolic and antioxidant benefits, yet its effects on pancreatic dysfunction associated with metabolic syndrome remain insufficiently explored.</p><p><strong>Objective: </strong>The aim of this work was to assess the pancreatic protective properties of ASD in high-fructose diet (HFrD)-fed rats and to characterize ASD-loaded poly(lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) as a delivery system to enhance its therapeutic potential.</p><p><strong>Methods: </strong>Rats were fed an HFrD and treated with ASD at two dose levels. Serum α-amylase and lipase activities were measured to assess digestive enzyme modulation. Pancreatic lipid peroxidation was quantified using thiobarbituric acid reactive substances (TBARS), while antioxidant enzyme activities, including superoxide dismutase, catalase, and glutathione peroxidase, were determined. Histopathological examination was performed to evaluate structural alterations in pancreatic tissues. ASD was encapsulated into PLGA NPs, and particle size, polydispersity index (PdI), zeta potential (ZP), and encapsulation efficiency (EE) were analyzed.</p><p><strong>Results: </strong>ASD significantly reduced serum α-amylase activity to 2285.3 ± 256.6 U/L (low dose) and 1846.4 ± 82.8 U/L (high dose) compared to HFrD controls. Serum lipase activity decreased by 13% and 18% at the respective doses. TBARS levels were markedly reduced, and antioxidant enzyme activities were restored to near-control levels. Histological analysis revealed improved β-cell morphology and reduced acinar degeneration. ASD-loaded PLGA NPs exhibited a mean size of 248 ± 5 nm, PdI of 0.13 ± 0.01, ZP of -24.7 ± 1.3 mV, and an EE of 75.5 ± 3.2%.</p><p><strong>Conclusion: </strong>ASD demonstrates significant pancreatic protective effects, and nanoencapsulation enhances its therapeutic promise for metabolic disorders.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1377-1390"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148005007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extraction, development, and <i>ex-vivo</i> evaluation of thermoresponsive mucoadhesive <i>in-situ</i> nasal gel incorporating <i>Lablab purpureus</i> mucilage and Pluronic F127 for enhanced intranasal delivery of Diclofenac Sodium.","authors":"Adarsha Bachhar, Amitava Roy, Sanchita Mandal","doi":"10.1080/03639045.2026.2670432","DOIUrl":"10.1080/03639045.2026.2670432","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to develop and evaluate a thermoresponsive, mucoadhesive <i>in-situ</i> nasal gel using <i>Lablab purpureus</i> mucilage and Pluronic F127 for intranasal delivery of Diclofenac Sodium to enhance bioavailability by bypassing first-pass metabolism, improving mucosal retention, and minimizing irritation.</p><p><strong>Significance: </strong>Incorporating <i>L. purpureus</i> mucilage with Pluronic F127 yields a stable, mucoadhesive gel enhancing Diclofenac nasal delivery.</p><p><strong>Methods: </strong>Twelve formulations containing varying ratios of <i>L. purpureus</i> mucilage, HPMC K-100, Carbopol 940, Pluronic F68, and Pluronic F127 were evaluated for pH, viscosity, gelling behavior, mucoadhesion, and drug content. <i>In-vitro</i> release, permeation, kinetic modeling, 6-month stability, and histopathological safety on goat nasal mucosa were also assessed.</p><p><strong>Results: </strong>Formulations showed pH 5.82 ± 0.02-6.52 ± 0.02, viscosity 97.63 ± 0.63 cP (25 °C) to 220.67 ± 1.21 cP (37 °C), and gelling temperatures 29.8 ± 0.21 -41.9 ± 0.52 °C. <i>Mucoadhesive strength</i> ranged from 3011.89 ± 1.21 to 6679.89 ± 0.45 dyne/cm², with drug content 87.8 ± 0.3-97.7 ± 0.8%. FA6 exhibited 95.8% release and 96.8% permeation following first-order kinetics, while FB6 followed the Korsmeyer-Peppas model.</p><p><strong>Conclusions: </strong>FA6 demonstrated optimal mucoadhesion, permeation, and stability, confirming strong potential as an effective thermoresponsive nasal delivery system for Diclofenac Sodium.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1357-1376"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147867127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pregabalin-loaded transferosomal gel for enhanced topical delivery in peripheral neuropathy: formulation, <i>in vitro</i> and <i>ex vivo</i> evaluation.","authors":"Mariya Sanjana A, Ashvini H M","doi":"10.1080/03639045.2026.2667232","DOIUrl":"10.1080/03639045.2026.2667232","url":null,"abstract":"<p><strong>Objective: </strong>To formulate and evaluate a pregabalin-loaded transferosomal gel for transdermal delivery aimed at, improving skin penetration, sustaining drug release, and increasing patient compliance in the management of peripheral neuropathy.</p><p><strong>Significance: </strong>Oral pregabalin therapy often leads to systemic side effects and variable pharmacokinetics. A transferosome-based gel offers a novel approach to improve dermal penetration, prolong drug release, and reduce systemic exposure, potentially enhancing therapeutic outcomes in neuropathic pain.</p><p><strong>Methods: </strong>Pregabalin-loaded transferosomes were prepared using the thin-film hydration method with soya lecithin and Tween 80 in varying ratios. Formulations were evaluated for particle size, polydispersity index, zeta potential, entrapment efficiency, and morphology. The optimized formulation was incorporated into a gel and assessed for pH, drug content, <i>in vitro</i> drug release, <i>ex vivo</i> permeation through goat ear skin, irritancy using the hen's egg test on the chorioallantoic membrane, and stability for 90 days.</p><p><strong>Results: </strong>The vesicles displayed particle sizes of 378.9-1471 nm, a PDI of 0.3-0.8, and a zeta potential from -17.2 to -31.6 mV. Entrapment efficiency[ee] ranged from 40.35% to 89.2%. Scanning electron microscopy confirmed smooth, spherical vesicles. The transferosomal gel showed pH 5.2-6.1 and drug content of 93.4%-98.8%. <i>In-vitro</i> studies demonstrated sustained 24-hour release following the Korsmeyer-Peppas model. <i>Ex-vivo</i> permeation showed 92.2% permeation, a flux of 467.18 µg/cm²/h, and a lag time of 0.99 h. The gel was nonirritant and stable for 90 days.</p><p><strong>Conclusions: </strong>The developed transferosomal gel exhibited sustained release, efficient permeation, and good stability, indicating strong potential as a transdermal system for peripheral neuropathy management.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1307-1320"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of formulation components on surface free energy of orodispersible films.","authors":"Motoki Inoue, Moyumi Odate, Toshiro Fukami","doi":"10.1080/03639045.2026.2675439","DOIUrl":"10.1080/03639045.2026.2675439","url":null,"abstract":"<p><strong>Objective: </strong>Surface free energy was demonstrated to be a useful formulation-guiding parameter relevant to the surface wettability of orodispersible film substrates, while also providing insight into disintegration behavior.</p><p><strong>Significance: </strong>Inkjet printing is a promising technology for on-demand and personalized pharmaceutical manufacturing; however, inadequate printability caused by uncontrolled ink spreading or poor adhesion remains a practical challenge. The role of substrate surface properties in orodispersible film formulation design has not been systematically addressed.</p><p><strong>Methods: </strong>Orodispersible films were prepared using hydroxypropyl methylcellulose as the film-forming polymer, glycerol as a plasticizer, and model active pharmaceutical ingredients. A central composite design was applied to evaluate the effects of formulation factors on total and polar components of surface free energy, determined by contact angle measurements using the Owens-Wendt method. Disintegration time and tensile strength were evaluated.</p><p><strong>Results: </strong>Surface free energy was influenced by formulation variables in an active pharmaceutical ingredient-dependent manner. Increased plasticizer and active pharmaceutical ingredient content reduced total and polar surface free energy components, whereas polymer concentration contributed positively. A significant negative correlation was observed between surface free energy and disintegration time, indicating that enhanced wettability promoted faster film disintegration. No direct correlation was found between surface free energy and tensile strength. Response surface modeling enabled identification of formulation regions balancing surface free energy, disintegration behavior, and mechanical strength.</p><p><strong>Conclusions: </strong>Surface free energy was demonstrated to be a useful formulation-guiding parameter for understanding the surface wettability of orodispersible film substrates relevant to pharmaceutical printing processes, while also providing insight into disintegration behavior.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1404-1411"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147962224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improvement of aqueous solubility and oral bioavailability of luteolin: a nanosuspension approach.","authors":"Hari Priya Sripadi, Sai Balaji Andugulapati, Vijaya Sarathi U V R, Ramakrishna Sistla","doi":"10.1080/03639045.2026.2655893","DOIUrl":"10.1080/03639045.2026.2655893","url":null,"abstract":"<p><strong>Objective: </strong>Luteolin (LT), a naturally occurring flavonoid and biopharmaceutical classification system (BCS) Class II compound, holds broad pharmacological potential. However, its clinical application is limited by poor water solubility and low intestinal permeability. This study aimed to enhance LT's solubility and oral bioavailability by formulating a nanosuspension using anti-solvent precipitation combined with ultrasonication.</p><p><strong>Significance: </strong>Improving the dissolution and absorption of poorly soluble phytoconstituents like LT, is critical to translate their pharmacological promise into effective oral therapies. A nanosuspension-based strategy offers a scalable and efficient approach to overcome bioavailability barriers.</p><p><strong>Methods: </strong>Luteolin nanosuspensions were developed via precipitation from an organic solvent into an aqueous anti-solvent under ultrasonic irradiation. Key formulation variables like stabilizer type, concentration, and sonication time were optimized to minimize particle size (PS) and improve stability. The final formulation was characterized using Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and <i>in vitro</i> dissolution studies. Pharmacokinetic performance was evaluated <i>in vivo</i>.</p><p><strong>Results: </strong>The optimized formulation, LT-NS-0.5% Pluronic F127 (F127), achieved a significantly reduced PS with a narrow size distribution and strong physical stability. Poloxamer 407 was the most effective stabilizer in controlling particle growth during ultrasonication. The formulation released LT more rapidly and completely than the raw compound, indicating improved dissolution behavior. <i>In vivo</i> pharmacokinetic studies demonstrated a significant increase in oral bioavailability.</p><p><strong>Conclusion: </strong>The anti-solvent precipitation-ultrasonication method effectively enhanced the solubility and bioavailability of LT. This nanosuspension approach provides a practical and scalable pathway to advance poorly soluble phytoconstituents towards clinical application.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1132-1146"},"PeriodicalIF":2.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147765517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}