Drug Development and Industrial Pharmacy最新文献

{"title":"pH-responsive chitosan-alginate hydrogel beads: for enhanced bioavailability and controlled release of omeprazole.","authors":"Anil K Philip, Betty Annie Samuel, Yagub Salem Saleh, Bassim I Mohammad, Hayder A Al-Aubaidy","doi":"10.1080/03639045.2025.2536620","DOIUrl":"10.1080/03639045.2025.2536620","url":null,"abstract":"<p><strong>Objective: </strong>To develop a pH-responsive drug delivery using chitosan-alginate hydrogel beads for enhanced therapeutic efficacy of omeprazole.</p><p><strong>Significance: </strong>The developed system offers improved drug entrapment, release profiles, and enhanced bioavailability for omeprazole compared to commercial formulation.</p><p><strong>Methods: </strong>pH-responsive chitosan-alginate hydrogel beads were prepared using a modified ionotropic gelation technique. The process was optimized <i>via</i> a two-level factorial design. Characterization involved drug entrapment efficiency determination, molecular dynamic simulations, <i>in vitro</i> drug release studies, and Caco-2 cell monolayer permeability assessments. Stability was evaluated under accelerated conditions, and <i>in vivo</i> efficacy was tested in rats with indomethacin-induced peptic ulcer disease.</p><p><strong>Results: </strong>The optimized formulation achieved 82.70 ± 2.02% drug entrapment efficiency. <i>In vitro</i> release studies demonstrated superior pH-dependent behavior, with minimal release (<20%) at pH 1.2 and sustained release (>92%) at pH 7.4 over 24 h. Molecular modeling revealed high entrapment efficiency. The Caco-2 cell study showed a 2-fold increase in drug permeability (2.8 × 10^-6cm/s) compared with that of free omeprazole (4.5 × 10^-6cm/s) and a commercial formulation (3.7 × 10^-6cm/s), with no significant cytotoxicity (cell viability > 95%). <i>In vivo</i> studies demonstrated significant ulcer healing, reducing the ulcer index from 3.96 to 1.20. Accelerated stability studies indicated a 24-month shelf-life under normal conditions.</p><p><strong>Conclusions: </strong>The novel chitosan-alginate hydrogel system offers a promising solution for improving omeprazole delivery, with significant enhancements in drug entrapment, release profile, bioavailability, and stability.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-16"},"PeriodicalIF":2.4,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648829","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":"Characterization and sensory evaluation of placebo OrPhyllo^TM orodispersible films as a versatile pediatric drug delivery platform.","authors":"Karolina Dziemidowicz, Jiao Jin, Sejal R Ranmal, Sirakarn Piumpongsuk, Samuel Aspinall, Christopher J Serpell, Conor McCann, Catherine Tuleu","doi":"10.1080/03639045.2025.2521664","DOIUrl":"10.1080/03639045.2025.2521664","url":null,"abstract":"<p><strong>Objective: </strong>Orodispersible films (ODFs) are a convenient form of pediatric drug delivery and for those with swallowing difficulties. They can be extemporaneously prepared in pharmacies using pre-formulated bases which simplify and fasten the process while reducing compounding errors. OrPhylloTM is a water-based commercial vehicle for preparing polymeric ODFs. It is chemically compatible with various clinically relevant active pharmaceutical ingredients (APIs) at different drug loadings.</p><p><strong>Methods: </strong>This study focuses on characterizing placebo OrPhylloTM films, including their morphological, mechanical, and textural properties, as well as physicochemical stability by thermal analysis and X-ray diffraction.</p><p><strong>Results: </strong>After local ethical approval, healthy adults explored stickiness, mouthfeel, and disintegration of these 3 × 3 cm ODFs following various modes of administration. OrPhyllo™ ODFs (185 ± 10 µm thick) exhibited distinct surface characteristics, one side (lower) smoother and the upper side rougher, as observed and shown by scanning electron and atomic force microscopy. However, both sides demonstrated similar mucoadhesive properties and rapid disintegration (between 60 and 140 s, depending on the method used). Both sides were well-accepted, whether administered on the tongue or in the cheeks, with minor differences in mouthfeel and fast disintegration perception. The hen's egg chorioallantoic membrane test showed no irritancy, supporting the good acceptability of these placebo ODFs. The films remained structurally stable over 6 months, with low residual moisture.</p><p><strong>Conclusion: </strong>The comprehensive in vitro and in vivo characterisation confirmed the suitability of OrPhylloTM ODFs for pharmaceutical applications.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-11"},"PeriodicalIF":2.4,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324710","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":"Polymorphic transformation of febuxostat after crystallization in presence of bentonite dispersion: characterization by the heat of fusion and heat of transition rule, and dissolution.","authors":"Mouli Das, Rakesh Swain, Souvik Nandi, Sk Habibullah, Subrata Mallick","doi":"10.1080/03639045.2025.2499880","DOIUrl":"10.1080/03639045.2025.2499880","url":null,"abstract":"<p><strong>Objective: </strong>Febuxostat (FBX) has been crystallized using bentonite dispersion as an antisolvent, and characterized by heat of fusion and heat of transition rule for possible polymorphic transformation and improved dissolution.</p><p><strong>Significance: </strong>Polymorphic transformation may exhibit significant alteration of melting temperature, solubility, dissolution rate, and stability. FBX is known for polymorphic/hydrate/solvate transformation in many forms wherein stable form has hardly been reported.</p><p><strong>Methods: </strong>Aqueous bentonite dispersion was used as antisolvent for crystallization of FBX and characterized by heat of fusion and heat of transition rule, and the effect of bentonite concentration on <i>in vitro</i> drug dissolution has also been confirmed.</p><p><strong>Results: </strong>Monotropic and enantiotropic relationships between the pair of polymorphs have been established with the help of transition enthalpy and transition entropy rule. Energy-entropy interplay showed that the transition occurred above the melting temperature indicating the monotropic relation between the FBX crystal pairs (from A to Q). Fourier Transform Infrared spectroscopy (FTIR) and X-ray diffraction (XRD) studies also confirmed the transformation of A (pure FBX) to Q form and its stability (40 °C, 75%RH, 3 months). The crystallite size was estimated from the graphical plot of major important XRD peaks using the least square method of altered Scherrer equation which is supposed to minimize the error associated with the original Scherrer equation. Williamson-Hall equation was used properly for determining strain from the positive slope avoiding misperception of negative slope.</p><p><strong>Conclusions: </strong>Prepared form Q was found stable and displayed <i>in-vitro</i> drug dissolution in an improved and controlled manner.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"720-734"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956650","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":"Albumin-based nanoparticles: a potential and emerging oral drug delivery system.","authors":"Yanping Sun, Huijia Song, Shuo Li, Huimin Zhang, Yongjun Sun, Zibin Gao","doi":"10.1080/03639045.2025.2504440","DOIUrl":"10.1080/03639045.2025.2504440","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this review is to elaborate current development and challenges of oral albumin nanoparticles, and realize their clinical application.</p><p><strong>Significance: </strong>Albumin is an emerging protein nanocarrier with a high degree of versatility, safety, stability, modifiability. These characteristics endow albumin nanoparticles with considerable attention and unique roles in drug delivery. However, most albumin nanoparticles are administered intravenously instead of orally, although oral administration is the most popular and common drug delivery route. Oral administration of albumin nanoparticles is their inevitable tendency, but researches referred to this area are still in infancy.</p><p><strong>Methods and results: </strong>Given that, firstly, the basic properties of albumin nanoparticles, like preparation methods, drug loading strategies, targeted drug delivery, and clinical application were simply discussed to provide design guide for their oral administration. Subsequently, the functions and challenges of albumin nanoparticles in oral drug delivery, and strategies to overcome the barriers were highlighted. Finally, aiming to realize their clinical potentials, the possible future trends of orally administrated albumin nanoparticles were also elaborated.</p><p><strong>Conclusions: </strong>In this review, albumin nanoparticles were comprehensively introduced, especially their functions and challenges in oral drug delivery, aiming to guide their design and development.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"679-690"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975846","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":"A comprehensive review of green approaches to drug solubility enhancement.","authors":"B S Mahesha, F R Sheeba, H K Deepak","doi":"10.1080/03639045.2025.2496940","DOIUrl":"10.1080/03639045.2025.2496940","url":null,"abstract":"<p><strong>Objective: </strong>This review explores green approaches to enhance poorly water-soluble drug solubility. Implementing sustainable and green techniques, it provides a comprehensive overview of advancements and applications in drug development.</p><p><strong>Significance of review: </strong>Drug solubility is a key challenge in pharmaceutical research, affecting bioavailability and efficacy. Conventional methods often rely on hazardous solvents and energy-intensive processes, posing environmental and safety concerns. This review emphasizes green chemistry principles as sustainable alternatives to enhance solubility while supporting global sustainability goals.</p><p><strong>Key findings: </strong>Natural and biodegradable polymers in solid dispersions offer effective, eco-friendly solubility enhancement. The application of supercritical CO₂ demonstrates significant potential as a green solvent for solubility enhancement, offering scalability while minimizing environmental impact. Plant-derived and renewable excipients offer a sustainable alternative to synthetic additives.</p><p><strong>Summary of challenges: </strong>Natural polymers face formulation, solubility, and batch variability issues. Deep eutectic solvents and ionic liquids face stability, regulatory hurdles, toxicity risks, and hygroscopicity. Supercritical fluid technology requires costly equipment and precise optimization. Green co-crystallization faces co-former selection, scalability, and stability issues. Further refinement, safety validation, and industrial feasibility studies are needed.</p><p><strong>Potential drawbacks of green approaches: </strong>Green solubility enhancement methods face scalability, regulatory, and cost challenges. Some offer limited solubility gains and stability issues. Ensuring cost-effectiveness, industrial viability, and compliance is key for broader adoption.</p><p><strong>Conclusion: </strong>Green solubility enhancement offers a sustainable solution to drug solubility challenges. Integrating these methods improves efficiency, safety, and environmental impact. This review highlights the need for further research and the adoption of sustainable drug delivery approaches.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"659-669"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969747","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":"Functionalized liposomes for intranasal levodopa delivery to the brain.","authors":"Daria S Gordeeva, Achraf Sym Tameloucht, Irina I Semina, Rouslan I Moustafine","doi":"10.1080/03639045.2025.2509273","DOIUrl":"10.1080/03639045.2025.2509273","url":null,"abstract":"<p><strong>Objective: </strong>The study evaluated functionalized liposomes as potential carriers for intranasal delivery of levodopa.</p><p><strong>Methods: </strong>Lipid film hydration method was used to obtain conventional and functionalized liposomes with polyethylene glycol or maleimide-PEG. The liposome structure was analyzed by dynamic light scattering and ¹H-NMR spectroscopy. Isolated sheep nasal mucosa was used for mucoadhesion and mucous penetration studies. Levodopa release was assessed using a Franz diffusion cell. <i>In vivo</i> experiments were conducted using a method based on the inhibition of dopaminergic transmission.</p><p><strong>Results: </strong>The average liposome diameter was 81-91 ± 1 nm. The Pdi was less than 0.300. The zeta potential was negative. An increase in the molar weight of polyethylene glycol in the liposome structure improved mucosa penetration to 0.4 mm. The presence of maleimide did not affect the mucoadhesive properties. The levodopa release profile corresponded to Fickian diffusion. Intranasal administration of levodopa <i>in vivo</i> caused dopaminergic transmission inhibition in rats after 1 h.</p><p><strong>Conclusion: </strong>According to the received results, functionalized liposomes are promising for further evaluation as intranasal drug carriers.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"758-770"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109843","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":"Combating breast cancer-associated metastasis using paclitaxel and tranilast-loaded human serum albumin nanoparticles.","authors":"Naitik Jain, Syed Shahrukh, Paras Famta, Saurabh Shah, Ganesh Vambhurkar, Dadi A Srinivasarao, Anamika Sharma, Giriraj Pandey, Suraj Wagh, Swapnil Shinde, Anjesh Khan, Prashanth Kumar, Saurabh Srivastava","doi":"10.1080/03639045.2025.2509861","DOIUrl":"10.1080/03639045.2025.2509861","url":null,"abstract":"<p><strong>Objective: </strong>The objective of the current study is to combat breast cancer-associated metastasis using paclitaxel (PTX) and tranilast (TRA)-loaded human serum albumin (HSA) nanoparticles.</p><p><strong>Significance: </strong>This combinatorial therapy uses microtubule stabilizing agent PTX, along with TGFβ inhibitor TRA. TRA may offer an improved therapeutic effect in breast cancer by inhibiting cell proliferation and metastasis.</p><p><strong>Methods: </strong>Inspired by the remarkable anticancer properties of both drugs, they were encapsulated into HSA nanoparticles to enhance tumor site-specific drug accumulation and ensure sustained release over a prolonged period. The HSA nanoparticles were fabricated using the desolvation method and optimized using a Box-Behnken design (BBD) with a three-level, two-factor approach. Further, these nanoparticles were characterized using TEM, FTIR, XRD, and particle size. <i>In vitro</i> experiments were conducted using the MDA-MB-231 cell line, employing cell viability, cellular uptake, nuclear staining, scratch assay, and cell cycle analysis.</p><p><strong>Key findings: </strong><i>In vitro</i> release kinetics reveal sustained PTX and TRA release from HSA nanoparticles. Wound healing assay depicted improved anti-migratory activity of PTX-TRA-NPs (30 nM to 75 µM). Furthermore, the novel combination treatment caused G2/M phase cell cycle arrest, as indicated by cell cycle analysis.</p><p><strong>Conclusion: </strong>HSA nanoparticles enhance the delivery and accumulation of hydrophobic drugs (PTX and TRA) in breast cancer cells, offering improved therapeutic outcomes. This combinatorial strategy permits further preclinical investigation for synergistic breast cancer management.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"786-798"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119088","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":"Phenyl boronic acid conjugated lipid nanoparticles for targeted delivery of gamma-secretase inhibitor to breast cancer cells.","authors":"Ramakrishna Gummadi, Lakshmi Prasanthi Nori, Sai Kiran S S Pindiprolu","doi":"10.1080/03639045.2025.2511291","DOIUrl":"10.1080/03639045.2025.2511291","url":null,"abstract":"<p><strong>Objective: </strong>The major objective of this study is to develop and evaluate phenyl boronic acid (PBA) conjugated solid lipid nanoparticles (SLNs) (PBA-SUL@SLN) for the targeted delivery of sulindac (SUL) to breast cancer (BC) cells.</p><p><strong>Significance: </strong>Utilizing a dual approach that combines PBA-mediated targeting with Notch-1 pathway inhibition by SUL, the study aims to enhance therapeutic selectivity and efficacy against an aggressive BC subtype, triple negative BC (TNBC), which lacks well-defined molecular targets.</p><p><strong>Methods: </strong>The PBA-SUL@SLN formulation was prepared using emulsification-solvent evaporation method and analyzed for the particle size (PS), zeta potential (ZP), entrapment efficiency (EE), and pH sensitive drug release. Cellular uptake studies were conducted to examine selective internalization in TNBC cells. The therapeutic efficacy was assessed by evaluating Notch-1expression modulation of epithelial-to-mesenchymal transition (EMT), cancer stem cell (CSC) activity, and cytotoxic effects in TNBC cell compared to normal cells.</p><p><strong>Results: </strong>The PBA-SUL@SLN formulation exhibited an optimal PS of (153.35 nm), a ZP of (22.87 mV), and an EE of 83.06%, with preferential drug release observed in the acidic tumor microenvironment. Increased cellular uptake in MDA-MB-231 cells led to notable downregulation of Notch-1, inhibition of EMT, and potential reduction in CSC activity. Cytotoxicity assays revealed strong and selective efficacy against TNBC cells while causing minimal effects on normal cells.</p><p><strong>Conclusions: </strong>The PBA-SUL@SLN formulation presents a promising targeted therapeutic strategy for TNBC, addressing key limitations of existing treatments.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"811-825"},"PeriodicalIF":2.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136144","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":"A review article on transethosomes: revolutionizing drug delivery through transdermal patches.","authors":"Siddharam Loni, Suma U S, R Zohmingliani, Sumanth Sumanth","doi":"10.1080/03639045.2025.2507688","DOIUrl":"10.1080/03639045.2025.2507688","url":null,"abstract":"<p><p>Transethosomes, advanced nanovesicular carriers, have emerged as a revolutionary drug delivery system, particularly for transdermal patches. Combining the structural flexibility of ethosomes and the penetration-enhancing properties of surfactants, transethosomes offer remarkable advantages in overcoming the skin barrier to deliver a broad range of therapeutic agents. These vesicles enhance drug permeation, improve bioavailability, and enable controlled and sustained release, making them a promising alternative to conventional drug delivery methods. This review explores the unique composition, mechanisms of action, and penetration pathways of transethosomes while highlighting their application in various therapeutic areas, including pain management, dermatology, and hormone replacement therapies. Additionally, the article discusses the potential for transethosomes to target specific skin layers or cells, improving drug localization and minimizing systemic side effects. Current challenges, such as formulation stability, variability in skin types, and regulatory hurdles, are critically analyzed, alongside underexplored areas like large biomolecule delivery and multi-drug systems. Emerging trends, including personalized medicine, combination therapies, and stimuli-responsive formulations, are also reviewed, emphasizing the future potential of transethosomes in drug delivery innovation. By addressing these aspects, this article provides comprehensive insights into the transformative role of transethosomes in revolutionizing transdermal drug delivery systems.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"691-701"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093103","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":"Storage and in-use stability of an excipient enhanced growth (EEG) synthetic lung surfactant powder formulation.","authors":"Mohammad A M Momin, Connor Howe, Worth Longest, Michael Hindle","doi":"10.1080/03639045.2025.2508845","DOIUrl":"10.1080/03639045.2025.2508845","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the storage and in-use stability of a novel synthetic lung surfactant (SLS) excipient enhanced growth (EEG) powder formulation.</p><p><strong>Significance: </strong>Aerosol delivery of surfactant formulations could address limitations of current instilled surfactant replacement therapy for neonatal respiratory distress syndrome. A stable surfactant powder formulation is essential for this approach.</p><p><strong>Methods: </strong>SLS-EEG powder was spray-dried from a formulation of dipalmitoyl -phosphatidylcholine (DPPC), surfactant protein B peptide mimic (B-YL), mannitol, sodium chloride, and l-leucine. Powders were filled into hydroxypropyl methylcellulose (HPMC) capsules and stored in aluminum-aluminum blisters at 25  °C, 5  °C and -20 °C (all ± 2 °C) and 40 ± 5% relative humidity (RH) for 6 months. Physicochemical and aerosol properties were assessed post-spray drying and post-storage. In-use stability was assessed by exposing powders to 22 °C/45% RH for 30 and 120 min and 30 °C/75% RH for 120 min before dry powder inhaler (DPI) actuation.</p><p><strong>Results: </strong>DPPC content remained stable for 6 months at all storage temperatures. Powder morphology and particle size were unchanged at 5 °C and -20 °C, but altered at 25 °C. Solid-state stability and surface activity were unaffected. Emitted doses remained high (>95%) after 3 months using an infant air-jet DPI, though <i>in vitro</i> lung deposition decreased from ∼50% to ∼40% and ∼30% at 3 and 6 months. In-use exposure of the formulation in device to 22 °C/45% RH caused no lung deposition changes, but it declined at 30 °C/75% RH (∼40% vs. ∼50%).</p><p><strong>Conclusions: </strong>A synthetic lung surfactant EEG powder formulation with physicochemical stability and acceptable aerosol performance up to 6 months storage has been successfully produced.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"747-757"},"PeriodicalIF":2.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}