Drug Development and Industrial Pharmacy最新文献

{"title":"Mirtazapine Loaded NLCs‑Based Hydrogel for Topical Delivery in Pruritus: Statistical Optimization, <i>In vitro</i> and Skin Irritation Evaluation.","authors":"Muhammad Akhtar, Aqeedat Javed, Abeer Tariq, Rashna Mirza, Ahmad Abdur Rahman, Hamid Khan, Ahmad Khan","doi":"10.1080/03639045.2025.2495846","DOIUrl":"10.1080/03639045.2025.2495846","url":null,"abstract":"<p><p>Systemic mirtazapine (MRT) delivery for the treatment of pruritus exhibits severe side effects which needs to be addressed. For this purpose, topical nanostructured lipid carriers (NLCs) containing MRT were developed to minimize side effects and enhance therapeutic efficacy. The microemulsion method was utilized for the preparation of MRT loaded NLCs and the final optimized formulation was loaded in the gel for effective topical application. The formulation was optimized in terms of particle size (PS), zeta potential (ZP), polydispersity index (PDI), and percentage entrapment efficiency (% EE) by keeping in view the quantity of drug, tween 80 and lipids ratio. Optimized nano formulation exhibited the PS of 186.3 ± 1.2 nm, with 0.217 ± 0.03 PDI, ZP of -26.0 ± 0.2 mV and %EE of 86.3 ± 0.3%. Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) analysis confirmed the compatibility of components of nano formulation and encapsulation of drug inside lipid matrix, respectively. Further, the gel-based optimized MRT-loaded NLCs dispersion was analyzed for rheology and textural characterization. The prepared hydrogel (MRT-loaded NLCs gel) had a transparent appearance, non-gritty texture, pH, and spreadability of 322.33 ± 0.25%, respectively. MRT loaded NLCs gel exhibited a drug release of 81% in 24 h and followed Korsmeyer-Peppas model. <i>Ex vivo</i> skin permeation depicted only 6.20 µg/cm² drug permeation across the skin after 24 h. Skin irritation study showed no signs of erythema and edema in nano formulation-treated group. MRT-loaded NLCs gel was formulated successfully and may be used as a promising vehicle for topical delivery of pruritus.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"634-646"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982806","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":"Design and optimization of venlafaxine niosomes loaded thermosensitive <i>in-situ</i> gel for prolonging intranasal residence in depressive disorder.","authors":"Purushottam Gangane, Mandar Thool, Sachin More, Amol Warokar, Kishor Salunkhe, Pankaj Dangre","doi":"10.1080/03639045.2025.2492193","DOIUrl":"10.1080/03639045.2025.2492193","url":null,"abstract":"<p><strong>Objective: </strong>Venlafaxine (VLF) is the most commonly used drug for the treatment of depressive disorder. The oral bioavailability of VLF is low. Therefore, the present study emphasized the development of niosomes formulation for solubility and permeation improvement.</p><p><strong>Methods: </strong>The niosome-VLF was formulated using a thin film hydration technique employing different molar ratios of Span 40 and cholesterol. The optimization of niosomes was performed using the Box-Behnken screening model, which employs numerical optimization.</p><p><strong>Results: </strong>The optimized niosmoes-VLF showed Particle size: 264.2 ± 2.2 nm; Zeta potential: 49.2 ± 1.3 mV; Polydispersity Index: 0.265 ± 0.15; Entrapment efficiency: 70.25 ± 1.5%. The niosome-VLF (OF) was incorporated into the thermosensitive <i>in situ</i> gel (TISG). The niosome-VLF TISG (OF-A) showed gelling temperature: 37 ± 0.5 °C; gelling time: 23 ± 2.2 s; viscosity: 4526 ± 142 cps; mucoadhesive strength: 3589 ± 65 dyne/cm², drug content: 88 ± 5.4%. The <i>in-vivo</i> pharmacokinetic study revealed a higher concentration of VLF in developed niosome-VLF TISG (OF-A) formulation than VLF suspension. The higher and sustained concentration of VLF in brain and plasma suggested a better therapeutic approach to counteract a chronic depressive disorder. Further, the accelerated stability studies of niosome-VLF TISG (OF-A) indicated good physical and chemical attributes.</p><p><strong>Conclusion: </strong>The intranasal niosome-VLF TISG (OF-A) can be sorted as an alternative approach for targeting the brain for the effective management of CNS conditions like depression.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"587-596"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986002","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":"Enhanced Tacrolimus efficacy in psoriasis with innovative transethosomes: a promising preclinical study on Wistar rats.","authors":"Vishwanath Jadhav, Kishori P Sutar, Sankalp S Sammasagi, Siddarth Usulkar, Vinayak Patil","doi":"10.1080/03639045.2025.2482664","DOIUrl":"10.1080/03639045.2025.2482664","url":null,"abstract":"<p><strong>Aim: </strong>This study focuses on the formulation and evaluation of Tacrolimus-loaded transethosomes, which are then incorporated into a gel for topical application. The goal is to achieve deeper transdermal penetration, enhancing the treatment regimen.</p><p><strong>Methods: </strong>Transethosomes were formulated using the cold method and optimized using 3² factorial design (DESIGN EXPERT^® Software) using different concentrations of lipid and ethanol. They were characterized for vesicle size, entrapment efficiency, zeta potential, and polydispersity index. The optimized batch was incorporated into the carbopol 940 gel base. <i>In vitro</i> and <i>ex vivo</i> permeation studies were carried out to determine the diffusion and release pattern. Skin irritancy and <i>in vivo</i> imiquimoid-induced anti-psoriatic activity were carried out on Wistar rats.</p><p><strong>Results: </strong>The F1 batch, characterized by a low concentration of ethanol and lipids, demonstrated a vesicle size of 168 nm, an entrapment efficiency of 85%, a zeta potential of -36 mV, and a polydispersity index of 0.12. <i>In vitro</i> release studies indicated an 85.32% drug release and a 76.34% drug permeation after 24 h. The drug release adhered to zero-order kinetics, with the Korsmeyer-Peppas model suggesting a non-Fickian diffusion mechanism. <i>In vivo</i> studies of Tacrolimus-loaded transethosomal gel in an imiquimod-induced psoriasis-like rat model demonstrated significant therapeutic effects within seven days. Histopathological analysis showed reduced hyperkeratosis, epidermal hyperplasia, and inflammation, with fewer inflammatory cells in the dermis. Stability tests confirmed the formulation's integrity at 4 and 25 °C over 90 days.</p><p><strong>Conclusion: </strong>The study's outcome revealed that tacrolimus-loaded transethosomes could effectively manage psoriasis.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"454-466"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718313","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":"Development of etoricoxib-loaded mesoporous silica nanoparticles laden gel as vehicle for transdermal delivery: optimization, <i>ex vivo</i> permeation, histopathology, and <i>in vivo</i> anti-inflammatory study.","authors":"Dibya Lochan Mohanty, Noota Divya, Ameeduzzafar Zafar, Musarrat Husain Warsi, Gnyana Ranjan Parida, Priyanka Padhi, Mohammad Khalid, Mohd Yasir, Md Ali Mujtaba","doi":"10.1080/03639045.2025.2490287","DOIUrl":"10.1080/03639045.2025.2490287","url":null,"abstract":"<p><strong>Objective: </strong>Etoricoxib (ETB) is a nonsteroidal anti-inflammatory therapeutic agent. It is poorly soluble and has various gastrointestinal side effects such as bleeding and ulcers after oral administration. The present research aimed to develop an ETB-loaded mesoporous silica nanoparticle-laden gel (ETB-MSNPs) for transdermal delivery to improve therapeutic efficacy.</p><p><strong>Methods: </strong>The ETB-MSNPs were synthesized using a precipitation and solvent evaporation technique and their optimization was performed using a Box-Behnken design. The optimized ETB-MSNPs were incorporated into a carbopol-chitosan gel and evaluated for <i>in vitro</i>, <i>ex vivo</i>, and <i>in vivo</i> anti-inflammatory activity.</p><p><strong>Results: </strong>The ETB-MSNPs displayed nanosize of particles with nanosize distribution and high entrapment efficiency of ETB. The Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) studies showed that ETB was encapsulated in MSNPs. The optimized ETB-MSNPs were successfully integrated into the carbopol and chitosan gel, which exhibited excellent viscosity and spreadability. The optimized ETB-MSNPs gel exhibited a significantly higher and more sustained release of ETB compared to pure ETB gel. Optimized ETB-MSNPs gel exhibited a considerably higher anti-inflammatory effect with a significant reduction in IL-1β and TNF-α levels compared to pure ETB gel. The histopathological examination confirmed that optimized ETB-MSNPs gel did not exhibit any toxicity on the skin.</p><p><strong>Conclusion: </strong>Based on the findings, the results suggest that the MSNPs gel has the potential as a carrier for enhancing the therapeutic efficacy of ETB through topical delivery, although further studies are needed to fully confirm its effectiveness.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"506-521"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794743","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":"Gliclazide loaded spanlastic nanovesicles: empowering bioavailability and antidiabetic efficacy.","authors":"Shimaa Mazyed, Soha M El-Masry, Haidy Abbas, Mohammad M Abd-Alhaseeb, Heba M Elbedaiwy","doi":"10.1080/03639045.2025.2480183","DOIUrl":"10.1080/03639045.2025.2480183","url":null,"abstract":"<p><strong>Objective: </strong>This work aimed to prepare spanlastics nanovesicles (SNVs) loaded with gliclazide (GCZ) to increase the drug's oral bioavailability and anti-diabetic effects.</p><p><strong>Methods: </strong>Two types of edge activators (tween 80 and/or brij35) and two types of spans (span 60 and span 80) were used to prepare SNVs using the ethanol injection method,2³ factorial design was used to investigate the effects of various span types, edge activator types, and the ratio of span to edge activator.</p><p><strong>Results: </strong>The optimum formulation (F6) was selected and its <i>in-vitro</i> drug release, <i>in-vivo</i> pharmacokinetics, and pharmacodynamics were evaluated. A transition electron microscope (TEM) showed spherical particles with smooth surfaces, (F6) drug release was (Q₁₂ 97.05 ± 4.85) while GCZ powder was (97.89 ± 4.56 after 4 h) also showed better entrapment efficiency (EE% 95.1 ± 3.8). <i>In- vivo</i> pharmacokinetic study showed an increase in C_max and t_max (12.93 ± 1.34, 3.2 ± 0.83) compared to unprocessed GCZ powder (2.88 ± 1.59, 1.8 ± 0.74). <i>In-vivo</i> pharmacodynamics study of diabetic rats demonstrated that GCZ-loaded SNVs has a higher % maximum decrease in blood glucose levels (MR) 58.31 ± 5.70 compared to 38.33 ± 8.18 for free drug and % total drop in blood glucose levels (TD) 25.78 ± 5.31% for GCZ-SNVs compared to 20.26 ± 6.05% for free drug. Histopathological examination revealed no cytotoxic signs in any of the examined samples.</p><p><strong>Conclusion: </strong>Results revealed a significant rise in relative bioavailability, sustained and prolonged drug release when compared to the unprocessed GCZ powder.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"440-453"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647552","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":"Formation of self-assembled polyelectrolyte complex derived from BSA and nanogels: a study to optimize processing parameters and preserve protein integrity.","authors":"Jahanzeb Mudassir, Aamir Jalil, Khizar Abbas, Yusrida Darwis","doi":"10.1080/03639045.2025.2479758","DOIUrl":"10.1080/03639045.2025.2479758","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this work was to identify, optimize, and use nondestructive process to develop nano-formulation using polyelectrolyte complexation (PEC) between polymeric nanocarrier and bovine serum albumin.</p><p><strong>Significance: </strong>Proteins are mostly degraded during preparation and loading into nano-carriers which hinders success in protein delivery.</p><p><strong>Method: </strong>Herein, novel PEC consisting of model protein BSA and nanogels (NGs), were prepared to form self-assembled polyelectrolyte nanocomplexes <b>(</b>BSA/NGs-PEC). The BSA/NGs-PEC were obtained by mixing BSA and nanogels at various weight ratios (1:2, 1:4, 1:5, 1:6, 1:8, 1:10), pH values of solution (1.2, 4.0, 6.0), incubation time (2, 4, 6, 8 h), and stirring rate (without, 100, 200 rpm). The prepared PEC were evaluated for particle size (PS), polydispersity index (PDI), zeta potential (ZP), and percentage of complexation efficiency (%CE). To study insights into structural integrity and biological activity, the SDS-PAGE and esterase activity assay was performed on BSA released from final optimized formulation.</p><p><strong>Results: </strong>The optimized parameters were BSA/nanogels mixing ratios at 1:8, pH of complex-forming medium at 4.0, incubation time of 6 h, and stirring rate at 100 rpm. The SDS-PAGE and esterase activity assay revealed that the primary structure and bioactivity, respectively, of BSA was still intact.</p><p><strong>Conclusion: </strong>The results suggest that current scheme for optimization has considerable potential for creating protein-based delivery system by using PEC <i>via</i> electrostatic interaction.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"430-439"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656401","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":"Advancements in skin cancer treatment: 5-fluorouracil and carvedilol-loaded transethosomes using Lipoid S100.","authors":"Prafull Shinde, Amit Page","doi":"10.1080/03639045.2025.2485313","DOIUrl":"10.1080/03639045.2025.2485313","url":null,"abstract":"<p><strong>Objective: </strong>This study investigates a hybrid drug delivery system combination of 5-Fluorouracil (5-FU) and Carvedilol (CVD) for enhanced chemotherapeutic efficacy in skin cancer treatment. The approach addresses challenges such as drug resistance and suboptimal delivery in conventional therapies.</p><p><strong>Methods: </strong>Transethosomes (TEs) were developed using the Modified Ethanol Injection method, with optimization based on the concentrations of Lipoid S100, Tween 80, Polyvinyl Alcohol, and ethanol <i>via</i> the Box-Behnken Design. Characterization techniques, including FT-IR, DSC, Raman spectroscopy, XRD, FESEM, TEM, and AFM, were utilized to evaluate the formulations. In vitro anticancer studies, including IC50 determination, MTT assays, and cell cycle analysis, were conducted alongside drug permeation and hemolysis evaluations performed in vitro and ex vivo.</p><p><strong>Results: </strong>The optimized transethosome formulation demonstrated a particle size of 113 nm, a zeta potential of 27.23 mV, and encapsulation efficiencies of 97.21% for 5-FU and 98.73% for CVD. Spectroscopic analyses indicated no significant drug-excipient interactions, while XRD confirmed the amorphous nature of the drug in the formulation. Microscopy revealed spherical vesicles with uniform coating. The formulation showed significant anticancer activity in in vitro studies.</p><p><strong>Conclusion: </strong>The combination of 5-FU and CVD within a transethosome-based delivery system presents a potential alternative for topical chemotherapy in skin cancer treatment, offering enhanced therapeutic efficacy. This study underscores the potential of hybrid drug carriers in advancing targeted cancer therapies.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"492-505"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751634","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":"Optimization of the manufacturing process of a pediatric omeprazole enteric pellets suspension: Full Factorial Design.","authors":"Khadija Rouaz-El-Hajoui, Pilar Pérez-Lozano, Àlex Fraschi-Nieto, Xavier Mula-Roldán, Marc Suñé-Pou, Blanca Chiclana-Rodríguez, Josep María Suñé-Negre, Encarnación García-Montoya","doi":"10.1080/03639045.2025.2476651","DOIUrl":"10.1080/03639045.2025.2476651","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of the present study was to apply the design of experiments (DoE) to develop an omeprazole enteric pellets suspension for use in the pediatric population.</p><p><strong>Methodology: </strong>This experimental study employed a Full Factorial Design for drug development, encompassing three factors (Aerosil^® R972, cetostearyl alcohol, and Span 80) at two levels (2% and 6% for factor A (Aerosil^® R972) and 2% and 4% for factors B and C (cetostearyl alcohol and Span 80, respectively)).</p><p><strong>Results: </strong>Following the statistical optimization, the suspension F10 was formulated and subjected to a stability study for one month. The dissolution test results were suboptimal, achieving only an 22% release. Subsequently, eight additional suspensions were devised using hydrophilic oily vehicles (Labraphac Hydrophile WL 1219, Labrafil M2125 CS, and Labrafil M 1944 CS) and excipients (Gelucire 44/14 and Aerosil^® 200) to enhance the dissolution profile. Suspension F17 showed over 75% within 30 min, displaying superior sedimentation time when compared to all other formulations, along with effortless resuspension.</p><p><strong>Conclusion: </strong>The findings suggest that the optimal vehicle for the administration of omeprazole enteric pellets in suspension is the formulation comprising Labrafil M 1944 CS, Span 80, and Aerosil^® 200. This study has paved the way for an oily suspension vehicle, opening new avenues of research for developing pediatric omeprazole formulations that fulfill gastro-resistance requirements.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"397-408"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566306","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":"Metabolomic profiles altered by erlotinib encapsulated in poly(lactide-co-glycolide) nanoparticles in non-small cell lung cancer.","authors":"Çiğdem Yücel, Ozgur Esim, Nurgül K Bakırhan, Sevilay Erdoğan Kablan, Engin Koçak, Meryem Sebla Ertuğrul, Cansel Köse Özkan, Emirhan Nemutlu, Ayhan Savaşer, Sibel A Özkan, Yalçın Özkan, Ahmet Rıfat Balık, Taner Özgürtaş","doi":"10.1080/03639045.2025.2484326","DOIUrl":"10.1080/03639045.2025.2484326","url":null,"abstract":"<p><strong>Objective: </strong>This research is focused on the metabolomics and cytotoxic effects of the anticancer drug erlotinib encapsulated in poly(lactide-co-glycolide) nanoparticles on non-small cell lung cancer (NSCLC) cell lines.</p><p><strong>Methods: </strong>Uniform-sized nanoparticles (0.325 and 0.068 PDI) with mean diameters of 264.5 and 268.4 nm for blank and erlotinib-PLGA nanoparticles (nanodrugs-NDs) were formulated, respectively. The encapsulation efficiency of prepared nanoparticles was found to be 90.1%. 36% of erlotinib was released from PLGA nanoparticles within 24 h, and the maximum sustained release was 43% at 72 h. The metabolomic and cytotoxic effects of ND were evaluated.</p><p><strong>Results: </strong>The Bax/Bcl-2 ratio was the lowest in the nanodrug group at 72 h, showing increased apoptosis, indicating that the most effective drug formulation is the combined nanoparticle at 72 h. The metabolomic studies revealed changing amino acids, antioxidant molecules, and carbohydrate profiles. The most significant changes were obtained in pathways related to the synthesis of p-glycoprotein, which is the principal protein for drug efflux and causes drug resistance. The lowest levels of amino acids and polyamines like serine, threonine, spermine, and spermidine were obtained at 72 h with erlotinib encapsulated in poly(lactide-co-glycolide) (PLGA) nanoparticles, showing that the drug resistance may in part be overcome with this nanoparticles.</p><p><strong>Conclusion: </strong>The encapsulation of erlotinib with PLGA showed effects and influenced critical metabolic pathways, especially pointing out the need to lower drug resistance and signifying it's potential use as an effective treatment strategy for NSCLC.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"467-476"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691506","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":"Optimization and assessment of three generation solid dispersion for enhancement of solubility and dissolution for montelukast sodium.","authors":"Kirti Rashmi, Kaushiki Ash, Abhimanyu Dev","doi":"10.1080/03639045.2025.2477722","DOIUrl":"10.1080/03639045.2025.2477722","url":null,"abstract":"<p><strong>Objective: </strong>To enhance the solubility of Montelukast sodium using three generation polymers by solid dispersion method.</p><p><strong>Material and method: </strong>Montelukast sodium with selected generation of carriers were used for phase solubility and to optimize the stoichiometric ratio for the preparation of SD with MS. Various characterization techniques (FTIR, DSC and XRD) have been used to evaluate the MS-SD formulations with selected hydrophilic carriers. Dissolution and stability study were also investigated.</p><p><strong>Result and discussion: </strong>The two best-selected formulations (MS-PVP & MS-HPMC SD) have shown the highest dissolution profile as compared to pure drug, physical mixture and commercially available marketed product (Montel-10, Cipla). The FTIR, DSC and XRD results of these SD formulations have shown interaction between drug and polymers, decrease in enthalpy compared to the drug and amorphous behavior respectively. Finally, MS-PVP & MS-HPMC SD formulations have shown good stability for one-month period under accelerated storage condition.</p><p><strong>Conclusion: </strong>The study showed increase in solubility of Montelukast sodium with second generation polymers (PVP & HPMC) in comparison to pure drug as well as marketed formulation.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"409-418"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143584908","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}