Drug Development and Industrial Pharmacy最新文献

{"title":"Formulation and optimization of <i>Dryopteris cochleata</i> extract-laden liposomes for immunostimulant activity in rats: <i>in vitro</i> and <i>in vivo</i> evaluation.","authors":"Shubhangi Patil, Popat Kumbhar, Rajnandini Patil, Sakshi Mane, Sameer Nadaf, Mansingraj Nimbalkar, Ashok Wali, Shailendra Gurav, John Disouza","doi":"10.1080/03639045.2026.2660831","DOIUrl":"10.1080/03639045.2026.2660831","url":null,"abstract":"<p><strong>Objective: </strong>This study sought to develop <i>Dryopteris cochleata</i> (DC) extract encapsulated liposomes and their characterization in order to increase its immunomodulatory activity.</p><p><strong>Significance: </strong>The significance of <i>DC</i> extract-laden liposomes is to improve their immunostimulant activity. Thus, this technology offers a novel immunotherapeutic strategy to combat a range of diseases.</p><p><strong>Methods: </strong><i>DC</i> extract was obtained using supercritical fluid extraction and screened for acute oral toxicity in Wistar rats. The extract-laden liposomes were optimized by Box-Behnken Design (BBD) and were evaluated for different <i>in vitro</i> parameters. Moreover, extract and liposomes were investigated for immunomodulatory activity in Wistar albino rats.</p><p><strong>Results: </strong>The extract was found to be safe in Wistar rats at a dose of 2000 mg/kg. The optimized liposomes fabricated with phosphatidylcholine (4.5 mg) and cholesterol (3.1 mg), and probe cycle number of 56.5, displayed particle size of 147.5 ± 8 nm and PDI of 0.239 ± 0.03, respectively. The liposomes exhibited zeta potential of -27.6 ± 4.6 mV and spherical morphology. The Fourier transformed infrared (FTIR) spectroscopy and differential scanning calorimetry (DSC) revealed compatibility and thermal stability of the formulation components. Moreover, Powder X-ray diffraction (PXRD) studies signify the amorphous nature of extract following incorporation into liposomes. The antioxidant activity of extract and liposome was observed to be similar to ascorbic acid. Furthermore, significant phagocytic index was shown by both extract and liposome in rats, revealing their potent immunostimulant activity.</p><p><strong>Conclusions: </strong>Thus, <i>DC</i> extract-laden liposomes may serve as a promising immunostimulant, particularly in recurrent infections, immunodeficiencies, and recovery from chronic illness.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-18"},"PeriodicalIF":2.2,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147722137","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":"1-19"},"PeriodicalIF":2.2,"publicationDate":"2026-05-06","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":"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":"https://doi.org/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":"1-14"},"PeriodicalIF":2.2,"publicationDate":"2026-05-06","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":"Study of compression effect on testosterone tablets.","authors":"Loise Silveira da Silva, Izabelle de Mello Gindri, Maria Johann Fensterseifer, Gustavo Ferrari, Eduardo Alberto Fancello, Carlos Rodrigo de Mello Roesler, Gean Vitor Salmoria","doi":"10.1080/03639045.2026.2642910","DOIUrl":"10.1080/03639045.2026.2642910","url":null,"abstract":"<p><strong>Objective: </strong>To analyze drug's physicochemical properties and dissolution profiles of testosterone tablets compressed with two different load levels (2 and 15 tons) and to evaluate the influence of process additive on tablet properties.</p><p><strong>Significance: </strong>Testosterone implants are inserted in the subcutaneous tissue and follow a superficial erosion process that leads to drug absorption during 4 to 5 months. Testosterone is a cholesterol derivative with an anhydrous form as their most stable structure, although another two hydrated polymorphic forms were also identified. Due to the fact that compression processes may induce polymorphic changes in some API, which can lead to different dissolution behavior, a study of physicochemical properties and polymorphic changes are important to tablet manufacturing.</p><p><strong>Methods: </strong>Tablets were manufactured by compression molding with a hydraulic press and analyzed by DSC, XRD, SEM, FTIR and drug dissolution tests.</p><p><strong>Results: </strong>It was observed that 15 tons represented an excessive load, resulting in a fragile tablet with lamination and cracks. DSC analysis indicated the presence of structural water, although XRD patterns indicated that the drug was in its anhydrous form. FTIR also revealed water presence, but not an indicative of a monohydrate structure. Dissolution tests suggested the applied load and process additive may have some minor influence on dissolution profile, although they are not the main attributes influencing tablet dissolution.</p><p><strong>Conclusions: </strong>This study provides insight on how compression load and process additive influences API properties and tablet behavior, showing the importance of these factors while developing a tablet manufacturing process.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"906-917"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147369010","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":"An innovative RP-HPLC strategy for dual-drug analysis: simultaneous estimation of selegiline and biochanin A in bulk and SNEDDS.","authors":"Shivani Tyagi, Manisha Trivedi, Jayendra Kumar","doi":"10.1080/03639045.2026.2644461","DOIUrl":"10.1080/03639045.2026.2644461","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to develop and validate a rapid, accurate, and robust RP-HPLC method for the simultaneous quantification of Selegiline (SEL) and Biochanin A (BCA) in bulk and in self-nanoemulsifying drug delivery system (SNEDDS). Developing a validated analytical method for the novel SEL-BCA combination is important for ensuring precise quantification of the combination's potential applicability in Parkinson's disease (PD) management.</p><p><strong>Methods: </strong>Chromatographic separation was performed using an Agilent 1220 Infinity II HPLC system equipped with a 5TC-C18(2) column (250 × 4.6 mm, 5 µm) and a variable wavelength detector (VWD). An isocratic mode with mobile phase of acetonitrile (ACN) and water containing 0.1% o-phosphoric acid (50:50 v/v) was used at a flow rate of 1 mL min^-1, with detection at isosbestic wavelength of 208 nm. Validation followed ICH Q2(R1) guidelines. SEL-BCA SNEDDS was formulated and characterized for particle size and PDI, and the validated method was applied to quantify <i>in vitro</i> drug release and % drug assay.</p><p><strong>Results: </strong>The method displayed excellent linearity over the 0.4-50 µg mL^-1 concentration range, with correlation coefficients of 0.9997 for SEL and 0.9995 for BCA. System suitability parameters, including tailing factor < 1.5, resolution > 2, and theoretical plates > 2000, were satisfactory. The method remained robust despite small variations in flow rate, column temperature, injection volume, wavelength, and mobile phase composition. The developed SNEDDS presented a particle size of 120.3 nm and a PDI of 0.1925.</p><p><strong>Discussion: </strong>A simple, sensitive, and robust RP-HPLC method was successfully developed and validated for the concurrent estimation of SEL and BCA in bulk drug and SNEDDS.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"990-1010"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147456000","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":"Stability, <i>in vitro</i> release, and pharmacokinetic evaluation of standardized crude extracts, isolated compounds, and their nano-liposomes derived from <i>Syzygium campanulatum</i> Korth using Sprague-Dawley rats.","authors":"Abdul Hakeem Memon, Osama Memon, Asad Ur Rahman, Muhammad Khan, Hosh Muhammad Lashari, Imran Suheryani, Muhammad Esa, Atif Ali Khan Khalil, Saqib Jahan","doi":"10.1080/03639045.2026.2631666","DOIUrl":"10.1080/03639045.2026.2631666","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to leverage nano-liposomes (NLs) for optimizing the solubility, bioavailability, and pharmacokinetic profiles of 7-hydroxy-5-methoxy-6,8-dimethyl flavanone (7-HMDF), 5,7-dihydroxy-6,8-dimethyl-flavanone (HMF), 2,4-dihydroxy-6-methoxy- 3,5-dimethylchalcone (DMC), betulinic acid (BA), and ursolic acid (UA) derived from the standardized ethanol extract (EE) and supercritical fluid extract (SFE) of Syzygium campanulatum Korth leaves.</p><p><strong>Significance: </strong>This study provides a comprehensive/validated approach for the nano-pharmaceutical development of poorly bioavailable phytomedicines.</p><p><strong>Methods: </strong>NLs encapsulating BA, DMC, EE, and SFE were prepared (thin-film hydration method), optimized, and subsequently characterized. Besides, 6-months stability test, NL-EE and NL-SFE also underwent oral pharmacokinetic evaluation using Sprague-Dawley (SD) rats.</p><p><strong>Results: </strong>HPLC analysis revealed higher concentration of marker compounds within SFE as compared to EE and in silico ADME-Tox profiling predicted safe and favourable pharmacokinetics of those marker compounds. Additionally, NLs demonstrated optimum size (70 238nm), polydispersity index (0.250.43), zeta potential (-28 to -49 mV), encapsulation efficiency (4065%), in vitro drug release, and six months stability. Shelf-life was temperature-dependent, with BA stable at 25°C and DMC moderately stable, but both declined sharply at 60 °C. NLs encapsulation noticeably increased the aqueous solubility of the marker compounds by 50%. Finally, in vivo pharmacokinetic evaluation confirmed the presence of 7-HMDF, HMF, and DMC in rats' plasma, indicating improved absorption, prolonged circulation, enhanced bioavailability, and sustained release of NLs as compared to their non-liposomal counterparts (EE/SFE).</p><p><strong>Conclusions: </strong>NL encapsulation significantly enhanced the solubility, entrapment efficiency, oral bioavailability, and pharmacokinetic profiles of 7-HMDF, HMF, and DMC from S. campanulatum extracts, demonstrating NLs as promising drug delivery systems.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"808-824"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147270061","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 nimesulide-loaded pH-triggered ocular <i>in situ</i> gels: <i>in vitro</i> characterization, MTT assay, and Drazie test.","authors":"Nasif Fatih Karakuyu, Heybet Kerem Polat, Sedat Unal, Muhammet Kerim Haydar, Behzad Mokhtare, Furkan Aykurt, Aleyna Aksit","doi":"10.1080/03639045.2026.2642082","DOIUrl":"10.1080/03639045.2026.2642082","url":null,"abstract":"<p><strong>Objective: </strong>The present study created nimesulide-loaded <i>in situ</i> gels and assessed their potential application in ocular inflammation.</p><p><strong>Methods: </strong>Because <i>in situ</i> gels have a low viscosity, sodium alginate, and hydroxypropyl methylcellulose combined to create a nimesulide CD complex that is easy to apply. However, due to the gelation creation with pH, washing and removing it from the ocular surface becomes challenging. Production was carried out using different ratios of sodium alginate, hydroxypropyl methylcellulose, and hyaluronic acid.</p><p><strong>Results: </strong>Characterization studies led to the determination of the optimized formulation. The optimized formulation viscosity <i>pH 5.5</i> = 547.3 ± 76cP, viscosity <i>pH 7.4</i> = 8798.3 ± 254 cP, and pH = 5.4 ± 0.01 were obtained. In <i>in vitro</i> release experiments, approximately 53% of nimesulide was released by burst action within 2 h, followed by a controlled release over 12 h. Mathematical modeling of the formulations' release kinetics revealed that they were consistent with the Korsemeyer-Peppas and Weibull models. It was determined that nimesulide-loaded <i>in situ</i> gels showed over 80% viability in the L929 cell line. Rats underwent no adverse conditions in Draize's <i>in vivo</i> experiment.</p><p><strong>Conclusion: </strong>For this reason, the TB5 formulation may be a good choice when treating ocular inflammation. These findings may be supported by future efficacy studies using this formulation.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"866-875"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147364419","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 <i>Clausena anisata</i> leaf extract lozenges as smoking cessation aid: Quality by Design approach, trial-scale production at manufacturing site, and stability evaluation.","authors":"Natawat Chankana, Poj Kulvanich, Jirapornchai Suksaeree, Laksana Charoenchai, Chaowalit Monton","doi":"10.1080/03639045.2026.2643480","DOIUrl":"10.1080/03639045.2026.2643480","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to develop and optimize <i>Clausena anisata</i> leaf extract (CLE) lozenges, a smoking cessation aid, using a Quality by Design (QbD) approach.</p><p><strong>Significance: </strong>Optimized CLE lozenges offer a scalable, stable herbal smoking-cessation formulation.</p><p><strong>Methods: </strong>The quality target product profile (QTPP) was defined, critical quality attributes (CQAs) were identified, and an initial risk assessment was performed. The formulation development of CLE lozenges was designed using a Box-Behnken design, incorporating three factors: compression force, microcrystalline cellulose content, and sodium starch glycolate content.</p><p><strong>Results: </strong>The results indicated that the optimal formulation contained 10% microcrystalline cellulose and 2% sodium starch glycolate, with a compression force of 2000 psi, yielding desirable physical properties, including hardness of 4-6 kgf, friability ≤1%, and disintegration time ≤30 min. This formulation was subsequently scaled up for trial production at a manufacturing site. The trial batch exhibited slight variations in some physical properties but remained within the defined design space. Moreover, the nitrate content and assay results between the laboratory-scale and trial-scale batches were comparable. The trial-scale batch completely dissolved within 1 h. Stability studies demonstrated that the lozenges were more stable when stored in aluminum foil bags with a heat seal than in polyethylene terephthalate (PET) bottles under both 30 °C/75% RH and 40 °C/75% RH conditions for six months.</p><p><strong>Conclusions: </strong>This study successfully developed and optimized CLE lozenges using the QbD approach. The results suggest that this herbal product can be further scaled up to pilot and production levels for potential use as a smoking cessation aid.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"918-933"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147431440","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":"Prediction of penicillin concentration using time series forecasting and machine learning techniques.","authors":"Michail Rekkas-Ventiris, Panorios Benardos","doi":"10.1080/03639045.2026.2642084","DOIUrl":"10.1080/03639045.2026.2642084","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Time-series forecasting is crucial in pharmaceutical fermentation, where early detection of deviations safeguards product quality. As the industry evolves toward Pharma 4.0, integrating machine learning into process monitoring and control presents an opportunity to enhance efficiency, consistency, and regulatory compliance. However, currently there is a notable lack of reliable machine learning based predictive tools for complex pharmaceutical fermentations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To develop a machine learning model based on Gated Recurrent Units (GRUs) for predicting penicillin concentration within a fermentation process, supporting process optimization and control in pharmaceutical manufacturing.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Significance: &lt;/strong&gt;Effective time-series forecasting of penicillin production is crucial for proactive control of critical quality attributes (CQAs). Integrating artificial intelligence techniques aligns with the goals of Pharma 4.0, enabling data-driven decision-making. This study demonstrates how a GRU-based soft sensor can support Pharma 4.0 by enabling accurate short-term forecasts of penicillin concentration under realistic industrial conditions. Using the IndPenSim dataset, which includes batch-to-batch variability and process disturbances, the model provides transparent, regulator-friendly predictions through integrated feature importance analysis. In practice, the GRU can act as an early-warning tool, alerting operators to deviations and allowing proactive adjustment of input variables.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A GRU-based neural network was trained on a simulated dataset of 100 penicillin fermentation batches from the IndPenSim platform. The model development procedure included input parameter selection using Random Forest and Extreme Gradient Boosting (XGBoost), followed by hyperparameter tuning across various activation functions, optimizers, and dropout rates.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The GRU model trained with the Adamax optimizer and tanh activation achieved a Mean Squared Error (MSE) of 7.20 × 10&lt;sup&gt;-4&lt;/sup&gt;. The data-driven feature selection approach improved predictive accuracy over manual selection. Graphical comparisons between the predicted and actual concentrations supported the model's reliability.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study shows the feasibility of GRU-based neural networks in forecasting penicillin concentration during fermentation. Beyond theoretical evaluation, the GRU framework provides a practical industrial use case: real-time forecasting of penicillin concentration to support proactive process control and deviation management. Such applications directly contribute to Pharma 4.0 initiatives by enabling digital twins, enhancing process transparency, and lowering barriers for deployment in regulated environments. Compared to recent approaches, our method emphasizes systematic hyperparameter tuning and input feature interpretability","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"890-905"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147364402","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":"Cabotegravir-loaded polymeric micelles: a promising strategy for improved solubility and therapeutic outcomes.","authors":"Siddharth Vernekar, Archana S Patil, Yadishma A Gaude, Rajashree S Masareddy","doi":"10.1080/03639045.2026.2648059","DOIUrl":"10.1080/03639045.2026.2648059","url":null,"abstract":"<p><strong>Objective: </strong>To design and optimize a d-α-tocopheryl polyethylene glycol 1000 succinate (TPGS)-stabilized polymeric micellar system for cabotegravir (CAB), strategically addressing its dissolution-rate and permeability constraints to potentiate oral bioavailability and maximize antiretroviral therapeutic outcomes.</p><p><strong>Significance: </strong>CAB, a potent HIV-1 integrase strand transfer inhibitor, suffers from dissolution-rate limitations and P-glycoprotein efflux, restricting oral utility. Incorporation of TPGS enables superior solubilization, enhances intestinal translocation, and circumvents efflux transporters, offering a transformative, noninvasive alternative to parenteral antiretroviral regimens while reinforcing patient adherence and therapeutic efficacy.</p><p><strong>Methods: </strong>CAB-loaded micelles were fabricated via the thin-film hydration technique and systematically optimized using a 3² full-factorial design by modulating TPGS concentration and rotary evaporation speed to minimize particle size (PS) and maximize drug encapsulation. The optimized formulation underwent physicochemical characterization, including PS, polydispersity index (PDI), zeta potential (ZP), and surface morphology. <i>In vitro</i> drug release was examined, followed by <i>in vivo</i> pharmacokinetic profiling in Wistar rats.</p><p><strong>Results: </strong>The optimized micellar system demonstrated a mean PS of 95.16 ± 0.12 nm, PDI of 0.411 ± 0.24, ZP of -4.72 ± 1.05 mV, and an exceptional encapsulation efficiency of 96.26 ± 1.21%. Compared to conventional CAB suspension, the TPGS-based micelles exhibited markedly enhanced dissolution kinetics and a 236.75 ± 0.74% increase in relative oral bioavailability, accompanied by prolonged systemic circulation.</p><p><strong>Conclusion: </strong>TPGS-enabled micellar encapsulation significantly enhances the oral delivery profile of CAB, offering a promising, noninvasive, and patient-compliant alternative to parenteral antiretroviral regimens, potentially improving therapeutic outcomes in HIV management.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"977-989"},"PeriodicalIF":2.2,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147503441","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}