Journal of Pharmaceutical Innovation最新文献

{"title":"Quercetin and Mirtazapine Co-Encapsulated Nanoparticles Fostered Protection Against CUMS-Induced Depression Associated Inflammation","authors":"Sailesh Gupta,&nbsp;Rajshekher Upadhyay,&nbsp;Kaisar Raza,&nbsp;Tanim Aijaz,&nbsp;Lokesh Kaushik,&nbsp;Madhuri Desavathu","doi":"10.1007/s12247-026-11097-6","DOIUrl":"10.1007/s12247-026-11097-6","url":null,"abstract":"<div><p>Major depressive disorder is the most common and prevalent depressive disorder, affecting about 300 million individuals globally. One of the contributing factors can be central inflammation associated with depression. While conventional treatment only targets monoamine imbalance, recent studies suggest that oxidative stress and neuroinflammation play a vital role in the pathophysiology of major depressive disorder. In this context, the current study aimed to target both monoamine disturbance and oxidative stress by intranasally delivering co-encapsulated mirtazapine and quercetin PEGylated solid lipid nanoparticle. The microemulsion technique was used to prepare nanoparticles, and was optimized based on entrapment efficiency. The optimized formulation after PEGylation demonstrated high entrapment efficiency (91.05 ± 0.089% for mirtazapine and 99.88 ± 0.01% for quercetin), nanoscale particle size (35.04 ± 1.0 nm), a polydispersity index (PDI) of 0.464, and a near-neutral zeta potential (− 9.14 ± 1.10 mV). In-vitro release study showed controlled and sustained drug release, whereas ex vivo permeation study showed improved nasal permeation of quercetin, while mirtazapine showed lower permeation from the PEGylated solid lipid nanoparticles compared to pure drugs. In a chronic unpredictable multiple stress-induced depression, intranasal treatment significantly decreases immobility time in the forced swim and tail suspension test, markedly increases sucrose preference, and further significantly decreases nitric oxide and malondialdehyde levels, indicating improvement in depressive-like behaviour. Furthermore, histological investigation of goat nasal tissue and mice’s vital organs provided preliminary evidence of tissue tolerability under the study conditions. Overall, administering Mirtazapine-Quercetin co-loaded PEGylated solid lipid nanoparticles via the intranasal route is a promising method of managing depression and associated inflammation.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132191","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 Risk-Based Digital Validation Workflow for Advanced Process Control in GMP-Regulated Manufacturing: A Model-Based Approach Demonstrated Through pH Control","authors":"Damian McCarthy,&nbsp;Dermot McMorrow,&nbsp;Amol Ganjare,&nbsp;Vivek Ranade,&nbsp;Conor T. McCarthy,&nbsp;Eoin P. Hinchy","doi":"10.1007/s12247-026-11080-1","DOIUrl":"10.1007/s12247-026-11080-1","url":null,"abstract":"<div><h3>Purpose</h3><p>This paper addresses the “digital validation chasm” in the life sciences sector, where stringent Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) 5 regulations often hinder the adoption of advanced control strategies. The research proposes a unified, risk-based digital validation workflow designed to integrate process understanding and model-based design with Quality Risk Management (QRM) and lifecycle-oriented validation principles, facilitating the transition toward Pharma 4.0.</p><h3>Methods</h3><p>The proposed workflow was demonstrated through the development of a Model Predictive Controller (MPC) for pH regulation. A data-driven Hammerstein–Wiener model was identified from experimental data to inform the MPC tuning within MATLAB/Simulink. A process- and control-focused Failure Mode and Effects Analysis (FMEA) was used to identify and prioritise relevant failure modes and to inform requirements and verification scope. Requirements-based verification was embedded directly into the engineering lifecycle using automated test harnesses to generate traceable evidence against defined requirements and acceptance criteria. Finally, the controller was deployed as IEC 61131-3 structured-text code on an industrial programmable logic controller (PLC).</p><h3>Results</h3><p>Experimental testing evaluated MPC performance across steady-state, disturbance rejection, and dynamic setpoint scenarios. The use of automated testing and simulation-based verification provided reproducible validation evidence linked to the identified risks and functional requirements. Experimental characterisation and system identification provided a data-driven representation of process behaviour that informed both controller development and risk-informed verification planning.</p><h3>Conclusion</h3><p>The study provides a practical proof-of-concept implementation of a workflow for bridging the gap between traditional validation practices and modern digital engineering. By integrating process understanding, QRM, model-based design, automated verification and deployment within a unified lifecycle, the approach demonstrates how advanced process-control development can be structured in alignment with risk-based and lifecycle-oriented validation principles relevant to regulated manufacturing.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132193","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 Brain Biodistribution of Quercetin and Rutin Co-Loaded Pegylated PLGA Nanoparticles Via Intranasal Delivery for Neuroblastoma Therapy","authors":"Nidhi Chaturvedi,&nbsp;Rupa Mazumder,&nbsp;Anmol Dogra,&nbsp;Anjna Rani,&nbsp;Ashish Joshi","doi":"10.1007/s12247-026-11088-7","DOIUrl":"10.1007/s12247-026-11088-7","url":null,"abstract":"<div><h3>Purpose</h3><p>Neuroblastoma (NB) is a frequent malignancy in children detected outside the brain with its feature of frequent relapses, poor outcome, and very high toxicity of standard chemotherapy. In order to treat NB, this effort aimed to develop and optimize PLGA-PEG-PLGA nanoparticles loaded with rutin and quercetin for nasal delivery to the brain.</p><h3>Methods</h3><p>The nanoparticle formulation was prepared by the method of nanoprecipitation and optimized by Central Composite Design (CCD) with PLGA and stabilizer (Poloxamer 188) concentrations as independent variables. After optimization, the polymeric formulation was assessed using particle dimensions, polydispersity index, zeta kinetic potential, entrapment efficiency (EE), SEM, FTIR, and in vitro drug release studies. The produced formulation’s anticancer efficacy was investigated using the MTT test on neuroblastoma cells, and biodistribution studies in Wistar rats after nasal administration were carried out.</p><h3>Results</h3><p>The nanoparticles had a zeta potential of -14.34 mV, with particle sizes varying between 213.7 and 245.8 nm, and an acceptable particle size distribution (0.218–0.258). For quercetin and rutin, the drug loading efficiency was determined to be 80% and 82%, respectively. FTIR analysis also showed that there was no drug-excipient interaction. With a cumulative percentage release of 82.3% from nanoparticles and 68.9% from the plain solution in a 24-hour period, the in vitro drug release research was shown to fit the Hixson-Crowell model. When compared to free drug, nanoparticles had a considerable cytotoxic impact on SH-SY5Y cells, with an IC₅₀ value of 568.1 ± 0.12 µg/ml. When compared to mucoadhesive suspension, the concentration of quercetin and rutin in brain tissue increased by 2.35 and 2.40 times, respectively, in an in vivo investigation of mucoadhesive nanoparticles through intranasal delivery.</p><h3>Conclusion</h3><p>The optimized PLGA-PEG-PLGA nanoparticle formulation offers a stable, sustained-release intranasal delivery system for co-administration of quercetin and rutin, with enhanced anticancer cell line efficacy relative to the free drugs, supporting further preclinical evaluation for NB treatment.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132277","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":"Machine Learning-Assisted Predictive Formulation Modeling for Segmented Combination Vaginal Rings: Construction and Validation","authors":"Zhihao Shu,&nbsp;Yang Huang,&nbsp;Jing Liu,&nbsp;Jintao Guo,&nbsp;Siyi Wu,&nbsp;Meiying Ning","doi":"10.1007/s12247-026-11027-6","DOIUrl":"10.1007/s12247-026-11027-6","url":null,"abstract":"<div><p>The vaginal ring represents an innovative sustained-release drug delivery system in the field of women’s reproductive health, demonstrating significant clinical value. However, its formulation development remains constrained by a traditional “trial-and-error” empirical approach, which often requires substantial cost investment for studies involving multiple factors and levels. To address evolving patient needs and diverse drug properties, this research investigates the application of machine learning algorithms in pharmaceutical development, with a specific focus on the development and optimization of vaginal ring formulations. A segmented combination(ATZ/LNG) IVR for the treatment of endometriosis is successfully fabricated and subjected to pre-formulation studies. Furthermore, the XGBoost machine learning model is selected and trained for the vaginal ring formulation. The feasibility of the developed machine learning-assisted predictive formulation framework was experimentally validated. In response to the high costs associated with the conventional trial-and-error method in formulation development, this study leveraged research on the complex formulation of the intravaginal ring (IVR) dosage form to develop an AI-based predictive model. It suggests the feasibility of AI-assisted pharmaceutical development and proposes a novel methodology for formulation research.</p><h3>Graphical abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-026-11027-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132398","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}

{"title":"Pharmaceutical Development of Apigenin–Berberine-Loaded PLGA Hydrogel Nanocomposite for Antioxidant and Anti-Inflammatory Osteoarthritis Therapy","authors":"Dhivya Viswanathan,&nbsp;Fahad M Alshabrmi,&nbsp;Mahdi H. Alsugoor,&nbsp;Naif ALSuhaymi,&nbsp;Muthu Thiruvengadam,&nbsp;Rajakumar Govindasamy","doi":"10.1007/s12247-026-11094-9","DOIUrl":"10.1007/s12247-026-11094-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Osteoarthritis (OA) is driven by interlinked oxidative stress, ferroptosis and inflammatory cartilage catabolism, yet no disease-modifying pharmacotherapy has been approved. Apigenin (AP) and berberine (BB) are chondroprotective phytochemicals whose therapeutic use is constrained by poor aqueous solubility, low bioavailability and rapid clearance from the joint cavity. This study aimed to develop and characterise an AP/BB-loaded PLGA hydrogel nanocomposite (AP/BB@PLGA) for sustained local antioxidant and anti-inflammatory therapy.</p><h3>Methods</h3><p>AP/BB-PLGA nanoparticles were prepared by a modified W1/O/W2 double-emulsion solvent-evaporation method at three AP: BB molar ratios (1:1, 2:1 and 1:2) and dispersed in a PLAG hydrogel. The nanocomposite was characterised by dynamic light scattering, zeta potential, scanning electron microscopy, FTIR spectroscopy, drug release, swelling and degradation studies, and evaluated in erastin-challenged chondrocytes and MC3T3-E1 pre-osteoblasts. </p><h3>Results</h3><p>The AP: BB 2:1 formulation was optimal (175 nm; PDI 0.21; −28 mV; encapsulation efficiency 85% for AP and 80% for BB). Release was burst-free, reaching 90% for AP and 80% for BB at 96 h, with 1,150–1,200% swelling and 47% mass loss at 28 days. AP/BB@PLGA was cytocompatible, restored chondrocyte viability and migration, normalised reactive oxygen species and malondialdehyde, restored GSH, CAT and SOD, suppressed MMP3, MMP9, MMP13, iNOS, ADAMTS5, IL-1β, IL-6 and TNF-α, and increased COL2A1, IL-10, IL-4, GPX4 and SLC7A11 while lowering ACSL4. </p><h3>Conclusion</h3><p>AP/BB@PLGA delivers sustained dual-drug release together with coordinated antioxidant, anti-ferroptotic and anti-inflammatory activity across the bone–cartilage unit, supporting its development as a biomaterial disease-modifying platform for osteoarthritis.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132278","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 Development of Advanced Biocompatible Hydrogels Loaded with Curcumin-propolis-rGO for Burn Wound Healing Applications","authors":"Amir Nezami Asl,&nbsp;Abolfazl Akbarzadeh,&nbsp;Amirreza Hajati Ziabari,&nbsp;Fatemeh Yarmohammadi,&nbsp;Negar Karimi Hajishoreh","doi":"10.1007/s12247-026-11087-8","DOIUrl":"10.1007/s12247-026-11087-8","url":null,"abstract":"<div><p>Burn injuries compromise skin function leading to delayed healing and infection risk. This study developed an alginate (ALG) hydrogel incorporating curcumin (Cur), propolis(Pro), and reduced graphene oxide (rGO) to enhance burn wound repair. Structural analyses (FTIR, SEM) confirmed successful integration within a porous 3D scaffold. In vitro, the hydrogel showed low cytotoxicity and potent antibacterial action against <i>Staphylococcus</i> aureus and <i>Pseudomonas aeruginosa</i>. In vivo, in a Wistar rat full-thickness burn model, the combined hydrogel significantly accelerated epithelialization, improved collagen deposition and alignment, reduced edema, and enhanced angiogenesis compared to controls. The synergistic effects of natural compounds Pro and rGO improved rapid, balanced tissue regeneration. This bioactive hydrogel holds strong potential as a natural, effective wound dressing for burn therapy.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132399","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":"Raman Spectroscopic Evaluation of Packaging-Associated Differences in Blow–Fill–Seal and Cold-Fill Ophthalmic Drug Products","authors":"Setayesh Yarahmadi,&nbsp;Sara Nemati,&nbsp;Akram Yarmohamadi","doi":"10.1007/s12247-026-11096-7","DOIUrl":"10.1007/s12247-026-11096-7","url":null,"abstract":"<div><p>This study investigated whether Raman spectroscopy could detect packaging-associated differences in ophthalmic drug formulations packaged using Blow–Fill–Seal (BFS) and conventional Cold-Fill systems and explored their relationship with pharmaceutical stability. Two liquid ophthalmic formulations, dorzolamide hydrochloride/timolol maleate and chloramphenicol, were evaluated in BFS and Cold-Fill packaging systems. Raman spectra were acquired using a 532 nm excitation laser at integration times of 300 and 600 ms, with four replicate measurements for each condition. Raman measurements were performed on aliquots of the ophthalmic formulations transferred from their original BFS and Cold-Fill primary containers into sterile glass vessels. Spectra were processed using asymmetric least-squares baseline correction and vector normalization. Stability was evaluated at 40 ± 2 °C and 75 ± 5% relative humidity at baseline and after 1, 3, and 6 months. Both formulations exhibited comparable principal Raman fingerprints, but reproducible differences in the relative normalized intensities of several Raman bands were observed between BFS- and Cold-Fill-packaged samples. These differences were maintained at both acquisition times. During accelerated storage, Dorzolamide-related impurity B increased to 4.6% at six months in the BFS-packaged formulation, exceeding the specified limit of 2.0%. Chloramphenicol assay decreased from 514 to 445 mg/100 mL and fell slightly below its lower specification limit at six months, whereas the corresponding Cold-Fill samples remained within applicable specifications. Overall, Raman spectroscopy demonstrated potential as a rapid, non-destructive complementary tool for detecting packaging-associated differences in ophthalmic drug products, although a direct causal relationship between Raman spectral changes and pharmaceutical degradation was not established.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132397","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 pH-responsive Mucoadhesive Nanohybrids of Eudragit-Ziziphus for Colonic Delivery of Quercetin-Lactobacillus plantarum in Inflammatory Bowel Disease","authors":"Priyanka Ray,&nbsp;Subhrajyoti Dhara,&nbsp;Subhojit Panja","doi":"10.1007/s12247-026-11076-x","DOIUrl":"10.1007/s12247-026-11076-x","url":null,"abstract":"<div><h3>Background</h3><p>Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract associated with oxidative stress and gut microbiota imbalance. This study aimed to develop a pH-responsive, mucoadhesive nanohybrid system incorporating quercetin and <i>Lactobacillus plantarum</i> for targeted colonic delivery.</p><h3>Methods</h3><p>Quercetin-loaded solid lipid nanoparticles were formulated using glyceryl monostearate and a lecithin–cholesterol combination. The formulations were coated with Ziziphus gum and Eudragit S100 to confer mucoadhesive and colon-targeting properties. The system was characterized using FTIR, DLS, zeta potential analysis, SEM, and XRD, and evaluated for encapsulation efficiency, probiotic viability, antioxidant activity, drug release, and mucoadhesion.</p><h3>Results</h3><p>The optimized formulation exhibited a particle size of 330.90 ± 1.21 nm, a polydispersity index (PDI) of 0.402, a zeta potential of −13 mV, and an encapsulation efficiency of 75.56%. Probiotic viability was maintained at 1.1 × 10⁸ CFU/mL. FTIR and XRD confirmed successful quercetin incorporation, while SEM revealed nanosized particles distributed within a polymeric matrix. The formulation demonstrated antioxidant activity (IC50 = 142.6 µg/mL) and pH-responsive drug release, with 10.94%, 51.56%, and 87.48% release at pH 1.2, 6.8, and 7.4, respectively. A bioadhesive force of 0.556 N indicated good mucoadhesive strength.</p><h3>Conclusion</h3><p>The Eudragit–Ziziphus-coated quercetin–probiotic nanohybrid system demonstrated controlled, pH-responsive drug release, sustained antioxidant activity, and effective probiotic protection, supporting its potential as a colon-targeted delivery strategy for the localized treatment of IBD.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132212","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 and Evaluation of Palbociclib Nanocrystals Using a Quality by Design Approach: In Silico, In Vitro, and In Vivo Pharmacokinetic Studies","authors":"Trupti Powar,&nbsp;Ashok Hajare,&nbsp;Sopan Nangare","doi":"10.1007/s12247-026-11092-x","DOIUrl":"10.1007/s12247-026-11092-x","url":null,"abstract":"<div><p>This study aimed to develop lyophilized palbociclib nanocrystals (PALB-NPs) with enhanced oral bioavailability using a Quality by Design (QbD)-based approach. A Plackett-Burman (PB) design was employed to investigate the influence of various process and formulation variables on the development of PALB-NPs. Among the investigated variables, high-pressure homogenization (HPH) cycles, concentration of soya lecithin, and concentration of poloxamer 407 were identified as critical factors and subsequently optimized using a Central Composite Design (CCD). The optimized lyophilized PALB-NPs exhibited a particle size of 269 ± 0.19 nm, drug content (DC) of 88.45 ± 0.48%, and entrapment efficiency (EE) of 98.98 ± 0.45%. SEM analysis revealed a uniform rod-shaped morphology of PALB-NPs. In vitro cytotoxicity studies demonstrated significantly enhanced anticancer activity, with IC50 values of 26.45 µg/mL for PALB-NPs and 65.4 µg/mL for PALB-aqueous dispersion (AQD). The dissolution study showed improvement in drug release, with dissolution rates of 96.366 ± 0.015% for PALB-NPs compared to 43.201 ± 0.025% for pure PALB within 60 min. Furthermore, pharmacokinetic studies revealed 1.77-fold and 2.38-fold increases in C_max and AUC₀₋t, respectively, for PALB-NPs compared with PALB-AQD. The relative bioavailability of PALB-NPs was found to be 2.24 ± 1.32, with higher drug accumulation observed in the liver during biodistribution studies. Overall, QbD-optimized lyophilized PALB-NPs demonstrated improved dissolution, enhanced oral bioavailability, favorable stability, and enhanced cytotoxic activity against MCF-7 cells. Keywords: Breast cancer, Palbociclib, Nanocrystal, Quality-by-Design approach, Lyophilisates, Bioavailability, In vitro cytotoxicity.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132207","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":"Global Regulatory Pathways for 3D-Printed Medical Devices: Comparative Analysis of US, EU, India, Japan, and Australia with Market Insights","authors":"Priyal Desai,&nbsp;Charmy S. Kothari","doi":"10.1007/s12247-026-11090-z","DOIUrl":"10.1007/s12247-026-11090-z","url":null,"abstract":"<div><h3>Purpose</h3><p>3D printing technology is being used extensively for medical devices including orthopaedic implants, cranial implants, dental restorations, and surgical instruments. Also, the development of global regulatory pathways governing these 3D printed medical devices have been evolving to meet the global regulations. Further, market analysis scrutinizes the growing need of 3D printed medical devices. This article aims to help define the regulatory pathways and commercial aspects of 3D printed medical devices in the current healthcare delivery system.</p><h3>Methods</h3><p>This review covers primarily the regulatory pathways available for 3D printed medical devices across United States, European Union, India, Japan and Australia, an analysis of the current and projected 3D printing market size and trends (2022–2035), and representative examples of case studies that demonstrate these elements.</p><h3>Results</h3><p>The 3D printing technology regulations vary significantly across United States, European Union, India, Japan and Australia. The regulatory bodies of United States and Australia have shown considerable advancement in regulations, while others are still emerging. Published market estimates coverage on a compound annual growth rate (CAGR) of approximately 17%.</p><h3>Conclusion</h3><p>Regulatory compliance requires manufacturers to follow strict, region-specific standards set forth by relevant agencies and to meet these, manufacturers must established robust quality management system and validate regulatory pathways.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132213","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}