Journal of Pharmaceutical Innovation最新文献

{"title":"Design and Evaluation of Netarsudil-Loaded Micelles Integrated within a Thermosensitive in situ Gel for the Treatment of Glaucoma","authors":"Shrestha Dubey,&nbsp;Vamika Khanna,&nbsp;Kalyani Barve,&nbsp;Kavita Singh","doi":"10.1007/s12247-026-11101-z","DOIUrl":"10.1007/s12247-026-11101-z","url":null,"abstract":"<div><h3>Background</h3><p>Glaucoma is recognized as the leading cause of irreversible blindness worldwide, primarily due to the excessive rise of intraocular pressure (IOP). Increased IOP can harm optic nerve function through mechanical impacts and reduced blood flow. Conventional antiglaucoma drugs such as beta-blockers, carbonic anhydrase inhibitors and miotics have reduced preference due to local adverse effects and suboptimal IOP reduction. Traditional formulations have the drawback of poor bioavailability due to ocular barriers, accompanied by poor adherence.</p><h3>Methods</h3><p>This study focuses on the development of micellar systems by the thin film hydration method as drug vehicles to enhance ocular bioavailability for the management of glaucoma. Netarsudil-loaded micelles were loaded into temperature-sensitive in situ gels to further extend precorneal retention of the drug. The micelles were evaluated in terms of vesicle size, morphology, surface charge, pH and encapsulation efficiency.</p><h3>Results</h3><p>The optimized micelles, comprising poloxamer 407 (P407), displayed a particle size of 95.9 ± 4.826 nm, a zeta potential of -20.5 mV ± 2.506, PDI of 2.691 ± 0.0362 and an encapsulation efficiency of 66.4 ± 9.526%. Gelation studies indicated gelation at 37 °C for the developed formulation consisting of gellan gum and P407 in the ratio 1:3. The formed gels displayed a sustained in vitro release pattern. In vivo animal studies, notably on rabbit models, showcased sustained reduction in IOP compared to conventional formulations, extending therapeutic efficacy and duration of action.</p><h3>Conclusion</h3><p>Hence, the developed temperature-stimulated micellar gelling system showed potential as a promising carrier for ophthalmic drug delivery and for improved management of glaucoma.</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":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132948","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 Comparative Evaluation of Benzoyl Peroxide-Loaded Polymeric Micelles Prepared by Thin-Film Hydration and Nanoprecipitation Methods for Acne Treatment","authors":"Sena Erbaş Somuncu,&nbsp;Emre Şefik Çağlar,&nbsp;Ayşegül Yoltaş,&nbsp;Ayşenur Bilgehan,&nbsp;Hande Sipahi,&nbsp;Neslihan Üstündağ Okur","doi":"10.1007/s12247-026-11069-w","DOIUrl":"10.1007/s12247-026-11069-w","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aimed to develop and compare benzoyl peroxide (BPO)-loaded polymeric micelle formulations prepared via thin-film hydration (FT-BPO) and nanoprecipitation (FN-BPO) methods as potential topical carriers for acne vulgaris treatment.</p><h3>Methods</h3><p>Pluronic F127 and F68 were utilized as amphiphilic polymers, with the addition of sodium alginate and chitosan oligosaccharide lactate to enhance stability and antimicrobial efficacy. The formulations were characterized in terms of particle size, polydispersity index (PDI), zeta potential, encapsulation efficiency, physicochemical properties, stability, in vitro release, ex vivo permeation and skin retention, sprayability, and antimicrobial activity.</p><h3>Results</h3><p>The optimized FT and FN formulations exhibited particle sizes of 262.4 ± 15.5 nm and 355.2 ± 11.4 nm, respectively, with PDI values below 0.5 indicating homogeneous dispersions. The zeta potential shifted positively upon chitosan addition, supporting colloidal stability. The encapsulation efficiencies were above 89% for both formulations. In vitro release studies demonstrated higher cumulative release from FT-BPO compared to FN-BPO, whereas ex vivo studies revealed greater skin retention for FT-BPO and a slightly higher 24-h cumulative permeated amount (Qn) for FN-BPO, although both micellar formulations showed lower steady-state flux than free BPO. Sprayability assessments indicated wider spray distribution for FN formulations. Antimicrobial testing against <i>Staphylococcus aureus</i> showed larger inhibition zones with the FN formulation compared to commercial products. Stability studies highlighted better physicochemical stability of FT formulation under various storage conditions.</p><h3>Conclusion</h3><p>These findings suggest that both preparation methods yield effective BPO-loaded micellar systems with distinct release and permeation profiles, offering promising platforms for improved topical acne therapy.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132947","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":"Translating Formulation and Process Robustness into Lifecycle Manufacturing Evidence: A Structured Framework for Evidence Qualification and Decision Routing","authors":"Yoseok Park","doi":"10.1007/s12247-026-11093-w","DOIUrl":"10.1007/s12247-026-11093-w","url":null,"abstract":"<div><h3>Purpose</h3><p>Formulation and process robustness are central to pharmaceutical development and commercial manufacturing, but development knowledge, monitoring signals, and routine records do not automatically become lifecycle manufacturing evidence. This study developed a structured framework for evidence qualification and decision routing across manufacturability, technology transfer, finished manufacturing, digital records, and continued verification.</p><h3>Methods</h3><p>A practice-oriented framework-development study used targeted source-domain mapping, concept extraction, explicit source-to-criterion derivation, generalized scenario application, and retrospective illustrative application to two publicly documented U.S. Food and Drug Administration (FDA) manufacturing cases. Each proposed criterion was traced to established pharmaceutical-development, manufacturing, validation, data-governance, or lifecycle-management concepts.</p><h3>Results</h3><p>The revised framework comprises four connected outputs plus seven structured qualification criteria addressing provenance/traceability, completeness/review, context, scientific or operational relevance, context-dependent corroboration, decision linkage, and residual uncertainty. Retrospective application to two public manufacturing cases illustrated different ways in which available information can remain insufficient for a defensible lifecycle decision when required review/routing is not operationalized or when risk relevance and residual uncertainty are handled inadequately. Generalized non-proprietary scenarios were retained as formative applications rather than empirical validation.</p><h3>Conclusion</h3><p>The framework provides structured criteria for organizing heterogeneous development and manufacturing information for lifecycle decisions while preserving clear limits on validation. Its contribution is an integrative evidence-qualification and decision-routing layer, not a replacement for product-specific validation, investigation, or regulatory assessment. Prospective product-specific evaluation remains necessary before implementation-effectiveness or predictive-validation claims can be made.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132657","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":"Zein–Pectin Nanoparticles for Encapsulation and Controlled Release of Polyphenols from Anacardium Occidentale: Preparation, Characterization and In Vitro Evaluation","authors":"T. M. Archana,&nbsp;Keerthi Mohan,&nbsp;M. V. Vinayak,&nbsp;C. Sarath chandran,&nbsp;S. Sudheesh","doi":"10.1007/s12247-026-11095-8","DOIUrl":"10.1007/s12247-026-11095-8","url":null,"abstract":"<div><h3>Purpose</h3><p><i>Anacardium occidentale</i> roots have traditional antidiabetic use, yet challenges such as poor solubility and limited bioavailability restrict their clinical applications. Nanoparticle-based delivery systems offer potential to overcome these limitations. This study aimed to develop and characterize zein–pectin nanoparticles encapsulating the polyphenol-rich column-purified 80% methanolic fraction of <i>A. occidentale</i> roots (FZPNP) and to evaluate their antioxidant and antidiabetic activities <i>in vitro.</i></p><h3>Methods</h3><p>Zein–pectin nanoparticles (FZPNP) were prepared using antisolvent precipitation. Physicochemical properties were characterized by SEM, TEM, DLS, zeta potential, TGA, DSC, and FTIR. Encapsulation efficiency and in vitro drug release (24 h, pH 1.2, 6.8 and 7.4, 37 ± 0.5 °C) were assessed. Antioxidant capacity was determined by DPPH and ABTS radical scavenging assays, while antidiabetic potential was assessed using α-glucosidase inhibition.</p><h3>Results</h3><p>FZPNP demonstrated spherical morphology with a hydrodynamic diameter of 394.9 nm and a non-monodisperse size distribution. FZPNPs exhibited a negative zeta potential (-28.9 ± 1.4 mV) and a good encapsulation efficiency. Thermal stability was confirmed by TGA and DSC. The nanoparticles exhibited a pH-dependent, sustained, diffusion-controlled drug release profile. The FZPNPs retained significant antioxidant and α-glucosidase inhibitory activities.</p><h3>Conclusion</h3><p>Zein–pectin nanoparticles encapsulating polyphenol-rich <i>A. occidentale</i> root fraction exhibited favorable physicochemical characteristics and pH-dependent, sustained drug release while retaining significant antioxidant and α-glucosidase inhibitory activities. These findings suggest that the FZPNP formulation provides a promising nanocarrier system for enhancing the therapeutic efficacy of <i>A. occidentale</i> roots in managing diabetes and associated oxidative stress.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132862","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":"Beyond Technology Readiness Levels: Developing and Evaluating an Industry 5.0 Innovation Readiness Framework for Regulated Life Sciences Manufacturing","authors":"Dermot McMorrow,&nbsp;Seamus Gordon,&nbsp;Shane Loughlin,&nbsp;Eoin P. Hinchy","doi":"10.1007/s12247-026-11116-6","DOIUrl":"10.1007/s12247-026-11116-6","url":null,"abstract":"<div><h3>Purpose</h3><p>Regulated life sciences manufacturing organisations face increasing pressure to adopt Industry 5.0 (I5.0) innovations while maintaining patient safety, product quality, data integrity, and regulatory compliance. Existing assessment models provide useful perspectives on technical maturity, expectation dynamics, and organisational innovation capability, but do not fully assess whether an innovation is ready to progress responsibly in a regulated, multi-stakeholder environment. This paper develops an I5.0 Innovation Readiness Framework and presents a preliminary practitioner-informed evaluation of its use in regulated life sciences manufacturing.</p><h3>Methods</h3><p>This paper uses design science research structured through the Double Diamond process. The framework was developed through literature review, advisory feedback, subject matter expert input, practitioner workshops, case-based application, surveys, and thematic analysis. Evaluation was conducted with a small, purposively selected cohort of 16 practitioners from a single educational-industry programme.</p><h3>Results</h3><p>The framework comprises three linked tools: the Innovation Maturity Assessment, Innovation Maturity Rubric, and Innovation Readiness Levels. Across two exploratory workshops involving 16 experienced practitioners, participants reported that the framework supported clearer discussion of readiness and improved visibility of adoption risks. In Workshop 2, descriptive feedback indicated that 91% of respondents viewed Innovation Readiness Levels as clearer than Technology Readiness Levels, 82% found the framework useful for comparing innovation timelines, and 75% would recommend it. These findings should be interpreted as preliminary practitioner feedback rather than sector-wide validation.</p><h3>Conclusion</h3><p>The findings support the conceptual distinction between innovation readiness and technology readiness and indicate the need to assess technical, regulatory, organisational, stakeholder, and societal dimensions together when evaluating I5.0 innovation in regulated manufacturing. Further evaluation with broader industry cohorts, quality and regulatory professionals, and regulatory stakeholders is required.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132854","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":"QbD-Guided Development of Isoconazole Nitrate Nanostructured Lipid Carrier Gel for Enhanced Topical Antifungal Therapy","authors":"Prajakta Patil,&nbsp;Indrayani Bandgar,&nbsp;Sandip Bandgar,&nbsp;Sachin Mali","doi":"10.1007/s12247-026-11099-4","DOIUrl":"10.1007/s12247-026-11099-4","url":null,"abstract":"<div><p>Cutaneous fungal infections (CFIs) are among the most common skin disorders and often require prolonged topical therapy. However, conventional topical antifungal formulations frequently exhibit poor aqueous solubility, inadequate skin permeation, and limited drug retention, resulting in suboptimal therapeutic outcomes. The present study aimed to develop and optimize an isoconazole nitrate-loaded nanostructured lipid carrier (NLC) gel using a Quality by Design (QbD) approach to enhance topical antifungal delivery. A systematic risk assessment followed by a 3² full factorial design was employed to optimize lipid mixture and surfactant/co-surfactant concentrations using particle size and drug loading as critical quality attributes. The optimized formulation (P1) exhibited a particle size of 93.3 ± 1.2 nm, zeta potential of − 20.2 mV, entrapment efficiency of 97.41 ± 0.42%, and drug loading of 4.871 ± 0.031%, with excellent agreement between predicted and experimental responses. The optimized NLC dispersion was incorporated into a 0.5% Carbopol 940 gel, which demonstrated acceptable physicochemical properties, including pH (6.3 ± 0.005), viscosity (2574 ± 65 cps), spreadability (4.49 g·cm/s), extrudability (4.38 ± 0.18%), and drug content (97.18 ± 0.71%). The formulation exhibited sustained in vitro drug release (72.55% over 12 h) following first-order kinetics (R² = 0.9959) and significantly enhanced ex vivo skin permeation (98.49% at 7 h) compared with the conventional gel. Antifungal evaluation against Candida albicans demonstrated superior activity of the NLC gel, producing a larger inhibition zone (22 ± 0.1 mm at 10 mg/mL) than the marketed formulation (17 ± 0.8 mm). The formulation also satisfied microbial quality requirements and remained stable during three months of accelerated stability testing. Overall, the QbD-optimized isoconazole nitrate-loaded NLC gel represents a promising topical delivery system with improved physicochemical characteristics, enhanced skin permeation, sustained drug release, and superior antifungal efficacy for the management of cutaneous fungal infections.</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":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132750","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":"Multimodal Imaging Reveals Microstructural Quality Attributes Associated with Disintegration and Product Variability in Liuwei Dihuang pills","authors":"Jian-Li Chen,&nbsp;Makai Li,&nbsp;Jianan Cheng,&nbsp;Hongzhao Zhang,&nbsp;Chunye Liu,&nbsp;Zhenyu Li","doi":"10.1007/s12247-026-11109-5","DOIUrl":"10.1007/s12247-026-11109-5","url":null,"abstract":"<div><p>Conventional quality evaluation of traditional Chinese medicine (TCM) pills relies mainly on chemical markers and compendial tests, with limited consideration of the physical microstructure of the finished dosage form. This study aimed to investigate whether imaging-derived microstructural characteristics could provide supplementary descriptors for quality-related characterization of complex herbal solid dosage forms using Liuwei Dihuang pills as a representative model. Water pills (WP), water-honey pills (WHP), honey pills (HP), and concentrated pills (CP) were characterized by scanning electron microscopy (SEM), fluorescence imaging (FL), and micro-computed tomography (micro-CT), combined with quantitative image analysis. SEM revealed a progressive transition from the loose and particulate structure of WP to the more compact matrix of WHP and the continuous matrix of HP, demonstrating the marked influence of binder composition on pill microstructure. Imaging-derived parameters further differentiated commercial products from different manufacturers and revealed measurable batch-to-batch variability. In controlled formulations, fluorescence intensity at Ex/Em 675/740 nm increased with refined-honey content (R² = 0.9991) and was altered by prolonged drying, while SEM and fluorescence imaging distinguished structural and compositional differences caused by honey refining and binder substitution. Micro-CT provided complementary information on internal low-attenuation regions and edge distributions among different pill types. Importantly, the complete disintegration time of commercial WHPs, ranging from approximately 18 to 40 min, was positively correlated with the SEM-derived area occupancy rate (R² = 0.7144) and fluorescence intensity (R² = 0.6279). These findings demonstrate that multimodal imaging can capture formulation- and manufacturing-related physical variability in complex solid dosage forms and suggest the potential value of imaging-derived descriptors for supplementary product characterization, subject to broader validation.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132258","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 a Dual-Drug Nanoparticle-Embedded Sublingual Film for Rapid Analgesia and Sustained Antiemetic Therapy in Acute Migraine","authors":"Khadija Nasir,&nbsp;Ghazala Ambreen,&nbsp;Muhammad Imran Khan,&nbsp;Badarqa Tul Ayesha,&nbsp;Syeda Momna Ishtiaq,&nbsp;Muhammad Yasir Ali,&nbsp;Sana Shafique","doi":"10.1007/s12247-026-11111-x","DOIUrl":"10.1007/s12247-026-11111-x","url":null,"abstract":"<div><p>Migraine is a common neurological condition often associated with nausea and vomiting. Conventional oral medications often are difficult to take and absorb during migraine attacks, as nausea and vomiting tend to accompany them. The objectives of the present study were to design and characterize a sublingual film containing Diclofenac Potassium (DK) and Ondansetron Hydrochloride (ONH) loaded Chitosan Nanoparticles (CS-Np) in the same dosage form. Particles of ONH were loaded into chitosan nanoparticles by ionic gelation and the particles were characterized in terms of particle size, polydispersity index (PDI), zeta potential, and entrapment efficiency. The optimized nanoparticles exhibited a mean size of 130 ± 2.0 nm, PDI of 0.13 ± 0.01 and a zeta potential of about + 10 mV with an entrapment efficiency of 78.4 ± 2.6%. DK was incorporated into HPMC E15-based sublingual films and nanoparticles were added to these. The films were assessed for physical properties, drug content uniformity, disintegration time, in vitro drug release, ex vivo permeation and short-term stability. The optimized formulation (NSF2) exhibited rapid DK release (57% released within 6 min) while ONH release from nanoparticle containing system was 75.5% after 12 h under in vitro test conditions. The permeation of ONH across goat sublingual mucosa was studied ex vivo separately for 12 min and the optimized formulation exhibited ~ 65% of cumulative permeation at the end of the study period. The measured physicochemical characteristics, drug content and drug release profile of the optimized films were maintained during the three-month stability study under the tested storage conditions. The results show that it is possible to develop a sublingual film containing DK directly incorporated into the film and nanoparticles of ONH loaded in it with different release properties. Additional kinetic, dynamic, safety and clinical trials are needed to confirm in vivo efficacy and clinical significance of formulation.</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":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132629","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":"Colour-Changing Hydrogels with Smartphone Assistance for Wound Monitoring and Bacterial Detection","authors":"Prasanna S,&nbsp;Jawahar Natrajan,&nbsp;Jubie S,&nbsp;Anandharaj S,&nbsp;Arun Kumar R,&nbsp;Ekanatha Sai Venkat Vagu","doi":"10.1007/s12247-026-11106-8","DOIUrl":"10.1007/s12247-026-11106-8","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;p&gt;Particularly in individuals with diabetes, vascular diseases, and weakened immune systems, wound infection continues to be one of the main causes of delayed healing and chronic wound development. Although they offer physical protection, conventional wound dressings are unable to continuously assess the condition of the wound or identify infection early on. Recent developments in biomaterials have resulted in the creation of intelligent, stimuli-responsive hydrogels that can combine medicinal administration, infection detection, and wound monitoring into a single multipurpose platform.&lt;/p&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;p&gt;With a focus on smartphone-assisted RGB colour analysis for quantitative point-of-care diagnostics, this study highlights current advancements in colour-changing smart hydrogels for wound monitoring and bacterial infection detection.&lt;/p&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;p&gt;A thorough review of the literature on infection-responsive hydrogels was conducted, with particular attention to polymeric materials, fabrication techniques, colourimetric sensing systems, theranostic applications, pH-, enzyme-, and bacteria-responsive mechanisms, and digital wound monitoring technologies. To provide real-time visual monitoring of wound condition, the review also addresses the integration of synthetic pH-sensitive dyes, natural pigments, and nanomaterial-based optical sensors into hydrogel matrices.&lt;/p&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;p&gt;Through reversible colour changes and regulated therapeutic release, smart hydrogels react dynamically to infection-associated indicators such as pH variations, reactive oxygen species, bacterial enzymes, and microbial metabolites. Anthocyanins and synthetic dyes like xylenol blue, bromothymol blue, and bromocresol purple have shown considerable promise for quick colourimetric detection of wound infection. Remote monitoring and telemedicine applications are made possible by the objective, quantitative, and non-invasive evaluation of wound progression made possible by integration with smartphone-assisted RGB picture analysis. Furthermore, a significant step toward precision wound care is represented by multifunctional theranostic hydrogels that combine wearable biosensing technologies, antimicrobial drug delivery, antioxidant activity, tissue regeneration, and infection sensing. Widespread clinical translation is still hampered by issues with long-term indicator stability, mechanical durability, large-scale production, clinical validation, and regulatory licensing, despite these encouraging advancements.&lt;/p&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;p&gt;Colour-changing smart hydrogels are a new class of intelligent wound dressings that integrate digital health technology, stimuli-responsive therapeutic delivery, and real-time infection monitoring on one platform. It is anticipated that future developments in biomaterials, nanotechnology, wearable electronics, artificial intelligence, and smartphone-assisted diagnostics will hasten their clinical translatio","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-026-11106-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132757","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":"Beyond Organic Synthesis: Impurity, Oxidative, and Solid-State Challenges in Pharmacopoeial-Grade Droperidol API Development","authors":"József Schindler,&nbsp;Ádám Szitás,&nbsp;Ferenc Matyuska,&nbsp;Csaba Marton,&nbsp;Imre Kovács","doi":"10.1007/s12247-026-11091-y","DOIUrl":"10.1007/s12247-026-11091-y","url":null,"abstract":"<div><p>The development of robust manufacturing processes for active pharmaceutical ingredients (APIs) requires considerably more than the successful execution of the target organic synthesis. In practice, reaction selectivity, competing transformation pathways, impurity formation, product isolation, and solid-state behavior are often tightly interconnected, ultimately determining whether pharmacopoeial-quality material can be consistently obtained. Despite their critical importance, these relationships are rarely discussed in the open literature because industrial process development is typically protected by proprietary know-how.</p><p>Droperidol represents an instructive model system for studying these challenges. Although its molecular structure appears synthetically straightforward, the preparation of pharmacopoeial-grade API is complicated by a series of coupled process phenomena, including competitive reagent consumption, structurally related impurities affecting downstream isolation, oxidative degradation during processing, and the influence of solvent selection on the final solid form.</p><p>In this work, these process vulnerabilities are examined through representative reaction pathways, while the corresponding pharmacopoeial impurities (Imp-C, Imp-D, and Imp-E) are prepared in analytically pure form to serve as mechanistic models and reference standards. Their structures were confirmed by NMR spectroscopy, mass spectrometry, HPLC, and LC-MS. Rather than presenting impurity synthesis as an isolated objective, the study demonstrates how the controlled preparation and characterization of representative impurities can support mechanistic understanding and impurity-control strategies during pharmaceutical process development.</p><p>Together, these findings illustrate how pharmacopoeial impurities can reveal process vulnerabilities that may remain hidden when API development is evaluated primarily through reaction conversion.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-026-11091-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132630","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}