Journal of Pharmaceutical Innovation最新文献

{"title":"Hemoglobin-Polyvinyl Alcohol (Hb-PVA) Macroporous Cryogels As Swelling-Controlled Drug Delivery System Optimization and Release Kinetics of Vancomycin","authors":"Arti Vishwkarma,&nbsp;Jaya Bajpai,&nbsp;A. K. Bajpai","doi":"10.1007/s12247-024-09909-8","DOIUrl":"10.1007/s12247-024-09909-8","url":null,"abstract":"<div><h3>Purpose</h3><p>The purpose of this study was to formulate and investigate biopolymer based cryogel as bioactive carriers, which is hydrophilic in nature.</p><h3>Methods</h3><p>A Contemporary research based on the preparation of hemoglobin protein-polyvinyl (Hb-PVA) macroporous cryogels of varying compositions through the freeze–thaw method, using deionized water as a plasticizer. Vancomycin drug loaded Hb-PVA gel applicable as a good platform to promote controlled antibiotic drug release into the specific sites of the body against antibiotic resistance diseases.</p><h3>Results</h3><p>The synthesized Hb-PVA cryogels were characterized by spectroscopic and microscopic techniques such as Fourier transform infrared (FTIR) spectroscopy and X-ray diffraction (XRD). Additionally, the morphological and thermal stability of the synthesized cryogels were studied by scanning electron microscopy (SEM) and differential scanning calorimetry. FTIR and XRD spectral assignments revealed the crystalline nature of the cryogel with semicrystalline segments. In addition, scanning electron microscopy (SEM) images revealed that the surface morphology was macroporous in nature; hence, the water-holding capacity of these materials increased. Atomic force microscopy images reveal that the surface roughness is enough for the adhesion of drug molecules, and the R_a/R_q ratio is equal to 1.24 for a Gaussian surface. The swelling properties of the prepared cryogels were investigated at different polymer compositions, temperatures, simulated biological solutions, pH media, salt solutions, and freeze thaw cycles at certain time intervals. The swollen gels were further investigated for vancomycin drug loading and release profiles under in vitro conditions, such as changes in the polymer (PVA, Hb) concentration, temperature, and pH of the release media. This drug-loaded cryogel was also examined for its antibacterial activity against gram-positive and gram-negative bacteria.</p><h3>Conclusions</h3><p>The protein based cryogels have great potential to deliver antibiotic drugs or other bioactive compounds. Based ontheir pore-sizes they may also use in water treatment and cell proliferation, wound dressing etc.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143396711","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":"Fabrication and Characterisation of Taste-Masked Orally Dissolving Films Containing Ondansetron Hydrochloride Using Novel Poly(Amide-Thioester) Nanocapsules Based on L-Cysteine Amino-Acid","authors":"Eman Zmaily Dahmash,&nbsp;Aayashasiddika Nazirbhai Patel,&nbsp;Ella Faizi,&nbsp;Dalia Khalil Ali,&nbsp;Abdi Ataei,&nbsp;Siamak Soltani-Khankahdani,&nbsp;Mahboub Merzouk","doi":"10.1007/s12247-024-09902-1","DOIUrl":"10.1007/s12247-024-09902-1","url":null,"abstract":"<div><h3>Purpose</h3><p>Ondansetron (OND) is 5-HT3 receptor antagonist commonly used to treat chemotherapy-induced nausea and vomiting. However, its short half-life, low bioavailability, and intense bitter taste have led to decreased patient compliance. Administering it via an oromucosal film encapsulated into polymeric nanoparticles without the need for water is advantageous due to the difficulty of taking the medication with water when experiencing nausea. Therefore, the aim of this study was to synthesise polymeric nanoparticles using L-cysteine amino acid to encapsulate the bitter-tasting OND and develop paediatric oral dissolving films (ODFs) using them.</p><h3>Method</h3><p>Cysteine-based poly(amide-thioester) nanoparticles (CYS-PATE NPs) were developed using the one-step interfacial polycondensation technique between aqueous and organic phases. The nanoparticles were extensively characterised and incorporated into ODFs prepared using various polymers (HPMC, Pullulan and Polyethylene oxide (PEO)).</p><h3>Results</h3><p>OND-loaded CYS-PATE NPs (OND/CYS-PATE NPs) were also synthesised with a particle size of 319.7 ± 44.59 nm and a zeta potential of -32.07 ± 0.31. The semi-crystalline nature of both the resultant CYS-PATE NPs and the OND-encapsulated ones was confirmed by DSC and XRD characterisation. In-vitro release studies of optimal formulation (OND/CYS-PATE NPs) showed a total release of 58 µg of OND in 10 mL of artificial saliva after 10 min, equivalent to 5.8 µg/mL, which did not reach the OND bitterness threshold (7.5 µg/mL). Incorporating these NPs into film-forming polymers led to the development of 0.1% HPMC ODFs with homogeneity and a good disintegration time of 49.33 ± 3.99 s.</p><h3>Conclusions</h3><p>This study confirms that encapsulating bitter actives in CYS-PATE NPs effectively masked the taste of bitter soluble APIs, formulating them into more palatable forms that can enhance acceptability and adherence, particularly in paediatrics CINV.</p><h3>Graphical Abstract</h3><p>Schematic representation diagram of synthesis and characterisation of L-cysteine amino acid based poly (thioester amide) nanoparticles containing OND for taste masking of it</p><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-024-09902-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143379844","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":"Enhanced delivery of Dacarbazine using Nanosponge loaded Hydrogel for Targeted Melanoma Treatment: Formulation, Statistical Optimization and Pre-clinical Evaluation","authors":"Sarah Vankudre,&nbsp;Nisha Shirkoli,&nbsp;Rahul Hawaldar,&nbsp;Hritika Shetti","doi":"10.1007/s12247-025-09929-y","DOIUrl":"10.1007/s12247-025-09929-y","url":null,"abstract":"<div><h3>Purpose</h3><p>Conventional cancer treatments often possess systemic side effects, limiting their efficacy. Nanosponges present a promising solution for targeted drug delivery, allowing precise release of encapsulated drugs and enhanced bioavailability.</p><h3>Methods</h3><p>Using a statistical design approach (Box- Behnken design), the nanosponges were optimized to achieve controlled particle size and drug % EE. The optimized formulation (DZ-NS 4) was incorporated into a hydrogel base using HPMC to enable controlled drug delivery. In-vitro, in-vivo, and ex-vivo characterisations were performed to assess drug release, skin permeation and biocompatibility.</p><h3>Results</h3><p>The optimized DZ nanosponges showed controlled particle size (338.6 nm) and high entrapment efficiency (92.2%). Subsequent in-vitro characterization of DZ nanosponge hydrogel demonstrated sustained drug release (82% over 12 h), and ex-vivo showed effective skin permeation (73% through sheep skin), and good in-vivo biocompatibility showing minimal signs of skin reactions. The optimized formulation exhibited substantial anti-proliferative activity, with an IC₅₀ value of 68.81 µg/mL, compared to the standard cisplatin, which had an IC₅₀ value of 6022.0 µg/mL, indicating superior inhibition of melanoma cell proliferation.</p><h3>Conclusion-</h3><p>Taken together, this study successfully designed a novel Dacarbazine nanosponges hydrogel with promising topical therapeutic option for Melanoma treatment, offering targeted delivery, sustained therapeutic effects, and minimal systemic side effects.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><img></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143184606","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":"Electrospun PCL/PVP Nanofibers Meshes, A Novel Bisabolol Delivery System for Antidermatophytic Treatment","authors":"Somayeh Farahmand,&nbsp;Saber SamadiAfshar,&nbsp;Nafise Alsadat Shahmoradi","doi":"10.1007/s12247-025-09928-z","DOIUrl":"10.1007/s12247-025-09928-z","url":null,"abstract":"<div><p>The emergence of antifungal resistance and suboptimal drug delivery systems presents a significant challenge in treating dermatophytosis, necessitating innovative therapeutic approaches. Here, we report the development of an advanced drug delivery platform utilizing electrospun nanofibers incorporating bisabolol, demonstrating superior antifungal efficacy and controlled release properties. Through systematic optimization of polymer compositions, we engineered nanofiber networks using precise combinations of polycaprolactone (PCL), polyvinylpyrrolidone (PVP), and gelatin, incorporating bisabolol at a carefully calibrated 5% w/w drug-to-polymer ratio. Comprehensive morphological characterization via scanning electron microscopy revealed that bisabolol incorporation significantly enhanced fiber uniformity and reduced diameter distributions, with the optimized PCL100/PVP80 formulation exhibiting exceptional structural integrity. This formulation demonstrated remarkable antifungal activity, producing substantial inhibition zones against clinically relevant dermatophytes: <i>Trichophyton mentagrophytes</i> (2.05–2.6 cm, <i>p</i> &lt; 0.001), <i>Trichophyton tonsurans</i> (2.5 cm, <i>p</i> &lt; 0.001), and <i>Alternaria alternata</i> (1.04 cm, <i>p</i> &lt; 0.01). High-performance liquid chromatography analysis confirmed sustained drug release kinetics over 48 h, maintaining therapeutic concentrations throughout the treatment period. Cytotoxicity evaluation through MTT assays revealed outstanding biocompatibility, with the PCL100/PVP80-bisabolol formulation maintaining 81.92 ± 4.33% fibroblast viability, significantly superior to conventional formulations (<i>p</i> &lt; 0.001). This study presents a paradigm shift in topical antifungal therapy, offering a precisely engineered, biocompatible platform that addresses current therapeutic limitations. The developed system’s demonstrated efficacy, controlled release properties, and excellent safety profile position it as a promising candidate for clinical translation in treating chronic dermatophytosis, particularly in cases resistant to conventional treatments.</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":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143109385","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":"Improving the Intestinal Permeability of Aprepitant via Self-Microemulsifying Delivery System: In Vitro Development and in Situ Permeation Assessment","authors":"Ziba Islambulchilar,&nbsp;Giso Akbarian,&nbsp;Mohammad Mahmoudian,&nbsp;Hadi Valizadeh,&nbsp;Parvin Zakeri-Milani","doi":"10.1007/s12247-025-09924-3","DOIUrl":"10.1007/s12247-025-09924-3","url":null,"abstract":"<div><h3>Background</h3><p>The present study aimed to design and develop aprepitant-loaded self-microemulsifying drug delivery systems (SMEDDS) and to characterize and assess their intestinal permeability.</p><h3>Methods</h3><p>D-optimal design has been used to design and optimize the ratio of formulation components. Prepared aprepitant-loaded SMEDDS formulations were subjected to in vitro characterization studies. Single pass intestinal perfusion method (SPIP) was applied to evaluate the intestinal permeation of aprepitant-loaded SMEDDS and compare it with free aprepitant.</p><h3>Results</h3><p>The optimum level of formulation components was determined as oleic acid 10%, Tween 80 60%, and Transcutol P 30%. The particle size of aprepitant-loaded SMEDDS was 152 nm and its PDI (polydispersity index) was 0.35. The optimized aprepitant-loaded SMEDDS showed a zeta potential of -21 ± 8. Effective intestinal permeability (P_eff) of free aprepitant was 1.27 ± 0.44 × 10^− 4 cm/s, whereas for the optimized aprepitant-loaded SMEDDS formulation, it was 2.61 ± 0.79 × 10^− 4 cm/s.</p><h3>Conclusion</h3><p>SMEDDS could be considered a promising delivery system for increasing oral bioavailability of aprepitant as the optimized aprepitant-loaded SMEDDS formulation revealed appropriate physicochemical properties and significantly enhanced intestinal permeability.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143109388","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":"Polymeric Film Loaded with Plinia cauliflora Peels Extract has a Differential Curative Effect on Injuries","authors":"Jessica Renata de Almeida Canoff,&nbsp;Guilherme Donadel,&nbsp;Mariana Dalmagro,&nbsp;Mariana Moraes Pinc,&nbsp;Ana Paula Sone,&nbsp;Paula Derksen Macruz,&nbsp;Reinaldo Aparecido Bariccatti,&nbsp;Rita de Cássia Lima Ribeiro,&nbsp;André Giarola Boscarato,&nbsp;Salviano Tramontin Belettini,&nbsp;Emerson Luiz Botelho Lourenço,&nbsp;Jaqueline Hoscheid","doi":"10.1007/s12247-025-09926-1","DOIUrl":"10.1007/s12247-025-09926-1","url":null,"abstract":"<div><h3>Purpose</h3><p>Bioprospect a polymeric film containing <i>P. cauliflora</i> extract (PCE) for the differential treatment of skin injuries.</p><h3>Methods</h3><p>Films containing 1%, 3% and 5% of PCE were prepared and subjected to physicochemical characterization, including thickness measurement, mechanical and barrier property analysis, colorimetric evaluation, FTIR, release profiles and antimicrobial properties. Additionally, in vivo wound healing efficacy was evaluated over 21 days.</p><h3>Results</h3><p>The films displayed uniform thickness and high malleability. Incorporating PCE improved water solubility, reduced water vapor permeability rate and moisture absorption capacity. The bioactive release was sustained for over 24 h, ensuring an extended therapeutic window. These properties make them ideal for topical applications by providing a structured matrix for controlled bioactive release upon wound contact. This design maintains a moist environment, prevents adherence to the wound, and minimizes common issues associated with traditional treatments, such as tissue trauma during dressing changes. Antimicrobial analysis confirmed the inhibitory activity against <i>Staphylococcus aureus</i> in films loaded with 3% and 5% PCE. In vivo studies demonstrated accelerated wound healing with a film loaded with 5% PCE.</p><h3>Conclusion</h3><p>The films loaded with 5% PCE demonstrated optimal therapeutic efficacy by promoting wound healing and providing sustained antimicrobial activity, thereby serving as a viable alternative to conventional films. These films offer a structured bioactive matrix with controlled release. Unlike conventional treatments such as ointments, they offer a promising and innovative approach for skin injury treatment.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143109263","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":"Transforming Traditional Industry Advisory Boards Into Mutually Beneficial Strategic Think Tanks: A Peer Review Council Case Series and Best Practices","authors":"Todd Williamson,&nbsp;John Fox,&nbsp;Scott Ramsey,&nbsp;Maria Martins-Lopes,&nbsp;Kevin M. Pantalone,&nbsp;C. Daniel Mullins,&nbsp;Kenneth Schaecher,&nbsp;Sean D. Sullivan","doi":"10.1007/s12247-025-09925-2","DOIUrl":"10.1007/s12247-025-09925-2","url":null,"abstract":"<p>The Bayer Data Generation and Observational Studies (DGOS) team has partnered longitudinally with a consistent advisor group (DGOS Council). The DGOS Council operates as an extension of the DGOS team, providing external strategic perspectives. Here, we describe Bayer’s engagement with the DGOS Council and how it contributes throughout a product’s lifecycle. We present the composition and organization of the DGOS Council, share case studies describing its relation to and impact across Bayer’s portfolio of products, and discuss bi-directional benefits to Bayer and DGOS Council members. We conclude with recommendations for best practices for an HEOR Peer Review Council model. Teaser. Bayer has partnered longitudinally with a group of strategic advisors. The relationship between Bayer and the advisors is described here as a consideration for best practice for evidence generation teams. </p>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-09925-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143109260","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":"Preparation of pH-Sensitive Astragalus Polysaccharide Nanoparticles Loaded with Paclitaxel and Evaluation of Antitumor Activity","authors":"Kaibin Wang,&nbsp;Yanqiang Li,&nbsp;Xiaoliang Zhao,&nbsp;Tianke Zhu,&nbsp;Li Luo,&nbsp;Hanwen Zhang,&nbsp;Yonggang Wang,&nbsp;Jing Zhang,&nbsp;Cunjin Wang,&nbsp;Weijie Zhang","doi":"10.1007/s12247-024-09914-x","DOIUrl":"10.1007/s12247-024-09914-x","url":null,"abstract":"<div><h3>Purpose</h3><p>Chinese medicine polysaccharide are considered as promising medical materials due to their good biocompatibility and safety. The aim of this study was to develop a novel amphiphilic drug carrier based on astragalus polysaccharide (APS) to optimise the delivery of paclitaxel.</p><h3>Methods</h3><p>The pH-sensitive histidine (His) and hydrophobic stearic acid (SA) were grafted onto astragalus polysaccharide and self-assembled into nanoparticles by ultrasonication. The nanoparticles were characterised by Fourier transform infrared (FTIR), dynamic light scattering (DLS), zeta potential, transmission electron microscopy (TEM), and X-ray diffraction, and tested for encapsulation efficiency (EE%), drug loading capacity(LC%) and in vitro release of paclitaxel. The effects of nanoparticles on the proliferation of immune cells RAW264.7 and breast cancer cells SUM149 were assessed by cck-8 assay, and their effects on SUM149 cell cycle block and apoptotic protein expression were detected.</p><h3>Results</h3><p>The EE% of nanoparticles on paclitaxel was 77.61% and the LC% was 9.96%. Under acidic conditions, the surface charge of nanoparticles was reversed and the structure was swollen to promote drug release. Cellular experiments showed that blank nanoparticles could promote the proliferation of immune cells, and the anticancer effect of drug-loaded nanoparticles was significantly better than that of paclitaxel alone.</p><h3>Conclusion</h3><p>The prepared pH-sensitive nanoparticles can effectively enhance the uptake of paclitaxel by tumour cells and induce apoptosis in breast cancer cells, making them a promising new type of paclitaxel drug carrier.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143109262","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":"3D Drug Printing by Semi-Solid Extrusion Through Reusable Cartridges: Usability Evaluation","authors":"Rohan Rege,&nbsp;Tessa Mellema,&nbsp;Arwin Ramcharan,&nbsp;Anouar Ait Hoummad,&nbsp;Sophie Verhoeven,&nbsp;Vibhas Mishra,&nbsp;Arjen J. Jansen,&nbsp;Niels Ouwerkerk,&nbsp;Fereshteh Shokri","doi":"10.1007/s12247-024-09904-z","DOIUrl":"10.1007/s12247-024-09904-z","url":null,"abstract":"<div><h3>Purpose</h3><p>Three-dimensional (3D) printing is revolutionising tablet fabrication in the field of pharmacy, offering personalised dosing through additive manufacturing techniques such as semi-solid extrusion (SSE). SSE traditionally uses disposable syringes, which pose challenges in temperature control and waste generation.</p><h3>Methods</h3><p>This article experimentally simulates various scenarios relevant to pharmacy practice to evaluate the usability of the semi-solid extrusion approach using a first-of-its-kind reusable cartridge. The research assesses the stability of formulations under thermal stress conditions that simulate commercial settings, demonstrating the robust performance of this 3D drug printing method across multiple uses.</p><h3>Results</h3><p>This study introduces pharmaceutical-grade stainless-steel cartridges as a sustainable alternative to disposable syringes, enhancing temperature management and reducing waste in SSE 3D printing.</p><h3>Conclusion</h3><p>Our findings highlight the potential of reusable cartridges to improve efficiency and sustainability in pharmaceutical manufacturing, with implications for future formulation developments and stability studies. The presented 3D drugprinting approach offers a promising solution for environmentally responsible practices in pharmacy.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143109005","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":"Sodium Alginate Beads Containing Epalrestat for Effective Management of Diabetic Mellitus","authors":"Rashmi Madhariya,&nbsp;Alpana Ram,&nbsp;Akhlesh K. Jain","doi":"10.1007/s12247-024-09905-y","DOIUrl":"10.1007/s12247-024-09905-y","url":null,"abstract":"<div><h3>Purpose</h3><p>Epalrestat is the most common Aldose reductase inhibitor (ARI) approved for blood glucose management in several countries and has also shown efficacy in preventing the onset of diabetic neuropathy (DN), and diabetic retinopathy. The present study aims to formulate and evaluate the effectiveness of Alginate beads of epalrestat in Streptozotocin-induced (STZ) diabetic rats in order to effectively manage the diabetes.</p><h3>Method</h3><p>Various formulations of Sodium cross-linked alginate beads containing epalrestat (F1 to F9) were prepared based on full factorial design by ionotropic gelation method. The formulations were characterized for particle size, % Drug entrapment efficiency (DEE), Fourier Transform Infra-Red Spectroscopy (FT-IR), Differential scanning calorimetry (DSC), X-ray Diffraction Study (X-RD), Scanning Electron Microscopy (SEM), and In-Vitro Release Studies. Optimized formulation (F6) [containing sodium alginate (2.5%w/v), epalrestat (2.5%w/v), and calcium chloride (2.5%w/v)] was subjected to in-Vivo efficacy testing in diabetic rats.</p><h3>Result</h3><p>Epalrestat-loaded beads were prepared (F1 to F9; Size = 3.21 μm; DEE = 97%) successfully using sodium alginate as polymer and calcium chloride solution as the crosslinking agent by modified ionotropic gelation method Optimized formulation showed a % DEE of 97% and highest drug release of 95% at the end of 10 hrs. Drug Release Kinetic of optimized formulation followed first-order kinetic. Further, the hypoglycemic effect was observed over a longer period 50% reduction after 2 hrs and continued till 4 hrs. In addition, normoglycemia was maintained till 12 hrs (20% reduction) in STZ-induced diabetic rats.</p><h3>Conclusion</h3><p>The formulation F6 was found to be superior compared to all the other formulations because the percentage drug entrapment efficiency was highest and there was no chemical interaction took place between the drug and polymer (Confirmed by DSC and XRD studies). In-vivo study showed prolonged hypoglycaemia till 12 hrs with a maximum reduction at 2 hrs Compared to plain drug suspension (20% reduction till 5 hrs).</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142995621","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}