Journal of Pharmaceutical Innovation最新文献

{"title":"Development and Characterization of Glimepiride-Loaded Polymeric Nanoparticles: Formulation Design and Evaluation","authors":"Zaiba Irfan,&nbsp;Muhammad Imran Khan,&nbsp;Muhammad Farhan Sohail,&nbsp;Muhammad Furqan Akhtar,&nbsp;Muhammad Naeem Qaisar,&nbsp;Muhammad Kashif Javed,&nbsp;Fareeha Anwar,&nbsp; Badarqa-tul-Ayesha,&nbsp;Majid Anwar,&nbsp;Aslam Khan,&nbsp;Faizan Akram","doi":"10.1007/s12247-024-09812-2","DOIUrl":"10.1007/s12247-024-09812-2","url":null,"abstract":"<div><h3>Purpose</h3><p>This study was aimed to develop polymeric nanoparticles (PNPs) using chitosan (CTN), polyvinyl pyrrolidone (PVP), and Tween 80 for dissolution enhancement of poorly water-soluble antidiabetic drug: glimeperide (GLM).</p><h3>Methods</h3><p>GLM-loaded PNPs were developed for increasing the dissolution and solubility of GLM by using different amounts of CTN as polymer, PVP, and Tween 80 as stabilizers and tri-polyphosphate (TPP) as a crosslinking agent. PNPs were prepared using a combined approach of solvent evaporation and ionic gelation techniques. The newly fabricated PNPs were further characterized for percent encapsulation efficiency (%EE), compatibility studies, average particle size, morphology, thermal behavior, XRD examination, and dissolution studies at different biorelevant pH conditions.</p><h3>Results</h3><p>The prepared PNPs showed % encapsulation efficiency in the range of 55.90 to 93.25%. Fourier transform infrared studies revealed compatibility of GLM with formulation composites. The optimized PNPs F_1PVP and F_4TW80 showed particle size in nanoscale range 323 nm and 149 nm, respectively. SEM indicated formation of irregular (flakes) shaped particles. DSC and PXRD studies revealed reduction in crystallinity of the GLM inside PNPs thus promoting the dissolution. The dissolution studies at biorelevant acidic pH 1.2 and biorelevant basic pH 6.8 demonstrated remarkable improvement in dissolution profile compared to pure aqueous dispersion of GLM.</p><h3>Conclusion</h3><p>Overall results of the study suggested that CTN-based PNPs stabilized with PVP and Tween 80 can act as promising carriers for oral drug delivery of GLM.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139506400","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":"Effect of Rosa damascena Essential Oil Loaded in Nanostructured Lipid Carriers on the Proliferation of Human Breast Cancer Cell Line MDA-MB-231 in Comparison with Cisplatin","authors":"Elham Yari,&nbsp;Soyar Sari,&nbsp;Hamidreza Kelidari,&nbsp;Kofi Asare-Addo,&nbsp;Ali Nokhodchi","doi":"10.1007/s12247-024-09809-x","DOIUrl":"10.1007/s12247-024-09809-x","url":null,"abstract":"<div><h3>Purpose</h3><p>As <i>Rosa damascena</i> essential oils (RDEOs) have antioxidant, antibacterial, antiviral, and insecticidal activity, they could therefore be useful in the treatment of breast cancer. In the current study, an attempt was made to incorporate RDEO in a lipid-based drug delivery system, namely, nanostructured lipid carrier (NLC) to boost its anticancer effect compared to cisplatin.</p><h3>Methods</h3><p>Gas chromatography (GC) identified the chemical compositions of RDEO. RDEO-NLCs were prepared using the probe ultrasonication method. The obtained nanoparticles were characterized in terms of particle size, polydispersity index, and zeta potential by dynamic light scattering. The encapsulation efficiency of the formulations and their loading capacity were also determined, and transmission electron microscopy (TEM) was employed to evaluate the morphology of the optimal formulation (quoted as RDEO-NLC2). The anticancer effect of RDEO-NLC2 on MDA-MB-231 cells and apoptosis were assessed using MTT and in vitro cellular assays respectively.</p><h3>Results</h3><p>TEM result revealed a distinct spherical shape for RDEO-NLC2, with an average particle size of 78.39 ± 1.5 nm obtained by Zetasizer. The results also showed that the obtained particles had a negative surface charge (− 31.0 mV) with a polydispersity index of 0.28 ± 0.01. The chemotherapy drug cisplatin showed more cytotoxicity than RDEO-NLC2 against cancer cells. Cellular data demonstrated that RDEO-NLC2 like cisplatin can decline the viability of MDA-MB-231 cells through apoptosis compared to cells treated with the placebo and free RDEO.</p><h3>Conclusion</h3><p>RDEO-NLC2 has the ability to stimulate apoptosis in the human BC cell line MDA-MN-231; hence, it can be beneficial in the treatment of patients suffering from breast cancer.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-024-09809-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139506554","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":"Surface Engineering and Optimizing DepoFoam System: A Robust Quality by Design Approach for Optimal Drug Delivery, Stability, and Quality","authors":"Jebastin Koilpillai,&nbsp;Damodharan Narayanasamy","doi":"10.1007/s12247-024-09808-y","DOIUrl":"10.1007/s12247-024-09808-y","url":null,"abstract":"<div><h3>Purpose</h3><p>The study utilized non-ionic polymer macrogol to transform the surface properties of the DepoFoam drug carrier system, developing “surface-remodeled DepoFoam (SR-DFO)” following quality by design (QbD) principles. The primary objectives were to prolong drug delivery, reduce sudden releases, and enhance the overall quality and stability of DepoFoam. The research hypotheses are centered on the capability of macrogol-based surface modification to create an optimized drug delivery system with improved stability, extended drug release, and enhanced pharmacokinetic properties.</p><h3>Methods</h3><p>In this research, surface remodeling was achieved through a series of processes, including high-shear homogenizer-assisted double emulsification, PEGylation, and purification. The resulting SR-DFO formulations were comprehensively characterized for critical quality attributes. Optimization was conducted using the Box-Behnken design, resulting in significant enhancements in both quality and stability compared to conventional liposomes and unmodified DepoFoam.</p><h3>Results</h3><p>Comprehensive product characterization validates anticipated quality parameters: entrapment efficiency (86.16 ± 0.44%), drug-loading capacity (25.28 ± 0.07%), vesicle size (40.47 ± 0.1 µm), polydispersity index (PDI) of 0.051 ± 0.03, lipocrit of 90.67 ± 0.26%, and zeta potential of − 31.25 ± 3.25 mV. Remarkably, macrogol-based SR-DFO consistently sustains drug release above 90% for 168 h, devoid of sudden spikes, and maintains stability at 4 °C for 180 days. Mathematical models confirm drug release mechanisms’ validity. Moreover, this study emphasizes the critical influence of key materials like macrogol, phospholipids, triglycerides, and process variables on shaping product quality.</p><h3>Conclusion</h3><p>These findings highlight the inventive promise of macrogol-coated DFO in transforming drug delivery, quality, and stability. This research, driven by a well-formed hypothesis, meticulous execution, and precise data analysis, opens new horizons in polymer-based DepoFoam systems.</p><h3>Graphical Abstract</h3><p>First author: Jebastin Koilpillai, M.Pharm.</p>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139496490","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":"Formulation and Characterization of Interpenetrating Polymer Network Hydrogel Bead as Drug Carrier System for Extended Release of Sulphonyl Urea Medication","authors":"Kalaiarasan Sellamuthu,&nbsp;Sheela Angappan","doi":"10.1007/s12247-024-09811-3","DOIUrl":"10.1007/s12247-024-09811-3","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aims to develop an interpenetrating polymer network (IPN) hydrogel bead. This drug carrier system with a hydrophilic polymer is designed through an ionotropic gelation technique using divalent calcium ions as a crosslinking agent. The resultant polymeric composite extends the release of the short-acting oral sulfonylurea drug, glipizide.</p><h3>Methods</h3><p>The IPN hydrogel beads prepared with more than one polymer bring forth better mechanical strength in contrast to a single polymeric-based network hydrogel system. This hydrogel bead of hydrophilic sodium alginate (SAL), the concentration of which ranges from 1.5 to 2.0% w/w, and xanthan gum (XAG) polymer, whose concentration ranges between 0.5 and 1.0% w/w, has been prepared to control the drug release profile. An ionotropic gelation technique with the crosslinking agent, calcium chloride at 2.5–7.5% w/w concentration, was adopted to prepare the IPN hydrogel bead drug carrier.</p><h3>Results</h3><p>The prepared hydrogel bead was studied for viscosity analysis of prepared composite dispersion, particle size, drug entrapment, swelling functions, and in vitro drug dissolution. An increase in xanthan gum quantity levels resulted in increased viscosity of prepared composite dispersions and hence the increased mean diameter of produced IPN hydrogel beads. Increased crosslinker concentration showed a slightly smaller IPN hydrogel bead mean diameter and increased encapsulation of loaded drug to about 88 to 91% glipizide. The in vitro drug dissolution was observed to be slower with increased xanthan gum polymer and calcium ion crosslinker concentration, which extended the drug release to 14 h. Thus, this work demonstrates that the XAG and calcium ion crosslinkers play a significant role in controlling the release of the loaded drug, glipizide.</p><h3>Conclusion</h3><p>Based on the results obtained, it can be concluded that the prepared novel polymeric-based IPN drug carrier system has beneficially controlled the drug release of short-acting oral sulphonyl medication and acted as an extended drug release system.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139481392","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":"Preparation and Physicochemical Characterizations of Niosomal Benzoyl Peroxide and Clindamycin Phosphate Formulation for Acne Vulgaris","authors":"Maryam Rezaeizadeh,&nbsp;Amir Eskanlou,&nbsp;Abbas Pardakhty,&nbsp;Mostafa Pournamdari,&nbsp;Mohammad Daneshpajooh","doi":"10.1007/s12247-024-09807-z","DOIUrl":"10.1007/s12247-024-09807-z","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aimed to prepare and characterize a topical niosomal formulation of benzoyl peroxide (BP) and clindamycin phosphate (CMP) for the treatment of acne vulgaris.</p><h3>Methods</h3><p>Different combinations of Polyoxyethylene Alkyl Ethers (Brij), sorbitan esters (Span), and their ethoxylated derivatives (Tween), and cholesterol were used to produce the niosomes. Encapsulation, release, chemical and physical stabilities of the prepared formulations were studied.</p><h3>Results</h3><p>The studied niosomes exhibited high physical stability, as evidenced by unchanged size distribution over a six-month storage period. Formulations composed of Brij-52 combined with 50 mol% of cholesterol showed the highest encapsulation efficiency for both CMP (81.5 ± 7.4%) and BP (95.6 ± 3.5%). The release rate of CMP was found to be greater than BP.</p><h3>Conclusions</h3><p>It was concluded that niosomes could serve as stable carriers for topical drug delivery of CMP and BP, specifically in the treatment of acne vulgaris.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139422294","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":"Formulation, Characterization, and Optimization of Transethosomes for Enhanced Transdermal Delivery of Methotrexate","authors":"Priyanka J. Veer, Vinayak S. Mastiholimath","doi":"10.1007/s12247-023-09799-2","DOIUrl":"https://doi.org/10.1007/s12247-023-09799-2","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>Methotrexate (MTX) is an antineoplastic drug used in the treatment of rheumatoid arthritis (RA). Given that it is a class IV drug with low permeability and solubility, this study aims to improve MTX skin permeation by loading it in transethosomes (TEs) and casting a transethosomal patch that allows for dose quantification to mitigate toxicity.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>To accomplish this goal, MTX transethosomes (TEs) were developed using the thin film hydration technique and optimized using the Box-Behnken design (BBD) with soya phosphatidylcholine 50, Tween 80, and ethanol as independent variables using the desirability function. Furthermore, zeta potential (ZP) analysis and high-resolution transmission electron microscopy (HR-TEM) were used to confirm the stability and surface morphology of TEs. A transdermal patch was also designed and evaluated from the optimized TE (OPTZ TEs) batch using a solvent casting method with hydroxypropyl methylcellulose (HPMC) as the polymer, dimethyl sulfoxide (DMSO) as a permeation enhancer, and polyethylene glycol (PEG 400) as the plasticizer. Furthermore, ex vivo skin permeation and deposition through rat skin proved that the TE patch had better drug permeation and retention within the skin layers.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>The highest desirability batch had 92.19 ± 3.826 nm vesicle size, 0.35 ± 0.062 PDI, 74.05 ± 5.157% EE and 62.75 ± 4.448% Q8h which were within the predicted results. Furthermore, ZP was found to be more than − 30 mV, and HR-TEM results proved that the TE vesicles were spherical. The results of the evaluation parameters such as weight variation, folding endurance, and thickness were 0.07 ± 0.01 g, 82.3 ± 1.52 folds, and 0.93 ± 0.01, respectively, and were well within the limits. The TE patch incorporated more than 90% of the drug confirmed by the drug content analysis which allowed ex vivo permeation for almost 24 h providing a sustained release action with a permeation flux of 19 ± 1.08 and an enhancement ratio of 3.68 when compared to the MTX solution.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>This study suggests that MTX-loaded transethosomal patch not only enhanced the skin permeation but also provided a 24-h release profile and reduced its toxicity.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\u0000","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"29 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139056204","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":"Enhancing the Dissolution of Flutamide Through Supersaturation Using Beta-Cyclodextrin: a Promising Approach for Improved Solubility of Poorly Water-Soluble Drugs","authors":"Shaghayegh Hoseini Aghdam, S. Allahyari","doi":"10.1007/s12247-023-09793-8","DOIUrl":"https://doi.org/10.1007/s12247-023-09793-8","url":null,"abstract":"","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"7 3","pages":""},"PeriodicalIF":2.6,"publicationDate":"2023-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138945079","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":"Elucidation of Tartaric Acid-Assisted Supersaturation Maintenance of Dipyridamole by Eudragit® E100","authors":"Maryam Maghsoodi, Vahid Baghcheh, Mohammad Feyzizadeh, Ashkan Barfar, Ali Nokhodchi","doi":"10.1007/s12247-023-09798-3","DOIUrl":"https://doi.org/10.1007/s12247-023-09798-3","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>The purpose of this study was to investigate the effect of tartaric acid on the maintenance of dipyridamole supersaturation using Eudragit E100 as a carrier.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The solubility of dipyridamole was determined in a buffer solution (pH = 6.8) containing Eudragit E100 and various concentrations of tartaric acid. Dissolution tests were conducted using a pH-shift method, transitioning from an acidic solution (pH = 1.2) to a buffer solution (pH = 6.8). The drug concentration in the buffer solution was measured to assess drug supersaturation. The dissolution behavior of binary and ternary combinations of dipyridamole, Eudragit E100, and tartaric acid was evaluated and compared. The interference of tartaric acid in the interaction between Eudragit E100 and dipyridamole was assessed using FT-IR and nuclear magnetic resonance (NMR) techniques.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>The addition of tartaric acid to Eudragit E100 exhibited a strong synergistic effect in stabilizing the supersaturation of dipyridamole. The results demonstrated that tartaric acid, by lowering the pH, increased the affinity of Eudragit E100 for dipyridamole, thereby enhancing its ability to maintain drug supersaturation.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>The presence of acidifiers such as tartaric acid significantly improved the maintenance of drug supersaturation by Eudragit E100 due to the synergistic effect between Eudragit E100 and the acidifier.</p>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"6 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138690558","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":"Coloaded Surface–Modified PLGA Nanoparticles for Sustained Ocular Delivery of Levofloxacin and Flurbiprofen","authors":"Ujwala Shinde, Yusra Barkat, Kavita Singh","doi":"10.1007/s12247-023-09796-5","DOIUrl":"https://doi.org/10.1007/s12247-023-09796-5","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>The purpose of the present work was to develop levofloxacin-flurbiprofen coloaded PLGA (LEV-FLU-PLGA) nanoparticles with surface modification using chitosan to attain mucoadhesion for the treatment of bacterial conjunctivitis.</p><h3 data-test=\"abstract-sub-heading\">Method</h3><p>Polymeric nanoparticles were prepared by nanoprecipitation method and evaluated for parameters like particle size, PDI, zeta potential, entrapment efficiency (%), in vitro drug release, ex vivo permeation studies, microbial assay against <i>Staphylococcus aureus</i> and ocular tolerance using Hen’s egg test-chorioallantoic membrane (HET-CAM). Furthermore, surface of optimized PLGA nanoparticle formulation was modified by coating with chitosan.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>LEV-FLU-PLGA nanoparticles demonstrated particle size of 166.1 nm with PDI of 0.137 and zeta potential of − 16.8 mV. The entrapment efficiency was found to be 39.37% for levofloxacin (LEV) and 48.33% for flurbiprofen (FLU), whereas for surface-modified nanoparticles, it was found to be 42.05% for LEV and 45.26% for FLU. LEV-FLU chitosan-coated PLGA nanoparticles showed an increase in particle size, i.e., 333.6 nm with PDI of 0.319 and an inversion of zeta potential to 37.67 mV. The developed nanosystems showed sustained release and improved eye permeability. Microbiological studies showed equivalent zone of inhibition to that of marketed formulation. HET-CAM assay revealed the non-irritant nature of drug-loaded PLGA nanoparticles; however, chitosan-coated PLGA nanoparticles were found to be moderately irritating owing to the acidic nature of formulation.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>The nanoparticulate system provides prolonged drug release making it a promising alternative to conventional dosage forms. It reduces systemic effects of locally acting drugs, improving therapeutic efficacy and patient compliance.</p>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"7 12","pages":""},"PeriodicalIF":2.6,"publicationDate":"2023-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138628820","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 Systems Evaluation Model for the Development of Companion Diagnostics and Associated Molecularly Targeted Therapies","authors":"Kozue Okamura,&nbsp;Hiroki Tsuchiya,&nbsp;Risa Hamada,&nbsp;Yusuke Hayashi,&nbsp;Sara Badr,&nbsp;Seiichi Ohta,&nbsp;Hirokazu Sugiyama","doi":"10.1007/s12247-023-09788-5","DOIUrl":"10.1007/s12247-023-09788-5","url":null,"abstract":"<div><h3>Purpose</h3><p>Monoclonal antibodies (mAbs) are important active ingredients of molecularly targeted drugs, which are only effective for specific patient groups. Early assessment of their effectiveness is important for more efficient use of time and resources. Companion diagnostics (CDx) are medical devices or tests to identify groups of promising patients based on specific biomarkers. This work offers a systems evaluation model and a comprehensive assessment from multiple stakeholder perspectives.</p><h3>Methods</h3><p>This work introduces a new systems model for assessing available treatment options. Process system diagrams, consisting of independently defined unit structures, are applied to represent the expected decision points and outcomes. A sensitivity analysis is conducted to identify the critical requirements for achieving cost-effectiveness. The model was applied to a case of terminal colorectal cancer treatment to compare mAb drugs to standard therapy.</p><h3>Results</h3><p>The results showed that from the payers’ perspective, the cost and response rates of the mAb drug were critical parameters to improve for achieving the target cost-effectiveness. The results give quantitative guidance for the required improvement.</p><h3>Conclusion</h3><p>This work represents an important step towards a fair and systematic assessment of treatment alternatives and serves as a guideline for future CDx and therapy technology development efforts.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 4","pages":"2265 - 2276"},"PeriodicalIF":2.6,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-023-09788-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138566339","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}