Journal of Pharmaceutical Innovation最新文献

{"title":"Editorial: Biologics and Parenterals: Major Newsmakers","authors":"Stephen Scypinski","doi":"10.1007/s12247-023-09726-5","DOIUrl":"10.1007/s12247-023-09726-5","url":null,"abstract":"","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 1","pages":"1 - 1"},"PeriodicalIF":2.6,"publicationDate":"2023-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4238264","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":"Editorial: December 2022: Welcome to the Postmodern World","authors":"Stephen Scypinski","doi":"10.1007/s12247-022-09700-7","DOIUrl":"10.1007/s12247-022-09700-7","url":null,"abstract":"","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 4","pages":"1073 - 1073"},"PeriodicalIF":2.6,"publicationDate":"2022-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4204235","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":"Editorial: September 2022, What’s Next?","authors":"Stephen Scypinski","doi":"10.1007/s12247-022-09682-6","DOIUrl":"10.1007/s12247-022-09682-6","url":null,"abstract":"","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 3","pages":"611 - 611"},"PeriodicalIF":2.6,"publicationDate":"2022-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4629776","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":"Box Behnken Design-Enabled Development of Nanostructured Lipid Carrier Transdermal Patch for Enhancement of Bioavailability of Olmesartan Medoxomil","authors":"Laxmidhar Sahoo,&nbsp;Goutam Kumar Jena,&nbsp;Chandra Sekhar Patro,&nbsp;Ch.Niranjan Patro,&nbsp;Sukanta Satapathy","doi":"10.1007/s12247-022-09675-5","DOIUrl":"10.1007/s12247-022-09675-5","url":null,"abstract":"<div><h3>Objective</h3><p>Olmesartan medoxomil is an antihypertensive agent used for the management of hypertension but it undergoes first-pass metabolism when taken orally and bioavailability is less than 28%. This can be overcome by choosing it for topical administration by loaded with nanostructured lipid carrier (NLC) and prolonging its action.</p><h3>Methods</h3><p>Nanostructured lipid carrier loaded with olmesartan was prepared by high-speed hot homogenization and melt emulsification low-temperature solidification method. The formulation was composed of solid lipid, liquid lipid, surfactants, and polymers. Formulation fabrication and optimization by Box Behnken design with Design Expert software version 8.0.0. The prepared NLC formulations were studied for drug loading, entrapment efficiency, transmission electron microscopy, zeta potential, and particle size and stability study. The transdermal patch loaded with NLC containing olmesartan was fabricated and optimized.</p><h3>Results</h3><p>The optimized NLC formulation of olmesartan was used to fabricate it into transdermal patches. The optimized formulation (NLC F13) was found to possess particle size, zeta potential, polydispersity index, and entrapment efficiency of 284 nm, − 24.16 mV, 0.8, and 80.17%, respectively. The prepared optimized NLC-loaded transdermal patch was evaluated for weight variation, folding endurance, drug content, and drug release; the results were found as 0.074 ± 0.003, 122 ± 2.56, 92.44 ± 1.89, and 94.24 ± 0.832, respectively. In vivo pharmacokinetic study was approved by IAEC Regd. No. 926/PO/Re/S/06/CPCSEA. The study was a comparison of the pure drug (oral), drug-loaded NLC (oral), and drug-loaded NLC patch (transdermal). It was found that AUC _0–24 and AUC _0-∞ of drug-loaded NLC patch were 17.257 ng. h/mL and 34.259 ng. h/mL as compared with pure drug for oral 8.603 ng. h/mL and 16.547 ng.h/mL, respectively. The AUC _0–24 and AUC _0-∞ of drug-loaded NLC for the oral route were found at 17.857 ng. h/mL and 29.727 ng. h/mL, respectively.</p><h3>Conclusion</h3><p>It was found that formulation was optimized successfully and the bioavailability of the drug enhances significantly as compared to the pure drug and drug-loaded NLC for the oral route. So, optimized formulation was a promising drug delivery system for the effective treatment of hypertension.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 4","pages":"1405 - 1419"},"PeriodicalIF":2.6,"publicationDate":"2022-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4847936","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 Optimization of HP-β-CD Inclusion Complex-Based Fast Orally Disintegrating Tablet of Pitavastatin Calcium","authors":"Prachi Pimple,&nbsp;Prabha Singh,&nbsp;Arati Prabhu,&nbsp;Sonika Gupta","doi":"10.1007/s12247-022-09661-x","DOIUrl":"10.1007/s12247-022-09661-x","url":null,"abstract":"<div><h3>Purpose</h3><p>The objective of the present study was to develop HP-β-cyclodextrin inclusion complex-based rapid orally disintegrating tablets of pitavastatin calcium by unique sublimation technique for enhancing solubility and dissolution profile of anti-lipidemic class II drug.</p><h3>Methods</h3><p>The inclusion complex was prepared by a physical mixing method containing HP-β-cyclodextrin and pitavastatin calcium. The inclusion complex formation between the guest and host was confirmed by molecular docking studies. The developed inclusion complex was further characterized using differential scanning calorimetry (DSC), Fourier transform-infrared spectroscopy (FT-IR), powder X-ray diffraction study (PXRD), and scanning electron microscopy studies. Fast orally disintegrating tablets of pitavastatin calcium inclusion complex were developed by a unique sublimation technique employing full factorial design (2⁴) using the Design Expert® software. Independent factors, namely, type of super disintegrants and sublimating agents at varying concentrations, were studied for effect on disintegration time, hardness of the tablet, and in vitro drug release.</p><h3>Results</h3><p>Molecular docking studies showed a score of −8.08. Optimized formulation containing 5% Ac-di-sol, 10% camphor showed hardness of about 3.37 ± 0.11 kg/cm², least disintegration time 15.31 ± 0.32 s, and highest in vitro drug release of 99.11 ± 0.23% at the end of 15 min.</p><h3>Conclusion</h3><p>The employed complexation method enhanced solubility and increased in vitro dissolution of pitavastatin calcium. It was concluded that fast orally disintegrating tablets containing inclusion complex gave desired characteristics which provided rapid onset of action by fast disintegration and could improve patient compliance.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 3","pages":"993 - 1010"},"PeriodicalIF":2.6,"publicationDate":"2022-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-022-09661-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4393511","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":"FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply","authors":"Philip J. Almeter,&nbsp;James T. Isaacs,&nbsp;Aaron N. Hunter,&nbsp;Bradley S. Henderson,&nbsp;Thomas Platt,&nbsp;Billie J. Mitchell,&nbsp;David Do,&nbsp;Alyssa B. Brainard,&nbsp;Joshua E. Brown,&nbsp;Rachael M. Stone,&nbsp;Bao-Han Nguyen,&nbsp;Matthew F. Warren,&nbsp;Smaran A. Bhaktawara,&nbsp;Megan N. Bossle,&nbsp;Lindsey M. Long,&nbsp;Stephanie P. Zapata,&nbsp;Cinnamon R. Larkin,&nbsp;Thomas A. Lyman,&nbsp;Seth A. Larkin,&nbsp;Jonathan A. Labuhn,&nbsp;Jeffrey W. Reynolds,&nbsp;Erin E. Schuler,&nbsp;Ryan W. Naseman,&nbsp;Gary L. Johnson,&nbsp;Robert A. Lodder","doi":"10.1007/s12247-022-09659-5","DOIUrl":"10.1007/s12247-022-09659-5","url":null,"abstract":"<div><p>Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.\u0000</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 2","pages":"269 - 282"},"PeriodicalIF":2.6,"publicationDate":"2022-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-022-09659-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4128158","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":"Design, Optimization, and Characterization of Lysozyme-Loaded Poly(ɛ-Caprolactone) Microparticles for Pulmonary Delivery","authors":"Burcu Devrim Gökberk,&nbsp;Nilhan Erdinç","doi":"10.1007/s12247-022-09648-8","DOIUrl":"10.1007/s12247-022-09648-8","url":null,"abstract":"<div><h2>Abstract\u0000</h2><div><h3>Purpose</h3><p>The success of the treatment of lung diseases with minimized side effects depends on the optimum design of microparticulate systems for pulmonary delivery that provide local delivery of drugs. This study aims to develop and evaluate optimized drug delivery systems against cystic fibrosis for pulmonary delivery.</p><h3>Methods</h3><p>Lysozyme, an antimicrobial peptide, was used as an alternative drug to conventional antibiotics. Since lysozyme is a water-soluble drug, lysozyme-loaded microparticles were prepared using the water-in-oil-in-water (w₁/o/w₂) double emulsion solvent evaporation method. Polycaprolactone (PCL) was chosen as a polymer due to its biocompatible and biodegradable properties. Designed microparticles were optimized utilizing 2⁴ full factorial experimental design based on desired response factors including particle size and encapsulation efficiency (%EE).</p><h3>Results and conclusion</h3><p>Optimized formulation was found to display particle size of 8.75 ± 0.04 µm and %EE of 65.15 ± 0.00%. Results of SEM analysis have shown the spherical structure of microparticles with a smooth surface. Optimized microparticles were found to exhibit sustained release for up to 35 days after initial burst release. Mean median aerodynamic diameter (MMAD) and fine particle fraction (FPF) values were found to be 5.44 ± 0.19 μm and 50.99 ± 2.89%, respectively. These results demonstrated that optimized PCL microparticles can be used for pulmonary delivery of lysozyme.\u0000</p></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 1","pages":"325 - 338"},"PeriodicalIF":2.6,"publicationDate":"2022-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4805130","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":"The Truth Is on the Shelves","authors":"Philip J. Almeter,&nbsp;Robert A. Lodder","doi":"10.1007/s12247-022-09660-y","DOIUrl":"10.1007/s12247-022-09660-y","url":null,"abstract":"","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 2","pages":"267 - 268"},"PeriodicalIF":2.6,"publicationDate":"2022-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4659481","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":"Rheological and Structural Study of Solid Lipid Microstructures Stabilized within a Lamellar Gel Network","authors":"Mohamed Kouider Amar,&nbsp;Soufiane Rahal,&nbsp;Maamar Laidi,&nbsp;Redha Rebhi,&nbsp;Mohamed Hentabli,&nbsp;Salah Hanini,&nbsp;Mabrouk Hamadache","doi":"10.1007/s12247-022-09642-0","DOIUrl":"10.1007/s12247-022-09642-0","url":null,"abstract":"<div><h2>Abstract\u0000</h2><div><h3>Purpose</h3><p>This study aimed to investigate the influence of different ratios and amounts of cetyl and stearyl fatty alcohols in interaction with cetyl palmitate fatty acid ester as they are responsible for the rheological and microstructural modifications in the SLMs.</p><h3>Methods</h3><p>SLMs were prepared as ternary systems in the absence of an oil phase; Tween 80 was selected as nonionic surfactant that was blended with the fatty amphiphiles forming the lipid phase, and ultra-purified water constituted the aqueous phase; the hot emulsification and high shear homogenization methods were used to produce the SLMs, and central composite face design was used to evaluate and model the SLMs particles size, polydispersity, and rheological parameters.</p><h3>Results</h3><p>The formulated SLMs have an average particle size ranging from 18.4 to 59.4 µm which showed that the lipids’ ratio and amount have affected significantly (<i>p</i> &lt; 0.05) the rheological and microscopic parameters, and the optimization led to lipid combination of SA/CA/CP/0.41:0.41:0.18 with a consistent structure and shear thinning behavior. The drug-loaded SLMs have a sustained release profile up to 12 h with a release rate ranged from 1.6 to 2.6 mg/h for 12% and 9% lipids content formulations.</p><h3>Conclusion</h3><p>The rheological and microstructural behaviors of the studied SLMs are strongly related with the swelling capacity of the formed gel network, while their ratios, amounts, and storage time controlled the structure. The findings in this study may provide further insights of SLMs rheological and structural behaviors in different dispersion mixtures.\u0000</p></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 4","pages":"1434 - 1450"},"PeriodicalIF":2.6,"publicationDate":"2022-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4507854","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 Optimization of Nanophytosomes Containing Mucuna prureins Hydroalcoholic Extract for Enhancement of Antidepressant Activity","authors":"Poonam Karekar,&nbsp;Suresh Killedar,&nbsp;Sudhanshu Kulkarni,&nbsp;Amir Shaikh,&nbsp;Poournima Patil","doi":"10.1007/s12247-022-09646-w","DOIUrl":"10.1007/s12247-022-09646-w","url":null,"abstract":"<div><h3>Purpose</h3><p>In this study, the herbal formulation containing nanophytosomes of <i>Mucuna prureins</i> extract (MPE) was engineered to ameliorate its rate of drug release, in vivo antidepressant profile, and stability.</p><h3>Method</h3><p>The <i>Mucuna prureins</i> nanophytosomes (MPP) were designed by using a full factorial design approach, taking into consideration various variables that could give optimized formulation. Then, pure extract and optimized formulation showing higher entrapment efficiency were studied for in vitro dissolution and in vivo antidepressant activity in depression models like forced swimming test (FST) and tail suspension test (TST) in Swiss albino mice. The physicochemical characterization was carried out using particle size analysis and zeta potential, Fourier transformation infrared spectroscopy, differential scanning calorimetry, proton nuclear magnetic resonance, powder X-ray diffractometer, scanning electron microscopy, and solubility studies. Moreover, the stability of nanophytosomes was assessed by subjecting optimized formulation to freeze–thaw cycle stability testing and calculating entrapment efficiency at the end of the cycle.</p><h3>Results</h3><p>PXRD and SEM revealed a decrease in the crystalline nature of nanophytosomes. ¹H NMR, DSC, and FTIR asserted the formation of the phyto-phospholipids complex. The rate and extent of dissolution were also found enhanced and sustained in nanophytosomes as compared to pure extract. In vivo antidepressant activity depicted a significant reduction of immobility in mice treated with nanophytosomes as compared to those treated with the pure extract. Moreover, optimized formulation was found stable as entrapment efficiency values were not reduced significantly.</p><h3>Conclusion</h3><p>Thus, nanophytosomes drug delivery could be the best strategy to improve physicochemical properties of extract and thus could be exploited for the extracts having poor solubility, poor permeability, and poor stability.</p><h3>Graphical Abstract</h3>\u0000 <figure><div><div><div><picture><source><img></source></picture></div></div></div></figure>\u0000 </div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 1","pages":"310 - 324"},"PeriodicalIF":2.6,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-022-09646-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4442052","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}