PharmaceuticsPub Date : 2025-06-30DOI: 10.3390/pharmaceutics17070860
Magdi Abobaker, Mershen Govender, Yahya E Choonara
{"title":"Co-Formulation of Iron Oxide and PLGA Nanoparticles to Deliver Curcumin and IFNα for Synergistic Anticancer Activity in A375 Melanoma Skin Cancer Cells.","authors":"Magdi Abobaker, Mershen Govender, Yahya E Choonara","doi":"10.3390/pharmaceutics17070860","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070860","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Skin cancer remains a significant global health issue, driving the development of new treatment strategies to improve clinical outcomes and prevent recurrence. Traditional monotherapies often face obstacles such as bioactive resistance, prompting interest in combination therapies that enhance efficacy, while minimizing side effects. This study investigated the use of a co-nanoparticle approach of iron oxide nanoparticles (NPs) surface-functionalized with curcumin (Cur-FeONPs) delivered with prolonged-release interferon alpha (IFNα)-loaded PLGA NPs (IFNα-PLGANPs) for the synergistic treatment of malignant melanoma tested in A375 cells. <b>Methods</b>: Extensive in vitro characterization studies of the Cur-FeONPs and IFNα-PLGANPs were performed, including zeta-size profiling, morphological studies, and structural validation, in addition to cytotoxicity assessments on A375 melanoma and NIH-3T3 fibroblast cells. <b>Results</b>: The Cur-FeONP and IFNα-PLGANPs synthesis processes yielded NPs with an average size of 111.0 nm and 97.0 nm, respectively. Morphological and structural validation studies determined the successful synthesis of the nanoparticulate systems, with cell viability analyses displaying significant cytotoxicity against A375 melanoma cells for the combination treatment, when compared to the individual platforms, with a minimal effect on NIH-3T3 fibroblast cells. <b>Conclusions</b>: The results of this study present a promising synergistic approach for enhanced anticancer activity in A375 melanoma skin cancer cells, providing a potential platform for future preclinical and clinical studies.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144743994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmaceuticsPub Date : 2025-06-30DOI: 10.3390/pharmaceutics17070858
Dorota Śpiewak, Łukasz Drzyzga, Mariola Dorecka, Katarzyna Witek, Dorota Wyględowska-Promieńska
{"title":"Efficacy of Faricimab in the Treatment of Diabetic Macular Edema and Faricimab-Related Changes in OCT and OCT Angiography.","authors":"Dorota Śpiewak, Łukasz Drzyzga, Mariola Dorecka, Katarzyna Witek, Dorota Wyględowska-Promieńska","doi":"10.3390/pharmaceutics17070858","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070858","url":null,"abstract":"<p><p>Our study aimed to assess the anatomical changes in the retina, including the assessment of the reduction of diabetic macular edema (DME) on optical coherence tomography (OCT) and the improvement of retinal microvascular parameters, defined by the reduction of nonperfusion areas on OCT angiography (OCTA) after intravitreal injections of 6 mg faricimab, an anti-VEGF drug used in the treatment of DME. The study included twenty-two patients aged between 61 and 74 years, each of whom received four loading doses of 6 mg faricimab at 1-month intervals, as described in the summary of product characteristics. Hemodynamic parameters were analyzed by OCT angiography before the first intravitreal injection of faricimab and one month after each subsequent injection. The following parameters were analyzed: non-perfusion area (NPA), superficial capillary plexus (SCP) and deep capillary plexus (DCP), outer retinal flow area (ORFA), choriocapillaris flow area (CCFA) and foveal avascular zone (FAZ). Despite differences in the magnitude of improvement and time to improvement from the start of treatment with intravitreal injections of 6 mg faricimab, reductions in DME and improvements in OCTA parameters resulted in increased retinal blood flow and better visual acuity.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmaceuticsPub Date : 2025-06-29DOI: 10.3390/pharmaceutics17070852
Alina Ionela Stancu, Magdalena Mititelu, Anton Ficai, Lia-Mara Ditu, Mihaela Buleandră, Irinel Adriana Badea, Elena Pincu, Marius Constantin Stoian, Oana Brîncoveanu, Adina Boldeiu, Eliza Oprea
{"title":"Comparative Evaluation of <i>β</i>-Cyclodextrin Inclusion Complexes with Eugenol, Eucalyptol, and Clove Essential Oil: Characterisation and Antimicrobial Activity Assessment for Pharmaceutical Applications.","authors":"Alina Ionela Stancu, Magdalena Mititelu, Anton Ficai, Lia-Mara Ditu, Mihaela Buleandră, Irinel Adriana Badea, Elena Pincu, Marius Constantin Stoian, Oana Brîncoveanu, Adina Boldeiu, Eliza Oprea","doi":"10.3390/pharmaceutics17070852","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070852","url":null,"abstract":"<p><p>Clove essential oil (<i>Eugenia caryophyllata</i> essential oil, ECEO) is known for its high eugenol content and notable antimicrobial properties. However, the volatility and instability of its active compounds hinder broader pharmaceutical applications. <b>Methods:</b> This study characterised the chemical composition of ECEO and comparatively evaluated four <i>β</i>-cyclodextrin (<i>β</i>-CD) encapsulation methods: kneading, co-precipitation, lyophilisation, and co-precipitation-lyophilisation for eugenol, eucalyptol, and ECEO. Encapsulation efficiency, physicochemical properties, and antimicrobial potential were assessed. Analytical techniques included Gas Chromatography-Mass Spectrometry (GC-MS), Headspace GC-MS (HS-GC-MS), Differential Scanning Calorimetry (DSC), Job's method, and Dynamic Light Scattering (DLS). <b>Results:</b> GC-MS identified eugenol (90.67%), eugenyl acetate (4.77%), and (E)-<i>β</i>-caryophyllene (3.98%) as major components of ECEO, while HS-GC-MS indicated a slightly reduced eugenol content (86.46%). The kneading method yielded the highest encapsulation efficiency for eugenol, whereas the co-precipitation-lyophilisation method was optimal for eucalyptol. DSC thermograms confirmed complex formation, and DLS analysis revealed nanostructures averaging 186.4 nm in diameter (PDI = 0.298). Antimicrobial assays showed MIC values ranging from 0.039 mg/mL to 10,000 mg/mL. Notably, ECEO and its <i>β</i>-CD complex displayed enhanced efficacy against <i>Escherichia coli</i> (0.039 mg/mL), surpassing the reference antibiotic gentamicin (0.049 mg/mL). <b>Conclusions:</b><i>β</i>-Cyclodextrin encapsulation significantly enhances the stability and bioactivity of volatile antimicrobial compounds, thereby supporting their potential integration into advanced essential oil-based pharmaceutical formulations.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144743996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmaceuticsPub Date : 2025-06-29DOI: 10.3390/pharmaceutics17070851
Ping Li, Yihua Tian, Hong Wang, Yuting Ji, Huiying Zeng, Shengman Zhang, Xiuli Gao, Xiaoyan Chen
{"title":"Effect of Hepatic Impairment on the Pharmacokinetics of Baicalin in Rats: Critical Roles of Gut Microbiota and Hepatic Transporters.","authors":"Ping Li, Yihua Tian, Hong Wang, Yuting Ji, Huiying Zeng, Shengman Zhang, Xiuli Gao, Xiaoyan Chen","doi":"10.3390/pharmaceutics17070851","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070851","url":null,"abstract":"<p><p><b>Background</b>: Baicalin (BG) has been used in the treatment of many diseases. However, the effect of hepatic insufficiency on its pharmacokinetics has not been reported, and there is a lack of clinical guidance for the use of BG in patients with hepatic impairment. <b>Methods</b>: Carbon tetrachloride (CCl<sub>4</sub>)-induced rat models were used to simulate hepatic failure patients to assess the effect of hepatic impairment on the pharmacokinetics and distribution of BG. In vitro metabolism and transporter studies were employed to elucidate the potential mechanisms. <b>Results</b>: After intragastric administration of 10 mg/kg of BG, the peak plasma concentration and exposure (AUC<sub>0-t</sub>) of BG decreased by 64.6% and 52.6%, respectively, in CCl<sub>4</sub>-induced rats. After intravenous administration, the AUC<sub>0-t</sub> decreased by 73.6%, and unlike in the control group, the second absorption peak of BG was not obvious in the concentration-time curve of CCl<sub>4</sub>-induced rats. The cumulative excretion of BG in the feces increased, but that in the bile decreased. In vivo data indicated that the absorption and enterohepatic circulation of BG were affected. In vitro studies found that the hydrolysis of BG to the aglycone baicalein decreased significantly in the intestinal tissues and contents of the CCl<sub>4</sub>-induced rats. And BG was identified as a substrate for multiple efflux and uptake transporters, such as breast cancer resistance protein (BCRP) and multidrug resistance-associated proteins (MRPs), organic anion transporting polypeptides (OATP1B1, 1B3, 2B1), and organic anion transporters (OATs). The bile acids accumulated by liver injury inhibited the uptake of BG by OATPs, especially that by OATP2B1. <b>Conclusions</b>: Hepatic impairment reduced BG hydrolysis by intestinal microflora and inhibited its transporter-mediated biliary excretion, which synergistically led to the attenuation of the enterohepatic circulation of BG, which altered its pharmacokinetics.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Potentials and Challenges in Development of Vesicular Phospholipid Gel as a Novel Dermal Vehicle for Thymol.","authors":"Sabina Keser, Zora Rukavina, Marica Jozić, Lea Pavlović-Mitrović, Magda Vodolšak, Kristina Kranjčec, Darija Stupin Polančec, Gordana Maravić-Vlahoviček, Jasmina Lovrić, Maja Šegvić Klarić, Željka Vanić","doi":"10.3390/pharmaceutics17070854","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070854","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Thymol, one of the main compounds of thyme essential oil, has shown promising effects in treating various skin disorders owing to its anti-inflammatory, antimicrobial and antioxidative activities. Due to its limited solubility in water, thymol is commonly used in higher concentrations to achieve a suitable therapeutic effect, which can consequently lead to skin irritation. To overcome these limitations, we incorporated thymol into a vesicular phospholipid gel (VPG), a novel semisolid dermal vehicle consisting of highly concentrated dispersion of phospholipid vesicles (liposomes). <b>Methods:</b> Thymol was successfully loaded into two VPGs differing in bilayer fluidity, which were characterized for the physicochemical and rheological properties, storage stability, in vitro release, ex vivo skin permeability, in vitro compatibility with epidermal cells, wound healing potential, and antibacterial activity against skin-relevant bacterial strains. <b>Results:</b> High pressure homogenization method enabled preparation of VPG-liposomes of neutral surface charge in the size range 140-150 nm with polydispersity indexes below 0.5. Both types of VPGs exhibited viscoelastic solid-like structures appropriate for skin administration and ensured skin localization of thymol. Although both types of VPGs enabled prolonged release of thymol, the presence of cholesterol in the VPG increased the rigidity of the corresponding liposomes and further slowed down thymol release. <b>Conclusions:</b> Loading of thymol into VPGs significantly reduced its cytotoxicity toward human keratinocytes in vitro even at very high concentrations, compared to free thymol. Moreover, it facilitated in vitro wound healing activity, proving its potential as a vehicle for herbal-based medicines. However, the antibacterial activity of thymol against <i>Staphylococcus aureus</i> and methicillin-resistant <i>S. aureus</i> was hindered by VPGs, which represents a challenge in their development.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Optimizing Burn Wound Healing: The Critical Role of pH and Rheological Behavior in Plant-Derived Topical Formulations.","authors":"Oana-Janina Roșca, Georgeta-Hermina Coneac, Roxana Racoviceanu, Alexandru Nistor, Ioana-Viorica Olariu, Ana-Maria Cotan, Roxana Negrea-Ghiulai, Cristina Adriana Dehelean, Lavinia Lia Vlaia, Codruța Marinela Șoica","doi":"10.3390/pharmaceutics17070853","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070853","url":null,"abstract":"<p><p><b>Background:</b> In burn injuries, wound healing effectiveness is complex and influenced significantly by the local biochemical environment and the physicochemical properties of topical preparations. pH lesions modulation can influence protection barrier integrity, inflammatory responses, and microbial colonization. Their antioxidant, antimicrobial, and anti-inflammatory properties, of the topical formulations enriched with plant extracts have demonstrated promising results. <b>Objective:</b> The aim of the study was to develop and characterize topical oleogel and hydrogel formulations containing ethanolic and hydroalcoholic extracts of medicinal plants (<i>Boswellia serrata</i>, <i>Ocimum basilicum</i>, <i>Sambucus nigra</i>, and <i>Galium verum</i>), and to evaluate the impact of their physicochemical properties, rheological behavior, in contrast with the wound pH modulation, and healing efficacy in an experimental burn model. <b>Methods:</b> Second-degree burns were induced uniformly on Wistar rats using the validated RAPID-3D device. All formulations were applied daily for 21 days, and wound healing was assessed through several measurements specific to the wound surface, skin temperature, pH, and, last but not least, histological analyses. Formulations' physicochemical and rheological properties, including pH, viscosity, and spreadability, were also analyzed and systematically characterized. <b>Results:</b> Oleogel formulations demonstrated superior wound healing performance compared to hydrogels. Formulations containing <i>Boswellia serrata</i> and <i>Ocimum basilicum</i> extracts significantly reduced wound size, inflammation, and melanin production by days 9 and 21 (<i>p</i> < 0.05). The beneficial outcomes correlated strongly with formulation acidity (pH < 6), high viscosity, and enhanced thixotropic behavior, indicating improved adherence and sustained bioactive compound release. Histological evaluations confirmed enhanced epithelialization and reduced inflammation. <b>Conclusions:</b> Particularly <i>Boswellia serrata</i> and <i>Ocimum basilicum</i> in oleogel formulations in ethanolic solvent effectively modulated wound pH, enhanced topical adherence, and improved burn wound healing. These findings highlight their potential clinical application and justify further clinical investigations.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmaceuticsPub Date : 2025-06-29DOI: 10.3390/pharmaceutics17070850
Azza A K Mahmoud, Géza Regdon, Katalin Kristó
{"title":"Cutting-Edge Approaches in the Co-Amorphization Process.","authors":"Azza A K Mahmoud, Géza Regdon, Katalin Kristó","doi":"10.3390/pharmaceutics17070850","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070850","url":null,"abstract":"<p><p><b>Background:</b> Recently, the co-amorphization method has been widely used to refine the bioavailability characteristics of poorly soluble drugs in addition to overcoming the drawbacks of other traditional amorphization techniques. <b>Objectives:</b> The main aim of this systematic review is to present an extensive outline of different co-former classes, co-former selection, and evaluation of produced co-amorphous systems. Methods: The systematic research was carried out based on three different databases, including PubMed, Scopus, and Web of Science time using co-amorphous, co-former, and drug as keywords. The selected papers were written in the English language and published between 2016 and 2024, and they focused on the co-amorphous systems, while articles discussing other amorphization techniques and crystallization processes were excluded. <b>Results:</b> 127 peer-reviewed articles were selected and summarized. <b>Conclusions:</b> This paper revealed that amino acid is the most commonly used co-former, specifically arginine with acidic drugs and tryptophan with acidic and basic drugs, and it reported other co-formers that were used and different co-amorphous systems with their dissolution behaviour and stabilities, and different computational tools that were applied in the selection of co-former and process result evaluation.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmaceuticsPub Date : 2025-06-28DOI: 10.3390/pharmaceutics17070849
Beáta-Mária Benkő, Bálint-Imre Szabó, Szabina Kádár, Edina Szabó, Gergő Tóth, Lajos Szente, Péter Tonka-Nagy, Romána Zelkó, István Sebe
{"title":"Development of Low-Dose Disulfiram Rectal Suppository Intended for Application in Post-Treatment Lyme Disease Syndrome.","authors":"Beáta-Mária Benkő, Bálint-Imre Szabó, Szabina Kádár, Edina Szabó, Gergő Tóth, Lajos Szente, Péter Tonka-Nagy, Romána Zelkó, István Sebe","doi":"10.3390/pharmaceutics17070849","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070849","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Early diagnosis and oral or, in severe cases, intravenous antibiotics are usually effective for Lyme disease, but some patients have persistent symptoms unresponsive to standards of care, requiring alternative therapies. Disulfiram (DIS), a drug for alcoholism, is under investigation as a potential adjunctive treatment, but its low bioavailability, rapid metabolism, and safety concerns urge the development of improved formulations for clinical translation. <b>Methods</b>: Screening dissolution and permeation studies were investigated for vehicle and excipient selection, following the pharmacopeia perspectives to develop and optimize the low-dose DIS rectal suppository intended for application in post-treatment Lyme disease syndrome (PTLDS). Further characterizations were carried out by differential scanning calorimetry, X-ray diffraction, and infrared spectroscopy. <b>Results</b>: Cyclodextrin (CD) encapsulation was investigated to improve the aqueous solubility of the hydrophobic drug. The dissolution of DIS from fatty base suppository was very slow; it was remarkably improved by the molecular encapsulation of the drug with CDs. The dissolution of DIS from a water-soluble base was more favorable, but incomplete. In the polyethylene glycol (PEG) based suppositories, the addition of CDs already in a physical mixture ensured the dissolution of the drug. The presented drug delivery system relates to a novel preparation for rectal administration comprising a low-dose disulfiram with improved solubility and permeability by the PEG and hydroxypropyl-β-cyclodextrin (HPBCD) synergistic matrix. <b>Conclusions</b>: The rectal dosage form containing the drug and CD in the physical mixture is advantageous, avoiding the hepatic first-pass effect, minimizing dose-limiting toxicity, simplifying production, and fasting the availability of the repositioned drug.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tear Film and Keratitis in Space: Fluid Dynamics and Nanomedicine Strategies for Ocular Protection in Microgravity.","authors":"Ryung Lee, Rahul Kumar, Jainam Shah, Joshua Ong, Ethan Waisberg, Alireza Tavakkoli","doi":"10.3390/pharmaceutics17070847","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070847","url":null,"abstract":"<p><p>Spaceflight-associated dry eye syndrome (SADES) has been reported among astronauts during both International Space Station (ISS) and Space Transportation System (STS) missions. As future missions extend beyond low Earth orbit, the physiological challenges of spaceflight include microgravity, radiation, and environmental stressors, which may further exacerbate the development of ocular surface disease. A deeper understanding of the underlying pathophysiology, along with the exploration of innovative countermeasures, is critical. In this review, we examine nanomedicine as a promising countermeasure for managing ophthalmic conditions in space, with the goal of enhancing visual health and mission readiness for long-duration exploration-class missions.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmaceuticsPub Date : 2025-06-28DOI: 10.3390/pharmaceutics17070848
Maria do Céu Costa, Ana Patrícia Gomes, Iva Vinhas, Joana Rosa, Filipe Pereira, Sara Moniz, Elsa M Gonçalves, Miguel Pestana, Mafalda Silva, Luís Monteiro Rodrigues, Anthony DeMeo, Logan Marynissen, António Marques da Costa, Patrícia Rijo, Michael Sassano
{"title":"Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use.","authors":"Maria do Céu Costa, Ana Patrícia Gomes, Iva Vinhas, Joana Rosa, Filipe Pereira, Sara Moniz, Elsa M Gonçalves, Miguel Pestana, Mafalda Silva, Luís Monteiro Rodrigues, Anthony DeMeo, Logan Marynissen, António Marques da Costa, Patrícia Rijo, Michael Sassano","doi":"10.3390/pharmaceutics17070848","DOIUrl":"https://doi.org/10.3390/pharmaceutics17070848","url":null,"abstract":"<p><p><b>Background/Objectives:</b> The industrial extraction and purification processes of <i>Cannabis sativa</i> L. compounds are critical steps in creating formulations with reliable and reproducible therapeutic and sensorial attributes. <b>Methods:</b> For this study, standardized preparations of chemotype I were chemically analyzed, and the sensory attributes were studied to characterize the extraction and purification processes, ensuring the maximum retention of cannabinoids and minimization of other secondary metabolites. The industrial process used deep-cooled ethanol for selective extraction. <b>Results:</b> Taking into consideration that decarboxylation occurs in the process, the cannabinoid profile composition was preserved from the herbal substance to the herbal preparations, with wiped-film distillation under deep vacuum conditions below 0.2 mbar, as a final purification step. The profiles of the terpenes and cannabinoids in crude and purified Full-spectrum Extract Cannabis Oil (FECO) were analyzed at different stages to evaluate compositional changes that occurred throughout processing. Subjective intensity and acceptance ratings were received for taste, color, overall appearance, smell, and mouthfeel of FECO preparations. <b>Conclusions:</b> According to sensory analysis, purified FECO was more accepted than crude FECO, which had a stronger and more polarizing taste, and received higher ratings for color and overall acceptance. In contrast, a full cannabis extract in the market resulted in lower acceptance due to taste imbalance. The purification process effectively removed non-cannabinoids, improving sensory quality while maintaining therapeutic potency. Terpene markers of the flower were remarkably preserved in SOMAÍ's preparations' fingerprint, highlighting a major qualitative profile reproducibility and the opportunity for their previous separation and/or controlled reintroduction. The study underscores the importance of monitoring the extraction and purification processes to optimize the cannabinoid content and sensory characteristics in cannabis preparations.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 7","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}