Pharmaceutics最新文献

{"title":"Optimisation of Medicine Compounding Using Quality by Design Approach: Case Studies of Two Aqueous Cream Formulations.","authors":"Okhee Yoo, Wenting Li, Siyu Ruan, Elizabeth Syme, Alisha Rodrigo, Connelia Locher, Sharmin Sultana, Lee Yong Lim","doi":"10.3390/pharmaceutics17091232","DOIUrl":"10.3390/pharmaceutics17091232","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Quality-by-Design (QbD) is a proactive, risk-based, regulatory-endorsed approach to the development and manufacture of medicinal products but is rarely applied to medicines compounded by pharmacists. This study aims to apply the QbD approach to optimise the compounding processes for the aqueous cream and cetomacrogol cream formulations listed in the Australian Pharmaceutical Formulary and Handbook (APF). <b>Methods</b>: The creams were prepared by varying the process conditions, including oil and water phase temperatures, stirring speed, cooling environment temperature, and the temperature at the end of stirring. Thirty-two samples of each cream type were prepared using combinations of processing conditions defined by a three-level factorial design. The viscosity, spreadability and creaming index of samples were assessed as response variables, and results were analysed using Stat-Ease 360© software to determine the optimal processing conditions for the two creams. To validate the predictive model and assess further cream stability, triplicate creams of each formulation were prepared using the optimised conditions and evaluated for dynamic viscosity, spreadability and creaming index. <b>Results</b>: Optimal conditions for aqueous cream involved heating the oil and water phases to 60 °C and 80 °C, respectively, followed by stirring the two phases at 250 rpm at 10 °C until cooling to 50 °C. For cetomacrogol cream, optimal compounding required heating the oil and water phases to 70 °C and 75 °C, respectively, with stirring the two phases at 220 rpm at ambient temperature (25 °C) until cooling to 40 °C. The conditions predicted by the models successfully yielded creams that met all specified targets. Creams compounded under optimal conditions exhibited well-defined oil droplets, with uniform droplet size in aqueous cream and mild size heterogeneity in cetomacrogol cream. Freeze-thaw testing demonstrated that both optimised creams were stable with no observable phase separation. <b>Conclusions</b>: This study demonstrates that a systematic experimental approach to optimising compounding parameters for the APF aqueous cream and cetomacrogol cream resulted in high-quality, stable, and reproducible products. Formulary guidelines, such as the APF, could benefit from adopting QbD approaches to improve the standardisation of compounding instructions in pharmacy practice.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145176706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Laponite^®-Based Smart Hydrogels for Sustained Topical Delivery of Silver Sulfadiazine: A Strategy for the Treatment of Contaminated or Biofilm-Forming Wounds.","authors":"Jonas Lira do Nascimento, Michely Conceição Viana da Costa, Leticia Farias de Macêdo, Luiz Henrique Chaves de Macêdo, Ricardo Olímpio de Moura, Tomás Jeferson Alves de Mélo, Wilma Raianny Vieira da Rocha, Ana Cristina Figueiredo de Melo Costa, José Lamartine Soares-Sobrinho, Dayanne Tomaz Casimiro da Silva","doi":"10.3390/pharmaceutics17091234","DOIUrl":"10.3390/pharmaceutics17091234","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Silver sulfadiazine (AgSD) is widely used in the topical treatment of burns and infected wounds, but its conventional formulations present drawbacks such as poor water solubility, the need for multiple daily applications, and patient discomfort. To overcome these limitations, this study aimed to develop and evaluate Laponite^® (LAP)-based hydrogels loaded with AgSD for controlled release and enhanced antimicrobial and antibiofilm efficacy, offering a promising alternative for the treatment of contaminated or biofilm-forming wounds. <b>Methods</b>: Laponite^®-based hydrogels containing 1% and 1.2% AgSD (LAP@AgSD) were prepared using a one-pot method. The formulations were characterized rheologically, thermally, and structurally. In vitro drug release was assessed using Franz diffusion cells, and mathematical modeling was applied to determine release kinetics. Antibacterial and antibiofilm activities were evaluated against <i>Staphylococcus aureus</i>, <i>Escherichia coli</i>, and <i>Pseudomonas aeruginosa</i> using standardized microbiological methods. <b>Results</b>: LAP@AgSD hydrogels exhibited pseudoplastic behavior, high structural integrity, and enhanced thermal stability. In vitro release assays revealed a sustained release profile, best fitted by the Weibull model, indicating diffusion-controlled mechanisms. Antibacterial assays demonstrated concentration-dependent activity, with LAP@AgSD 1.2% showing superior efficacy over LAP@AgSD 1% and comparable performance to the commercial silver sulfadiazine cream (CC-AgSD). Biofilm inhibition was significant for all formulations, with CC-AgSD 1% exhibiting the highest immediate activity, while LAP@AgSD 1.2% provided sustained antibiofilm potential. <b>Conclusions</b>: LAP-based hydrogels are promising smart delivery systems for AgSD, combining mechanical robustness, controlled drug release, and effective antibacterial and antibiofilm activities. These findings support their potential use in topical therapies for infected and chronic wounds, particularly where biofilm formation is a challenge.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Evaluation of a Modified Fixed-Dose Combination Antihypertensive Tablet Containing S-Amlodipine Besylate: A Bioequivalence and Stability Study.","authors":"Hyeon Woo Moon, Jin-Hyuk Jeong, Chun-Woong Park","doi":"10.3390/pharmaceutics17091235","DOIUrl":"10.3390/pharmaceutics17091235","url":null,"abstract":"<p><p><b>Background</b>/<b>Objectives</b>: Fixed-dose combination (FDC) antihypertensive medications containing olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are widely used for the treatment of essential hypertension. Although effective, the use of racemic amlodipine, which contains both active S(-)-amlodipine and inactive R(+)-amlodipine, has been associated with dose-dependent adverse effects, such as peripheral edema. S-amlodipine, a pharmacologically active enantiomer, provides comparable antihypertensive efficacy at half the dose with a lower incidence of side effects. <b>Methods</b>: In this study, a modified FDC formulation was developed by replacing racemic amlodipine with S-amlodipine to enhance tolerability while maintaining therapeutic efficacy. <b>Results</b>: A bilayer tablet design was employed to minimize the formation of impurities and ensure formulation stability, which was confirmed under stress and accelerated conditions. In vitro dissolution testing demonstrated pharmaceutical equivalence with the marketed reference FDC, and an in vivo pharmacokinetic study confirmed bioequivalence. <b>Conclusions</b>: These results suggest that the newly developed S-amlodipine besylate-containing FDC tablet is a viable alternative to existing olmesartan/amlodipine/hydrochlorothiazide combinations, offering comparable efficacy and pharmacokinetic properties with the potential for improved safety and patient adherence in the management of hypertension.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Daunomycin Nanocarriers with High Therapeutic Payload for the Treatment of Childhood Leukemia.","authors":"Rosa M Giráldez-Pérez, Elia M Grueso, Antonio J Montero-Hidalgo, Cristina Muriana-Fernández, Edyta Kuliszewska, Raúl M Luque, Rafael Prado-Gotor","doi":"10.3390/pharmaceutics17091236","DOIUrl":"10.3390/pharmaceutics17091236","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Malignant neoplasms in children include leukemias. The main types are B-cell acute lymphoblastic leukemia (B-ALL) and acute myeloid leukemia (AML). Treatments are expensive, which is a particular problem in low-income countries. The main objective of this work was to develop specific nanosystems with small amounts of drug, allowing for affordable treatments. To this end, we designed ternary gold nanosystems (Au@16-Ph-16/DNA-Dauno) composed of daunomycin, a DNA biopolymer as a stabilizer, and the cationic surfactant gemini (TG) as a compacting agent for the DNA-daunomycin complex. <b>Methods</b>: Fluorescence, UV-visible, and CD spectroscopy, DLS and zeta potential, cell viability assays, TEM, AFM, and confocal microscopy were used to characterize and optimize nanocomposites. <b>Results</b>: The nanoparticles (Au@TG) obtained were small, stable, and highly charged in solution, allowing for optimal absorption and efficacy, capable of inducing the aggregation of the ternary nanosystem upon entering the cell, further enhancing its anticancer effect. Using nanoparticles, treatments can be redirected to the site of action, increasing the solubility and stability of the drug, minimizing the side effects of traditional treatments, and helping to overcome resistance to chemotherapy <b>Conclusions</b>: A significant decrease in the growth of pediatric B-ALL-derived cell lines (SEM and SUP-B15), constituting a potential and more affordable therapy for this type of pathology.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antiviral Activity of Liposomes Containing Natural Compounds Against CHIKV.","authors":"Marília Freitas Calmon, Luiza Araújo Gusmão, Thalles Fernando Rocha Ruiz, Guilherme Rodrigues Fernandes Campos, Gabriela Miranda Ayusso, Tamara Carvalho, Isabella do Vale Francisco Bortolato, Pâmela Joyce Previdelli Conceição, Sebastião Roberto Taboga, Ana Carolina Gomes Jardim, Andres Merits, Paula Rahal, Antonio Claudio Tedesco","doi":"10.3390/pharmaceutics17091229","DOIUrl":"10.3390/pharmaceutics17091229","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Chikungunya virus (CHIKV), a mosquito-borne single-stranded RNA virus belonging to the genus <i>Alphavirus</i> (family <i>Togaviridae</i>), causes large-scale outbreaks. However, no specific treatment for CHIKV infections is currently available. Berberine and emodin are plant-derived compounds with anti-CHIKV activities. This study aimed to evaluate the antiviral efficacy of liposomes containing berberine (LB) or emodin (LE) against CHIKV in vitro, since nanocarriers incorporating zwitterionic polymers are known to enhance the biostability, biocompatibility, and therapeutic efficacy of drug candidates. <b>Methods:</b> Liposomes were synthesized and characterized, and cell viability was assessed to determine appropriate concentrations for subsequent assays. Confocal microscopy, antiviral assays, and western blotting were performed in BHK-21 and Huh7 cells. <b>Results:</b> In BHK-21 and Huh7 cells, LB and LE were well tolerated at concentrations of 5 and 10 µM, respectively. In both cell types, liposomes were internalized; LE was predominantly localized in the cytoplasm, whereas LB was also detected in the nucleus. EGCG, used as a standard drug against CHIKV in antiviral assays, exhibited virucidal activity and inhibited RNA replication and multiple stages of the CHIKV replication cycle in BHK-21 and Huh7 cells. Both the nanoformulations and EGCG consistently suppressed the expression of CHIKV replicase and virion proteins. <b>Conclusions:</b> These findings highlight the potential of berberine- and emodin-loaded liposomes as antiviral agents against CHIKV infection.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473542/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emerging Approaches for the Discovery of Lipid-Based RNA Delivery Systems.","authors":"Paul Meers","doi":"10.3390/pharmaceutics17091231","DOIUrl":"10.3390/pharmaceutics17091231","url":null,"abstract":"<p><p>This brief review is a non-comprehensive look at some of the important aspects of lipidic nucleic acid delivery systems with a focus on RNA. In the context of this review on lipid-based formulation, nucleic acids are one of the key cargoes. Here, a brief historical background is given, highlighting a few of the key newly developing approaches to aid formulation design. These new techniques are discussed within a framework of \"bottom-up\" (rational) versus \"top-down\" (combinatorial) design. Evolving areas of interest that are discussed include multiplexed formulation and efficacy testing, new principles established in the role of the protein corona, details of the biophysical mechanism of delivery and machine learning approaches to design.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Indirect Modeling of Post-Prandial Intestinal Lymphatic Uptake of Halofantrine Using PBPK Approaches: Limitations and Implications.","authors":"Malaz Yousef, Farag E S Mosa, Khaled H Barakat, Neal M Davies, Raimar Löbenberg","doi":"10.3390/pharmaceutics17091228","DOIUrl":"10.3390/pharmaceutics17091228","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Despite the recognized importance and distinctive characteristics of the intestinal lymphatic pathway in drug absorption, its pharmacokinetic modeling remains largely unexplored. This study aimed to address this gap by developing a physiologically based pharmacokinetic model (PBPK) to represent the oral lymphatic uptake of halofantrine following a fatty meal. <b>Methods</b>: Using GastroPlus™ 9.8.3 and published literature data, halofantrine absorption, distribution, metabolism, and elimination in both fasting and fed states were modeled. As the used software does not directly simulate intestinal lymphatic transport, lymphatic involvement in the fed state was examined indirectly through parameter adjustments such as first-pass metabolism, pKa-driven solubility changes, and bile-salt-mediated solubilization, with the aid of molecular dynamics simulations under post-prandial pH. <b>Results</b>: The pharmacokinetic models revealed a reduction in the first-pass effect of halofantrine in the fed state compared to that in the fasting state. While adjustments in metabolism kinetics sufficed for constructing a representative PBPK model in the fasting state, capturing the fed-state profile required both modifications to metabolism kinetics and other parameters related to the structural rearrangements of halofantrine driven by the changes in intestinal pH following food intake. These changes were confirmed using molecular dynamics simulations of halofantrine in pHs reflecting the post-prandial conditions. <b>Conclusions</b>: This study underscores the need for further exploration and direct modeling of intestinal lymphatic uptake via PBPK models, highlighting its underexplored status in simulation algorithms. Moreover, the importance of integrating representative physicochemical factors for drugs, particularly in post-prandial conditions or lipid formulations, is evident. Overall, these findings contribute to advancing predictive regulatory and developmental considerations in drug development using post hoc analyses.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473779/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhanced Efinaconazole Permeation and Activity Against <i>Trichophyton rubrum</i> and <i>Trichophyton mentagrophytes</i> with a Self-Nanoemulsifying Drug Delivery System.","authors":"Seo Wan Yun, Jeong Gyun Lee, Chul Ho Kim, Kyeong Soo Kim","doi":"10.3390/pharmaceutics17091230","DOIUrl":"10.3390/pharmaceutics17091230","url":null,"abstract":"<p><p><b>Background</b>: Onychomycosis responds poorly to topical therapy, and efinaconazole (EFN) has low aqueous solubility. <b>Methods</b>: This study aimed to develop a 10% <i>w</i>/<i>w</i> EFN self-nanoemulsifying system (SNEDDS) with improved solubility, permeation, antifungal activity, and stability. Excipients were screened by EFN saturation solubility. An MCT oil/Solutol HS 15/Labrafil M2125 CS SNEDDS (5/75/20, <i>w</i>/<i>w</i>) was optimized via a pseudo-ternary diagram. Characterization included droplet size, PDI, and zeta potential, morphology, and drug-excipient compatibility. Solubility was measured across pH. Permeation of EFN SNEDDS vs. EFN suspension was tested by Franz diffusion cells. Antifungal activity against <i>Trichophyton rubrum</i> and <i>Trichophyton mentagrophytes</i> was assessed by paper-disc diffusion, and hyphal damage on human nails was examined by SEM. Stability was studied for six months under room, accelerated, and stress conditions. <b>Results</b>: The optimized SNEDDS formed sub-50 nm droplets with low polydispersity and favourable zeta potential. Solubility was maintained across pH, and cumulative permeation increased 13.6-fold versus suspension. Paper-disc assays showed larger inhibition zones at lower EFN doses. SEM on human nails revealed marked hyphal destruction. TEM confirmed spherical nanoemulsion droplets. FT-IR showed no new peaks, supporting compatibility. Particle size, PDI, zeta potential, and drug content remained stable over six months under all storage conditions. <b>Conclusions</b>: A 10% <i>w</i>/<i>w</i> EFN SNEDDS enhanced solubility, transungual permeation, and antifungal efficacy while maintaining robust stability, supporting its potential as an ethanol-free therapy for onychomycosis.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473344/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic Approach Based on Nanotechnology with Chitosan-Coated Zein Nanoparticles Containing Quercetin Against Resistant <i>Klebsiella pneumoniae</i> Clinical Isolates.","authors":"Azael Francisco Silva-Neto, Maria Anndressa Alves Agreles, Ana Alice Venancio Correia, Hanne Lazla Rafael de Queiroz Macêdo, Alane Rafaela de Carvalho Amaral, Alexsandra Maria Lima Scavuzzi, João Victor de Oliveira Alves, Ana Catarina Souza Lopes, Márcia Vanusa da Silva, Maria Tereza Dos Santos Correia, Isabella Macário Ferro Cavalcanti, Luís André de Almeida Campos","doi":"10.3390/pharmaceutics17091227","DOIUrl":"10.3390/pharmaceutics17091227","url":null,"abstract":"<p><p><b>Background/Objectives:</b> The study developed, characterized, and evaluated the toxicity, antibacterial and antibiofilm activity of quercetin encapsulated in chitosan-coated zein nanoparticles (QUER-ZNP-CH). <b>Methods:</b> QUER-ZNP-CH were prepared by the nanoprecipitation method and characterized by physicochemical analyses, stability (12 months), and release kinetics. Toxicity was evaluated through hemocompatibility and a <i>Tenebrio molitor</i> larval model. Antibacterial activity (MIC/MBC, CLSI) and antibiofilm potential (crystal violet assay) were tested against resistant <i>Klebsiella pneumoniae</i> strains. <b>Results:</b> The nanoparticles were prepared, and physicochemical analyses revealed chemical interactions, efficient encapsulation of the drug, and thermal stability. The formulations remained stable over 12 months, and the release kinetics demonstrated controlled release for 72 h. No hemotoxic profile was observed and there was 95% survival of <i>Tenebrio molitor</i> larvae after treatment with QUER-ZNP-CH. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of QUER-ZNP-CH revealed enhanced antibacterial activity of QUER, as indicated by a 32 to 64-fold reduction in the MIC and MBC values. The biofilm inhibition potential of QUER-ZNP-CH showed 60-100% inhibition and 25-95% eradication in concentrations from 0.12 to 62.5 μg/mL. <b>Conclusions:</b> Thus, this nanotechnology-based formulation suggests potential for the treatment of bacterial infections caused by multidrug-resistant <i>K. pneumoniae</i> strains.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictive Modeling of Drug Product Stability in Pharmaceutical Blister Packs.","authors":"Jan Pech, Christoph Kaminski, Matthias Markus, Werner Hoheisel, Roman Heumann, Judith Winck, Markus Thommes","doi":"10.3390/pharmaceutics17091233","DOIUrl":"10.3390/pharmaceutics17091233","url":null,"abstract":"<p><p><b>Background/Objectives:</b> The principal function of pharmaceutical blister packaging is to provide protection for the drug product. Moisture is regarded as a critical factor in the physical and chemical aging of drug products. The present work proposes a modeling framework to predict the performance of tablet blister materials based on the moisture uptake profile of the drug product as well as degradation characteristics of the drug substance, while the consumption of water due to degradation is included. <b>Methods:</b> The model incorporates three kinetic superimposed processes that define moisture uptake and drug stability. The processes of permeation, sorption and degradation are each described with a rate constant. Based on a mass balance, these rate processes are interconnected and the relative humidity in the blister cavity is predicted. <b>Results:</b> In a case study, the model was applied to demonstrate the feasibility of predicting the stability of blistered tablets. By establishing a correlation between the moisture uptake of the tablet and the drug stability demonstrated in the model, it was feasible to predict the drug content over shelf life. <b>Conclusions:</b> Modeling of the drug stability of blister-packed products enables a rational packaging which offers novel possibilities for reducing material in order to avoid overpackaging of pharmaceutical products. As some of the commonly used barrier materials are considered to not be sustainable, this model can be used to consider a rationally justified reduction or even abandonment of the barrier materials.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}