Journal of pharmaceutical sciences最新文献_第8页

Efflux and uptake of androgen sulfates using transporter-overexpressing HEK293 cells and membrane vesicles. 转运蛋白过表达HEK293细胞和膜泡对硫酸雄激素的外排和摄取

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-22 DOI: 10.1016/j.xphs.2025.103705

Arttu Uoti, Erkka Järvinen, Noora Sjöstedt, Jan Koenderink, Moshe Finel, Heidi Kidron

{"title":"Efflux and uptake of androgen sulfates using transporter-overexpressing HEK293 cells and membrane vesicles.","authors":"Arttu Uoti, Erkka Järvinen, Noora Sjöstedt, Jan Koenderink, Moshe Finel, Heidi Kidron","doi":"10.1016/j.xphs.2025.103705","DOIUrl":"10.1016/j.xphs.2025.103705","url":null,"abstract":"<p><p>Hydrophilic steroid conjugates require active and facilitated transport mechanisms for their distribution into tissues and excretion from the body. The ATP-binding cassette (ABC) and solute carrier organic anion (SLCO) transporters involved in androgen sulfate (-S) disposition have been poorly characterized. In this study, we investigated the in vitro transport of testosterone-S, epitestosterone-S, dehydroepiandrosterone-S (DHEA-S), androsterone-S, and etiocholanolone-S by the multidrug resistance-associated proteins 2-4 (MRP2-4, ABCC2-4), breast cancer resistance protein (BCRP, ABCG2), and organic anion-transporting polypeptides (OATP) 1B1, 1B3, and 2B1 (SLCO1B1, SLCO1B3, and SLCO2B1) using human transporter-overexpressing HEK293 cells and membrane vesicles. We found testosterone-S, epitestosterone-S, and DHEA-S to be selectively transported by BCRP and/or MRP4, whereas all studied androgen sulfates were substrates of MRP3, OATP1B1, OATP1B3, and OATP2B1. MRP2 did not transport any of the studied compounds. Evaluation of transport kinetics revealed MRP4 to interact with its substrates at high to moderate affinity, whereas the observed affinities towards MRP3, BCRP, and OATPs were mostly moderate. These results help to build a better mechanistic understanding of the disposition of androgen sulfates in the human body. Additionally, this data may be used to assess the feasibility of androgen sulfates as additional biomarkers in doping detection.</p>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":"103705"},"PeriodicalIF":3.7,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143492497","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}

引用次数: 0

Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals 探索行业利益相关者对评估医院处理蛋白质药物的临床试验平台的看法。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-22 DOI: 10.1016/j.xphs.2025.103704

Jesper Arvidsson , Yaser Alkhatib , Marc Egen , Ulla Elofsson , Anna Fureby Millqvist , Carmen López-Cabezas , Marie Wahlgren , Marika Rosenberger , Mattias Paulsson

{"title":"Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals","authors":"Jesper Arvidsson , Yaser Alkhatib , Marc Egen , Ulla Elofsson , Anna Fureby Millqvist , Carmen López-Cabezas , Marie Wahlgren , Marika Rosenberger , Mattias Paulsson","doi":"10.1016/j.xphs.2025.103704","DOIUrl":"10.1016/j.xphs.2025.103704","url":null,"abstract":"<div><div>Protein drugs, such as therapeutic antibodies, are complex and require careful handling to maintain their efficacy and quality. Stress factors in hospitals, like temperature variations and mechanical shocks during transport, may negatively impact the stability of protein drugs (e.g. various monoclonal antibodies). The pharmaceutical industry possesses extensive knowledge about their product formulations but often the transfer of knowledge from lab studies into in-hospital handling procedures is challenging. To address this gap and find a way to bridge academia, healthcare, and industry, seven semi-structured interviews were conducted with experts from pharmaceutical companies across five countries. This study aimed to explore the opinions of formulation experts regarding stress evaluation in clinical settings. Thematic analysis of the interviews revealed four key themes: The human factor in clinical sites, clinical sites as data providers, potential complexities in conducting tests within a clinical setting, and challenges associated with product-specific methods, equipment and devices. This study also suggests tools for setting up clinical test beds that can help the pharmaceutical industry improve stress evaluation and understand clinical product handling. Direct collaboration with clinical sites is crucial, as experts perceive improved evaluation methods and education to be necessary for ensuring safe medicines for patients.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103704"},"PeriodicalIF":3.7,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143492498","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}

引用次数: 0

Preparation, in vitro and in vivo evaluation and anti-renal injury effects of Niazimicin-loaded mixed polymeric micelles 硝齐霉素混合聚合物胶束的制备、体外和体内评价及抗肾损伤作用。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-22 DOI: 10.1016/j.xphs.2025.103703

Xia Jiang , Mingie Gong , Yue Jia , Michael Adu-Frimpong , Xiaowen Wang , Qinyang Hua , Tingyuan Li , Jiaying Li , Pengfei Pan , Elmurat Toreniyazov , Jiangnan Yu , Xia Cao , Qilong Wang , Ximing Xu

{"title":"Preparation, in vitro and in vivo evaluation and anti-renal injury effects of Niazimicin-loaded mixed polymeric micelles","authors":"Xia Jiang , Mingie Gong , Yue Jia , Michael Adu-Frimpong , Xiaowen Wang , Qinyang Hua , Tingyuan Li , Jiaying Li , Pengfei Pan , Elmurat Toreniyazov , Jiangnan Yu , Xia Cao , Qilong Wang , Ximing Xu","doi":"10.1016/j.xphs.2025.103703","DOIUrl":"10.1016/j.xphs.2025.103703","url":null,"abstract":"<div><h3>Background</h3><div>Chronic Kidney Disease (CKD) has become one of the major life-threatening conditions. Moringa seeds have been reported to exhibit renoprotective effects, with Niazimicin as its characteristic component. Objective: To investigate the anti-renal injury effects of Niazimicin and its mixed micelles (N-M) that composed of monomethyl ether poly (ethylene glycol)-polycaprolactone (mPEG-PCL) and polyethylene glycolated chitosan (PEG-CS) on adenine-induced CKD mice. Methods: PEG-CS was prepared via formaldehyde linkage method. The thin film dispersion method was employed for the preparation of N-M before it was characterized <em>in vivo</em> and <em>in vitro</em>. The anti-renal injury effects were evaluated by analyzing the serum levels of creatinine (Cr), p-Cresol sulphate (pCs), indole sulphate (IS) and hematoxylin-eosin (HE)-stained sections of hepatic and renal pathological tissues in CKD mice. Results: The N-M were spherical micelles of uniform size and highly dispersed with particle size of 42.94 ± 0.58 nm, encapsulation efficiency (EE) of 97.73 ± 2.33% and drug loading (DL) of 16.17 ± 0.28%, as well as good stability, and a very low critical micelle concentration (CMC) value of 0.00731 mg/mL. The N-M had a delayed-release effect and higher oral bioavailability compared to Niazimicin. Conclusion: In CKD mice, Niazimicin exhibited an anti-renal injury effect, while the renoprotective effect of N-M was superior to that of Niazimicin.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103703"},"PeriodicalIF":3.7,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482081","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}

引用次数: 0

A new model for ionizable drug dissolution in intestinal bicarbonate buffer 肠内碳酸氢盐缓冲液中可电离药物溶出的新模型。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-20 DOI: 10.1016/j.xphs.2025.103702

Jozef Al-Gousous , Adrin Jalali Sohi , Niloufar Salehi , Gordon L. Amidon , Peter Langguth

{"title":"A new model for ionizable drug dissolution in intestinal bicarbonate buffer","authors":"Jozef Al-Gousous , Adrin Jalali Sohi , Niloufar Salehi , Gordon L. Amidon , Peter Langguth","doi":"10.1016/j.xphs.2025.103702","DOIUrl":"10.1016/j.xphs.2025.103702","url":null,"abstract":"<div><div>In order to achieve the desired effect <em>in vivo</em>, drugs taken orally must first be dissolved in the gastrointestinal tract. With the majority of the commercially available drugs having acidic and/or basic groups, ionization and intestinal buffering are important factors underlying adequate dissolution and, accordingly, bioavailability. The aim of this work was therefore to develop a dissolution model that properly takes these factors into account when dealing with the intestinal bicarbonate buffer. Based on the assumptions that, during dissolution, steady state is reached instantaneously, all the reactions are at equilibrium save for the interconversion between H<sub>2</sub>CO<sub>3</sub> and CO<sub>2</sub>, and diffusion of the reactants occurs over a boundary layer of a defined thickness <em>h</em>, a system of differential algebraic equations was developed and solved numerically using Wolfram Mathematica. The model provided very good predictions for flux values obtained from different literature sources, while involving less simplifying assumptions compared to previous models, thus enhancing its accuracy and making it a proper and promising approach for simulating dissolution in intestinal media.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 5","pages":"Article 103702"},"PeriodicalIF":3.7,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476667","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}

引用次数: 0

Particle formation during peristaltic pumping of therapeutic proteins: Hofmeister anions effect 治疗性蛋白蠕动泵送过程中的粒子形成：霍夫迈斯特阴离子效应。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-14 DOI: 10.1016/j.xphs.2025.103700

Amanda Västberg , Natalia Markova , Lars Nilsson , Tommy Nylander , Balasubramanian Sivakumar , Marie Wahlgren , Ulla Elofsson

{"title":"Particle formation during peristaltic pumping of therapeutic proteins: Hofmeister anions effect","authors":"Amanda Västberg , Natalia Markova , Lars Nilsson , Tommy Nylander , Balasubramanian Sivakumar , Marie Wahlgren , Ulla Elofsson","doi":"10.1016/j.xphs.2025.103700","DOIUrl":"10.1016/j.xphs.2025.103700","url":null,"abstract":"<div><div>This study reveals specific ion effects on particle formation during peristaltic pumping of a monoclonal Antibody (Antibody A). For this purpose, three anions in the direct Hofmeister series were selected, ranging from the kosmotropic SO<sub>4</sub><sup>2-</sup> to the more neutral Cl<sup>-</sup> and the chaotropic SCN<sup>-</sup>. Protein particle formation during peristaltic pumping is described primarily as a surface-driven mechanism. Therefore, the effect of the anions was hypothesised to affect the particle formation with the smallest amount of protein adsorbing and the least particles formed in the presence of SCN<sup>-</sup>, followed by the highest in SO<sub>4</sub><sup>2-</sup>. The alternative hypothesis was that most protein particles would be formed in SCN<sup>-</sup> due to the lower intrinsic stability of Antibody A. On the other hand, if none of the factors dominates the particle formation, it would not necessarily follow the Hofmeister series linearly. This was shown to be the case as significantly more particles were formed in the presence of NaCl, which could be explained by the interplay of the protein's intrinsic, colloidal, and interfacial stability. Antibody A had the highest protein adsorption in NaCl and the lowest colloidal stability compared to Na<sub>2</sub>SO<sub>4</sub> or NaSCN, which led to the highest amount of subvisual particles formed during pumping.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103700"},"PeriodicalIF":3.7,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425510","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}

引用次数: 0

Structural studies on the interaction of CTAB with alginate: Possibility of surfactant therapy with chemo sensitization effect CTAB与海藻酸盐相互作用的结构研究：表面活性剂治疗具有化疗增敏作用的可能性。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-13 DOI: 10.1016/j.xphs.2025.103701

Anand A. Sable , Minati Nayak , Sugam Kumar , Amit Kunwar , Atanu Barik

{"title":"Structural studies on the interaction of CTAB with alginate: Possibility of surfactant therapy with chemo sensitization effect","authors":"Anand A. Sable , Minati Nayak , Sugam Kumar , Amit Kunwar , Atanu Barik","doi":"10.1016/j.xphs.2025.103701","DOIUrl":"10.1016/j.xphs.2025.103701","url":null,"abstract":"<div><div>The present study reports the preparation of sodium alginate-cetyltrimethylammonium bromide (CTAB) nanoparticles (SANPs) through the interaction of a fixed concentration of alginate (0.2% w/v in water) with two different concentrations of CTAB i.e., below (0.4 mM) and above (1.2 mM) critical micelle concentration (CMC) and the elucidation of its structure on the basis of dynamic light scattering, transmission electron microscopy, small angle neutron scattering and zeta potential measurements. The results indicated that the concentration of CTAB dictated the hydrodynamic shape and size of SANPs. While both the micellized (> CMC) and monomeric forms (< CMC) of CTAB resulted in the formation of negatively charged near spherical particles, the SANPs containing micellized form of CTAB exhibited smaller and more compact hydrodynamic structure compared to those containing monomeric form of CTAB. The cytotoxicity studies involving cancerous cell lines (A549 and L132) indicated that the anticancer activity of CTAB was retained in the SANPs. Subsequently, encapsulation of doxorubicin (DOX), a potent anticancer drug in to SANPs enhanced the efficacy of the overall nano-formulation for effectively killing A549 and L132 cells. Additionally, the DOX loaded SANPs also exhibited the sustained and pH dependent drug release under reservoir-sink model. Together, polyelectrolyte complexation between alginate and CTAB appears as a novel strategy to design nano formulation exhibiting anticancer activity perse as well as for sensitizing the efficacy of chemotherapeutic drugs.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103701"},"PeriodicalIF":3.7,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425514","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}

引用次数: 0

Co-processing acetaminophen with nanocellulose to enhance tabletability 对乙酰氨基酚与纳米纤维素的协同加工提高其耐药性。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-12 DOI: 10.1016/j.xphs.2025.02.004

Maxx Capece

引用次数: 0

Development of transethosomes patch for delivery atorvastatin calcium transdermally: In vitro and in vivo studies 经皮给药阿托伐他汀钙的体贴的开发：体外和体内研究。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-11 DOI: 10.1016/j.xphs.2025.02.001

Pramulani Mulya Lestari , Yahdiana Harahap , Melva Louisa , Silvia Surini

{"title":"Development of transethosomes patch for delivery atorvastatin calcium transdermally: In vitro and in vivo studies","authors":"Pramulani Mulya Lestari , Yahdiana Harahap , Melva Louisa , Silvia Surini","doi":"10.1016/j.xphs.2025.02.001","DOIUrl":"10.1016/j.xphs.2025.02.001","url":null,"abstract":"<div><div>Atorvastatin calcium is an antihyperlipidemic with low bioavailability, and to address this limitation, a transdermal delivery system utilizing transethosomes as a carrier was developed. This study aimed to enhance the bioavailability of atorvastatin calcium by transitioning from oral to transdermal administration. The six different formulas of transethosomes were observed based on particle size, PDI, zeta potential, deformability index, and morphology. Furthermore, the patch's characteristics, penetration, pharmacokinetic, and irritation studies of transethosomes patch were observed. The results showed that atorvastatin calcium transethosomes had a particle size of ≤ 130.59 nm with PDI and zeta potential values of ≤ 0.24 and ≥ −51.87 mV, respectively. The vesicles featured spherical morphology and an excellent deformability index. The transethosome patches obtained had a pH and viscosity value of 5.7 and ≥ 8741 mPa.s, respectively. The properties of transethosomes loaded in the patch were observed to show a particle size of ≤ 249.83 nm and zeta potential ≥ −44.73 mV. A penetration study of the atorvastatin calcium transethosomes patch reveals high flux, especially the G6 formula, increasing bioavailability by 3.67-fold and not irritating. In conclusion, developing a transethosomes patch for transdermal delivery proved to be an effective method for enhancing the bioavailability of atorvastatin calcium.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103695"},"PeriodicalIF":3.7,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414635","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}

引用次数: 0

Possible applications of the Polli dissolution mechanism: A case study using molecular dynamics simulation of Bupivacaine 花粉溶解机制的可能应用：以布比卡因分子动力学模拟为例。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-11 DOI: 10.1016/j.xphs.2025.02.003

Peter J. Skrdla , Andrea Browning , Shiva Sekharan , Jacob Gavartin

{"title":"Possible applications of the Polli dissolution mechanism: A case study using molecular dynamics simulation of Bupivacaine","authors":"Peter J. Skrdla , Andrea Browning , Shiva Sekharan , Jacob Gavartin","doi":"10.1016/j.xphs.2025.02.003","DOIUrl":"10.1016/j.xphs.2025.02.003","url":null,"abstract":"<div><div>The recently proposed Polli equation [Polli JE. A simple one-parameter percent dissolved versus time dissolution equation that accommodates sink and non-sink conditions via drug solubility and dissolution volume. AAPS J 2023;25:1] has been discussed in the context of its ability to fit experimental dissolution transients obtained under either sink or non-sink conditions. In this work, we reveal that the Polli equation describes a complex dissolution mechanism that combines classical first-order (Noyes-Whitney, N-W) kinetics with a second-order mechanism. Possible origins of the second-order process are discussed within the framework of small-molecule drug dissolution, after first probing the general utility of the higher-order rate term in more precisely fitting typical dissolution transients (for ibuprofen and ketoconazole) taken from the referenced work. Lastly, molecular dynamics (MD) simulations are performed using the prototypical drug, bupivacaine, that is shown to dimerize in aqueous solution under acidic conditions. Our findings point us to conclude that the Polli mechanism best describes cases where the drug forms dimers in solution at a rate comparable to that with which it dissolves (per the N-W mechanism), given non-sink conditions. Under sink conditions, the Polli mechanism is first-order in drug concentration.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103697"},"PeriodicalIF":3.7,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414638","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}

引用次数: 0

Time to break and evaporation (TBE): A quality attribute of pharmaceutical topical foams 破裂和蒸发时间（TBE）：药物外敷泡沫的质量属性。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-11 DOI: 10.1016/j.xphs.2025.02.005

Bhoomika Holla , Prajwal N. Murthy , Anusha V. Matadh , S.G. Pragathi , L. Rakshitha , Harini Priya Pa , H.N. Shivakumar , Mohammad Moinul Hossain , Santanu Kundu , Srinath Rangappa , Ureña-Benavides Esteban , S. Narasimha Murthy

{"title":"Time to break and evaporation (TBE): A quality attribute of pharmaceutical topical foams","authors":"Bhoomika Holla , Prajwal N. Murthy , Anusha V. Matadh , S.G. Pragathi , L. Rakshitha , Harini Priya Pa , H.N. Shivakumar , Mohammad Moinul Hossain , Santanu Kundu , Srinath Rangappa , Ureña-Benavides Esteban , S. Narasimha Murthy","doi":"10.1016/j.xphs.2025.02.005","DOIUrl":"10.1016/j.xphs.2025.02.005","url":null,"abstract":"<div><div>The quality attributes of topical foams are critical in determining the rate and extent of drug absorption across the skin and mucous membranes. A generic product is required to match the reference-listed drug (RLD), with respect to its composition and characteristics. Time to break (TB) is one of the critical quality attributes to consider during the evaluation of some of the generic products, as per the product-specific guidance from the Food and Drug Administration (FDA). This paper proposes a slightly modified protocol for conducting TB studies to improve the robustness of the test and reduce the ambiguity in its assessment. The proposed modified method “Time to Break and Evaporation (TBE)” is a gravimetric method that considers the collapse and loss of solvents and other volatile components from the foam. A marketed salicylic acid foam product was used as a model to demonstrate the practicality of this modified approach.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 4","pages":"Article 103699"},"PeriodicalIF":3.7,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143408613","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}

引用次数: 0