Drug Development and Industrial Pharmacy最新文献

Coreopsis Tinctoria flavonoids phospholipid complex: molecular dynamics simulation, preparation, characterization, and in vitro release. 黄酮类磷脂复合物：分子动力学模拟、制备、表征和体外释放。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-20 DOI: 10.1080/03639045.2025.2519975

Kaixuan Wang, Xinmei Chen

{"title":"Coreopsis Tinctoria flavonoids phospholipid complex: molecular dynamics simulation, preparation, characterization, and in vitro release.","authors":"Kaixuan Wang, Xinmei Chen","doi":"10.1080/03639045.2025.2519975","DOIUrl":"10.1080/03639045.2025.2519975","url":null,"abstract":"Objective: To prepare the Coreopsis tinctoria flavonoids phospholipid complex(CTF-PC) and evaluate its physical characterization and release profile.Significance: Coreopsis Tinctoria flavonoids (CTF) have excellent antioxidant and liver-protective activity. However, CTF exhibits low solubility and permeability, restricting its in vivo absorption and effectiveness. The phospholipid is a nontoxic amphiphilic substance with excellent biocompatibility. It can complex drugs to promote absorption and is expected to be a potentially effective drug delivery system.Methods: In this study, the following components were utilized as indicator components in CTF: Quercetagitrin, Marein, and Luteolin. The molecular docking and molecular dynamics simulation were used to predict the binding forms and affinity of the phospholipid to CTF. CTF-PC was prepared based on the solvent evaporation method. The structure of CTF-PC was characterized by ultraviolet spectroscopy (UV), infrared spectroscopy (IR), X-ray diffraction (XRD), and differential scanning calorimetry (DSC). Equilibrium solubility and oil-water partition coefficients of CTF components in extract and phospholipid complex were determined. Furthermore, in vitro release assays were designed to assess the release characteristics of CTF-PC.Results: CTF was mainly bound to the phosphate groups of phospholipid through hydrogen bonding with strong affinity. CTF-PC could significantly improve the lipid solubility of CTF. Besides, the CTF-PC exhibited a slow-release effect. Its release characteristic in the gastrointestinal tract conformed with the first-class model.Conclusions: CTF-PC improved the lipid solubility and slow release of CTF. It potentially promoted the absorption of CTF in the stomach, duodenum, and jejunum. It holds promise for improving the absorption and therapeutic efficacy of CTF.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316166","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}

引用次数: 0

Characterisation and sensory evaluation of placebo OrPhyllo^TM orodispersible films as a versatile paediatric drug delivery platform. 表征和感官评价安慰剂OrPhylloTM或分散膜作为一个通用的儿科给药平台。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-19 DOI: 10.1080/03639045.2025.2521664

Karolina Dziemidowicz, Jiao Jin, Sejal R Ranmal, Sirakarn Piumpongsuk, Samuel Aspinall, Christopher J Serpell, Conor McCann, Catherine Tuleu

{"title":"Characterisation and sensory evaluation of placebo OrPhylloTM orodispersible films as a versatile paediatric drug delivery platform.","authors":"Karolina Dziemidowicz, Jiao Jin, Sejal R Ranmal, Sirakarn Piumpongsuk, Samuel Aspinall, Christopher J Serpell, Conor McCann, Catherine Tuleu","doi":"10.1080/03639045.2025.2521664","DOIUrl":"https://doi.org/10.1080/03639045.2025.2521664","url":null,"abstract":"Orodispersible films (ODFs) are a convenient form of paediatric drug delivery and for those with swallowing difficulties. They can be extemporaneously prepared in pharmacies using pre-formulated bases which simplify and fasten the process while reducing compounding errors. OrPhylloTM is a water-based commercial vehicle for preparing polymeric ODFs. It is chemically compatible with various clinically relevant active pharmaceutical ingredients (APIs) at different drug loadings.This study focuses on characterising placebo OrPhylloTM films, including their morphological, mechanical, and textural properties, as well as physicochemical stability by thermal analysis and X-ray diffraction. After local ethical approval, healthy adults explored stickiness, mouthfeel, and disintegration of these 3 × 3cm ODFs following various modes of administration.OrPhyllo™ ODFs (185 ± 10µm thick) exhibited distinct surface characteristics, one side (lower) smoother and the upper side rougher, as observed and shown by scanning electron and atomic force microscopy. However, both sides demonstrated similar mucoadhesive properties and rapid disintegration (between 60 and 140s, depending on the method used). Both sides were well-accepted, whether administered on the tongue or in the cheeks, with minor differences in mouthfeel and fast disintegration perception. The hen's egg chorioallantoic membrane test showed no irritancy, supporting the good acceptability of these placebo ODFs. The films remained structurally stable over 6 months, with low residual moisture.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-15"},"PeriodicalIF":2.4,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324710","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}

引用次数: 0

HPLC-based quantitative assessment of antiviral agents in artificial saliva. 基于高效液相色谱的人工唾液中抗病毒药物的定量评价。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-18 DOI: 10.1080/03639045.2025.2519977

Aysun Dinçel, Feyyaz Onur

{"title":"HPLC-based quantitative assessment of antiviral agents in artificial saliva.","authors":"Aysun Dinçel, Feyyaz Onur","doi":"10.1080/03639045.2025.2519977","DOIUrl":"10.1080/03639045.2025.2519977","url":null,"abstract":"Background: The efficient analytical method for antiviral drug quantification is crucial in pharmaceutical and biomedical research, particularly for ensuring accurate dosage and monitoring therapeutic efficacy. Accurate quantification of these compounds in artificial saliva is essential for pharmacokinetic studies, as saliva-based drug monitoring offers a noninvasive alternative to traditional blood sampling.Objective: A novel high-performance liquid chromatographic (HPLC) method for simultaneous analysis of three selected antivirals: Tenofovir Disoproxil Fumarate (TDF), Favipiravir (FAV), Ritonavir (RIT) and internal standard as another antiviral (emtricitabine) in artificial saliva was optimized and validated, including sample preparation using new extraction procedure.Methods: The chromatographic separation was achieved with XTerra, C18 (250 × 4.6 mm, 3.5 µm) analytical column (20 °C) at a wavelength of 215 nm, and the mobile phase was composed of 0.1% phosphoric acid, methanol, and an acetonitrile mixture; 32:60:8 (v/v) at a flow rate of 0.8 mL/min. The method was linear over the range of 0.1-1.0 µg/mL.Results: The method has been found according to ICH guidelines specific, accurate (recovery, 93.003%-103.357%), sensitive (LOD and LOQ were values found as 0.03 and 0.1 µg/mL, respectively), and precise (RSD; 0.412%-3.175%).Conclusion: A validated HPLC method was developed for the precise determination of different antiviral agents in artificial saliva.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-8"},"PeriodicalIF":2.4,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274444","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}

引用次数: 0

Hypolipidemic and HMG-CoA reductase inhibitory effects of 15-oxoursolic acid from Rhododendron arboreum: An In-vivo and In-silico study. 杜鹃花15-Oxoursolic酸抑制降血脂和HMG-CoA还原酶的作用：体内和计算机研究。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-18 DOI: 10.1080/03639045.2025.2519976

Sajid Ali, Usman Ali, Muhammad Ishtiaq Jan

{"title":"Hypolipidemic and HMG-CoA reductase inhibitory effects of 15-oxoursolic acid from Rhododendron arboreum: An In-vivo and In-silico study.","authors":"Sajid Ali, Usman Ali, Muhammad Ishtiaq Jan","doi":"10.1080/03639045.2025.2519976","DOIUrl":"10.1080/03639045.2025.2519976","url":null,"abstract":"Background: Hyperlipidemia is an identified risk factor for metabolic syndrome, obesity and cardiovascular complications characterized by elevated levels of lipids in blood.Objective: The present study aimed to inhibit HMG-CoA reductase with 15-oxoursolic acid through in-vivo and in-silico assessments.Methods: The amorphous compound 15-oxoursolic acid was obtained from plant material through purification with a rotary evaporator and column chromatography. The male BALB/c mice were maintained under stabilized ambient conditions and sustained with standard food and water ad libitum. HFD was used to induce hyperlipidemia in rats.Results: HFD-induced hyperlipidemia in rats was developed with a marked increase in total cholesterol (58.34 ± 0.21 mg/dL), triglycerides (45.45 ± 0.39 mg/dL), LDL-c (66.12 ± 0.10 mg/dL), VLDL-c (19.34 ± 0.16 mg/dL), and a decrease in HDL-c (10.34 ± 0.18 mg/dL). The oral administration of 15-oxoursolic acid at a concentration of 30 mg/Kg b.w significantly reduced the serum concentration of total cholesterol (42.65 ± 0.54 mg/dL), triglycerides (32.33 ± 0.16 mg/dL), LDL-c (50.34 ± 0.15 mg/dL) and VLDL-c (13.15 ± 0.45 mg/dL), respectively and an increased in the serum HDL-c (18.56 ± 0.34 mg/dL). 15-oxoursolic acid also caused a decrease in the coronary risk index and atherogenic risk index. In-silico studies of 15-oxoursolic acid with HMG-CoA reductase showed significant interaction capability with binding energy (-9.26805 Kcal/mol).Conclusions: It is concluded that 15-oxoursolic acid could significantly reduce the total cholesterol, triglycerides and LDL levels in HFD-induced hyperlipidemia rats, which might lead to new medication with significant hypolipidemic potential.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-8"},"PeriodicalIF":2.4,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274413","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}

引用次数: 0

Reducing residual solvent levels in poly (D, L-lactic-co-glycolic acid) microspheres: a roadmap for scalable industrial production. 减少聚（D， l -乳酸-羟基乙酸）微球的残留溶剂水平：可扩展工业生产的路线图。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-16 DOI: 10.1080/03639045.2025.2514214

Somayeh Khanmohammadi, Samira Sadeghi, Samira Ansari, Milad Jafari-Nodoushan, Mahdieh Farhangi

{"title":"Reducing residual solvent levels in poly (D, L-lactic-co-glycolic acid) microspheres: a roadmap for scalable industrial production.","authors":"Somayeh Khanmohammadi, Samira Sadeghi, Samira Ansari, Milad Jafari-Nodoushan, Mahdieh Farhangi","doi":"10.1080/03639045.2025.2514214","DOIUrl":"10.1080/03639045.2025.2514214","url":null,"abstract":"Objective: Poly (D, L-lactic-co-glycolic acid) (PLGA) microspheres have garnered significant attention as biocompatible and biodegradable carriers for sustained drug delivery. However, the production of PLGA microspheres typically involves organic solvents, such as ethyl acetate and benzyl alcohol. Residual solvents are undesirable given their potential toxicity and adverse effects on product stability. Effective solvent removal is critical for ensuring the safety and functionality of microspheres.Method: In this study, 12 formulations were designed by altering the conditions of solvent extraction, washing, and solvent evaporation steps to reduce residual solvents and determine critical parameters in process. Microspheres were evaluated based on residual solvent content, drug loading, size, morphology, moisture content, injectability, and release kinetics.Result: In five formulations (F06-F10), at least the residual amount of one organic solvent was significantly reduced. Prolonging the microspheres' residence time in ethanolic solution during the second extraction phase (F11) resulted in notable organic solvent reductions (ethyl acetate 93% and benzyl alcohol 60% compared to formulation F01). Further, these microparticles were spherical with a geometric diameter of 75.8 μm, a drug loading percentage of 33.7%, and a reasonable release profile, representing significant achievements.Conclusion: This study highlighted the importance of some modifications in preparing PLGA microspheres that have not been reported previously. These modifications greatly affected the residual solvent amount as well as other physicochemical properties of microspheres including size, morphology, and release profile. Overall, some practical methods could be used for feasible industrial production of PLGA microspheres.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-10"},"PeriodicalIF":2.4,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293507","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}

引用次数: 0

Development, characterization and in vitro evaluation of capecitabine-loaded chitosan nanoparticles. 卡培他滨负载壳聚糖纳米颗粒的制备、表征及体外评价。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-13 DOI: 10.1080/03639045.2025.2518304

Debarati Ghosh, Ketousetuo Kuotsu

{"title":"Development, characterization and in vitro evaluation of capecitabine-loaded chitosan nanoparticles.","authors":"Debarati Ghosh, Ketousetuo Kuotsu","doi":"10.1080/03639045.2025.2518304","DOIUrl":"10.1080/03639045.2025.2518304","url":null,"abstract":"Objective: To formulate capecitabine-loaded nanoparticles by the ionotropic gelation method, using low molecular weight (LMW) chitosan polymer and sodium tripolyphosphate (STPP) as the cross-linking agent.Methods: Nanoparticles were prepared using the ionotropic gelation method. They were characterized for particle size, polydispersity index (PDI), entrapment efficiency (%), and percentage yield (%) using dynamic light scattering (DLS), UV-Visible spectrophotometry, and other analytical techniques.Results: The optimized formulation (CN-4) showed a particle size of 166.5 nm ± 2.3 nm, PDI of 0.346 ± 0.01, entrapment efficiency of 65.34 ± 1.8%, and percentage yield of 90.32 ± 2.1%. The zeta potential of CN-4 was found to be +37.4 mV, confirming its colloidal stability and cationic surface characteristics. An increase in particle size and PDI was observed with higher concentrations of chitosan.Conclusions: No appreciable difference in particle size, polydispersity index (PDI) and percentage intensity was observed for CN-4 formulation after storing it for a period of 15 days at 2-4 °C. However, significant changes were observed after 30 days of storage, indicating destabilization and precipitation of the formulation.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-13"},"PeriodicalIF":2.4,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257604","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}

引用次数: 0

Dextran-based prodrug-nanoassemblies responsively releasing pidotimod and camptothecin for anti-breast cancer. 基于右旋糖酐的前药纳米组装体响应性释放匹多莫德和喜树碱抗乳腺癌。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-11 DOI: 10.1080/03639045.2025.2517726

Peng-Fei Gao, Jia-Jun Cui, Jia-Min Li, Bing-Feng Zhang

{"title":"Dextran-based prodrug-nanoassemblies responsively releasing pidotimod and camptothecin for anti-breast cancer.","authors":"Peng-Fei Gao, Jia-Jun Cui, Jia-Min Li, Bing-Feng Zhang","doi":"10.1080/03639045.2025.2517726","DOIUrl":"10.1080/03639045.2025.2517726","url":null,"abstract":"Objective: The aim of this study was to develop a pH/GSH-responsive dextran-based drug delivery system, co-delivering camptothecin (CPT) and pidotimod (PTD), to increase anti-breast cancer efficacy.Methods: CPT was grafted onto dextran via disulfide bond, and PTD were concurrently conjugated into dextran by the instrumentality of ester bond. The synthesized conjugate could self-assemble to form prodrug-nanoassemblies (CPT-SS-DEX-PTD NPs) in solution. The feature of prodrug-nanoassemblies was assayed, and the synergetic effect of chemo-immunotherapy against solid tumor was investigated in 4T1 breast cancer xenograft models.Results: The CPT-SS-DEX-PTD NPs were approximately spherical and about 180 nm. In drug release experiment, the prodrug-nanoassemblies showed more prolonged circulation time and selective pH or GSH-responsive release profile. The PTD was released in weak acidity tumor microenvironment (TME), then induced immune cells to activate and secret anti-tumor cytokines. The CPT was released via GSH-responsive in tumor cell to exert anti-tumor efficiency. In 4T1 breast cancer model, the CPT-SS-DEX-PTD NPs displayed synergistic anti-tumor efficacy and lower side effects of CPT due to the combination of chemo-immunotherapy.Conclusions: The dextran-based pH/GSH-responsive prodrug-nanoassemblies with synergistic therapy efficacy and low systemic toxicity may offer a novel strategy for breast cancer therapy.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-10"},"PeriodicalIF":2.4,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246975","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}

引用次数: 0

An overview of novel formulations for ocular viral infections: focused on nanomedicines. 眼部病毒感染的新配方综述：以纳米药物为重点。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-10 DOI: 10.1080/03639045.2025.2515998

Shalu Verma, Nidhi Nainwal, Divya Juyal

{"title":"An overview of novel formulations for ocular viral infections: focused on nanomedicines.","authors":"Shalu Verma, Nidhi Nainwal, Divya Juyal","doi":"10.1080/03639045.2025.2515998","DOIUrl":"10.1080/03639045.2025.2515998","url":null,"abstract":"Ocular viral infections are a common cause of blindness globally. Many ocular viral infections are mistakenly identified as bacterial infections. In these situations, treatment is initiated belatedly and fails to address the root cause of the infection, which frequently results in serious ocular complications like corneal infiltrates, conjunctival scarring, and decreased visual acuity. The efficacy of conventional treatments for viral infections suffers from poor bioavailability, which requires the development of novel methods of drug delivery, accurate diagnosis, and efficient treatment choices. As nanotechnology in medicine advances at a rapid pace, multifunctional nanosystems are being prioritized more and more to address the problems brought on by viral infections of the eyes offering targeted delivery, increased bioavailability and decreased systemic toxicity. This study delivers a thorough overview of the use of nanomedicines in the treatment of ocular viral infections, with a particular emphasis on how they may enhance the safety and efficacy of antiviral drugs. We address a range of nanocarrier systems, such as liposomes, nanoparticles, nanosuspension, proniosomes, in-situ gels, dendrimers, and nanogels, emphasizing their distinct characteristics that facilitate the effective transportation of antiviral drugs to ocular tissues. This article also highlighted the regulatory barriers of ocular nanoformulation. The transition of in-vitro studies to in-vivo and clinical models has been discussed. This review also highlights the Preclinical studies of ocular viral treatment, ocular nanotoxicology and advancement of ocular antiviral treatments in the form of patents, ongoing clinical trials and marketed formulations.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-23"},"PeriodicalIF":2.4,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233421","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}

引用次数: 0

Innovative strategies in the formulation and applications of mouth dissolving films for enhanced oral drug delivery. 提高口服给药能力的口腔溶膜的配方和应用的创新策略。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-09 DOI: 10.1080/03639045.2025.2510581

Varun S, Keerthy H S

{"title":"Innovative strategies in the formulation and applications of mouth dissolving films for enhanced oral drug delivery.","authors":"Varun S, Keerthy H S","doi":"10.1080/03639045.2025.2510581","DOIUrl":"10.1080/03639045.2025.2510581","url":null,"abstract":"Objective: The main objective is to provide an overview of the advantages of mouth dissolving films (MDFs) by addressing the limitations of traditional oral dosage forms such as tablets and capsules, particularly for pediatric and geriatric patients with dysphagia. Also to explore its potential to revolutionize the oral drug delivery system supported by advancements in technology.Significance: Mouth dissolving films offer a transformative approach for the delivery of drugs with rapid disintegration, ease of administration, and water-free administration that improve patient compliance significantly. This review highlights the MDFs formulation strategies, applications, patent portfolio, and role of emerging technologies like 3D printing and artificial intelligence in enhancing drug absorption and bioavailability with substantial commercial potential and versatility, offering a patient-centric solution to modern pharmaceutical challenges.Key findings: Mouth dissolving film helps in addressing potential limitations in the traditional drug delivery system by enhancing patient compliance. This formulation relies on hydrophilic polymers and excipients to achieve desired characteristics, with techniques like solvent casting and 3D printing playing a pivotal role in their development, ensuring critical quality parameters that are essential for maintaining the efficacy and safety of the film with significant market potential. These dosage forms can offer good absorption and bioavailability by the use of artificial intelligence and microfabrication.Conclusion: Mouth dissolving films are a transformative progress in oral drug delivery with future advancements in AI, robotics, and microfabrication that hold promise to further enhance bioavailability, targeted delivery, and sustained release solidifying their role in modern pharmaceutics.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-10"},"PeriodicalIF":2.4,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136141","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}

引用次数: 0

Establishing virtual bioequivalence and bio-related dissolution specifications for naproxen using physiologically based pharmacokinetic modeling and in vitro biorelevant dissolution testing. 利用基于生理的药代动力学模型和体外生物相关溶出度测试建立萘普生的虚拟生物等效性和生物相关溶出度规范。

IF 2.4 4区医学

Drug Development and Industrial Pharmacy Pub Date : 2025-06-09 DOI: 10.1080/03639045.2025.2515999

Chenxia Bai, Jiaming Zhang, Xiaolan Xu, Xiaoting Li, Tianhong Zhang

{"title":"Establishing virtual bioequivalence and bio-related dissolution specifications for naproxen using physiologically based pharmacokinetic modeling and in vitro biorelevant dissolution testing.","authors":"Chenxia Bai, Jiaming Zhang, Xiaolan Xu, Xiaoting Li, Tianhong Zhang","doi":"10.1080/03639045.2025.2515999","DOIUrl":"10.1080/03639045.2025.2515999","url":null,"abstract":"Objective: The aim of the present study was to assess the accuracy of the PBPK model in predicting the pharmacokinetic behavior of weakly acidic BCS class II drugs in humans through a multipronged approach of in vitro dissolution, in vivo studies, and in silico simulations.Significance: We envision that accurate prediction of in vivo pharmacokinetic behavior of drugs is expected to be achieved if physiological pharmacokinetic models can be organically combined with the physicochemical and bio pharmacological properties of the drugs, as well as their in vitro dissolution behavior.Methods: In the current study, using naproxen, a BCS class II drug, as a model drug, GastroPlus® was applied to bridge the in vitro dissolution and in vivo pharmacokinetic behaviors to establish an alternative method for predicting pharmacokinetics in humans.Results: The test products with different in vitro dissolution profiles were shown to be bioequivalent to the reference product. In addition, a Biphasic In vitro Dissolution Test method of bio-related dissolution methods was constructed to correctly predict the bioequivalence of naproxen tablets. Finally, extrapolation of the combined PBPK model to humans showed that drugs with different in vitro dissolution profiles are bioequivalent in humans.Conclusions: These findings will help demonstrate the biowaiver of naproxen tablets, which has implications for scale-up or post-approval changes in naproxen tablets.","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224619","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}

引用次数: 0