[Translation] A human bioequivalence clinical trial of flurbiprofen gel patch in Chinese healthy volunteers after single administration under topical conditions

以持证商为MIKASA SEIYAKU CO.,LTD的氟比洛芬凝胶贴膏[规格：每贴含氟比洛芬40mg（面积13.6cm×10.0cm，含膏量12g）；商品名：泽普思®（Zepolas®）]为参比制剂，以汕头经济特区明治医药有限公司研制的氟比洛芬凝胶贴膏[规格：每贴（面积13.6cm×10.0cm）含膏体12g，含氟比洛芬40mg]为受试制剂，评价两种制剂在中国健康受试者中外用条件下的生物等效性。

[Translation]

Flurbiprofen gel patch [specification: each patch contains 40 mg of flurbiprofen (area 13.6 cm×10.0 cm, paste content 12 g); trade name: Zepolas®] produced by MIKASA SEIYAKU CO., LTD. was used as the reference preparation, and flurbiprofen gel patch [specification: each patch (area 13.6 cm×10.0 cm) contains 12 g of paste and 40 mg of flurbiprofen] developed by Shantou SEZ Meiji Pharmaceutical Co., Ltd. was used as the test preparation to evaluate the bioequivalence of the two preparations under topical use conditions in Chinese healthy subjects.

Start Date26 Mar 2025

Sponsor / Collaborator

Shantou SEZ Meiji Pharmaceuticals Co., Ltd.

CTR20250422

/ CompletedNot Applicable

氟比洛芬凝胶贴膏（40mg）在中国健康受试者空腹外用条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of flurbiprofen gel patch (40 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择持证商为Mikasa Seiyaku Co.,Ltd的氟比洛芬凝胶贴膏（商品名：泽普思®，规格：40mg）为参比制剂，对江苏万高药业股份有限公司生产，江苏济茗医药有限公司提供的受试制剂氟比洛芬凝胶贴膏（规格：40mg）进行空腹外用条件下人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在外用条件下的生物等效性。次要研究目的： 1、观察中国健康受试者外用受试制剂氟比洛芬凝胶贴膏（规格：40mg）和参比制剂氟比洛芬凝胶贴膏（商品名：泽普思®，规格：40mg）后的安全性。 2、评估健康志愿受试者在试验期间，外用受试制剂氟比洛芬凝胶贴膏（规格：40mg）或参比制剂氟比洛芬凝胶贴膏（商品名：泽普思®，规格：40mg）的附着力及外用刺激性情况。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the flurbiprofen gel patch (trade name: Zepusi®, specification: 40mg) with the license holder Mikasa Seiyaku Co., Ltd was selected as the reference preparation, and the test preparation flurbiprofen gel patch (specification: 40mg) produced by Jiangsu Wangao Pharmaceutical Co., Ltd. and provided by Jiangsu Jiming Pharmaceutical Co., Ltd. was subjected to human bioequivalence test under fasting external use conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under external use conditions. Secondary research objectives: 1. Observe the safety of Chinese healthy subjects after external use of the test preparation flurbiprofen gel patch (specification: 40mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi®, specification: 40mg). 2. To evaluate the adhesion and external irritation of the test preparation flurbiprofen gel patch (specification: 40 mg) or the reference preparation flurbiprofen gel patch (trade name: Zepus®, specification: 40 mg) applied externally to healthy volunteers during the trial.

Start Date24 Feb 2025

Sponsor / Collaborator

Zhong Xi （ Fu Jian ） Yao Ye You Xian Gong Si

NCT06823284

/ CompletedPhase 1

Characterization of Relative Bioavailability of a Newly Developed Esflurbiprofen Topical System (EFTS) in Comparison with a Marketed Oral Flurbiprofen-containing Tablet Formulation After Multiple-dose Administration Including EFTS Adhesion Assessment - a Phase I, Open-label, Randomized, 2-period, Cross-over Study in Healthy Subjects

This study is a single-center, open-label, multiple-dose trial performed in a 2-period, 2- sequence-cross-over design in healthy volunteers. The primary purpose of this study is to assess non-superiority of the bioavailability of TK-254RX compared with that of a marketed oral flurbiprofen-containing tablet formulation in healthy volunteers in a 2-period, 2- sequence-cross-over design and evaluate adhesion of TK-254RX. Secondary purpose is to assess safety of TK-254RX and residual amount of the patch.

Start Date21 Jan 2025

Sponsor / Collaborator

Teikoku Seiyaku Co. Ltd.

[+3]

100 Clinical Results associated with Flurbiprofen

100 Translational Medicine associated with Flurbiprofen

100 Patents (Medical) associated with Flurbiprofen

5,586

Literatures (Medical) associated with Flurbiprofen

01 Jun 2025·BIOMATERIALS

Inhibition of PDT-induced PGE2 surge for enhanced photo-immunotherapy

Article

Author: Mao, Jiapeng ; Lu, Yichao ; Liu, Xu ; Huang, Jiaxin ; Yang, Fuchun ; Zhou, Huanli ; Li, Xiang ; Guo, Xuemeng ; Luo, Lihua ; You, Jian ; Du, Yongzhong ; Wang, Sijie

Nowadays, photodynamic therapy (PDT) offers a non-invasive tumor treatment with high safety profiles and minimal side effects, implying a promising clinical application for patients with malignant tumors. However, the lack of efficacy in metastasis and recurrence still notably limits its application. To solve this problem, one promising strategy is to improve the immune response activated by PDT. Unfortunately, tumor cells derived PGE2 could create immunosuppressive microenvironments and impair the function of multiple immune cells, leading to a failure of immune system activation. Moreover, our research revealed the up-regulation of Ptgs2 in tumor cells after the PDT process, which is associated with a series of pro-tumor effects, including proliferation, invasion, metastasis, apoptotic resistance, and immune evasion. Consequently, controlling the PGE2 surge induced by PDT is crucial for optimizing the efficacy of photo-immunotherapy. Therefore, we combined the regulation of the COX2-PGE2 axis with PDT. The addition of COX inhibitors (COX-Is) could improve the efficiency of PDT, reduce the immunosuppressive effect of PGE2, and help dying tumor cells activate the immune system. Herein, a tumor-targeted nano-delivery platform (FI@T-Lipo) was developed using advanced microfluidic technology. FI@T-Lipo based PDT showed a systemic therapeutic effect in triple negative breast cancer through reclaiming the anti-tumor effect of the immune system under COX2-PGE2 blockage. In a word, we developed an in-situ tumor vaccination strategy based on COX-Is enhanced PDT, which could alleviate intra-tumoral immune suppression and boost immune system activation. Our study offers a promising modality for advancing clinical treatment strategies for metastatic malignant tumors.

01 Jun 2025·WATER RESEARCH

CO2 geological sequestration can remove emerging contaminants in groundwater: The important role of secondary mineral carbonates

Article

Author: Hu, Bingbing ; Cui, Zhongjie ; Zhang, Xuejie ; Huang, Li-Zhi ; Zhu, Liandong

Carbon dioxide (CO₂) injection has been proposed as a strategy for carbon sequestration, while uncertainties persist regarding its effects on groundwater. Concerns have been raised that CO₂ mineralization and sequestration could potentially lead to groundwater contamination. However, our study demonstrates its capability to mitigate pollution. The injection of CO₂ facilitates the rapid dissolution of minerals, releasing Ca(II), Mg(II), and Fe(II) and forming secondary carbonate minerals, such as CaCO₃, MgCO₃, and FeCO₃. The in-situ generated FeCO₃ can activate oxygen to produce hydroxyl radicals (•OH) under oxic condition, thereby enhancing the degradation of emerging organic contaminants in groundwater, such as 2,4,6-tribromophenol, flurbiprofen, diclofenac, carbamazepine, phenol, and sulfamethoxazole. Mechanism studies suggest that this process is enhanced by the conversion of in-situ formed FeCO₃ into a two-dimensional goethite nanosheet structure, which provides a larger specific surface area and enables more Fe(II) to be adsorbed on the mineral surface. The formation of Fe-O coordination bonds effectively reduces the loss of •OH at the interfacial reaction layer. The study further distinguishes and quantifies the contributions of different Fe(II) forms to •OH generation. The transformation pathways of the six contaminants and the toxicity of their intermediates are also analyzed. CaCO₃ and MgCO₃ do not exhibit the ability to degrade pollutants, but play a role in carbon mineralization. This work reveals that secondary minerals generated through the CO₂ mineralization and sequestration process display simultaneous capabilities of contaminant degradation and carbon fixation. Such activities are pivotal not only for the environmental fate and transformation of emerging contaminants in groundwater but also for regulating the carbon cycle.

01 May 2025·EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Studying the effects of polymers on therapeutic deep eutectic solvents’ formation and stability: A thermal analysis-based approach to optimise polymer selection

Article

Author: Andrews, Gavin P ; Li, Shu ; Jones, David S ; Abdelquader, Magdy M

Therapeutic deep eutectic solvents (THEDES) are the liquids produced upon mixing two solid materials, where at least one of them is an active pharmaceutical ingredient. The strong hydrogen bonding (HB) between the parent materials is the reason for such profound depression in their melting points. THEDES formation can improve drugs' solubility and permeation characteristics. However, this can be limited by their encapsulation within drug delivery platforms e.g., polymeric matrices which might disrupt the HB network of THEDES by introducing new HB active sites into the mixture. Despite this, the effects of polymers on THEDES stability are not well-documented. In addition, the polymers' impact on THEDES formation during end-to-end production has not been studied. In this work, these issues were addressed by employing thermal processing of polymers and drugs. The dually active lidocaine: flurbiprofen (1:1) THEDES was utilized in addition to model polymers, namely polyethylene-co-vinyl acetate (PEVA), polyethylene oxide (PEO) and Eudragit® RL PO (EuRLPO). Firstly, probing the interaction between the polymers and the individual components of THEDES revealed that PEVA has no affinity towards both drugs while PEO can interact with flurbiprofen, and EuRLPO can interact with lidocaine. Then, to study the effect of the polymers on THEDES formation and stability, a valid in-situ method was developed to quantify THEDES in its mixture using modulated temperature differential scanning calorimetry (MTDSC). MTDSC data showed that the three polymers retarded THEDES formation in the following order PEVA < EuRLPO < PEO. This retardation was attributed to increased medium viscosity and the subsequent reduction in THEDES formation rate. Increasing the heating time led to complete THEDES formation in the case of PEVA and EuRLPO but not with PEO. This result was explained based on the polymers' interaction with THEDES parent drugs and inputs from polymers' viscoelastic properties. On the other hand, introducing the polymer after THEDES formation mitigated their viscosity effect but their interaction with the parent drugs remained an issue, where PEO and EuRLPO were able to destabilize the pre-formed THEDES to variable extents. Long-term storage stability study further confirmed this conclusion. Therefore, this study will provide valuable information regarding the interaction (or lack of) of THEDES with model pharmaceutical polymers that have been thermally processed and will provide recommendations regarding the rational choice of polymers to maintain THEDES stability.

News (Medical) associated with Flurbiprofen

17 Apr 2023

·www.drugs.com

Get Pain Relief With the Most Common Arthritis Medications

MONDAY, April 17, 2023 -- Arthritis is a common disease that causes pain and inflammation in different body joints, making it difficult to enjoy everyday tasks and physical activity. Fortunately, there are many different medications for arthritis. Depending on what type of arthritis you have and its severity, an arthritis medication may help you manage pain and other symptoms. Here is a breakdown of the most common arthritis medications, how they work and their potential side effects. The Arthritis Foundation lists the following as the medications used to treat arthritis: Analgesics including acetaminophen (Tylenol) and opioids Nonsteroidal anti-inflammatory drugs (NSAIDs) Corticosteroids Disease-modifying antirheumatic drugs (DMARDs) including biologics and targeted DMARDs Analgesics The Arthritis Foundation reports that analgesics may help with mild to moderate pain, but they will not help with the inflammation associated with arthritis. Analgesics work in the nervous system and alter how your brain perceives pain. They can be used to treat the pain associated with any type of arthritis, although more effective options are available. Analgesics can be opioid, non-opioid or a combination. Common analgesics are: Acetaminophen (Tylenol) Codeine Oxycodone Fentanyl Hydrocodone Potential side effects: Kidney damage Liver damage Addiction Constipation Gastrointestinal bleeding Use caution when taking these medications; take only as prescribed. NSAIDs NSAIDs work by blocking prostaglandin. According to the Cleveland Clinic , one role prostaglandins play is forming clots and causing inflammation at the site of an injury. NSAIDs are used to treat the pain and inflammation associated with rheumatoid arthritis and osteoarthritis . Common over-the-counter (OTC) NSAIDs are: Aspirin (Bayer, St. Joseph, Anacin, Excedrin and more) Ibuprofen (Motrin, Advil) Naproxen sodium (Aleve) Prescription NSAIDs are: Celecoxib (Celebrex) Diclofenac (Voltaren, available by brand name in topical form) Fenoprofen (Nalfon) Indomethacin (Indocin, available by brand name in liquid form) Ketorolac tromethamine (Toradol) Meclofenamate sodium (Meclomen) Diflunisal (Dolobid) Tolmetin (Tolectin) Ketoprofen (Orudis) Flurbiprofen (Ansaid) Potential side effects of NSAIDs are: Increased risk of stomach and bowel issues like ulcers and bleeding Increased risk of stroke Heart problems Stomach pain Nausea Diarrhea/constipation Corticosteroids According to the Arthritis Foundation , corticosteroids mimic cortisol, a hormone your body produces naturally. They are used to treat inflammatory types of arthritis, including rheumatoid arthritis and psoriatic arthritis. They are great for short-term relief of inflammation but are not recommended for long-term use because of their side effects. Your doctor may prescribe a lower dose if you require them for long-term use. Common corticosteroids: Prednisone (Deltasone, Prednicot, Cotolone) Prednisolone (Orapred, Omnipred) Cortisone (Cortone) Hydrocortisone (Cortef, Hydrocort) Triamcinolone (Aristocort) Dexamethasone (Decadron) Common side effects of corticosteroids: Blood sugar spikes Weight gain Bone loss Risk of cataracts High blood pressure Infections Mood changes DMARDs The Arthritis Foundation says that DMARDs work with the body to “stop or slow the disease process in inflammatory forms of arthritis.” They work by blocking inflammation. There are many different DMARDs on the market, and they all have different ways of working in the body. Conventional DMARDs work by broadly suppressing the immune system. Often they are used in combination with other therapies. Targeted DMARDs block specific pathways inside immune cells. Biologic DMARDs are produced by live cells and work on specific immune proteins called cytokines. Common DMARDs: Apremilast (Otezla) Baricitinib (Olumiant) Cyclophosphamide (Cytoxan) Cyclosporine (Gengraf, Neoral) Hydroxychloroquine (Plaquenil) Leflunomide (Arava) Methotrexate (Otrexup, Rasuvo, RediTrex) Mycophenolate mofetil (CellCept) Sulfasalazine (Azulfidine) Tofacitinib (Xeljanz, Xeljanz XR) According to the Cleveland Clinic , common side effects of traditional DMARDs include: Loss of appetite Nausea Diarrhea Abdominal pain Rash, allergic reaction Liver problem Increased risk of infection Low blood cell counts Common side effects of biologic DMARDs include: Increased risk of common and serious infections Reactivation of tuberculosis, herpes zoster, and hepatitis B and C Increased cholesterol levels, increased liver enzymes and low blood cell counts Increased risk of clotting When prescribed DMARDs, inform your doctor of any other medications, including over-the-counter medicines, you are taking to avoid drug interactions. Some of these medications can cause teratogenicity (defects in a developing fetus.) Writing recently in the Journal of the American Academy of Physician Assistants (JAAPA ), physician assistant Michelle DiBiase and Dr. Samantha Kohn remind people that "The mainstay of pharmacologic therapy is early intervention with use of nonbiologic and biologic DMARDs together with adjunctive medications such as NSAIDs, oral and intra-articular corticosteroids, and analgesic medications, including opioids." Your primary care provider or rheumatologist will work closely with you to determine which medications are best for your treatment. It is vital to keep them apprised of any side effects and let them know if the treatment is ineffective. They can work with you to find a treatment that helps relieve the pain and inflammation caused by arthritis. Posted April 2023

Drug Approval

100 Deals associated with Flurbiprofen

External Link

KEGG	Wiki	ATC	Drug Bank
D00330	Flurbiprofen	M01AE09 M02AA19 R02AX01	DB00712

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Myalgia	Japan	Mikasa Seiyaku Co. Ltd.	14 Mar 2008
Periarthritis	Japan	Mikasa Seiyaku Co. Ltd.	14 Mar 2008
Pharyngitis	Australia	Reckitt Benckiser (Australia) Pty Ltd.	01 Dec 2007
Analgesia	Japan	Tokuhon Corp.	14 Mar 2001
Inflammation	Japan	Tokuhon Corp.	14 Mar 2001
Musculoskeletal Pain	Japan	Taikyo Pharmaceutical Co. Ltd.	10 Mar 1992
Bursitis	Japan	Kaken Pharmaceutical Co., Ltd.	01 Sep 1989
Epicondylitis	Japan	Kaken Pharmaceutical Co., Ltd.	01 Sep 1989
Pain	Japan	Kaken Pharmaceutical Co., Ltd.	01 Sep 1989
Tenosynovitis	Japan	Kaken Pharmaceutical Co., Ltd.	01 Sep 1989
Tumescence	Japan	Kaken Pharmaceutical Co., Ltd.	01 Sep 1989
Low Back Pain	Japan	Kaken Pharmaceutical Co., Ltd.	31 Oct 1981
Periodontitis	Japan	Kaken Pharmaceutical Co., Ltd.	31 Oct 1981
Pulpitis	Japan	Kaken Pharmaceutical Co., Ltd.	31 Oct 1981
Osteoarthritis	Japan	Kaken Pharmaceutical Co., Ltd.	19 Apr 1979
Rheumatoid Arthritis	Japan	Kaken Pharmaceutical Co., Ltd.	19 Apr 1979

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	China	Beijing Tide Pharmaceutical Co., Ltd.	31 Mar 2020
Osteoarthritis, Knee	Phase 3	China	Mikasa Seiyaku Co. Ltd.	31 Mar 2020
Moderate pain	Phase 3	China	Wuhan Daan Pharmacy Co. Ltd.	08 Nov 2013
Acute pharyngitis	Phase 3	United States	Reckitt Benckiser LLC	01 Sep 2013
Cough	Phase 1	Australia	Reckitt Benckiser LLC	01 Jul 2023
Respiratory Tract Infections	Phase 1	Australia	Reckitt Benckiser LLC	01 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01048866 (CTgov)	Phase 3	Pharyngitis	198	acetaminophen 650mg+flurbiprofen (Flurbiprofen 8.75 mg Lozenge)	melyaztsea(shcbxbgmem) = qhwvynbzhn tzavpahddm (syceapghhj, 476.54) View more	-	21 Sep 2017
				placebo+acetaminophen 650mg (Placebo Lozenge)	melyaztsea(shcbxbgmem) = urakytpofo tzavpahddm (syceapghhj, 386.83) View more
NCT01049334 (CTgov)	Phase 3	Pharyngitis	204	Flurbiprofen (Flurbiprofen 8.75 mg Lozenge)	ptgmhfwkue(zwvdcclige) = okencsuldw qblrloolag (ajclfbvsla, 45.4428) View more	-	21 Sep 2017
				Placebo (Placebo Lozenge)	ptgmhfwkue(zwvdcclige) = ckpsfyecln qblrloolag (ajclfbvsla, 45.6708) View more
NCT01986361 (CTgov)	Phase 3	Acute pharyngitis	122	flurbiprofen (Flurbiprofen 8.75 mg Lozenge)	ibvpcbgoaj(hejrgfskgf) = ysndrcifut irpregorqp (sezhktflzx, bjvssvbgcp - cydbkfyxqi) View more	-	24 Aug 2017
				placebo (Placebo Lozenge)	ibvpcbgoaj(hejrgfskgf) = klefcschcn irpregorqp (sezhktflzx, obtrptuyln - pbyaccyunn) View more
ARVO2017	Not Applicable	Macular Edema	20	Nepafenac	aurzlvejbf(mvphtjcszn) = agabwmbwiq wdbtihacbg (ueyqjwrlwl )	-	07 May 2017
				Diclofenac	aurzlvejbf(mvphtjcszn) = gmzksijglo wdbtihacbg (ueyqjwrlwl )
NCT01048866 \| NCT01049334 (Pubmed \| Int J Clin Pract)	Phase 3	Streptococcal Infections	402	Flurbiprofen 8.75 mg lozenges	qlcumbotuu(rqwcdqeglq) = A single flurbiprofen lozenge provided significantly greater relief than placebo for all three throat symptoms, lasting 3-4 h for patients with and without Strep A/C ulvxhwienb (lfckbsfqrd ) View more	Positive	01 Jan 2015
Iritis prevention study (ARVO2004)	Not Applicable	Iritis	64	Topical flurbiprofen 300 mcg/ml	lkciugoqem(mqitkzvvwk) = 7/30 treated patients and 0/34 control patients had increased stinging wolnqcqtpj (qxuwtrmeml )	Negative	01 May 2004
				Placebo

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