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Diclofenac sodium topical gel

Steven Nisticò, Ester Del Duca, Valeria Torchia, Micaela Gliozzi, Ugo Bottoni, Carolina Muscoli
Actinic keratosis (AK) is a clinical condition characterized by keratinocytic dysplastic lesions of the epidermis, affecting individuals chronically exposed to sunlight. Topical therapies allow the treatment of a whole area of affected skin and currently include diclofenac sodium gel, 5-fluorouracil cream, 5-fluorouracil and acetylsalicylic acid solution, imiquimod cream, and ingenol mebutate gel. Due to the comparable efficacy of 3% diclofenac, ingenol mebutate, and 3.75% imiquimod in treating AK multiple lesions, a pharmacoeconomic evaluation of cost-effectiveness of the three treatments was needed...
January 2018: International Journal of Immunopathology and Pharmacology
Lorena Tavano, Elisabetta Mazzotta, Rita Muzzalupo
HYPOTHESIS: Due to the well-know surfactant-like properties of diclofenac sodium (DS), vesicular systems consisting exclusively of DS, named diclosomes, were designed with the aim to minimize or avoid the use of other excipients and to improve the formulation biocompatibility. EXPERIMENTS: Diclosomes were designed and characterized in terms of dimensions, polydispersity index, ξ-potential, drug retained, stability as a function of storage time and ex-vivo percutaneous permeation profiles...
April 1, 2018: Colloids and Surfaces. B, Biointerfaces
Amanda Katarinny Goes Gonzaga, Patrícia Teixeira de Oliveira, Éricka Janine Dantas da Silveira, Lélia Maria Guedes Queiroz, Ana Miryam Costa de Medeiros
OBJECTIVE: Actinic cheilitis (AC) is a potentially malignant lesion caused by prolonged exposure to ultraviolet light. The aim of this research was to analyze the efficacy of diclofenac sodium 3% gel in the treatment of this condition, through clinical follow-up. METHODS: Thirty-one patients diagnosed with AC were instructed to perform a topical application of the gel three times a day for a period of 90 days. In each visit, a digital photography was obtained for verified progress and response to treatment...
October 6, 2017: Clinical Oral Investigations
Gianni Paulis, Andrea Paulis, Gennaro Romano, Davide Barletta, Andrea Fabiani
Peyronie's disease (PD) is a connective tissue disorder involving the tunica albuginea of the corpora cavernosa of the penis. We have published several studies describing a "combined therapy" for PD patients, but the present study aims to clearly demonstrate how the association between various antioxidants in PD treatment can significantly increase the likelihood of therapeutic success. We used the following substances: silymarin, ginkgo biloba , vitamin E, bilberry, topical diclofenac sodium, and pentoxifylline (PTX)...
2017: Research and Reports in Urology
Keith Tolley, Giuseppe Argenziano, Pier Giacomo Calzavara-Pinton, Thomas Larsson, Lasse Ryttig
Actinic keratoses (AKs) develop as a consequence of chronic ultraviolet (UV) exposure and exist on a continuum with squamous cell carcinoma (SCC). As one of the most common conditions treated by dermatologists, AK places a significant burden on patients and the healthcare system. A range of treatments are used, including topical treatments that target the visible and subclinical lesions. The goal of such therapies is to achieve complete clearance of AKs and eliminate the risk of progression to SCC. Robust meta-analyses of trial data can provide valuable information for the optimal management of AK and cost-effectiveness evaluations of topical treatments, such as ingenol mebutate gel and diclofenac...
June 2017: International Journal of Immunopathology and Pharmacology
Aruna Khanolkar, Viraj Thorat, Preeti Raut, Gautam Samanta
The objective of the present study was to develop and optimize generic topical gel formulation of diclofenac sodium through quality by design approaches. The quality target product profile was set for the critical quality attributes of the gel. The key material variables like hydrophilic gelling agent carbopol and penetration enhancer kolliphor were optimized using design of experiments. A central composite design was used considering viscosity and cumulative percent diffusion of the drug after 0.5, 1, 2, 4 and 6 h as responses...
October 2017: AAPS PharmSciTech
Poonam Negi, Madhur Aggarwal, Gajanand Sharma, Charul Rathore, Gaurav Sharma, Bhupinder Singh, O P Katare
The present work endeavors for development and evaluation of resveratrol loaded niosomal hydrogel system for its anti-inflammatory action. Niosomes were prepared by thin film hydration and ether injection methods employing Span 80 as a surfactant at three different levels. Best optimized formulation was selected on the basis of entrapment efficiency (% EE), mean particle size, sedimentation volume, and microscopy. The vesicular and spherical nature of the niosomes was confirmed by optical microscopy and transmission electron microscope (TEM)...
April 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
Jaywant Pawar, Rajkiran Narkhede, Purnima Amin, Vaishali Tawde
The aim of the present context was to develop and evaluate a Kolliphor® P407-based transdermal gel formulation of diclofenac sodium by hot melt extrusion (HME) technology; central composite design was used to optimize the formulation process. In this study, we have explored first time ever HME as an industrially feasible and continuous manufacturing technology for the manufacturing of gel formulation using Kolliphor® P407 and Kollisolv® PEG400 as a gel base. Diclofenac sodium was used as a model drug. The HME parameters such as feeding rate, screw speed, and barrel temperature were crucial for the semisolid product development, and were optimized after preliminary trials...
January 20, 2017: AAPS PharmSciTech
Sebastian A Moreira, D Jeffery Liu
OBJECTIVE: Evaluate systemic exposure with repeated topical application of a fixed-combination topical gel product containing 1% diclofenac sodium and 3% menthol in either of 2 formulation packages relative to oral administration. METHODS: In this phase 1, single-center, 4-way crossover study, healthy volunteers aged 18 - 50 years underwent consecutive 3-day treatment regimens in a randomly assigned sequence with each of 4 treatment groups: 4 g of topical 1% diclofenac + 3% menthol gel administered via an aluminum tube or roll-on device applied 4 times daily; 4 g of topical 1% diclofenac sodium gel (Voltaren Gel) applied 4 times daily; and oral diclofenac sodium tablets 50 mg 3 times daily...
April 2017: International Journal of Clinical Pharmacology and Therapeutics
Dongzhou Jeffery Liu, Agron Collaku, Jonathan S Dosik
Phase I, randomized, controlled patch studies were conducted to evaluate skin sensitization and irritation potential of a new gel formulation containing 1% diclofenac and 3% menthol as a fixed-combination product.In study A, healthy volunteers were exposed to 4 test patches containing 1% diclofenac+3% menthol, diclofenac, menthol, or placebo gels during an induction (nine 48 to 72-h applications) and challenge phase (one 48-h application). Some subjects were re-challenged to evaluate suspected sensitization...
February 2017: Drug Research
Sandra Jerkovic Gulin, Anca Chiriac
Allergic contact dermatitis is an immune-mediated antigen-specific skin reaction to an allergenic chemical that corresponds to a delayed-type hypersensitivity response (type IV reaction). Allergic contact dermatitis should be suspected when skin lesions are localized to the site of previous applications of the culprit drug. Lesions appear after re-exposure in susceptible persons, with delayed onset (more than 24 h after exposure). The gold standard for diagnosis is patch (epicutaneous) testing; identification and removal of any potential causal agents is crucial...
December 2016: Drug Safety—Case Reports
Mohammed H Mahdi, Barbara R Conway, Thomas Mills, Alan M Smith
Diclofenac topical formulations are often preferred for drug administration to patients who experience serious GIT problems. Absorption of the drug through the skin, however, can be challenging due to the natural protective feature of the stratum corneum (SC). In this article, fluid gels prepared from gellan gum were explored as a topical drug delivery vehicle. Rheological analysis of the formulations showed that it was possible to produce a topical gel with a viscosity and the mechanical strength similar to that of the commercially available Voltaren(®) gel using 1% w/w of a 50:50 low acyl/high acyl (LA/HA) gellan blend...
December 30, 2016: International Journal of Pharmaceutics
Gita Faghihi, Azam Elahipoor, Fariba Iraji, Shadi Behfar, Bahareh Abtahi-Naeini
Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks...
2016: Advances in Medicine
Sergio Santos-Alarcon, Celia Sanchis-Sanchez, Almudena Mateu-Puchades
BACKGROUND: Darier's disease (DD) is an autosomal dominant skin disorder which causative gene, ATP2A2, is located atchromosome 12q23-24. The lesions of DD are skin-coloured to brown, hyperkeratotic, greasy papules that coalesce into warty plaques commonly involving the seborrhoeic areas of the trunk and face, especially the scalp margins, temples, ears, and scalp. The most common complaint associated with the disease is itching, with exacerbations attributed to heat, sweating, sunlight, lithium, steroid therapy, stress, and menstruation OBJECTIVES: We report a patient with DD treated with topical diclofenac sodium 3%...
April 18, 2016: Dermatology Online Journal
Robert R Edwards, Andrew J Dolman, Marc O Martel, Patrick H Finan, Asimina Lazaridou, Marise Cornelius, Ajay D Wasan
BACKGROUND: Patients with painful knee osteoarthritis (OA) demonstrate hyperalgesia and altered pain-modulatory responses. While some prior work has demonstrated cross-sectional associations between laboratory and clinical pain measures, it is unknown whether individual variability in quantitative sensory testing (QST) responses at baseline can prospectively predict analgesic treatment responses. METHOD: Patients with knee OA (n = 35) were compared on QST responses to a demographically-matched pain-free control group (n = 39), after which patients completed a month-long treatment study of diclofenac sodium topical gel (1 %), applied up to 4 times daily...
July 13, 2016: BMC Musculoskeletal Disorders
Carlos A Carmona-Moran, Oleksandra Zavgorodnya, Andrew D Penman, Eugenia Kharlampieva, S Louis Bridges, Robert W Hergenrother, Jasvinder A Singh, Timothy M Wick
Enhancing skin permeation is important for development of new transdermal drug delivery formulations. This is particularly relevant for non-steroidal anti-inflammatory drugs (NSAIDs). To address this, semisolid gel and solid hydrogel film formulations containing gellan gum as a gelling agent were developed and the effects of penetration enhancers (dimethyl sulfoxide, isopropyl alcohol and propylene glycol) on transport of the NSAID diclofenac sodium was quantified. A transwell diffusion system was used to accelerate formulation development...
July 25, 2016: International Journal of Pharmaceutics
Atousa Ziaei, Shamim Sahranavard, Mohammad Javad Gharagozlou, Mehrdad Faizi
BACKGROUND: Many plants have been introduced in Iranian traditional medicine for treatment of different joint problems including knee pain. Topical application of the mixture of Lawsonia inermis L. leaves (Henna) with aqueous extract of Ricinus communis L. leaves have been mentioned to have significant effects on reducing knee pain. The present study was designed to evaluate the analgesic and anti-inflammatory effects of the mixture of these two herbs in male rats. METHODS: We induced knee osteoarthritis as a model of chronic pain by intra-articular injection of mono sodium iodoacetate (MIA)...
May 3, 2016: Daru: Journal of Faculty of Pharmacy, Tehran University of Medical Sciences
Tjinta Brinkhuizen, Kiki J A Frencken, Patty J Nelemans, Marlou L S Hoff, Nicole W J Kelleners-Smeets, Axel Zur Hausen, Michiel P J van der Horst, Dorit Rennspiess, Véronique J L Winnepenninckx, Maurice A M van Steensel, Klara Mosterd
BACKGROUND: Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC). OBJECTIVE: We investigated the efficacy of topically applied diclofenac sodium 3% gel, calcitriol 3 μg/g ointment, and a combination of both in superficial BCC (sBCC) and nodular BCC. METHODS: Patients with a primary, histologically proven sBCC (n = 64) or nodular BCC (n = 64) were randomized to topical diclofenac, calcitriol, combination of both, or no topical treatment (control group)...
July 2016: Journal of the American Academy of Dermatology
Carl V Asche, Panagiotis Zografos, Jenny M Norlin, Bill Urbanek, Carl Mamay, Charles Makin, Sandra Erntoft, Chi-Chang Chen, Dionne M Hines, Daniel Mark Siegel
OBJECTIVE: To compare health care resource utilization and treatment patterns between patients with actinic keratosis (AK) treated with ingenol mebutate gel (IngMeb) and those treated with other field-directed AK therapies. METHODS: A retrospective, propensity-score-matched, cohort study compared refill/repeat and adding-on/switching patterns and outpatient visits and prescriptions (health care resource utilization) over 6 months in patients receiving IngMeb versus those receiving imiquimod, 5-fluorouracil, diclofenac sodium, and methyl aminolevulinate or aminolevulinic acid photodynamic therapy (MAL/ALA-PDT)...
March 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
L Tyler Wadsworth, Jeffrey D Kent, Robert J Holt
OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are standard therapy for osteoarthritis (OA). Topically applied NSAIDs reduce systemic exposure compared with oral NSAIDS, and European guidelines recommend their use. The NSAID diclofenac is available in a range of topical formulations. Diclofenac 1% gel and 1.5% four times daily and 2% twice daily (BID) solutions are approved to reduce pain from OA of the knee(s). The objective of this study was to investigate the efficacy and safety of diclofenac sodium 2% topical solution BID versus vehicle control solution for treating pain associated with OA of the knee...
2016: Current Medical Research and Opinion
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