It can be concluded that preparation of diclofenac sodium by using 2% carbopol 934p grade. Topical nsaid formulations pain medicine oxford academic. Formulation and evaluation of diclofenac sodium gel by using. Diclofenac na 5% gel has a higher viscosity at 10 s. Voltaren gel diclofenac sodium topical gel, 1%, for topical use only initial u. Voltaren gel is a nonsteroidal antiinflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Voltaren gel is contraindicated in the following patients. Diclofenac sodium is a benzeneacetic acid derivative. Topical bioavailability of diclofenac from locallyacting. Composition of gel formulation is given in table 1. Diclofenac sodium is a white to slightly yellow crystalline powder.
Comparison between marketed formulations of diclofenac. Diclofenac gel fda prescribing information, side effects. These gel formulations were further compared with marketed diclofenac sodium gel. Voltaren emulgel gel was chosen as the reference formulation, as it is the current global sales leader for topical pain relief and because it has been studied previously using microdialysis md 712. Formulation and evaluation of topical gel of diclofenac. Nonformulary diclofenac sodium gel voltaren gel will be covered on the prescription drug benefit when the following criteria are met. Pdf development and optimization of novel diclofenac. A single oral diclofenac application at the dose of. Patient information for diclofenac emulgel 1% including dosage instructions and possible side effects. For enhancing the viscosity, carbopol was used to form an mebased gel. Comparison between two diclofenac diethylamine gel. Formulation and evaluation of transdermal patch of diclofenac. Formulation and evaluation of transdermal patch of.
Naresh ahuja, vipin saini, vijay kumar bishnoi, atul garg, monika hisoria, joyati sharma and kunal nepali department of pharmaceutics, bharti institute of pharmaceutical sciences, sriganganagar335001 raj. The gel formulation contains propylene glycol and benzyl benzoate, which may cause mild. Results of in vitro diffusion studies showed that formulation f3 and f6 exhibited 64% and 65% drug release respectively over a period of 6 hrs. Formulation code %moisture content %moisture uptake drug content mg f1 6. Diclofenac sodium topical gel, 1% is a nonsteroidal antiinflammatory drug nsaid for topical use only. Addition of pe to veg 2% resulted in an up to 3fold increased diclofenac skin permeation which correlated with the pe dose concentrations. Diclofenac sodium is the sodium salt form of diclofenac, a benzene acetic acid derivate and nonsteroidal antiinflammatory drug nsaid with analgesic, antipyretic and antiinflammatory activity. In conclusion, a physiochemical stable diclofenac emulgel was formulated, which could deliver significant amount of drug across the. In vitro and in vivo evaluation of diclofenac sodium gel. Diagnosis of joint pain from osteoarthritis in the knees, ankles, feet, elbows, wrists, or hands and 2. Percutaneous absorption of diclofenac in healthy volunteers. Request pdf formulation and evaluation of topical gel of diclofenac sodium using different polymers a wide choice of vehicles ranging from solids to semisolids form has been used for skin care. The aim of this study was to develop and optimize a transdermal gel formulation for diclofenac diethylamine ddea and curcumin crm.
All gel formulations showed acceptable physical properties concerning color, homogeneity, consistency, spreadability and ph value. Evaluation of skin penetration of diclofenac from a novel topical non aqueous solution. A microemulsion me was prepared using caprylocaproyl polyoxyl8 glycerides, diethylene glycol monoethyl ether, and propylene glycol monolaurate. The active substance is diclofenac diethylammonium 1. The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis. The gel formulation contains propylene glycol and benzyl benzoate, which may cause mild localised skin irritation in some people. Rheological measurements revealed that the formulations containing different gelling agents carbomer in diclofenac dea 1. Formulation and evaluation of diclofenac transdermal gel.
Diclofenac sodium topical gel 1%, approved in october 2007 diclofenac sodium topical solution 1. Its molecular formula is c 14 h 10 cl 2 nnao 2, and it has the following chemical structure. Diclofenac sodium using 12 healthy indian male subjects. Roy sharad, pawar college of pharmacy, wanadongri, hingna road, nagpur441110, india high molecular weights water soluble homopolymer of acrylamide are reported to possess. Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Formulation of diclofenac for dermal delivery sciencedirect. Criteria for drug coverage diclofenac sodium gel voltaren gel. How to use voltarol emulgel always use voltarol emulgel exactly as your doctor has told you. The use of voltaren gel is contraindicated in pa tients with a known hypersensitivity to diclofenac. Standard plot values of diclofenac diethylamine figure 1. The chemical name is 22,6dichlorophenyl aminobenzene acetic acid, monosodium salt.
Conclusion the transdermal patch of diclofenac sodium. Ingredient quantity physical description solubility therapeutic activity. Optimization and formulation design of gels of diclofenac and. Local accumulation efficiency lac values, representing the ratio of diclofenac accumulated into the whole skin versus the amount that permeated through the skin were also calculated as 0. The pharmacodynamic studies showed the enhanced anti. Among all the gel formulations, carbopol with hpmc in ratio of 1. The aim of the current research was to investigate the release of diclofenac sodium, a poorly watersoluble drug from different formulations in vitro. It contains the active ingredient, diclofenac sodium, in an opaque, white gel base.
Highlights of prescribing information these highlights do. Carbopol 934p and sodium cmc were purchased from s. The percutaneous absorption of diclofenac was studied in ten healthy volunteers treated with emulgel containing 1. Nanoemulsionbased gel formulation of diclofenac diethylamine. The other ingredients are diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, propylene. See full prescribing information for complete boxed warning. The gel was prepared and evaluated for ph, spreadability, consistancy, homogeneity, drug content, skin irritation test and in vitro diffusion study. Solaraze 3% diclofenac sodium gel is topically applied, twice a day for three months, to manage the skin condition known as actinic or solar keratosis. Aug 30, 2017 one formulation, solaraze diclofenac topical gel 3%, is used to treat actinic keratosis, while the other two, voltaren diclofenac topical gel 1% and pennsaid diclofenac topical solution 2%, are for pain relief in particular forms of arthritis. Listing a study does not mean it has been evaluated by the u. Jun 06, 2011 voltaren gel diclofenac sodium topical gel is a nonsteroidal antiinflammatory drug nsaid for topical use only. Formulation and evaluation of diclofenac sodium gel by. Pdf formulation and evaluation of topical gel of diclofenac.
Highlights of prescribing information these highlights do not. Although topical diclofenac agents are designed to act locally at the site of application, consideration of the degree of systemic. Hec formulation was developed and in vitro transdermal penetration of this formulation was compared with that commercial vurdon gel 1% help. Read the medication guide and patient instructions for use provided by your pharmacist before you start using diclofenac and each time you get a refill. Prior adequate trial and failure of 4 formulary nsaids meloxicam, etodolac, nabumetone. This product contains a variety of additional ingredients in the vehicle including isopropyl alcohol, propylene glycol, and water to assist in drug penetration of.
It comes as a topical gel, oral capsule, oral tablet, eye drops, transdermal patch, topical solution, and powder packets for oral solution. The objective of present study was conducted to develop a topical gel formulation of diclofenac sodium using hec polymer. Mar 02, 2020 the pharmacokinetics of voltaren gel were assessed in healthy volunteers following repeated applications during 7 days of voltaren gel to 1 knee 4 x 4 g per day or to 2 knees and 2 hands 4 x 12 g per day versus the recommended oral dose of diclofenac sodium forthe treatment of osteoarthritis 3 x 50 mg per day. In vitro evaluation of diclofenac gels 11 the diclofenac sodium gels were subjected to. The gel were kept in plastic well closed container and stored at room temperature until the time of analysis. Voltaren gel should not be administered in patients who have experienced asthma, urticaria, or other allergictype reactions after taking aspirin or other nsaids. Naresh ahuja, vipin saini, vijay kumar bishnoi, atul garg, monika. Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium is a nonselective reversible and competitive inhibitor of cyclooxygenase cox, subsequently blocking the conversion of arachidonic. Can topical and oral nsaids be combined for pain relief. Gel and emugel formulation was applied on one forearm whereas the spray was applied on the other arm. Our results suggest that the ethosomes are an efficient carrier for dermal and transdermal delivery of diclofenac potassium. The physical characteristics of the 2 formulations were.
A new topical formulation enhances relative diclofenac. Diclofenac sodium was a gift sample from yacht pharma, hyderabad. The new gel is expected to have a lasting effect, e. Formulation and stability of chloramphenicol gel and emulgel. Apr 12, 2019 rheological measurements revealed that the formulations containing different gelling agents carbomer in diclofenac dea 1. The influence of the type of the gelling agent and the concentration of vormulation the oil phase and emulsifying agent on the drug release from the prepared emulgels was investigated using a 2 3 factorial design. New, highly efficient formulation of diclofenac for the. Diclofenac sodium 1% gel voltaren gel is approved for the relief of pain due to osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
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