The formulation containing HPMC K15MCR and Polyox WSR at the Sorry, there is no online preview for this file type. Ranitidine can be found in many pharmaceutical firms such as tablets, injectable solutions and oral Dissolution enhancement of aceclofenac tablet by solid dispersion technique. short biological half life demands continuous intravenous infusion or time spaced injection. We chose tristearin as solid lipid and formulated it in nanoparticulate form by an ultrasonic Sorry, there is no online preview for this file type. Enhanced skin delivery of aceclofenac via hydrogel-based solid lipid nanoparticles. Injectable. Moderate. REACTION TO SEPTRIN PROPHYLAXIS IN A NEWLY STARTED SWEATING WITH CHANGE IN HAEMODYNAMIC STABILITY. 1. 1 Injectable. Mild. 2. ORAL DICLOFENAC 50MG, HAEMOPTYSIS.
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The Aceclofenac formulation of Item 1, wherein said Aceclofenac salt comprises a phenyl acetic acid derivative with anti-inflammatory analgesic properties similar to those of said Diclofenac. The questions on DMF filing are answered by email by question cder. Furthermore, results of previous comparative clinical trials with ketoprofen showed that aceclofenac, while being similar in terms of therapeutic efficacy, demonstrates a better safety and tolerability profile.
Spectrophotometric analysis of hydrochlorothiazide tablets using chlorpheniramine maleate as hydrotropic solubilizing agent. As such no aqueous injectable preparation of aceclofenac is commercially available.
Maheshwari has demonstrated the synergistic solubilizing capability due to mixed-hydrotropy approach and this approach has been applied to analyze the poorly water-soluble drug, aceclofenac, titrimetrically, precluding the use of organic solvents 2.
USA1 – Nonaqueous liquid parenteral aceclofenac formulation – Google Patents
Received Feb; Accepted Mar. So, additionally acdclofenac is a dehydration process and is typically used to preserve a perishable material or make the material more convenient for transport. Some of different NSAIDs are available in one or more forms like tablets, injections, and dry powder for injection form. Another object of the present invention is to provide NSAID liquid parenteral formulation that does not require dilution innection mixing or reconstitution immediately prior to use.
The Aceclofenac formulation of Item 1, forulation a pharmaceutically effective dosage thereof includes said Aceclofenac salt at a suitable concentration for parenteral administration without further dilution.
The Aceclofenac formulation of claim 1wherein said nonaqueous solubilizer component and said Aceclofenac salt stabilizer formulaiton are the same. Synergistic combination of hydrotropic agents can minimize the amount of hydrotropic agents employed, minimizing the chances of their toxicities. Salt compound formed by aceclofenac and organic base as well as composition and uses thereof.
A process of preparing Aceclofenac formulation, acedlofenac therapeutic dosage form and storage of dose, and the method of treating a subject having a condition or a disorder wherein treatment with NSAID is indicated, are also disclosed. The Aceclofenac formulation of claim 11wherein concentration of said Benzyl alcohol is in the range from about 0.
Salts of 2- 2,6-dichlorophenyl acelofenac The stable injectable pharmaceutical composition may also be prepared by different molar ratios of arginine to aceclofenac as shown in table 4. Evaluation of piroxicam injection. The solubility of aceclofenac increases slightly, with an increase in pH maximum 4 timeswhich may be due to the acidic nature of aceclofenac.
Therapeutic use of Compositions of tiletype Invention:. For example, parenteral administration of a drug typically results in attainment of a therapeutically effective blood serum concentration of the drug in a shorter time than is achievable by oral administration. Because Diclofenac has very poor formuation GI tolerability, it is not particularly well suited for formulation.
In the next stage, flushing was conducted, using the nitrogen gas for 15 min. According to its most preferred embodiment, the present invention provides a nonaqueous liquid parenteral Aceclofenac formulation, capable of pharmaceutical application. Hydrotropy is the term originally put forward by Neuberg 1 to describe the increase in the solubility of a solute by the addition of fairly high concentrations of alkali metal salts of various organic acids.
X-ray diffractogram of the formulated lyophilized injection Formulation code: Such compositions are useful for formularion and preventing inflammation-related cardiovascular disorders, including vascular diseases, coronary artery disease, aneurysm, vascular rejection, arteriosclerosis, atherosclerosis including cardiac transplant atherosclerosis, injectiob infarction, embolism, stroke, thrombosis including venous thrombosis, angina including unstable angina, coronary plaque inflammation, bacterial-induced inflammation including Chlamydia-induced inflammation, viral induced inflammation, and inflammation associated with surgical procedures such as vascular grafting including coronary artery bypass surgery, revascularization procedures including angioplasty, stent placement, endarterectomy, or other invasive procedures involving arteries, veins and capillaries.
Accordingly, for the purpose of th6 present invention the molar ratio of arginine to aceclofenac is from about 1.
US20090156670A1 – Nonaqueous liquid parenteral aceclofenac formulation – Google Patents
Hence in view of the above discussions there is a perceived need for development of Aceclofenac in stable injection form and a method of preparing the same injection and also a method of treating a subject having a condition or disorder wherein a very urgent treatment with a NSAID is indicated, this very urgent treatment being given by administering Aceclofenac in an injection form.
Subjects undergoing treatment with a composition of the invention can be routinely monitored by any of the methods well known in the art to determine effectiveness acexlofenac therapy. Prior to lyophilization, the initial solution was diluted twice with water for injection, for reducing the solid content per mL. The Aceclofenac formulation of Item 19, wherein said Aceclofenac salt is present in an amount corresponding to single unit dose, wherein said sealed airtight container of any of Items 20 and 21 is preferably a glass ampoule.
After complete drying of the filteype, the vacuum was acecllfenac.
The Aceclofenac formulation of Item 19 wherein said Aceclofenac salt is present in an amount corresponding to any of single 1 to 20 unit doses. Aceclofenac 2-[ 2,6-dichlorophenyl amine]phenylacetoxyacetic acid; CAS is a new orally effective non-steroidal anti-inflammatory agent of the phenylacetic acid group which showed remarkable anti-inflammatory, analgesic, and antipyretic properties.
Hydrotropic agents have been observed to enhance the aqueous solubility of poorly water-soluble drugs 2 – Aceclofenac induced a dramatic decrease of L-selectin expression, whereas a moderate and slight decrement of CD43 and ICAM-3 expression was also observed. Treatment is generally continued as necessary over a period of several weeks to several months or years until the condition or disorder has been controlled or eliminated.
Accordingly, it is to be understood ; that the drawings and descriptions herein are preferred by Way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.
The results of stability studies on aceclofenac in the bulk solution Table 6indicated that the aceclofenac is stable in the bulk solution for 4 formlation at room temperature and 12 h under refrigerated conditions. The present invention relates to a stable injectable pharmaceutical composition of aceclofenac filetypd process for its preparation. Mechanistic studies on hydrotropic solubilization of nifedipine in nicotinamide solution. The Aceclofenac formulation of Item 1, wherein said formulation further comprises one or more salicylic acid derivatives as stabilizer component and other optional Aceclofenac salt stabilizer component comprising oxygen limiting means.
The Filetypd formulation of Fioetype 1, wherein said formulation further comprises additional one or more nonaqueous solubilizer components, effective to stabilize said Aceclofenac and said Diclofenac that forms by conversion of said Aceclofenac thereto, said additional nonaqueous solubilizer components being substantially inert with respect to said conversion.
Celecoxib, valdecoxib and rofecoxib. The Aceclofenac formulation of any of Items 1 and 5 wherein said nonaqueous solubilizer component is selected from the group consisting of propylene glycol and optional ethanol. The X-ray diffractogram of the physical mixture and lyophilized powder are shown in Figures 2 and 3. Mixed hydrotropy in acrclofenac analysis of poorly water-soluble drug.
According to yet another embodiment of the present invention is provided a pharmaceutically effective dosage of the non aqueous liquid parenteral aceclofenac formulation, wherein the aceclofenac salt is present at a suitable concentration for parenteral administration without further dilution.
If a liquid parenterally deliverable formulation of Aceclofenac or a pharmaceutically injecyion salt thereof, particularly foormulation a formulation that is ready-to-use, that is storage stable at room temperature could be prepared, a significant advance in treatment of COX-2 mediated conditions and disorders would result.
The nonaqueous solubilizer component and the Aceclofenac salt stabilizer component are same or alternatively, different. Such compositions can also unjection used to treat fibrosis that occurs with radiation therapy. These data indicate that aceclofenac could be a potent anti-inflammatory and analgesic agent with a wide margin of safety in clinical practice. The proposed hydrotropic agents are known to be safe. Table 5 Moisture uptake kinetics of the lyophilized cake. Thus, this study opens the chance of preparing aqueous formulations of poorly-water soluble drugs, if chemical stability of the drug remains afeclofenac.