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.
|Published (Last):||17 May 2015|
|PDF File Size:||11.16 Mb|
|ePub File Size:||11.28 Mb|
|Price:||Free* [*Free Regsitration Required]|
Aceclofenac component in a form of non-water-soluble Aceclofenac salt. They also can be of use for decreasing bone loss particularly in postmenopausal women i. The questions on DMF filing are answered by email by question cder. The vacuum was set at mTorr and the vials were allowed to dry for 72 h.
One embodiment of the present invention relates to provide a stable injectable pharmaceutical composition comprising an aqueous solution of arginine and aceclofenac, wherein a molar ratio of arginine to aceclofenac is from about 1.
It can be downloaded free of cost for reference purpose.
It is concluded that the solubility of aceclofenac increases synergistically by mixed hydrotropy. The Aceclofenac salt stabilizer component comprises an oxygen limiting means for limiting the effective exposure of the Aceclofenac formulation to oxygen, wherein the oxygen limiting means comprises one or more antioxidants which are selected from the group consisting of inmection hydroxyanisole, propyl gallate and butylated hydroxytoluene.
A method of treating a subject having a condition or disorder wherein a treatment with NSAID is indicated, which method comprises parenterally administering a therapeutically effective amount of said nonaqueous injectioj parenteral Aceclofenac formulation of Item 1.
Subjects undergoing formultaion with a composition of the invention can be routinely monitored by any of the methods well known in the art to determine effectiveness of therapy.
Parenteral administration is generally the preferred method of drug delivery in emergency situations, and is also useful in treating subjects who are uncooperative, unconscious, or otherwise unable or unwilling to accept oral medication, and where a acecoofenac relief is required in lesser time, specially in acute and chronic painful condition.
USA1 – Nonaqueous liquid parenteral aceclofenac formulation – Google Patents
The solution stability study of the solution of arginine and aceclofenac before lyophilization by adjusting the pH in between about 6. The results of stability studies on aceclofenac in the bulk solution Table 6indicated that the acecloffnac is stable in the bulk solution for 4 h at room temperature and 12 h under refrigerated conditions. We have found that adjusting the pH of the solution of arginine and aceclofenac in between about 6. The Aceclofenac formulation of any one of claims 1 and 5 wherein said nonaqueous solubilizer component is selected from the group consisting of acec,ofenac glycol and polyethylene glycol.
An aceclofenac salt stabilizer component such as salicylic acid derivatives and the optional Aceclofenac salt stabilizer component comprising oxygen limiting factors. The written regulation are either misleading or wrongly understood. The top hole can be sealed by an aluminum foil. Such compositions can be used to treat subjects having adenomatous polyps, including those with familial adenomatous polyposis FAP.
This study was performed to check the stability towards precipitate formation, when the drug is administered through an iv infusion LVPs. The dose is lOOmg twice daily. A method of Item 30 wherein said disorder is COX-2 mediated and wherein said therapeutically effective amount is a daily dosage of about 1 mg per day to about mg per day, preferably of about 10 mg per filteype to injecttion mg per wceclofenac, more preferably of about 30 mg per day to about mg per day, still more preferably of about 50 mg per day to about mg per day.
Next, the volume was made up to 50 mL with the same hydrotropic blend solution.
The present invention utilizes arginine or its pharmaceutically acceptable salt forms, preferably L-arginine or arginine hydrochloride, more preferably L-arginine for solubilization. It is an another object of the present invention to provide a process to prepare a stable injectable pharmaceutical composition comprising an aqueous solution of arginine and aceclofenac in the molar ratio of arginine to aceclofenac in the range of about 1.
The analgesic effect of aceclofenac on the pain elicited by chemical and mechanical stimuli was nearly equal to or slightly better than that of indometacin and diclofenac. Fever induced by brewer’s yeast injection in rats was also markedly suppressed by aceclofenac.
Such compositions are useful filehype treating and preventing inflammation-related cardiovascular disorders, including vascular diseases, coronary artery disease, aneurysm, vascular rejection, arteriosclerosis, atherosclerosis including cardiac transplant atherosclerosis, myocardial 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.
The cake was then exposed to atmospheric condition. It seems from the results that the aqueous solubility of aceclofenac was increased more than times in iinjection blends except for blend A which was In the present invention for pharmaceutical composition of aceclofenac and acecolfenac for its preparation, the therapeutic effective amount of arginine that may be used is in the range from about 2 gm to about 8 gm per day.
Similar to the aceclofenac aqueous formulation, made using a combination of physiologically compatible hydrotropic agents urea and sodium citratethere is a good scope for other poorly water-soluble drugs to be developed as their aqueous formulation. In the next stage, flushing was conducted, using the nitrogen gas for 15 min.
US20090156670A1 – Nonaqueous liquid parenteral aceclofenac formulation – Google Patents
Possible spectroscopic changes in the structure of aceclofenac in the presence of hydrotropes were subsequently investigated. Additionally solutions of acelofenac are prone to degradation even at acidic or neutral pH.
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. The Aceclofenac formulation of claim 1wherein 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 component thereto, said additional nonaqueous solubilizer components being substantially inert with respect to said conversion.
Such compositions inhibit prostanoid-induced smooth muscle contraction by inhibiting synthesis of contractile prostanoids and hence can be of use in treatment of pain caused by dysmenorrhea, premature labor, asthma and cosinophil-related disorders. We have surprisingly found that a stable injectable pharmaceutical composition of dofenac can be prepared by solubilizing aceclofenac in arginine at a pH of about 20 6: This could be done, using a combination of suitable hydrotropic agents at reduced concentrations.
Preferably, the Aceclofenac salt is administered in a daily dosage amount of about 1 mg to about mg. In case of dilution with the normal saline solution the precipitation was observed within 24 h of 1: Then, the plate was left for 10 min to be dried and transferred to a solvent jar saturated with solvent system composed of mixture of chloroform, methanol and ammonia solution II Physical stability study of formulated lyophilized injection of aceclofenac. The present invention relates to a stable injectable pharmaceutical composition of aceclofenac and process for its preparation.
At a pH of less thari;6.