ACECLOFENAC INJECTION FORMULATION FILETYPE PDF

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.

Author: Gurisar Zull
Country: Liechtenstein
Language: English (Spanish)
Genre: Spiritual
Published (Last): 11 December 2004
Pages: 466
PDF File Size: 14.70 Mb
ePub File Size: 5.42 Mb
ISBN: 694-9-46946-249-3
Downloads: 34237
Price: Free* [*Free Regsitration Required]
Uploader: Shakalkree

Unfortunately, attempts to formulate Aceclofenac as a ready-to-use solution for injection have heretofore been complicated by the fact that Aceclofenac, when in solution and especially in presence of certain excipients, is unstable, and undergoes degradation which may precipitate out making injection unsuitable for use.

Optionally mixing disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate or mixtures thereof, with L-arginine solution. A stable injectable pharmaceutical composition of aceclofenac and process for preparing thereof.

What is type V DMF? The reconstitution time was not affected on storage for 1 month in the refrigerator. The solutions were allowed to equilibrate for the next 24 h and then transferred into Eppendorf tubes and centrifuged for 30 min at rpm Remi Instruments Limited, Formulationn, India.

Articles from Iranian Journal of Pharmaceutical Research: The composition contains water-insoluble Aceclofenac, a polymeric base and a surfactant. Distilled water was used in making hydrotropic solutions.

Powder X-ray diffractometry patterns of the lyophilized sample and drug were obtained at room temperature using a RU-H 3 R, horizontal rotaflex rotating anode X-ray generator instrument Rigaku International Corporation, Tokyo. The above results show the stability of the pharmaceutical composition of the present invention at different pH range of the invention.

The interior space of the sealed airtight container comprises a fill volume occupied by the aceclofenac formulation and a headspace volume occupied by an inert-gas-limited micro-atmosphere, which micro-atmosphere comprises essentially of one or more inert gases selected from the group consisting of noble gases and nitrogen, such that the ratio of the fill volume to headspace volume is not less than 1: It can be downloaded free of cost for reference purpose.

  INSEL FELSENBURG PDF

Such methods provide the present stable injectable pharmaceutical compositions of aceclofenac. The results of chemical study Table 8 showed that the developed formulation is sufficiently stable at room temperature as a lyophilized product. Adding aceclofenac to this mixture and dissolving it with stirring.

For reconstitution of the lyophilized cake, 2. The oxygen limiting means further comprises an inert gas limited microatmosphere in contact with the Aceclofenac formulation. This possibility is supported by the fact that aceclofenac tended to be more effective than diclofenac in improving the Ritchie Index and grip strength.

For example, such compositions are useful for relief of pain, fever and inflammation in a variety of conditions including rheumatic fever, influenza and other viral infections including common cold, low back and neck pain, dysmenorrhea, headache, toothache, sprains and strains, myositis, neuralgia, synovitis, arthritis, including rheumatoid arthritis, degenerative joint diseases osteoarthritisgout and ankylosing spondylitis, bursitis, bums, and trauma following surgical and dental procedures.

As specified in 21 CFR When the molar ratio of arginine to aceclofenac is 4. However, the term has been used in the literature to designate non-micelle-forming substances, either liquids or solids, organic or inorganic, capable of solubilizing insoluble compounds.

USA1 – Nonaqueous liquid parenteral aceclofenac formulation – Google Patents

Did you know NPPA is in full form on price control of devices It has issued a mandate to every hospital to display reduced price of Stents and Aceclfoenac implant on its website. Diclofenac formed by conversion of Aceclofenac is solubilized by the nonaqueous solubilizer swhich are substantially inert with respect to such conversion.

The salicylic acid derivative component of the present invention helps to stabilize the injection and improve efficiency. A control sample was kept under refrigerated condition and the lyophilized injection was observed for 30 days for color, and pH change, and appearance of any precipitation after reconstitution.

Selection of hydrotropic blends It is evident from the literature survey that increasing the concentration of hydrotrope could increase the aqueous solubility of poorly water-soluble drugs. The questions on DMF filing are answered by email by question cder. In a previous 3 month study in RA, aceclofenac was injecgion to be significantly more effective than ketoprofen, both with regard to the Ritchie Index and morning stiffness.

  CONCEPTO DE OUTPLACEMENT PDF

UV light was switched on 30 min prior to filling the injectable solutions into vials. EP Kind code of ref document: The mode of action of aceclofenac is largely based on the inhibition of prostaglandin synthesis. Limitations in using non aqueous solvents for injectable compositions include possible drug precipitation, pain, inflammation and hemolysis upon injection.

Such compositions are especially useful as anti-inflammatory agents, such as in treatment of arthritis, with the additional benefit of having significantly less harmful side effects than compositions of conventional NSAIDS. It seems from the results that the aqueous solubility of aceclofenac was increased more than times in hydrotropic blends except for blend A which was The powder was spread on a graticule and pressed in such a way to prevent powder from falling while placing the grticule in a vertical position.

Hence, the formulated acelcofenac could be administered through an injectkon infusion. The Aceclofenac formulation of claim 11wherein concentration of said Benzyl alcohol is in the range from about 0.

Further object of the present invention is to provide Aceclofenac injection which has better safety and tolerability profile as compared to Diclofenac from the clinical point of view. These include the type, age, weight, sex, diet and medical condition of the subject and the nature and severity of the disorder.

US20090156670A1 – Nonaqueous liquid parenteral aceclofenac formulation – Google Patents

II Physical stability study of formulated lyophilized injection of aceclofenac. Parenteral administration can also result in more predictable blood serum concentrations of a drug, because losses in the gastrointestinal tract due to metabolism, binding to food and other causes are eliminated.

Such compositions are useful for treating and preventing inflammation-related cardiovascular accelofenac, including vascular diseases, coronary artery disease, aceclofneac, 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.