ACECLOFENAC INJECTION FORMULATION FILETYPE PDF

Mezizahn The nonaqueous solubilizer component and the Aceclofenac salt stabilizer component are same or alternatively, different. Disodium hydrogen phosphate dihydrate and sodium dihydrogen phosphate monohydrate were dissolved to it under stirring. Formualtion stable injectable pharmaceutical compositibn of aceclofenac may, be prepared as given in table 1. In a previous 3 month study in RA, aceclofenac was found to be significantly more effective than ketoprofen, both with regard to the Ritchie Index and morning stiffness. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range.

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Yorisar This proved a synergistic enhancement in solubility of a poorly water- soluble drug due to mixed hydrotropy. This is especially true of intravenous injection, whereby the drug is placed directly in the bloodstream. Celecoxib, valdecoxib and rofecoxib. The Health Ministry banned fixed drug combinations through a gazette notification.

Such compositions can also be used to treat fibrosis that occurs with radiation therapy. The Aceclofenac salt of the present invention comprises a phenyl acetic acid derivative with anti-inflammatory analgestic properties similar to those of Diclofenac. Aceclofenac is used for the relief of pain and inflammation in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

The above results show the stability of the pharmaceutical composition of the present invention at different pH range of the invention. The Aceclofenac formulation of claim 20wherein interior space of said sealed airtight container comprises a fill volume occupied by said Aceclofenac formulation and a headspace volume occupied by an inert—gas—limited microatmosphere, wherein said microatmosphere comprises essentially of one or more inert gases selected from the group consisting of noble gases and nitrogen such that the ratio of said fill volume to said headspace volume is not less than 1: The aqueous solubility of aceclofenac can be enhanced by mixing it with arginine in a specified molar ratio, which can be used to prepare the said pharmaceutical composition of aceclofenac.

The composition has Aceclofenac salt stabilizing means for inhibiting precipitation of Aceclofenac. Other features of this invention will be in part apparent and in part pointed out hereinafter. Application of hydrotropic solubilization in the analysis of aceclofenac. This possibility is supported by the fact that aceclofenac tended to be more effective than diclofenac in improving the Ritchie Index and grip strength.

In order to check any interaction between drug and the hydrotropic agents, UV spectral studies of aceclofenac were performed in different hydrotropic solutions. Aceclofenac is a new phenylacetic acid derivative provided with marked anti-inflammatory, antiarthritic, analgesic and antipyretic activities in animal experimental models.

This technique can provide additive or synergistic enhancement effect on solubility of poorly water-soluble drugs. The stable injectable pharmaceutical composition may also be prepared by different molar ratios of arginine to aceclofenac as shown in table 4. The questions on DMF filing are answered by email by question cder. Aceclofenac is a non-steroidal anti-inflammatory drug NSAID that exhibits analgesic, antipyretic and anti-inflammatory activities. The Aceclofenac formulation of Item 19, wherein said Aceclofenac salt is present in an amount corresponding to single unit formulqtion, wherein said sealed airtight container of any of Items 20 and 21 is preferably a glass ampoule.

USA1 — Nonaqueous liquid parenteral aceclofenac formulation — Google Patents Aceclofenac is a new NSAID of the phenylacetic acid class of Innjection 2-[ 2,6-dichlorophenyl amino]phenylacetoxyacetic acidwhich has been shown to exhibit good analgesic, antipyretic and anti-inflammatory efficacy in several animal models of acute and chronic inflammation. The amount of individual hydrotropic agent required is less, compared to the other blends with higher solubilities.

The aceclofeac regulation are either misleading or wrongly understood. In case of dilution with the normal saline solution, precipitation was observed within 24 h at 1: For reconstitution of the lyophilized cake, 2.

National Center for Aaceclofenac InformationU. However, aceclofenac is practically insoluble in water, freely soluble in acetone and soluble in alcohol. The results also showed a trend towards a better safety and tolerability profile of aceclofenac over diclofenac resinate from a clinical point of view.

Therapeutic use of Compositions of the Invention:. 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. When the molar ratio of arginine to aceclofenac is 4.

Articles from Iranian Journal of Pharmaceutical Research: Titrimetric analysis of aceclofenac in tablets using hydrotropic solubilization technique.

Hence, the formulated injection could be administered through an iv infusion. Formuoation compositions are useful in treatment of pain and inflammation caused by asthma, bronchitis, menstrual cramps, preterm labor, tendonitis, bursitis, allergic neuritis, cytomegalovirus infection, apoptosis including HIV-induced apoptosis, lumbago, skin-related conditions such as psoriasis, eczema, acne, burns, dermatitis and ultraviolet radiation damage including sunburn, and post-operative inflammation including that following ophthalmic surgery such as cataract surgery or refractive surgery.

Hence, aceclofenac possesses a potent inhibitory activity in several models of acute and chronic inflammation in rodents, and resembles indometacin and diclofenac in its pharmacodynamic profile, being superior to naproxen and phenylbutazone. US Patent application publication no. The powder was spread injectkon a graticule and pressed in such a way to prevent powder from falling while placing the grticule in a vertical position. If any one can guide me on marketing authorization procedure for Pharmaceuticals in Yemen What is the dossier format?

The Aceclofenac formulation of claim 19 wherein said pharmaceutically effective dosage is provided in a sealed airtight container which is selected from the group consisting of a vial, an ampoule, a syringe, a packet, a pouch and an auto—injector. Prior to lyophilization, the initial solution was diluted twice with water for injection, for reducing the solid content per mL.

Cyclooxygenase-2 inhibitor compositions having rapid onset of therapeutic effect. Parenteral routes of administration, including subcutaneous, intramuscular and intravenous injection, offer numerous benefits over oral delivery in xceclofenac situations, for a wide variety of drugs. TOP Related Posts.

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ACECLOFENAC INJECTION FORMULATION FILETYPE PDF

Grogar Sufficient excess amounts of drug were added to screw capped 10 mL glass vials containing distilled water, solutions of individual hydrotropic agents, solution containing blends of hydrotropic agents and buffers of pH 7. Evaluation of piroxicam injection. Limitations in using non aqueous solvents for injectable compositions include possible drug precipitation, pain, inflammation and hemolysis upon injection. Although maintaining a similar pharmacodynamic profile to that of indomethacin and diclofenac, aceclofenac has shown better gastric tolerance when compared to other NSAIDs.

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Yozshular This study further opens the chance of preparing such lyophilized injection powders for many other poorly water-soluble drugs, using the concept of mixed-hydrotropy. 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. National Center for Biotechnology InformationU. USA1 — Nonaqueous liquid parenteral aceclofenac formulation — Google Patents Initial treatment can begin with a dose regimen as indicated herein.

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