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|Title:||Pharmaceutical compositions of cefixime|
|Abstract:||A pharmaceutical suspension dosage form comprising greater than 80 mg/ml and not more than 150 mg/ml of Cefixime and pharmaceutically acceptable excipients.|
|Inventor(s):||Kole; Shrenik Annasaheb (Pune, IN), Metkar; Bharat Raghunath (Pune, IN), Avachat; Makarand Krishnakumar (Pune, IN)|
|Assignee:||LUPIN LIMITED (Mumbai, Maharashtra, IN)|
1. A powder for oral suspension of Cefixime comprising 100 mg/ml of Cefixime upon reconstitution and pharmaceutically acceptable excipients wherein-said suspension is
bioequivalent to 200mg/5 ml of currently available marketed suspension of Cefixime trihydrate under fast and fed conditions.
2. The dosage form of claim 1, wherein the pharmaceutically acceptable excipients include diluents selected from the group consisting of sucrose, sorbitol, xylitol, dextrose, fructose, maltitol, aspartame, saccharin, saccharin sodium, and mixtures thereof.
3. The dosage form of claim 1, wherein the pharmaceutically acceptable excipients include sweeteners selected from the group consisting of fructose, glucose, sucrose, mannitol, sorbitol, sodium saccharine, sodium cyclamate, aspartame and mixtures thereof.
4. The dosage form of claim 1, wherein the pharmaceutically acceptable excipients include viscosity enhancing agents selected from the group consisting of xanthan gum, guar gum, acacia, alginic acid, sodium alginate, propylene glycol alginate, povidone, carbomer, salts of carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, bentonite, polydextrose, carrageenan, sucrose, sorbitol, xylitol, dextrose, fructose, maltitol, gelatin, tragacanth, polyvinyl alcohol, cetearyl alcohol, colloidal silicon dioxide, and mixtures thereof.
5. The dosage form of claim 1, wherein the pharmaceutically acceptable excipients include dispersing agents selected from the group consisting of colloidal silicon dioxide and surfactants.
6. The dosage form of claim 1, wherein the pharmaceutically acceptable excipients include flavoring agents selected from the group consisting of strawberry flavor, banana flavor, cream flavor and mixtures thereof.
7. The suspension dosage form of claim 1, wherein the pharmaceutically acceptable excipients include preservatives selected from the group consisting of sodium benzoate, benzoic acid, ethylenediaminetetraacetic acid, sorbic acid, benzethonium chloride, benzalkonium chloride, bronopol, butyl paraben, methyl paraben, ethylparaben, propyl paraben, thiomerosol, sodium propionate, chlorhexidine, chlorobutanol, chlorocresol, cresol, imidurea, phenol, phenylmercuric salts, potassium sorbate, propylene glycol, and mixtures thereof.
8. A method of treating a subject having acute bacterial otitis media, pharyngitis, tonsillitis, acute bronchitis or chronic bronchitis, said method comprising administering the suspension of claim 1 to the subject in need thereof.
9. A method of treating a subject having uncomplicated urinary tract infections, gonorrhea or both said method comprising administering the suspension of claim 1 to the subject in need thereof.
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