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|Abstract:||The present invention relates to an oral controlled release pharmaceutical composition in the form of a unit dosage form comprising: (a) a highly soluble high dose active ingredient consisting essentially of therapeutically effective amount of levetiracetam or a pharmaceutically acceptable derivative thereof, and (b) a rate controlling means comprising a rate-controlling agent and/or a coating selected from (i) a active ingredient permeable coating surrounding the unit dosage form, and (ii) an active ingredient impermeable coating covering one or more surfaces but not all the surfaces of the unit dosage form, wherein the composition is in the form of a compact tablet and the levetiracetam or a pharmaceutically acceptable derivative thereof is present in an amount ranging from about 55% to about 90% by weight of the tablet.|
|Inventor(s):||Zala; Yashoraj Rupsinh (Mumbai, IN), Dharmadhikari; Nitin Bhalachandra (Mumbai, IN)|
|Assignee:||Sun Pharma Advanced Research Company Limited (Mumbai, IN)|
1. A compact tablet comprising 55% to 90% by weight of levetiracetam or pharmaceutically acceptable derivative thereof, in an amount from 750 mg to 1600 mg, in admixture
with a rate-controlling agent, wherein the tablet is suitable for once-a-day administration.
2. The compact tablet as described in claim 1, wherein the rate-controlling agent is selected from the group consisting of water-soluble hydrophilic polymers, water-insoluble hydrophobic polymers, hydrophobic excipients and mixtures thereof.
3. The compact tablet as described in claim 2, wherein the water soluble hydrophilic polymers are selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethyl cellulose, methyl cellulose, vinyl acetate copolymers, polysaccharides, polyethylene oxide, methacrylic acid copolymers, maleic anhydride/methyl vinyl ether copolymers and derivatives and mixtures thereof.
4. The compact tablet as described in claim 2, wherein the water-insoluble hydrophobic polymers are selected from the group consisting of acrylates, ethylcellulose, cellulose acetate, methacrylates, acrylic acid copolymers and high molecular weight polyvinylalcohols and mixtures thereof.
5. The compact tablet as described in claim 2, wherein the hydrophobic excipients are selected from a natural fat, beeswax, polyethoxylated beeswax, a mono-, bi- or tri-substituted glyceride, glycerylpalmitostearate, glycerylbehenate, diethyleneglycolpalmitostearate, a polyethyleneglycol stearate, a polyoxyethyleneglycolpalmitostearate, glycerylmonopalmitostearate, cetylpalmitate, polyethyleneglycolpalmitostearate, mono- or di-glycerylbehenate, a fatty alcohol associated with a polyethoxylate fatty alcohol, cetyl alcohol, stearic acid, a saturated or unsaturated fatty acid or a hydrogenated derivative thereof, and/or hydrogenated castor oil and mixtures thereof.
6. The compact tablet as described in claim 2, wherein the rate-controlling agent is used in an amount ranging from 1 to 20% by weight of the compact tablet.
7. The compact tablet as described in claim 3, wherein the rate-controlling agent used is xanthan gum.
8. The compact tablet as described in claim 7, wherein the xanthan gum is used in an amount ranging from about 1% to about 20% by weight of the compact tablet.