Proactively manage your pharmacy inventory
Drug patents …
… from Kazakhstan to Kalamazoo
Deep knowledge on
small-molecule drugs and
the 110,000 global patents
Manage your formulary budget
Anticipate generic drug launch
Find generic entry opportunities
Flat-rate pricing for predictable budgeting
Short-term plans for project- or client-based billing
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.