Sustained-release formulations of topiramate

  • US 10,314,790 B2
  • Filed: 03/30/2017
  • Issued: 06/11/2019
  • Est. Priority Date: 11/17/2006
  • Status: Active Grant
First Claim
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1. A sustained release formulation of topiramate comprising topiramate as an active ingredient, the formulation comprising:

  • (a) at least two extended release (XR) topiramate-containing components, wherein each component comprises a coating material selected from the group consisting of cellulosic polymers and acrylic polymers, and, optionally,(b) an immediate release (IR) topiramate-containing component comprising;

    (i) a complexing agent selected from the group consisting of hydroxypropyl-beta-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, alpha-cyclodextrin, cyclodextrin, and cyclodextrin derivative, and/or(ii) an enhancing agent selected from the group consisting of Vitamin E TPGS, glutamic acid, glycine, sorbitol, mannose, amylose, maltose, mannitol, lactose, sucrose, glucose, xylitose, dextrins, glycerol-polyethylene glycol oxystearate, polyethylene glycol-32, glyceryl palmitostearate, sodium lauryl sulfate, polyoxyethylene sorbitan monooleate, benzyl alcohol, sorbitan monolaurate, polyethylene-polypropylene glycol, polyethylene glycol-3350, polyvinylpyrrolidone-K25, oleic acid, glyceryl monooleate, sodium benzoate, cetyl alcohol, sucrose stearate, crospovidone, sodium starch glycolate, croscarmellose sodium, carboxymethylcellulose, starch, pregelatinized starch, hydroxypropylmethylcellulose (HPMC), substituted hydroxypropylcellulose, microcrystalline cellulose, sodium bicarbonate, calcium citrate, sodium docusate, menthol, and combinations thereof,wherein the formulation exhibits an in vivo steady state maximum plasma concentration of topiramate at 3 or more hours after administration.

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