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US 9,849,147 B2Granted
Pharmaceutical composition containing phosphate binding polymer
AssigneePharmathen S.A.
InventorsEvangelos Karavas, Efthimios Koutris, Vasiliki Samara, Analia Diakidou, Georgia Papanikolaou, Panagiotis Mparmpalexis
Life of this patent
Estimating the term…
Abstract
The present invention relates to a fast dissolving tablet comprising a therapeutically effective amount of a phosphate binding polymer, such as sevelamer or pharmaceutically acceptable salt or derivative thereof, that exhibit limited swelling in the oral cavity, has pleasant taste and mouth feel, high phosphate binding capacity with fast binding kinetics and require limited amount of water intake. A process for the preparation thereof is disclosed.
Claims6
A pharmaceutical composition comprising:
- sevelamer or a pharmaceutically acceptable salt or derivative thereof, as the active ingredient;
- a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient comprises at least one of carnauba wax, glyceryl behenate, glyceryl monostearate, or mixtures thereof;
- wherein the pharmaceutically acceptable excipient forms a homogeneous mixture with the active ingredient via melt mixing and in the homogeneous mixture the pharmaceutically acceptable excipient bonds directly to the active ingredient and forms hydrogen bonds with amine groups of the active ingredient, thereby reducing swelling of the active ingredient in an oral cavity;
- wherein the pharmaceutical composition comprises a tablet that is orally dispersible, chewable, sublingual, or lozenges;
- wherein the pharmaceutically acceptable excipient comprises an amount of at least 3% of the total weight of the tablet;
- and
- wherein the pharmaceutical composition dissolves or disintegrates in the oral cavity releasing the active ingredient in the oral cavity in less than 5 minutes.
4 more elements
A pharmaceutical composition comprising:
- sevelamer or a pharmaceutically acceptable salt or derivative thereof, as the active ingredient;
- a coating formed over granules of the active ingredient, wherein the coating comprises a pharmaceutically acceptable excipient that comprises at least one of carnauba wax, glyceryl behenate, glyceryl monostearate, or mixtures thereof;
- wherein the pharmaceutically acceptable excipient forms a homogeneous mixture with the active ingredient via melt mixing and in the homogeneous mixture the pharmaceutically acceptable excipient bonds directly to the active ingredient and forms hydrogen bonds with amine groups of the active ingredient, thereby reducing swelling of the active ingredient in an oral cavity;
- wherein the pharmaceutical composition comprises a tablet that is orally dispersible, chewable, sublingual, or lozenges;
- and
- wherein the pharmaceutical composition dissolves or disintegrates in the oral cavity releasing the active ingredient in the oral cavity in less than 5 minutes.
3 more elements
Dependencies are inferred from the claim text.