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US 12,702,643 B2Granted
Ion-exchange composition with water-soluble mucoadhesive polymers
AssigneeFertin Pharma A/S
InventorKent Albin Nielsen
Life of this patent
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Abstract
The present invention relates to an oral tablet for oromucosal delivery of biologically active compounds, the tablet comprising a sugar alcohol composition comprising one or more sugar alcohol particles in an amount of at least 20% by weight of the tablet, an ion-exchange composition comprising a plurality of particles of at least one water-soluble anionic mucoadhesive polymer loaded with a cationic biologically active compound.
Claims18
An oral tablet for oromucosal delivery of biologically active compounds, the tablet comprising:
- i) a sugar alcohol composition in powder form comprising one or more sugar alcohol particles selected from the group consisting of sorbitol particles, erythritol particles, xylitol particles, lactitol particles, maltitol particles, mannitol particles, isomalt particles, and combinations thereof, in an amount of at least 60% by weight of the tablet;
- and
- ii) an ion-exchange composition in powder form, the ion-exchange composition in powder form being located in the tablet as a separate composition mixed with the sugar alcohol composition in powder form, and the ion-exchange composition in powder form comprising a plurality of particles consisting of at least one water-soluble anionic mucoadhesive polymer loaded with nicotine,
- wherein an average particle diameter of the plurality of particles consisting essentially of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine is from 10 to 1000 microns,
- wherein the at least one water-soluble anionic mucoadhesive polymer is selected from sulfonated polysaccharides, anionic polysaccharides, polyacrylic acid, and combinations thereof,
- wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to form a gel in contact with the oral mucosa when hydrated with saliva,
- wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to protect the nicotine until adherence to the oral mucosa,
- wherein the weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 20:1, and
- wherein the oral tablet is an orally disintegrating tablet.
6 more elements
A powder composition comprising:
- i) a sugar alcohol composition in powder form comprising one or more sugar alcohol particles selected from the group consisting of sorbitol particles, erythritol particles, xylitol particles, lactitol particles, maltitol particles, mannitol particles, isomalt particles, and combinations thereof, in an amount of at least 60% by weight of the powder composition;
- and
- ii) an ion-exchange composition in powder form for oromucosal delivery of biologically active compounds, the ion-exchange composition comprising:
- a plurality of particles consisting of at least one water-soluble anionic mucoadhesive polymer loaded with nicotine,
- wherein an average particle diameter of the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine is from 10 to 1000 microns,
- wherein the at least one water-soluble anionic mucoadhesive polymer is selected from the group consisting of xanthan gum, carrageenan, carbomer, carboxymethyl cellulose and combinations thereof,
- wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to form a gel in contact with the oral mucosa when hydrated with saliva,
- wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to protect the biologically active compound until adherence to the oral mucosa, and
- wherein the weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 20:1.
6 more elements
A powder composition comprising:
- i) a sugar alcohol composition in powder form comprising one or more sugar alcohol particles selected from the group consisting of sorbitol particles, erythritol particles, xylitol particles, lactitol particles, maltitol particles, mannitol particles, isomalt particles, and combinations thereof, in an amount of at least 60% by weight of the powder composition;
- and
- ii) an ion-exchange composition in powder form for oromucosal delivery of nicotine, the ion-exchange composition comprising:
- a plurality of particles consisting essentially of at least one polacrilex resin loaded with nicotine, the polacrilex resin loaded with nicotine being at least partly coated with at least one water-soluble anionic mucoadhesive polymer,
- wherein the at least one water-soluble anionic mucoadhesive polymer is selected from sulfonated polysaccharides, anionic polysaccharides, polyacrylic acid, and combinations thereof,
- wherein the at least one water-soluble anionic mucoadhesive polymer is operable to form a gel in contact with the oral mucosa when hydrated with saliva,
- wherein the at least one water-soluble anionic mucoadhesive polymer is operable to protect the nicotine until adherence to the oral mucosa, and
- wherein the weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 20:1.
5 more elements
Dependencies are inferred from the claim text.