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US 2026/0183230 A1Published application
Fluid-absorptive gastroretentive dosage form for prolonged drug delivery
AssigneeDr. Aron H. Blaesi
InventorsAron H. Blaesi, Nannaji Saka
Life of this patent
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Abstract
In this specification, anew expandable dosage form is presented where the post-expansion mechanical properties and the drug release rate can be independently controlled. The dosage form generally comprises a three-dimensional structural framework of one or more substantially orderly arranged fluid-absorptive elements, a mechanically strengthening semi-permeable layer substantially encapsulating said fluid-absorptive elements, and a drug-containing solid applied outside said encapsulated elements.
Claims24
A pharmaceutical solid dosage form comprising:
- an expandable, three dimensional structural framework of one or more substantially orderly arranged fluid-absorptive structural elements, a mechanically strengthening semi-permeable layer, and a drug-containing solid;
- said structural framework of one or more elements comprising segments spaced apart from adjoining segments by element-free spacings defining one or more element-free spaces within an outer volume of said structural framework;
- said structural framework further substantially encapsulated by said mechanically strengthening semi-permeable layer;
- and
- at least part of said mechanically strengthening semi-permeable layer disposed between one or more elements or segments of said structural framework and said drug-containing solid.
2 more elements
A pharmaceutical solid dosage form comprising:
- a fluid-absorptive, expandable solid core comprising at least a first pharmaceutical excipient, a mechanically strengthening semi-permeable layer comprising at least a second pharmaceutical excipient, and a drug-containing solid comprising at least an active ingredient and at least a third pharmaceutical excipient;
- said fluid-absorptive, expandable solid core substantially encapsulated by said mechanically strengthening semi-permeable layer;
- and
- at least part of said mechanically strengthening semi-permeable layer disposed between said solid core and said drug-containing solid;
- wherein
- said first excipient is substantially mutually soluble with gastric fluid under physiological conditions and selected from the group consisting of hydroxypropyl methylcellulose, hydroxyethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, sodium alginate, hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, hydroxypropyl methyl ether cellulose, starch, polymethacrylates, poly(methacrylic acid, ethyl acrylate) 1:1, butylmethacrylat-(2-dimethylaminoethyl)methacrylat-methylmathacrylat-copolymer, polyethylene oxide, xanthan gum, or vinylpyrrolidone-vinyl acetate copolymer;
- the solubility of gastric fluid in said second excipient is no greater than 700 mg/ml, and said second excipient is selected from the group consisting of methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl methacrylate copolymer, ethyl acrylate-methylmethacrylate copolymer, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate, polymers including methacrylic acid, polymers including ethyl acrylate, polymers including methyl methacrylate, polymers including methacrylate, Poly[Ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride], and ethylcellulose;
- said third excipient comprises a solubility in gastric fluid greater than 1 mg/ml under physiological conditions and is selected from the group consisting of hydroxypropyl methylcellulose, hydroxyethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, sodium alginate, hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, hydroxypropyl methyl ether cellulose, starch, polymethacrylates, poly(methacrylic acid, ethyl acrylate) 1:1, butylmethacrylat-(2-dimethylaminoethyl)methacrylat-methylmathacrylat-copolymer, polyethylene oxide, or vinylpyrrolidone-vinyl acetate copolymer;
- and
- upon immersing said pharmaceutical solid dosage form to gastric fluid under physiological conditions, the substantially encapsulated solid core expands with fluid absorption and said drug-containing solid releases said active ingredient over time.
7 more elements
Dependencies are inferred from the claim text.