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US 2020/0268680 A1Published application
Expandable structured dosage form for immediate drug delivery
AssigneeAron H. Blaesi
InventorsAron H. Blaesi, Nannaji Saka
Life of this patent
Estimating the term…
Abstract
In this specification, a pharmaceutical dosage form comprising a three-dimensional structural framework of thin, solid elements surrounded by interconnected void space is disclosed. The elements comprise at least a drug, a water-absorptive, polymeric excipient, and a hydrophilic surface composition. Upon immersion in a dissolution fluid the three-dimensional structural framework is wetted uniformly, transitions from solid to viscous due to the diffusion of dissolution fluid into the thin elements, expands in all dimensions, and disintegrates and releases drug. The disclosed dosage form enables greater drug delivery rates and better control of the drug concentration in blood for improving the efficacy and safety of drug therapies.
Claims37
A pharmaceutical dosage form comprising:
- a drug-containing solid having an outer surface and an internal three dimensional structural framework of one or more thin structural elements, said framework contiguous with and terminating at said outer surface;
- said thin structural elements comprising at least an active pharmaceutical ingredient, at least an absorptive polymeric excipient, and at least a hydrophilic surface composition;
- said thin structural elements further having segments spaced apart from adjoining segments, thereby defining free spaces, wherein a plurality of adjacent free spaces combine across the drug-containing solid to define one or more interconnected free spaces forming an open pore network;
- whereby
- upon immersion in a physiological fluid said open pore network enables uniform wetting of the structural framework, and the drug-containing solid transitions to a viscous medium, thereby expanding in all dimensions.
2 more elements
A pharmaceutical dosage form comprising:
- a drug-containing solid having an outer surface and an internal three dimensional structural framework of one or more thin structural elements with average element thickness in the range of 1 μm to 1 mm said framework contiguous with and terminating at said outer surface;
- said thin structural elements comprising at least an active pharmaceutical ingredient, at least 15 weight percent of one or more absorptive polymeric excipients having a molecular weight in the range between 2 kg/mol and 500 kg/mol, and at least a hydrophilic surface composition;
- said thin structural elements further having segments spaced apart from adjoining segments, thereby defining free spaces, wherein a plurality of adjacent free spaces combine across the drug-containing solid to define one or more interconnected free spaces forming an open pore network;
- wherein
- upon immersion in a physiological fluid said open pore network enables uniform wetting of the structural framework, and the physiological fluid penetrates into the thin fibers, so that the drug-containing solid expands isotropically in all dimensions and within no more than 20 minutes of immersion transitions to a viscous medium having a viscosity in the range of 0.01 to 10,000 Pa·s and a length at least 1.15 times the initial length of the drug-containing solid;
- and
- whereby
- said viscous medium disintegrates in said physiological fluid during or after transitioning to a viscous medium, thereby releasing drug.
5 more elements
A pharmaceutical dosage form comprising:
- a drug-containing solid having an outer surface and an internal three dimensional structural framework comprising a plurality of criss-crossed stacked layers of fibrous structural elements with average fiber thickness in the range of 1 μm to 1 mm said framework contiguous with and terminating at said outer surface;
- said fibrous structural elements comprising at least an active pharmaceutical ingredient, at least 15 weight percent of one or more absorptive polymeric excipients having a molecular weight in the range between 2 kg/mol and 500 kg/mol, and at least a hydrophilic surface composition;
- said fibrous structural elements further having segments spaced apart from like segments of adjoining fibrous elements, thereby defining free spaces, wherein a plurality of adjacent free spaces of successive layers combine to define one or more interconnected free spaces forming an open pore network;
- wherein
- upon immersion in a physiological fluid said open pore network enables uniform wetting of the structural framework, and the physiological fluid penetrates into the thin fibers, so that the drug-containing solid expands isotropically in all dimensions and within no more than 20 minutes of immersion transitions to a viscous medium having a viscosity in the range of 0.01 to 10,000 Pa·s and a length at least 1.15 times the initial length of the drug-containing solid;
- and
- whereby
- said viscous medium disintegrates in said physiological fluid during or after transitioning to a viscous medium, thereby releasing drug.
5 more elements
Dependencies are inferred from the claim text.