Expandable multi-excipient dosage form
AssigneeAron H. Blaesi
InventorsAron H. Blaesi, Nannaji Saka
Life of this patent
Estimating the term…
Abstract
Many drug therapies could be greatly improved by dosage forms that reside in the stomach for prolonged time and release the drug slowly. In this specification, therefore, an expandable, multi-excipient dosage form for prolonged release is disclosed. The dosage form generally comprises a three-dimensional structural framework of solid elements. The elements comprise at least a drug, at least a physiological fluid-absorptive excipient, and at least a strength-enhancing excipient. Upon ingestion, the three-dimensional structural framework expands in at least one dimension and forms an expanded semi-solid mass that can be retained in the stomach and release drug over prolonged time.
Claims30
A pharmaceutical dosage form comprising:
- a drug-containing solid comprising an outer surface and an internal three dimensional structural framework of one or more structural elements, said framework contiguous with and terminating at said outer surface;
- said elements having segments spaced apart from adjoining segments, thereby defining one or more free spaces in the drug-containing solid;
- said elements further comprising at least one active ingredient and at least two excipients;
- said at least two excipients comprising at least one physiological fluid-absorptive polymeric constituent and at least one strength-enhancing polymeric constituent;
- wherein
- upon exposure to a physiological fluid, said strength-enhancing excipient forms a fluid-permeable, semi-solid network mechanically supporting said framework;
- and
- said fluid-absorptive excipient transitions to a viscous mass or a viscous solution expanding said framework along at least one dimension with absorption of said physiological fluid.
A pharmaceutical dosage form comprising:
- a drug-containing solid comprising 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 elements having segments spaced apart from adjoining segments, thereby defining one or more interconnected free spaces through the drug-containing solid;
- said elements further comprising at least one active ingredient and at least two excipients;
- said at least two excipients comprising at least one physiological fluid-absorptive polymeric constituent and at least one strength-enhancing polymeric constituent;
- whereby
- upon immersion in a physiological fluid, said fluid percolates at least one interconnected free space and diffuses into one or more said elements, so that the framework expands in at least one dimension and transitions to a semi-solid mass;
- wherein
- said semi-solid mass releases drug over prolonged time.
A pharmaceutical dosage form comprising:
- a drug-containing solid comprising an outer surface and an internal three dimensional structural framework of one or more structural elements, said framework contiguous with and terminating at said outer surface;
- said elements having segments spaced apart from adjoining segments, thereby defining one or more interconnected free spaces through the drug-containing solid;
- said elements further comprising at least one active ingredient and at least two excipients;
- said at least two excipients comprising one or more fluid-absorptive polymeric constituents within which the solubility of a physiological fluid is greater than 600 mg/ml;
- said at least two excipients further comprising one or more strength-enhancing polymeric constituents;
- said one or more strength-enhancing polymeric constituents having an elastic modulus in the range between 0.2 MPa and 200 MPa, and a strain at fracture greater than 0.2 after soaking with a physiological fluid under physiological conditions;
- wherein
- upon exposure to a physiological fluid, said strength-enhancing excipient forms a fluid-permeable, semi-solid network mechanically supporting said framework;
- and
- said fluid-absorptive excipient transitions to a viscous mass or a viscous solution expanding said framework along at least one dimension with absorption of said physiological fluid.
Dependencies are inferred from the claim text.