Oral delivery of active drug substances

Inventors

Skak, Nikolaj • Lindhardt, Karsten • Elhauge, Torben • Olsen, Martin Rex

Assignees

Biograil ApS

Abstract

The present disclosure relates to a delivery device capable of delivering compositions. In some embodiments, the delivery device may deliver compositions to the gastrointestinal tract. In some embodiments, the compositions contain active drug substances. In some embodiments, the active drug substances are low permeable active drug substances.

Core Innovation

The invention relates to an orally deliverable delivery device for low-permeable active drug substances, including a body and a delivery part. The delivery part has one or more attachment parts whose distal ends are configured to position themselves in an internal surface of a subject, and the attachment part extends along an axis that forms a first angle with a longitudinal axis of less than 75° and has a first attachment length in the range from 1.0 mm to 20 mm.

The device further provides controlled attachment geometry and spacing relative to a body surface, including distal-end spacing from the body surface of at least 0.5 mm. The distal ends are configured for penetration and attachment to an internal GI surface using bevel cutting edges having a hooking zone and a cutting zone, and optional embodiments include a star-shaped multi-cutting-edge cross-section with cut-outs and multiple cutting edges.

The device may include payload cavities for an active drug substance and material choices such as thermoplastic and/or pH-dependent and biodegradable polymers. Optional separation parts may break upon attachment, and the attachment part can include barbs, adhesive and/or enhancer elements, and coatings such as silicone. The disclosed GI positioning and localization mechanism uses GI peristaltic forces to position the device and localize release at the attachment sites.

Claims Coverage

The independent claim is clm-00001. It defines a delivery device geometry and attachment configuration by specifying the internal-surface positioning of a first attachment part, with an attachment axis angle less than 75° relative to a longitudinal axis, and an attachment length from 1.0 mm to 20 mm.

Claim clm-00001 centers on an attachment part whose distal end is configured to position in an internal surface of a subject, with the attachment part extending along an axis that forms an angle less than 75° to the longitudinal axis and having a length between 1.0 mm and 20 mm. Dependent claims refine additional geometry and related features such as distal-end spacing, breakable separation parts, drug-containing attachment material, and star-shaped cutting-edge cross-sections.

Stated Advantages

Documented Applications