Pre-fabricated semi-permeable capsule shells containing a semipermeable layer on a water-dispersible/soluble gelatinous shell for osmotic drug delivery system

Abstract

The present invention is centered on the design, manufacturing and use of a novel capsule system made up of a bi- or multi-layered two piece capsule shell made of a water soluble/dispersible layer coated with water-insoluble semi-permeable membrane capsule shell. The therapeutic agent is formulated in the drug layer and the osmotic layer is compacted together. The osmotic layer is a rate controlling agent. This compacted core is then inserted in the body of the layered body followed by encapping with a layered cap (which is pre-drilled or drilled after inserting the core) followed by applying a sealing agent as a band where the body and the cap of capsule meet.

Description

Claims

1. Bi- and multi-layered hard shells made of two parts a body and a telescopically fitting cap where the composition of the shell's outer layer is a water insoluble semi-permeable membrane and the inner layer is made up of a natural, synthetic or semi-synthetic, gelatinous water soluble or dispersible polymer as shown in Drawing FIG. 1 for osmotic drug delivery with core tablet made of an osmotic layer and one or more drug or nutrient layers.

2. A new design of an oral osmotic drug delivery system is claimed in which unlike conventional spray pan coating of the tablet, the tablet is put in a semi-permeable two piece shell made up of a body and a fitting cap, drilled and sealed, in claim 1, for controlling drug delivery and the delivery rate.

3. In claim 1 the thickness of each layer of the shell is 1 micrometer to 5 millimeter and that these shells are made encompassing all sizes available for the conventional hard gelatin capsules including US or European size 000, 00, 0, 1, 2, 3, 4, 5 known in the pharmaceutical art (but not limited to these sizes) and that the shell is pre-drilled or can be drilled post-assemblage with the core inside.

4. In claim 1 the outer layer of the shell is made from synthetic or semi-synthetic polymers including cellulose acetate or similar or equivalent polymers containing optionally a coloring agent, plasticizer, opacifier or other additives as the outer layer and an inner layer made up of gelatinous, water soluble, hydrophilic polymer(s) such as gelatin, hydroxypropyl methyl cellulose, carboxymethyl cellulose (or its sodium) salt or synthetic or semi-synthetic polymer containing optionally a coloring agent, plasticizer, opacifier or other additives.

5. In claim 1 the rate controlling shell is pre-fabricated in form of a capsule shell (in two parts, a body and a cap) which is drilled with a hole in pre-fabrication stage or post drilled after inserting the osmotic and drug layer assembly.

6. In claim 1 the osmotic layer is made of polymer such as polyethylene oxide or similar or equivalent with 1,000,000 to 15,000,000 molecular weight with other additives including osmotic agent(s) and the drug layer is made of 1000 to 500,000 molecular weigh polyethylene oxide or similar or equivalent polymer containing therapeutic agent from 1 micro gram to 1 gram and other ingredients.

7. In claim 1 the shape of the core is a tablet in which the body is cylindrical with the parabolic or hemispherical ends or other suitable shapes such as parabola or conical.

8. The method of use of the shell in claim 1 is for making oral osmotic drug delivery system in which a core described in claim 6 is inserted in the shell followed by sealing the shell with water insoluble-polymer solution, solvent, heat, adhesive or other means or a combination of these agents.

9. The dosage form claimed in claim 1 is for use of delivering therapeutic or nutritional agent to a mammal.