# US 2013/0156822 A1 · Drug delivery system and method for the treatment of neuro-degenerative disease

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- Number: US 2013/0156822 A1
- Document ID: US20130156822A1
- Status: Published application
- Kind: A1
- Application number: 13/720,157
- Filed: 2012-12-19
- Published: 2013-06-20
- Earliest claimed: 2011-12-19
- Assignees: Aphios Corporation
- Inventors: Trevor Percival CASTOR
- Web page: https://patentgrep.com/patent/US20130156822A1

## CPC

- A61K 9/5153: {Polyesters, e.g. poly(lactide-co-glycolide)}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- A61K 9/4858: {Organic compounds}
- A61K 31/365: Lactones
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Embodiments of the present invention are directed to the oral administration of Bryostatins for the treatment of neuro-degenerative disease.

## Claims

### Claim 1

As an article of manufacture, an effective amount of a Bryostatin in a biopolymer said biopolymer comprising a plurality of spheres in which said spheres have a diameter of one to 1000 nanometers, for the treatment of neuro-degenerative disease.

### Claim 2 (depends on 1)

The article of manufacture of claim 1 wherein said a Bryostatin is selected from the group consisting of Bryostatins 1-20.

### Claim 3 (depends on 1)

The article of manufacture of claim 1 wherein said biopolymer is resistant to acid.

### Claim 4 (depends on 3)

The article of manufacture of claim 3 wherein said biopolymer is a poly (D, L-lactide-coglycoside).

### Claim 5 (depends on 4)

The article of manufacture of claim 4 wherein said poly (D, L-lactide-co-glycoside) has a ratio of lactide and glycoside of 25-75% lactide.

### Claim 6 (depends on 1)

The article of manufacture of claim 1 wherein said microspheres are lyophilized for reconstitution in an aqueous solution.

### Claim 7 (depends on 1)

The article of manufacture of claim 1 wherein said microspheres are held in suspension for oral administration.

### Claim 8 (depends on 1)

The article of manufacture of claim 1 wherein said microspheres are held in an oral dosage form selected from the group of tablets, capsules, gel caps, and powders.

### Claim 9

A method of treating neuro-degenerative disease comprising the steps of administering an effective amount of a Bryostatin held in a plurality of microspheres, each microsphere comprising a biopolymer and Bryostatin said microspheres having a diameter of one to 1000 nanometers.

### Claim 10 (depends on 9)

The method of claim 9 wherein said Bryostatin is selected from the group consisting of Bryostatins 1-20.

### Claim 11 (depends on 9)

The method of claim 9 wherein said biopolymer is resistant to acid.

### Claim 12 (depends on 11)

The method of claim 11 wherein said biopolymer is a poly (D, L-lactide-coglycoside).

### Claim 13 (depends on 12)

The method of claim 12 wherein said poly (D, L-lactide-co-glycoside) has a ratio of lactide and glycoside of 25-75% lactide.

### Claim 14 (depends on 9)

The method of claim 9 wherein said microspheres are lyophilized for reconstitution in an aqueous solution.

### Claim 15 (depends on 9)

The method of claim 9 wherein said microspheres are held in suspension for oral administration.

### Claim 16 (depends on 9)

The method of claim 9 wherein said microspheres are held in an oral dosage form selected from the group of tablets, capsules, gelatin capsules, and powders.

### Claim 17

As an article of manufacture, an effective amount of a Bryostatin dissolved in olive oil for oral administration for the treatment of neuro-degenerative disease.

### Claim 18 (depends on 17)

The article of manufacture of claim 17 wherein said neuro-degenerative disease in selected from the group consisting of Alzheimer's Disease, Hutchinson's Disease, Parkinson's Disease, Down's Syndrome, Kuru, Creutzfeldt-Jakob Disease and spongiform encephalopathies.

### Claim 19 (depends on 17)

The article of manufacture of claim 17 wherein said effective amount of Bryostatin is approximately 3-10 ug per kilogram body weight per day.

### Claim 20

A method of treating neuro-degenerative disease comprising the steps of administering orally an effective amount of a Bryostatin dissolved in olive oil.

### Claim 21 (depends on 20)

The method of claim 20 wherein said effective amount of Bryostatin is approximately 3-10 ug per kilogram body weight per day.

### Claim 22

A method of treating a neuro-degenerative disease comprising the step of orally administering an effective a Bryostatin.