Drug delivery system and method for the treatment of neuro-degenerative disease
Inventors
Castor, Trevor Percival • Alexander, Jonathan Steven • Purdum, Geoffrey • Rios, J. David • Schrott, Lisa M. • Tyler, Theodore A. • Vizcaino, Maria I.
Assignees
BOARD OF SUPERVISORS OF LOUISIANA STATE UNIVERSITY AND AGRICULTURAL AND MECHANICAL COLLEGE ACTING ON BEHALF OF LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER AT SHREVEPORT • Aphios Corp • Louisiana State University
Publication Number
US-10485766-B2
Publication Date
2019-11-26
Expiration Date
2032-12-19
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Abstract
Embodiments of the present invention are directed to the oral administration of Bryostatins for the treatment of neuro-degenerative disease.
Core Innovation
Embodiments of the present invention are directed to developing drug delivery systems, dosage forms, and methods for the treatment of neuro-degenerative diseases such as Alzheimer's disease, Hutchinson's Disease, Parkinson's disease, Down's syndrome, Kuru, Creutzfeldt–Jakob disease, and other spongiform encephalopathies. The invention utilizes Bryostatins or their derivatives delivered orally, primarily encapsulated in nanometer-scale microspheres, or dissolved in pharmaceutically acceptable oils suitable for ingestion.
The core innovation lies in providing an oral administration method for Bryostatins, specifically Bryostatin-1, by enclosing them in acid-resistant biopolymer microspheres composed of poly(D,L-lactide-co-glycolic acid) with controlled ratios of lactide and glycolic acid. These microspheres, ranging from one to 1000 nanometers in diameter, can be formulated for reconstitution in aqueous solutions, or incorporated into common oral dosage forms such as suspensions, tablets, capsules, gel caps, and powders.
A key problem addressed by the invention is the lack of simple, effective therapies for neuro-degenerative diseases, especially those that can be administered without trained healthcare providers. Existing treatments are limited, and as these diseases progress, affected individuals become less able to access complex medical care. This invention seeks to provide a stable, effective, and convenient oral drug delivery approach that protects Bryostatin from gastric acid degradation, ensures intestinal absorption, and is adaptable to various patient-friendly dosage forms.
Claims Coverage
The patent contains one independent claim that defines the main inventive features of the oral administration method for Bryostatins in treating neuro-degenerative diseases.
Oral administration of Bryostatin in microspheres for treatment of neuro-degenerative disease
A method of treating neuro-degenerative disease by orally administering an effective amount of a Bryostatin, selected from the group consisting of Bryostatins 1-20, encapsulated in a plurality of microspheres. - Each microsphere comprises both a polymer and the Bryostatin. - The microspheres have a diameter of one to 1000 nanometers. - The polymer consists of poly(D,L-lactide-co-glycolic acid). - The microspheres are contained in an oral dosage form selected from suspensions, tablets, capsules, gelatin capsules, and powders.
The inventive feature centers upon the oral administration of Bryostatin encapsulated in specific polymeric microspheres for convenient and effective treatment of neuro-degenerative diseases, utilizing controlled sizes, polymer composition, and oral dosage form.
Stated Advantages
The biopolymer microspheres are resistant to gastric acid degradation and allow oral delivery of the drug to the small intestine for absorption.
The oral dosage forms allow simple administration of therapy without the need for specially trained healthcare providers.
Microsphere formulations are stable at 4-25°C for at least one week and remain stable in acidic solutions similar to stomach environment.
Oil-based formulations of Bryostatin are developed to increase bioavailability and improve patient acceptance through oral dosing.
Documented Applications
Oral treatment of neuro-degenerative diseases including Alzheimer's disease, Hutchinson's Disease, Parkinson's disease, Down's syndrome, Kuru, Creutzfeldt–Jakob disease, and spongiform encephalopathies.
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