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
FOR BOARD OF SUPERVISIORS OF LOUISIANA STATE UNIVERSITY AND AGRICULTURAL AND MECHANICAL COLLEGE ACTING ON BEHALF OF LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER AT SHREVEPORT • Arphios Corp • Aphios Corp • Louisiana State University
Publication Number
US-9034347-B2
Publication Date
2015-05-19
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
The invention concerns drug delivery systems, dosage forms, and methods for the treatment of neuro-degenerative diseases by oral administration of Bryostatins. It includes formulations where an effective amount of a Bryostatin is incorporated either in a biopolymer microsphere or dissolved in pharmaceutically acceptable oils, such as olive oil. The delivery systems are specifically tailored to facilitate oral administration, offering options such as lyophilized spheres for aqueous reconstitution, suspensions, and solid oral dosage forms like tablets, capsules, and gel caps.
A major goal addressed by the invention is the lack of simple, effective therapies for neuro-degenerative diseases, most of which require treatment approaches that are straightforward to administer and do not demand highly trained healthcare professionals. The background details the significant burden these diseases pose, especially for older individuals, and highlights the need for orally deliverable medications.
Key technical elements of the invention include the use of acid-resistant biopolymers such as poly (D, L-lactide-co-glycoside) for the formation of microspheres with diameters between one and 1000 nanometers, enabling protection of the Bryostatin from gastric acid degradation and allowing for absorption in the small intestine. Alternatively, Bryostatins are dissolved in various pharmaceutically acceptable oils, including olive oil, with ingredients such as antioxidants and emulsifiers to enhance stability and bioavailability. The invention covers both articles of manufacture and methods of treatment using these formulations.
Claims Coverage
There are two primary inventive features covered by the independent claims.
Oral administration of Bryostatin dissolved in olive oil for neuro-degenerative disease treatment
An article of manufacture includes an effective amount of a Bryostatin dissolved in olive oil, which is specifically formulated for oral administration for the treatment of neuro-degenerative diseases. - The Bryostatin is selected from Bryostatins 1-20. - The effective amount is about 3-10 micrograms per kilogram body weight per day. - The formulation targets neuro-degenerative diseases.
Oral treatment method using Bryostatin in pharmaceutically acceptable oil for neuro-degenerative disease
A method of treating neuro-degenerative disease is provided, involving the oral administration of an effective amount of Bryostatin dissolved in a pharmaceutically acceptable oil. - Bryostatin is selected from the group consisting of Bryostatins 1-20. - The dosage is 3-10 micrograms per kilogram body weight per day. - The method applies to a range of neuro-degenerative disorders.
The claims focus on oral drug delivery systems and methods using Bryostatin dissolved in olive oil or other pharmaceutically acceptable oils, specifically for the treatment of neuro-degenerative diseases, with defined dosage ranges and Bryostatin types.
Stated Advantages
Oral formulations enable administration without the need for specially trained healthcare providers.
The acid-resistant biopolymer protects Bryostatin from gastric acid degradation, allowing delivery to the small intestine for absorption.
Flavored suspensions improve patient acceptance of oral administration.
Oil-based formulations increase the bioavailability of Bryostatin.
Documented Applications
Treatment of neuro-degenerative diseases such as Alzheimer's Disease, Hutchinson's Disease, Parkinson's Disease, Down's Syndrome, Kuru, Creutzfeldt-Jakob Disease, and spongiform encephalopathies.
Use in water maze studies in mouse models of Alzheimer's disease to protect against memory loss associated with APP/PS1 mutations.
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