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Patent for License with Right to Enforce:

Mesoporous Compositions For Use In Oral Drug Delivery    

Oral drug delivery and flavor-masking vehicles for vitamin E, K, D, other water-insoluble drugs and nutraceuticals using novel mesoporous compositions comprising vitamin E and alumina.

Overview

This technology is methods of synthesizing and uses for novel mesoporous compositions comprised of vitamin E and alumina. The mesoporous compositions can be synthesized under specific conditions to produce varied morphologies including, but not limited, to gyroids, hexagons, hexagonal rods, discs, and spheres. The synthesis conditions can be modified to control particle morphology, while maintaining a hexagonal mesoporous structure.

These new classes of compositions have applications as drug delivery vehicles for vitamin E, K, D and other water-insoluble drugs; as a catalyst by fixation of large active complexes in the mesopores; as fiber optic sensors by depositing the mesoporous composition comprising a fluorescent dye at the tip of an optical fiber; in the preparation of mesoporous membranes for use in separation, fuel cells, and catalytic membrane reactors.

For the primary application, this technology allows for a lipid-soluble drug to be encapsulated inside a micelle in which the molecules are oriented such that the hydrophilic end is exposed to water and the core is hydrophobic. This micelle is then coated with molecular sieve material. The result is a porous ceramic powder, which contains vitamin E, which contains the lipid-soluble drug. This enables a pill that once it enters the stomach, the ceramic coating would dissolve away, releasing the micelles which would then go to the intestines to release lipid-soluble drugs. Using this technology, insulin could potentially be delivered orally. This could also be used to mask the taste of medicine or a nutraceuticals.

Other potential applications include uses as a catalyst by fixation of large active complexes in the mesopores; as fiber optic sensors by depositing the mesoporous composition comprising a fluorescent dye at the tip of an optical fiber; and in the preparation of mesoporous membranes for use in separation, fuel cells, and catalytic membrane reactors.

Primary Application of the Technology

Mesoporous oral drug delivery vehicles for vitamin E and other water-insoluble drugs. It can also be used to mask the flavor of a drug and to deliver nutraceuticals and potentially insulin. Primary target market is pharmaceutical companies that are interested in delivering water-insoluble drugs orally or masking the flavor of orally-delivered drugs.

The Problem Solved by the Technology

This technology facilitates the oral delivery of water-insoluble drugs.

Competitive Advantage

Drug insolubility is one of the most challenging issues in the development of many pharmaceutical products. Over one third of the drugs listed in the U.S. Pharmacopedia and about 50% of new chemical entities are insoluble or poorly soluble in water. As a result, many drugs are marketed as sub-optimal formulations, often giving poor or erratic bioavailability or a greater risk of adverse side effects. This technology can be used to facilitate the in situ delivery of insoluble or poorly soluble drugs by using a vitamin E TPGS micelle as a host for the delivery of guest molecules.

Patent Summary

U.S. Patent Classes & Classifications Covered in this listing:

Class 424: Drug, Bio-Affecting And Body Treating Compositions

This class includes the following subject matter, not provided for elsewhere: 1. Drug and bio-affecting compositions which are capable of: preventing, alleviating, treating, or curing abnormal and pathological conditions of the living body; maintaining, increasing, decreasing, limiting, or destroying a physiologic body function; diagnosing a physiological condition or state by an in vivo test; controlling or protecting an environment or living body by attracting, disabling, inhibiting, killing, modifying, repelling or retarding an animal or micro-organism. 2. Body treating compositions generally intended for deodorizing, protecting, adorning, or grooming a body. 3. Fermentates. Plant and animal extracts, or body fluids or material containing plant or animal cellular structure. 4. Compositions of this class defined in terms of specific structure; e.g., layered tablet, capsule. 5. Processes of using or preparing subject matter of the Class Definition.

Subclass 400: PREPARATIONS CHARACTERIZED BY SPECIAL PHYSICAL FORM
Subclass 484: Matrices
Subclass 489: Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)
Subclass 691: Aluminum oxide

Class 264: Plastic And Nonmetallic Article Shaping Or Treating: Processes

Processes for molding, casting, or shaping of nonmetallic materials to produce articles. Liquid or melt comminuting of materials other than glass or metal. Uniting or compacting of bulk or randomly assembled particles. Furnace Lining or repair. Melt shaping in the absence of a mold or shaping surface, e.g., spheroidizing of particles. Working or treatment of nonmetallic materials not otherwise provided for.

Subclass 41: PORE FORMING IN SITU (E.G., FOAMING, ETC.)

Class 423: Chemistry Of Inorganic Compounds

This class provides for what is generally termed the field of inorganic chemistry. It includes inorganic compounds, nonmetallic elements and processes of producing the same involving a chemical reaction. The products are generally in a relatively pure state but may be a mixture with no other utility than as a source material for an inorganic compound or element. This includes metal compound products useful in metallurgical processes of obtaining free metals.

Subclass 625: Aluminum
Subclass 628: Forming catalyst, sorbent activated, or narrow pore alumina

Class 514: Drug, Bio-Affecting And Body Treating Compositions

This class is an integral part of Class 424. It includes the following subject matter, not provided for elsewhere: 1. Drug and bio-affecting compositions which are capable of: preventing, alleviating, treating, or curing abnormal and pathological conditions of the living body; maintaining, increasing, decreasing, limiting, or destroying a physiologic body function; diagnosing a physiological condition or state by an in vivo test; controlling or protecting an environment or living body by attracting, disabling, inhibiting, killing, modifying, repelling or retarding an animal or micro-organism. 2. Body treating compositions generally intended for deodorizing, protecting, adorning, or grooming a body. 3. Fermentates. Plant and animal extracts, or body fluids or material containing plant or animal cellular structure. 4. Compositions of this class defined in terms of specific structure; e.g., layered tablet, capsule. 5. Processes of using or preparing subject matter of the Class Definition.

Subclass 458: Tocopherols (e.g., vitamin E, etc.)
Subclass 769: DESIGNATED INORGANIC NONACTIVE INGREDIENT OR ELEMENTAL MATERIAL OTHER THAN WATER

Class 549: Organic Compounds -- Part Of The Class 532 Series

The classes of the 532 series embrace monomeric organic carbon compounds and polymeric organic carbon compounds that are not solid synthetic resins, natural rubbers, or hydrocarbons.

Subclass 408: Chalcogen bonded directly to the carbocyclic ring of the bicyclo ring system (e.g., tocopherols, etc.)