# US 9,750,786 B2 · Treatment of thrombocytopenia using orally administered interferon

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- Number: US 9,750,786 B2
- Document ID: US9750786B2
- Status: Granted
- Kind: B2
- Application number: 15/338,772
- Filed: 2016-10-31
- Published: 2017-02-16
- Granted: 2017-09-05
- Earliest claimed: 2012-05-03
- Assignees: Amarillo Biosciences, Inc.
- Applicants: Amarillo Biosciences, Inc.
- Inventors: Martin Joseph Cummins; Chau-Ting Yeh; Ching-Yuan Lee
- Web page: https://patentgrep.com/patent/US9750786B2

## CPC

- A61K 38/212: {IFN-alpha}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 38/21: Interferons {[IFN]}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

An interferon composition is provided for enhancing the platelet count, reducing the recurrence rate of hepatitis, and/or improving the social function of hepatitis patients. The method comprises administering a low dose of IFN (about 5 IU to about 2500 IU of IFN-alpha) to a patient in need thereof. In one embodiment the IFN is alpha IFN or beta IFN, and more particularly, in one embodiment the administered biologically active IFN is human alpha IFN.

## Claims

### Claim 1

A method of enhancing the platelet count of a patient having thrombocytopenia, the method comprising:
identifying a patient with platelet blood levels of less than 150,000 platelets per microliter,
wherein the normal level of blood platelets in the patient is at or above 150,000 platelets per microliter, and
orally administering a daily dosage of about 500 IU of interferon-alpha to the patient to stimulate a more rapid increase of blood platelets to a normal level of blood platelets in the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the patient is infected with hepatitis C virus.

### Claim 3 (depends on 1)

The method of claim 1, wherein the thrombocytopenia is due to a reduction of blood platelets in the patient receiving intravenous interferon.

### Claim 4 (depends on 1)

The method of claim 1, wherein the interferon-alpha is orally administered bucally.

### Claim 5 (depends on 1)

The method of claim 1, wherein the interferon-alpha comprises a first interferon-alpha and a second interferon-alpha.

### Claim 6 (depends on 5)

The method of claim 5, wherein the first interferon-alpha is an interferon-α2b and the second interferon-alpha is an interferon-α8a.

### Claim 7 (depends on 5)

The method of claim 5, wherein the ratio of the first interferon-alpha to the second interferon-alpha is 3:1.

### Claim 8 (depends on 1)

The method of claim 1, wherein the interferon-alpha is formulated in a liquid or a saliva-soluble lozenge dosage form.

### Claim 9 (depends on 8)

The method of claim 8, wherein the interferon-alpha is formulated as the saliva-soluble lozenge dosage form, and orally administering the interferon-alpha comprises:
introducing the saliva-soluble lozenge dosage form into the mouth of the patient;
allowing the saliva-soluble lozenge dosage form to dissolve in the patient's mouth to form an interferon-containing solution; and
contacting the interferon-containing solution with the oral mucosa and the pharyngeal mucosa of the patient.