Orally dissolving thin films containing allergens and methods of making and use

Patent metadata

Field	Value
Publication number	US-9539334-B2
Application number	US-201314400856-A
Country	US
Kind code	B2
Filing date	May 17, 2013
Priority date	May 17, 2012
Publication date	Jan 10, 2017
Grant date	Jan 10, 2017

Abstract

The present invention provides a thin mucoadhesive sublingual film composition which provides improved allergen delivery and efficacy at a smaller dose while prolonging the contact time between the allergen and oral antigen presenting cells (APCs), and therefore minimizing the risk of systemic side effects. The thin film compositions of the present invention are also easier to standardize, and removes any need for measuring allergen doses at the physician's office, and which allows for a simplified dosing schedule. Methods of making the thin film compositions and methods for their use are also disclosed.

First claim

The invention claimed is:

1. A pharmaceutical composition suitable for use in the treatment of an allergic response in a subject consisting of:
a) about 74% w/w of a primary film forming agent, wherein the agent comprises a sufficient amount of hydroxypropyl methyl cellulose; or polyethylene glycol, wherein the film forming agent is also a mucoadhesive polymer;
b) about 1.5% w/w of a biodegradeable plasticizer is glycerols,
c) about 14.8% w/w of at least one allergen extract comprising peanut extract,
d) about 0.2% w/w of a flavoring agent, wherein the flavoring agent is also the coloring agent; and
e) about 7.4% w/w of a sweetening agent.

2. The pharmaceutical composition of claim 1 , wherein the composition is prepared as a thin film with a thickness of between about 50 to about 500 pm.

3. The pharmaceutical composition of claim 2 , wherein the thin film is cut into strips having dimension of about 1×2 cm.

4. A method for treatment of an allergic response to an antigen in a subject comprising administering to the subject a sufficient amount of at least one pharmaceutical composition consisting of a sufficient amount of hydroxypropyl methyl cellulose; or polyethylene glycol, wherein the film forming agent is also a mucoadhesive polymer;
b) about 1.5% w/w of a biodegradeable plasticizer is glycerols,
c) about 14.8% w/w of at least one allergen extract comprising peanut extract,
d) about 0.2% w/w of a flavoring agent, wherein the flavoring agent is also the coloring agent; and
e) about 7.4% w/w of a sweetening agent.

5. The method of claim 4 , wherein the route of administration is buccal or sublingual.

6. The method of claim 5 , wherein the route of administration is sublingual.

7. A kit comprising the pharmaceutical composition of claim 1 , in an airtight container and instructions for use.

Assignees

• Univ Johns Hopkins
• John Hopkins Univ

Inventors

• Wood Robert
• Mao Hai-Quan
• Keet Corinne
• Martin Russell

Classifications

• A61K39/35

  Allergens · CPC title

• A61K47/10

  Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers · CPC title

• A61K47/38 Primary

  Cellulose; Derivatives thereof · CPC title

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• B29C39/02

  for making articles of definite length, i.e. discrete articles · CPC title