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New delivery vehicle for therapeutic gases

a technology of gas delivery and gas bottle, which is applied in the direction of nervous disorders, inorganic active ingredients, non-active ingredients of pharmaceuticals, etc., can solve the problems of inability to store gas bottles for patients, and the inability of patients to administer certain classes of drugs by oral administration

Inactive Publication Date: 2017-08-24
DISTRIBUTIONS KHLÔROS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention provides a new way to give gas therapy to patients. The method allows the patient to self-administer the therapy.

Problems solved by technology

However, per-oral administration of drugs has disadvantages such as hepatic first pass metabolism and enzymatic degradation within the gastro-intestinal tract, that prohibit oral administration of certain classes of drugs especially peptides and proteins.
Moreover, patients are generally not equipped to store gas bottles.

Method used

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  • New delivery vehicle for therapeutic gases
  • New delivery vehicle for therapeutic gases

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of the Buccal Delivery Dosage Form

[0059]A buccal delivery dosage form is prepared by heating the excipient, the isomalt, to a temperature of about 330-338° C. for the isomalt to melt and turn liquid. Then inject into the mixture under agitation pressurized Argon, the therapeutic gas, about 600 pounds per square inch; or approx. 41.37 Bar and allow the isomalt / gas mixture to cool down, whereby Argon is entrapped with the re-crystalized isomalt. The process causes tiny high pressure bubbles to be trapped inside the re-crystallized isomalt. The dosage form is then broken down and sieved to the desired size (from 1 to 5 mm), and bagged into 2 grams doses.

example ii

Absorbed Argon for Reducing Stress / Anxiety

[0060]Bags of 2 grams of the Argon-containing buccal delivery dosage form as prepared in Example 1 were handed out to volunteers for testing. The cohort consisted of 8 healthy volunteers between the age of 15 and 60 years old. To better access the effect and absorption of Argon, the experiment was repeated on the same volunteers with a buccal delivery dosage form containing carbon dioxide only.

Protocol:

[0061]Before any uptake, each volunteer was asked to evaluate is stress level on a scale from 1 to 10 (1 is near a meditative state and 10 is the maximum stress and anxiety). This value is the control value.[0062]Then 2 g was taken orally (avoiding swallowing); wait 5 minutes after complete melting and re-evaluation the level of stress / anxiety.[0063]After 5 minutes, take a second 2 g of the buccal delivery dosage form and re-evaluate the level of stress / anxiety.

[0064]The volunteers repeated the protocol 3 times on different days for the CO2-co...

example iii

Effect of Absorbed Argon or CO2 on the Heart Beat Rate

[0067]The same protocol as used in Example II was used in this example. The heart beat rate was measured after 2 g and after 4 g of the buccal delivery dosage form (representing about 2.76 and 5.52 ml of gas, respectively) as prepared in Example 1 was orally taken.

[0068]Each volunteer repeated the protocol 3 times on different days for each one of the CO2-containing dosage form and the Argon-containing dosage form.

[0069]These results as illustrated in FIG. 2 show that the Argon was released and absorbed through the buccal mucosa into the body of the volunteers. The absorption of 2 to 4 g of trapped Argon in a crystallized isomalt did reduce significantly the heart beat rate by 3-6 bpm in average (4-8%, see FIG. 2). It is worthy to note that the CO2-containing dosage form did not cause a reduction of the heart beat rate. In fact, the effect of the CO2 is about equal to the effect of the control, as if no gas was being administered...

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Abstract

The present invention relates to a buccal delivery dosage form and its use for administration of a therapeutic gas for buccal mucosal absorption of the therapeutic gas in the mouth of a subject. The buccal delivery dosage form comprises at least one crystallized excipient and at least one therapeutic gas entrapped within the crystalized excipient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This is the first application filed for the present invention.TECHNOLOGICAL FIELD[0002]The present invention generally relates to a therapeutic gas-containing crystal for use as a vehicle for absorption or uptake of the therapeutic gas through the buccal mucosa.BACKGROUND ART[0003]Sublingual and buccal medications are administered by placing them in the mouth, either under the tongue (sublingual) or between the gum and the cheek (buccal). The medications dissolve rapidly and are absorbed through the mucous membranes of the mouth, where they enter into the bloodstream. Within the oral mucosal cavity, the buccal, including sublingual, region offers an attractive route of administration for systemic drug delivery. The mucosa has a rich blood supply and it is relatively permeable.[0004]Amongst the various routes of drug delivery, oral route is perhaps the most preferred to the patient and the clinician alike. However, per-oral administration ...

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K9/50A61K9/00
CPCA61K33/00A61K9/5015A61K9/006A61K47/10A61K47/26A61P25/22
Inventor PURCELL, MARC
Owner DISTRIBUTIONS KHLÔROS INC