Title:  Process for manufacturing a pharmaceutical chewing gum

United States Patent:  6,322,828

Assignee:  Deseret Laboratories, Inc. (St. George, UT); Josman Laboratories, Inc. (Irvine, CA)

Filed:  September 13, 1999

The present invention provides a process for preparing a chewing gum tablet, in which a chewing gum composition is cooled to a temperature at which the composition is brittle, and the composition is ground while brittle to form a fine powder. In a preferred process, the composition is cooled by mixing with a coolant, such as solid carbon dioxide, and the mixture is ground to a powder. The powder can be mixed with a pharmaceutical active ingredient capable of topical absorption in the buccal cavity or in the mucous layer of the upper or lower intestinal tract, and formed into a tablet. Preferably, the mixture of the powder, pharmaceutical active ingredient, and other additives such as coating agents, binders, additional active ingredients, and sweeteners, are granulated in a fluidized bed granulator prior to forming the mixture into a tablet. The resulting tablet provides a dosage form of the pharmaceutical active ingredient having a more accurate and uniform dose of the active ingredient.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a process for preparing chewing gum dosage forms of therapeutic agents topically effective toward the gastrointestinal tract having improved dose accuracy and uniformity.

It is also an object of the present invention to provide a process for preparing chewing gum dosage forms of therapeutic agents topically effective toward the gastrointestinal tract having a precise and well-defined form, shape and weight.

It is also an object of the present invention to provide a process for preparing chewing gum dosage forms of therapeutic agents topically effective toward the gastrointestinal tract, wherein the therapeutic agent is not subjected to elevated temperatures.

It is further an object of the present invention to provide processes for preparing chewing gum dosage forms of therapeutic agents topically effective toward the gastrointestinal tract capable of being carried out in high-speed, efficient manufacturing processes.

It is still a further object of the present invention to provide chewing gum dosage forms of therapeutic agents topically effective toward the gastrointestinal tract.

The foregoing objects and other advantages are achieved by the process of the present invention, in which a chewing gum composition is cooled to a temperature at which the composition is brittle, and the composition is ground while brittle to form a fine powder. In a preferred process, the composition is cooled by mixing with a coolant, such as solid carbon dioxide, and the mixture is ground to a powder. The powder can be mixed with a pharmaceutical active ingredient capable of buccal and/or upper or lower gastrointestinal tract topical absorption (i.e., topically effective toward the gastrointestinal tract), and formed into a tablet. Preferably, the mixture of the powder, pharmaceutical active ingredient, and other additives such as coating agents, binders, additional active ingredients, and sweeteners, are granulated in a fluidized bed granulator prior to forming the mixture into a tablet. The resulting tablet provides an improved dosage form of the pharmaceutical active ingredient.

Thus, in one aspect, the present invention provides a process for preparing a chewing gum tablet, the process including the steps of cooling a chewing gum composition to a temperature at which the composition is brittle, grinding the cooled chewing gum composition, and forming the ground chewing gum composition into a tablet.

In another aspect, the present invention provides a process for preparing a chewing gum tablet, the process including the steps of providing a mixture including a chewing gum composition and solid carbon dioxide, grinding the mixture to form a powder, removing the solid carbon dioxide from the powder, and forming the powder into a tablet.

In another aspect, the present invention provides a process for preparing a dosage form of an active ingredient topically effective toward the gastrointestinal tract, the process including the steps of providing a mixture including a chewing gum composition and solid carbon dioxide, grinding the mixture to form a powder, removing the solid carbon dioxide from the powder, mixing the powder with a composition including the active ingredient to form an active ingredient-containing powder, granulating the active ingredient-containing powder in a fluidized bed granulator, and compressing the granules into a tablet to form a dosage form containing the active ingredient.

In another aspect, the present invention provides a chewing gum dosage form of an active ingredient topically effective toward the gastrointestinal tract, the dosage form including a gum base and an active ingredient and being formed of a plurality of compressed granules containing the gum base and active ingredient.

Claim 1 of 32 Claims

What is claimed and desired to be secured by United States Letters Patent is:

1. A process for preparing a chewing gum tablet, the process comprising:

(a) cooling a chewing gum composition to a temperature at which the composition is brittle;

(b) grinding the cooled chewing gum composition to form a chewing gum powder;

(c) mixing the chewing gum powder with a composition comprising a pharmaceutical therapeutic active ingredient to form an active-containing powder;

(d) granulating the active-containing powder to form active-containing granules; and

(e) forming the active-containing granules into a tablet.

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