Method for manufacturing medicated chewing gum without cooling

Abstract

An improved method for manufacture of chewing gums containing active ingredient(s) that preserves the efficacy of the active ingredient(s) by avoiding exposure to high heat and extreme cold during milling that can otherwise degrade the active's efficacy. A chewing gum base is used, along with one or more therapeutically-active ingredients, one or more sweeteners (alcohol-based and / or natural), and one or more flavorings and optional flavor modifiers. The method generally comprises heating the gum base in ovens to melt the gum base. Separately, the active ingredient(s), sweeteners and flavorings are combined in a mixer. The melted gum base is added to the mixer and cools to produce a particulate mixture. As mixing continues the mass cools to room temperature and forms granular pieces. The granular pieces are ground into a powder at room temperature, mixed at room temperature with tableting excipients, and tableted. Several variations on the foregoing are also described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]In accordance with 37 CFR §1.76, a claim of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority as a divisional of U.S. patent application Ser. No. 14 / 732,072, entitled “METHOD FOR MANUFACTURING MEDICATED CHEWING GUM WITHOUT COOLING”, filed Jun. 5, 2015, which claims priority to U.S. Provisional Patent Application No. 62 / 008,211, filed Jun. 5, 2014.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates generally to the manufacture of chewing gums containing active ingredients and, more specifically, to a method for manufacture of such chewing gums that preserves the efficacy of the active ingredient(s).[0004]2. Description of the Background[0005]The conventional methods of producing compressible chewing gums entail freezing the gum base and then grinding to obtain a particulate material, mixing the particulate material with...

AI Technical Summary

Benefits of technology

The invention provides an improved method for making chewing gums with active ingredients that preserve their effectiveness. This is achieved by avoiding heat and cold exposure during the manufacturing process. The method allows for direct mixing of oil-based active ingredients into the chewing gum base, resulting in more active ingredients with less weight and making the tableting process more efficient and cost-effective. The use of a suitable gum base, therapeutically-active ingredients, sweeteners, and flavorings is recommended for this method. The process involves heating and mixing the gum base and then adding the powdered ingredients, where the temperature of the gum base gradually lowers as it cools. The mixture is then ground and tableted to achieve the desired texture and consistency.

Problems solved by technology

It is noted that the elevated temperatures used in the melt can adversely affect the chemical stability of the therapeutic agent.

Neither prior method is optimal for chewing gums with active ingredients since heating and / or cooling can erode the effectiveness of the active.

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