Chewable tablets containing mannitol and aspartame

Details Chewable tablets containing mannitol and aspartame Chewable tablets containing mannitol and aspartame

1998-11-19

2001-10-02

Harrison, Robert H. (Department: 1619)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C424S464000, C424S465000, C424S489000, C424S499000, C427S002150

Reexamination Certificate

active

06296868

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to alcohol sugar high intensity sweetener agglomerate compositions which are useful in food and pharmaceutical products because of their flowability, compressibility, mixability, stability and dissolution characteristics, among others and, in particular, to agglomerates of an alcohol sugar preferably mannitol and a high intensity sweetener preferably Aspartame which agglomerates are made using a fluid bed process and are used to make chewable tablets and particulate products requiring a high intensity sweetener, and to processes for making the co-agglomerates, tablets and particulate products.
2. Description of Related Art
A need has long existed in the food and pharmaceutical industry for high intensity sweetener containing products in a solid form which store well, are convenient Sand pleasant to take, efficacious, fast acting and storage stable. For example, a particulate product such as a sugar free ice tea mix requires that the product be free flowing and the high intensity sweetener stable to ingredients in the mix such as acidulents like citric acid. A high intensity sweetener is also used for a masking purpose to-mask the bad taste of active ingredients in a product such as a chewable tablet containing acetaminophen. Additionally, solid swallowable antacid tablets are not particularly good tasting and do not sweeten the breath, which would be extremely desirable characteristics of a chewable tablet product for those who suffer from esophagal reflux or sour breath.
High intensity sweeteners such as Aspartame unfortunately are not easily formulated in food and pharmaceutical products and this presents a formidable problem in the food and drug industries. Aspartame, for example, contains groups such as dipeptide linkages which are unstable when mixed with acidulents such as citric acid or an alkatine antacid material such as magnesium hydroxide. The breaking of the dipeptide link results in a loss of sweetness. Aspartame also enters into Maillard type “browning” reactions when mixed with a reducing sugar such as dextrose. Dissolution of the high intensity sweetener is also a problem because they generally evidence slow and undesirable dissolution in water, e.g., the sweetener floats on the surface of the water and slowly dissolves or the sweetener sinks to the bottom of the water and slowly dissolves. High intensity sweeteners typically are commercially available as fine powders which have a high degree of discernible static charge which makes homogenous mixing of the formulation difficult. Poor compressibility of high intensity sweeteners is an additional problem for formulators.
Bearing in mind the problems and deficiencies of the prior art, it is therefore an object of the present invention to provide a high intensity sweetener agglomerate composition which is stable, free flowing, compressible, mixable and has rapid dissolution properties and which is capable of being used in a variety of solid food and pharmaceutical products such as food and drink mixes and chewable tablets.
It is another object of the present invention to provide a tablet containing a high intensity sweetener which stores well and liquefies quickly in the mouth upon chewing and is pleasant tasting.
It is another object of the present invention to provide a tablet containing a high intensity sweetener which is made by direct compression and which tablet includes a substantial quantity of the sweetener which in its raw material form is a powder that can not be easily compacted into a cohesive tablet.
It is a further object of the invention to provide process for making high intensity sweetener containing agglomerates which can be used to make particulate and tablet food and pharmaceutical products.
Other objects and advantages of the invention will be readily apparent from the following description.
SUMMARY OF The INVENTION
The above and other objects and advantages, which will be apparent to those skilled in the art, are achieved in the present invention which is directed to, in a broad aspect, an agglomerate sweetener composition comprising an alcohol sugar such as mannitol and a high intensity sweetener. The agglomerate typically has a porous, high surface area void-like structure and is preferably made using a fluidized bed process. The agglomerates preferably comprise mannitol as the alcohol sugar and Aspartame as the high intensity sweetener. A water soluble binder is used to form the agglomerate and is selected from the group consisting of an alcohol sugar which can be the same as the alcohol sugar forming the base of the composition, a water soluble carbohydrate, maltodextrin, polyvinylpyrrolidone and carboxy methyl cellulose (CMC) among others. The preferred binders are the same alcohol sugar forming the base and maltodextrin.
The quantity of water-soluble binder is an effective amount needed to form the agglomerate and is in the range of up to about 10 percent by weight of the agglomerate,(including the high intensity sweetener), and preferably from about 1 percent to about 5 percent. The alcohol sugar particles comprise about 80 percent to about 97 percent and the high intensity sweetener about 1 percent to 10 percent by weight of the agglomerate (including the high intensity sweetener). The ranges vary depending on the product in which the agglomerate is to be used. The particle size of the materials used to make the agglomerates and the particulate size of the agglomerates may likewise vary widely as described below.
A tablet made according to the present invention is directly compressed from the high surface area porous alcohol sugar based high intensity sweetener agglomerate particles preferably using a relatively low tabletting pressure to form a relatively soft, quick-liquefying interior and a relatively hard, protective outer shell which resists liquefaction even though it is formed from the same agglomerate particles which form the tablet interior. At least some of the ingredients of the agglomerate particles jn the interior of the tablet quickly dissolve or partially dissolve when the tablet is broken into pieces and contacted with small amounts of a liquid, particularly water and/or saliva, as during mastication for example, and any remaining ingredients which do not dissolve in the liquid become dispersed in the liquid and dissolved ingredients, so that the resulting liquid is smooth and essentially without perceivable grit. The relatively hard outer shell resists liquefaction until it is broken, for example, by chewing. Accordingly, the overall preferred chewable tablet structure is such that the tablet is storage stable and easily portable, thereby providing a unit dose in a most convenient form, but is also readily liquefied and melts in the saliva of the mouth during mastication without requiring water or some other liquid, so that the tablet provides all of the benefits normally associated only with liquid dosage forms.
Quick-liquifying, chewable tablets are shown in U.S. Pat. No. 4,684,534, which patent is incorporated herein by reference and which patent is assigned to the assignee of the present invention. The patent discloses carbohydrate-based agglomerates, a method for making the agglomerates and tablets made from the agglomerate.
The storage stable high intensity sweetener containing agglomerate comprises an alcohol sugar, high intensity sweetener and a water-soluble binder. The agglomerate may be used in food products without an active ingredient. Typically the agglomerate is used with an active ingredient such as in an ice tea mix or an antacid tablet. The agglomerate is preferably blended with an active ingredient in the formulation. The active ingredient and agglomerate can also be mixed together to;cause the active ingredient to be entrained by and dispersed in the agglomerate. This agglomerate can then be added to the product formulation. The active ingredient can also be formed as part of the agglomerate during the agglomeration process. The high intensity sweetener

Affiliated with

Also associated with

Rating

Chewable tablets containing mannitol and aspartame does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Chewable tablets containing mannitol and aspartame, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Chewable tablets containing mannitol and aspartame will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-2616923