Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
1999-03-24
2001-04-03
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S401000, C424S455000, C424S452000, C514S772200, C514S778000, C514S772300
Reexamination Certificate
active
06210709
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a flexible capsule which is largely free of animal based gelatin.
BACKGROUND OF THE INVENTION
The use of gelatin capsules as delivery devices is well-known in many art fields, such as paint balls, pharmaceutical gelatin capsules, vitamin/health formulations using capsules, perfume/cosmetic/bath and gel encapsulated products. Such capsules are flexible and easily dissolved.
All conventional and present day commercial capsules use animal-based gelatin to provide the needed combination of flexibility and strength. However, the use of animal based gelatin has become undesirable in certain cases from the viewpoint of the transmission of diseases, such as the now well known “mad cow” disease in Europe. Furthermore, there is an increasing demand for encapsulation products free of any animal-based components to serve increasing market segments who make judgments based on health considerations as well as other factors.
There are a number of prior art patents that describe capsule formulations. U.S. Pat. No. 5,434,069 discloses a capsule for protecting sensitive ingredients in detergent compositions. The shell is formed from a water soluble polymer selected from polyvinyl alcohol, polyacrylamide, polyvinyl pyrrolidone, carrageenan, guar gum, xantham gum, cellulose or protein.
U.S. Pat. No. 5,641,512 discloses a soft edible gelatin capsule formed from gelatin, plasticizer and a xanthine derivative.
U.S. Pat. No. 3,989,852 discloses a method for encapsulation which utilizes cellulose. Gelatin is listed as a suitable filler. This patent teaches that starch and water should not be used because they form a brittle and flaky layer upon drying. U.S. Pat. No.4,935,243 discloses chewable, edible soft gelatin capsule which contains gelatin and hydrogenated starch hydrolysate. U.S. Pat. No. 5,817,323 discloses a soft edible gelatin capsule which is formed from gelatin, plasticizer and a starch.
SUMMARY OF THE INVENTION
An objective of the invention is to provide a flexible capsule free of animal based gelatin. The above objective and other objectives are surprisingly obtained by using a plant based starch which has been modified to possess gelatin like properties.
The invention provides a novel encapsulated material comprising:
a capsule defining a closed interior chamber, the capsule being formulated from a composition which is free of animal based gelatin comprising at least one plant based starch having been modified to have gelatin like properties; and
a material contained within the capsule.
The invention also provides a novel paint ball comprising:
a capsule defining a closed interior chamber, the capsule being formulated from a composition which is free of animal based gelatin comprising at least one plant based starch having been modified to have gelatin like properties; and
a paint material contained within the capsule.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The flexible capsules according to the present invention are free of animal based gelatin. In place of the gelatin, a starch is utilized which has been modified to have gelatin like properties. The flexible capsules include, for example, paint balls, pharmaceutical gelatin capsules, vitamin/health formulations using capsules, perfume/cosmetic/bath and gel encapsulated products.
Starch is a carbohydrate polymer having the following repeating unit:
Starches vary largely in the number of the repeating unit (n) in the polymer, which to a major extent depends on the source of the starch. Starch is normally composed of about 25% amylose and 75% amylopectin. Amylose is currently considered by scientists as a mixture of linear and slightly branched molecules whereas amylopectin is considered a densely branched, high molecular weight molecule. In some cereal starches, the amylose content can be as low as 0-1% as in waxy barley, waxy sorghum, and waxy corn and can be as high was 50-70% in some corn hybrids. Starch is often described as a repeating polymer of glucose units linked together by glycosidic bonds.
Starch is a polysaccharide obtained from plants, of which wheat, corn, potato, tapioca and rice are common commercial sources. Without the various modifications discussed herein, starch is a white, semi-crystalline, tasteless powder often in granule form. When starch is mixed with hot water in sufficient amount, such as at a temperature of 65° C. or higher, irreversible gelatinization can occur. Swelling of starch granules can be induced at lower temperatures by the addition of such compounds as formamide, formic acid, and strong bases and certain metallic salts. A large number of pure starch grades are available including those commonly referred to as commercial, powdered, pearl, laundry, technical and edible. Preferably, edible starches are modified and used to form the flexible capsule.
The starch must be modified to have gelatin like properties. Gelatin like properties include the combination of flexibility and strength when formed into a capsule or film. Based on the disclosure provided herein, one skilled in the art will easily be able to formulate and select modified starches which are suitable for forming flexible capsules according to the present invention. As shown in the Examples, by using animal based gelatin as a control, those modified starches which provide a film having at least 80% of both flexibility and strength of the control gelatin film are suitable (index of at least 4). Preferably, a modified starch is selected which provides a film having at least 90% of both flexibility and strength of the control gelatin film. Combinations of modified starches with film strengtheners such as polyvinyl alcohol can be used to provide the required combination of flexibility and strength.
Examples of suitable modifications for modifying the strength and flexibility characteristics of starches include cross-linking, substituting functional groups on the polymer chain, oxidizing, and acid-thinning. Preferably, the starch is modified by well known oxidizing techniques. The Code of Federal Regulations, which is incorporated herein by reference, describes in detail starches and modified starches intended for industrial or food applications. For example, 21 CFR 172.892 describes modification of starch for food use and 21 CFR 178.3520 covers the modification of starch for industrial applications. Starch-based polymers are reaction polyols derived from a reaction, using catalysts, of a starch with dibasic acids and hydrogen-donating compounds dissolved in a water slurry; the slurry is subjected to high temperatures and pressures, yielding a low-viscosity polymer in an aqueous solution. Molecular rearrangement takes place, and the starch-derived polymer formed can be very different from natural starch in structure. The polymer can be further reacted with acids, bases, and cross-linking agents.
A preferred modified starch is derived from wheat produced by Rheox Inc. bearing the commercial designation EA-2865. EA-2865 is an instant or pregelatinized starch obtained by physical modification of wheat starch.
The modified starch should be present in an amount of from about 20 to about 80% by weight, preferably about 20 to about 50% by weight, based on the total weight of the capsule formulation.
In a preferred embodiment, the flexible capsules of this invention also contain a plasticizer and water.
Any conventional plasticizer can be utilized. Examples of suitable plasticisers include glycerin, xylitol, sorbitol, polyglycyerol, non-crystallizing solutions of sorbitol, glucose, fructose and glucose syrups with varying equivalents. A commercial plasticizer is ANIDRISORB, which is a proprietary mixture of sorbitol, sorbitans, maltitol and mannitol. Most preferably, the plasticizer is glycerin.
The plasticizer should be present in an amount of from about 5 to about 50% by weight, preferably about 10 to about 40% by weight, based on the total weight of the capsule formulation.
Water should be present in an amount of from about 10 to about 70% by weight, preferably about 20 to about 60% by weight,
Gambino James
Laba Dennis
Cronin Michael J.
Elementis Specialties, Inc.
Spear James M.
LandOfFree
Flexible gelatin free encapsulation material useful for... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Flexible gelatin free encapsulation material useful for..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Flexible gelatin free encapsulation material useful for... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2531589