Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing
Reexamination Certificate
2000-07-18
2001-07-10
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
C424S643000, C424S646000, C424S667000, C514S052000, C514S168000, C514S351000, C514S356000, C514S458000, C514S474000, C514S725000
Reexamination Certificate
active
06258384
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a nutritional dietary supplement delivery system and, more specifically, to a frozen product and a method for the oral delivery of nutrients and/or other active ingredients into the bloodstream of mammals for systemic effect.
2. Discussion of the Related Art
The traditional program for obtaining necessary vitamins, minerals and other nutrients is to attempt to eat a balanced diet and then to make up for the inevitable nutritional deficiencies by taking nutritional supplements and vitamin pills. However, for children, pill taking is difficult and sometimes impossible. Thus, instead of pills, liquid nutritional supplement solutions have been developed, particularly for use by children. Unfortunately, children resist taking liquid supplements due to the unappealing taste of such products. In addition, even if the liquid supplement is provided with flavoring to improve taste, many children still resist taking the liquid substance due to stubbornness.
The problem associated with taking pills is further exasperated when it is necessary to administer a medicine. In some cases, liquid formulations, such as syrups, are available. However, these syrups usually taste unpleasant and are often rejected by both children and adults.
Elderly patients, or those who have been weakened by a debilitating disease, radiation therapy, chemotherapy, or another medical condition or treatment may require the administration of oral medication. In such instances, it is often not possible for the patient to swallow pills. Further, syrups and other liquid products can be irritating to the mouth and difficult to swallow, particularly if the patient is suffering from painful lesions in the oral mucosa, such as those associated with candidiasis, also known as thrush.
For athletes, nutritional supplements are typically packaged as sports drinks. Sports drinks help to replace fluids and electrolytes by containing water and nutrients. However, even when refrigerated, sports drinks do not cool the person as quickly and effectively as a frozen product. In the case of a drink containing ice, the liquid is cooled to just above the freezing point, but the liquid being consumed does not undergo a phase change inside the drinker's body. A phase change of solid to liquid (i.e., ice to water) absorbs significantly more heat than the heat transfer from the simple warming of a liquid. Moreover, the electrolytes or active ingredients are not absorbed into the bloodstream until the liquid settles in the person's stomach. This method of delivery is less effective and not as rapid as delivery through the oral mucosa.
In the past, others have proposed various approaches to the administration of all medication as well as other active ingredients by oral administration. For example, frozen electrolyte compositions are available under the trade name PEDIALYTE®, a registered trademark of Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio. These freeze pops contain a solution with electrolytes. The composition is designed to prevent dehydration particularly in infants. The PEDIALYTE® composition does not include other active ingredients such as nutrients, including carbohydrates, vitamins, minerals and medicine. Further, the delivery and absorption of the active ingredients is not enhanced by magnetic treatment and/or ozonation of the delivery fluid, as in the present invention.
U.S. Pat. No. 5,431,915 to Harvey, et al. discloses a frozen oral medication delivery system and method for oral administration of pharmaceutically active agents. The medication is mixed and frozen in a storage container until hard, at which time it can be administered to the patient in the form of a frozen Popsicle. In particular, the oral medication delivery system in Harvey, et al. is particularly well suited for delivering Nystatin to oral candidiasis lesions, especially in very young as well as elderly patients who are unable to take medications by traditional administration methods.
U.S. Pat. No. 5,132,114 to Stanley, et al. discloses a method for the transmucosal delivery of medication which can have local and/or systemic effect. The therapeutic agent is incorporated into a candy matrix in powder form and is compressed to form a lollipop which includes a suitable holder.
U.S. Pat. No. 4,238,475 to Witzel, et al. discloses a chewing gum formulation that releases a small continuous dose of a medication, such as Nystatin, or an orally beneficial material into the mouth. This means of delivering medication to the mouth and oral mucosa can be very effective. However, persons with dentures or bridgework, persons with orthodontic appliances, and very young children are unable to chew gum, which limits the use of this medication delivery system to that segment of the population capable of chewing gum comfortably. Moreover, Witzel, et al. fail to provide means for enhancing the delivery and absorption of the active ingredients through the oral mucosa. Specifically, there is no teaching or suggestion in the patent to Witzel, et al. of magnetic treatment and/or ozonation of the delivery vehicle to enhance delivery and absorption of the active ingredients.
U.S. Pat. No. 4,478,822 to Haslam, et al. discloses a drug delivery system which can be used to deliver drugs to, inter alia, the oral cavity. This drug delivery system uses an aqueous vehicle that includes a polymer which causes the aqueous system to deliver a gel at temperatures encountered in body cavities. While this drug delivery system may be somewhat effective for its intended use, it is not likely to be the most effective method of delivery and absorption of active ingredients through the oral mucosa.
SUMMARY OF THE INVENTION
The present invention is directed to a frozen comestible composition containing at least one active ingredient. For purposes of this invention, an active ingredient is a substance that has a local or systemic effect once administered to the patient or user.
The active ingredient can include a nutrient mixture consisting of essential vitamins and minerals. The mixture may further be provided with flavor agents or other pleasant tasting ingredients. To add to the aesthetic attractiveness, as well as to help the consumer identify the flavor, food coloring can be added to the composition. Preferably, the composition is administered in the form of a frozen Popsicle or squeeze pop. The composition can be varied for different applications such as children, athletes, geriatric users, invalids, or infirm individuals.
The vitamins and minerals contained in the nutrient mixture may include vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, Niacinamide, pantothenic acid, paba, choline, inositol, folic acid, d-Biotin, calcium, magnesium, iron, manganese, zinc, potassium, selenium, and iodine. The nutrients can also include nutritional energy sources such as carbohydrates, protein, and electrolytes.
Children prefer the frozen composition over other means of obtaining vitamins and nutrients because the composition contains flavors and sweeteners and is provided in the form of a frozen product which resembles a favorite refreshing dessert, namely an ice pop or Popsicle.
For athletes, the frozen composition provides a means to quickly absorb nutrients, replace fluids, and to rapidly cool the athlete.
Infirm patients who have upset stomachs or lack of appetite may find the frozen composition to be a more convenient and soothing way to obtain nutrients.
The composition can include an active ingredient that is a medicinal substance. Examples of medicines which may be included as active ingredients in the composition include, but are not limited to, over-the-counter medications as well as those sold by prescription. By delivering medicine in the form of a frozen pop, patients who are unable to swallow pills are provided with an alternative means for administration of required medicines. Further, because the composition is provided with flav
Annis John R.
Pachivas John A.
Stanley Steven A.
Downey PA Robert M.
Henley III Raymond
Med Tech Industries, Inc.
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