Method of forming decontaminant food product

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical

Reexamination Certificate

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Details

C424S439000, C424S440000

Reexamination Certificate

active

06294189

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method for forming an antidotal food product containing activated charcoal that is administered to poisoning victims for decontamination of various poisonous substances that may have been ingested. In particular, this invention relates to a method of producing an antidotal food product containing activated charcoal that is an orally administered antidotal substance having the visual appearance and physical properties to entice proper oral administration to even young children.
More in particular, this invention is directed to a method for forming an activated charcoal decontaminant food product having an appearance, texture and taste that emulates that of a baked cookie.
Still further, the method of this invention includes the steps of mixing activated charcoal with a filler, a binder and water to form a slurry; spray drying the slurry to form a granular composition; blending the granular composition with a friction reducing composition; and, compressing the blended mixture to form a dry friable wafer. Still more in particular, the method of this invention further includes the step of inserting a sweet creamy filling mixture composition between a pair of wafers to form a cookie sandwich-type food product.
2. Prior Art
Poisonings are the ingestion of toxic substances and have historically been and continue to be a significant problem today. With the ongoing proliferation of an expansive variety of commercially-available household products, access to a plethora of toxic substances in the average home is currently at or near an all-time high. While efforts in recent years, such as conspicuous labeling, tamper-proof sealing campaigns, and limiting the number of tablets in bottles of children's medicines, as well as a concerted informational program, appear to have been successful in preventing dramatic growth in the number of poisoning deaths that occur annually, significant numbers of poisoning incidents continue to occur. An overwhelming percentage of those incidents occur at a residence, and the majority of the victims tend to be young children. In 1993 alone, for instance, there were 1,751,476 human poisoning cases reported to recognized Poison Centers, over 90% of which occurred at a residence, according to the 1993
Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System
. Children under the age of six made up approximately 56% of the victims in those cases. Considering that at that time only about 70% of the American population actually had access to a Poison Center recognized in the study, the number of incidents that actually occurred in 1993 is likely to have been significantly higher than these numbers would indicate, with the total number of cases more realistically been on the order of 2,500,000.
In the emergency treatment of poisoning victims, the effort centers around two main objectives: general support and stabilization of the victim, and decontamination of the victim. As decontamination and treatment must begin immediately in such toxicological emergencies, often without the benefit of full and thorough clinical information on the patient, it is particularly important that any drug or therapeutic substance administered to the patient be substantially free of unwanted side effects that may cause unforeseen complications, or even death. For this reason, sorbents which, when introduced into the patient's gastro-intestinal tract, resist decomposition and adsorb the ingested toxins until eventual excretion by the patient, have been employed for decontamination. Of those sorbents, activated charcoal has emerged in the field of emergency toxicological treatment as the decontaminant of choice. Its routine use in the treatment of poison victims did not become widespread until the 1980's. However, its administration to poisoning victims has now surpassed the administration of syrup of ipecac as the single most important general toxicological treatment measure.
Activated charcoal is a fine, black, powdery substance which is tasteless, odorless, and non-toxic. Activated charcoal is generally formed by oxidation (activation) of combustion residue derived from a controlled combustion process performed on wood, peat, or other organic material. The oxidation and controlled combustion steps combine to yield a substance composed of extremely porous particles which give it extraordinarily high internal surface area, typically ranging between 900 m
2
/g and 2400 m
2
/g. Due to its extraordinary surface area, activated charcoal exhibits great adsorptivity and, thus, has proven to be quite effective as a decontaminant when introduced in sufficient quantities into the gastro-intestinal tract of a poisoning victim. The highly adsorptive activated carbon particles within the gastro-intestinal tract are capable of adsorbing toxin, not only from the contents of the gastro-intestinal tract but even from the bloodstream (by “intestinal dialysis”), from the blood vessels which supply the gastro-intestinal tract. Those toxins become bound to the activated charcoal, and are then excreted in the stool.
Activated charcoal is currently available in several forms to be orally administered to poisoning victims. In the most widely used form, activated charcoal is contained in a suspension such as the commercially available ACTIDOSE AQUA and CHARCOAID 2000 suspensions. Activated charcoal is also available extensively in Europe, and to a more limited extent in the United States, simply in its powdered or granulated form for mixture within a drinkable liquid prior to ingestion. In yet another form, activated charcoal is contained in over-the-counter tablets or capsules widely available in Europe for the treatment of gas and upset stomach. Use of these tablets or capsules for decontamination in toxicological treatment, however, is not readily feasible. Even if all the active ingredients other than activated charcoal were removed therefrom, the relatively high dosages required in most poisoning incidents would necessitate the ingestion of many such tablets or capsules, a daunting task even for the average adult, let alone for the average young child.
In whatever form activated charcoal is delivered to the gastro-intestinal tract, suspended in a liquid, compressed within a tablet or capsule, or simply in its raw powdery state, the activated charcoal is likely to have significantly beneficial, if not life-saving, effects on the poisoning victim, if it can be properly delivered in the necessary dosage to the gastro-intestinal tract of the victim. Therein lies the single greatest obstacle to optimal utilization of activated charcoal as a decontaminant in toxicological treatment. Each of the currently available forms in which activated charcoal is available for oral ingestion utterly fails to adequately induce or at least encourage proper ingestion of a significant dose of the activated charcoal by the victim. Essentially, except for the tablet or capsule form (which presents its own obstacles to ingestion), the antidotal substances are extremely unpalatable and, quite noxious. Liquid antidotal suspensions containing activated charcoal, for instance, form a black gritty liquid bearing a striking resemblance to old engine crank case oil and lacks the pleasant taste which, theoretically, might cause the ingesting individual to even momentarily forget the unpleasant appearance, texture, and consistency of that which he or she is ingesting.
Whereas to a mature adult poisoning victim, the noxiousness of an activated charcoal-containing antidote may simply represent a trivial, though unpleasant, consequence that must be tolerated to avoid the far greater consequences of his or her serious predicament, it would hardly be such a trivial matter to a young child victim. To that young child or any other victim lacking the mental or emotional capacity to fully appreciate the magnitude of the situation and therefore incapable of seeing beyond the overbearing experience of ingestin

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