Drug – bio-affecting and body treating compositions – Identification or warning feature – Color or color change feature
Reexamination Certificate
2000-09-07
2001-10-16
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Identification or warning feature
Color or color change feature
C424S009321, C424S009322, C424S010100, C106S031030, C106S031130, C106S031320, C106S031640
Reexamination Certificate
active
06303102
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a marker that is useful in combination with all manners of vaccines, implants or treatment drugs, applied either topically or orally, in either animals or humans. The invention particularly relates to a combined medicament/marker having a controlled clearing time.
BACKGROUND OF THE INVENTION
In the treatment of both animals and humans, it is often useful to provide a means for marking the site where a medicament is injected, inserted or otherwise applied.
More specifically, when dealing with animals which are being raised for food, it is often required that the animals be inoculated with a variety of materials in order to insure that the food harvested therefrom is wholesome. Furthermore, certain medicaments, albeit useful during the animal's growth phase, are nevertheless prohibited at the time of harvest. Regulations prescribe time limits regarding the use of such medicaments to insure a sufficient time period for clearing via natural biodegradation prior to harvest.
Industry compliance with the stated guidelines is a particularly vexing problem, which the industry has been recalcitrant in monitoring. For example, although feedlot attendants may be supplied with the required immunization or medicament, they may be derelict in their responsibilities and fail to apply the material to the animal.
Alternatively, a particular material might need to be given a clearing time period, for example 30 days prior to harvest, thereby allowing a safe clearing time from the animal's flesh. If the feed lot attendant is tardy in making the application, or simply becomes confused about the dates or inoculates a group of animals in error, harmful concentrations of the prohibited materials may find their way into the food supply.
With regard to human applications, there are instances where certain inoculations or tests are initiated and follow-up must occur at a prescribed time interval. In other instances, medicaments are provided in the form insertable implants which reside within the body for extended periods. Furthermore, in a military or possibly a hospital or nursing care environment, it might be beneficial to include a visual confirmation that an individual has received an inoculation.
In all of the above noted circumstances, the inclusion of a marking ingredient or tell-tale which has a controlled biodegradability can act as either evidence of instillation or evidence that a particular period of time has elapsed subsequent to instillation or application of the medicament.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 6,013,122 discloses tattoo inks which can be designed to degrade after a predetermined time. However, there is no disclosure that these inks can be used as indicators to show how long ago a medication was administered.
U.S. Pat. No. 3,416,530 discloses a tablet-like body for insertion along the scleral radius. The tablet is designed to dispense medication to the eye at a predetermined and continuous rate, and utilizes a dye, such as methylene blue, to provide a visual indication that the tablet continues to dispense the medicament. The reference fails to provide a marking device capable of providing a residual marker subsequent to medicament dosage or one that remains visible for a predetermined clearing time.
U.S. Pat. No.3,427,377 proposes a composition of penicillin and a dye of 2,4-disulfo-5-hydroxy-4′, 4″-bis-(diethylamino)-triphenyl-carbinol calcium salt, for administration to the udders of dairy animals. This formulation indicates the presence of penicillin in milk as long as the antibiotic is excreted by the udders.
U.S. Pat. No. 4,572,831 teaches a combination of flourescamine or other furanones and a visible, fugitive dye or pigment. Said composition is useful in marking skin for radiological purposes without leaving visible markings on a patient for an extended period of time.
U.S. Pat. No. 4,152,412 to Brewer discusses an injectable marking vaccine carried on a physiologically acceptable colored particle (e.g., activated charcoal) so as to provide a clearly visible mark evidencing the administration of the desired vaccine.
What is lacking in the art is a cutaneously applied biodegradable tell-tale composition, which composition includes an effective amount of a marker formulation having a pigment or dye in combination with a suitable carrier therefore, and further containing a therapeutically effective amount of one or more medicaments having a controllable period of efficacy or clearing time, and including one or more of a variety of compatible medicaments, vaccines or combinations thereof; wherein instillation/application of the tell-tale marker formulation/medicament combination provide visual evidence for gauging both the application, per se, and time since application of said medicament.
SUMMARY OF THE INVENTION
The instant invention provides a biodegradable tell-tale composition which is applied cutaneously or subcutaneously to a human or animal subject for aiding in the determination of instillation of medicament and furthermore for providing, via the biodegradable functionality, a useful tool for measuring the period of time passed since the most recent inoculation.
It is envisioned that the tell-tale composition of the instant invention will have a plurality of utilities. For example:
1) the tell-tale composition can be given by itself (single injection);
2) the tell-tale composition can be used in or as a carrier agent in a vaccine;
3) the tell-tale composition can be added in small amounts to a vaccine thereby converting it to a marker vaccine;
4) the tell-tale composition can be used in combination with a pour on medicament;
5) the tell-tale composition can be used as an added ingredient in a topdress product (dry product).
Accordingly, it is an objective of the instant invention to provide a tell-tale composition comprising one or more biodegradable tell-tale materials, in combination with a chemical agent, e.g. a medicament, thereby providing a biodegradable marker.
It is a further objective of the instant invention to teach a method wherein the tell-tale composition is utilized In the food and health industry, such that inspectors in the meat processing industries are provided with a tool for ascertaining the safety of any harvestable animal for inclusion within the human food chain.
DETAILED DESCRIPTION OF THE INVENTION
Now with reference to the instillation/application of medicaments, inclusion of a marker as taught by the instant invention will provide the harvester (packer) with a tool for identifying any animals that pass through their plants. The instant invention particularly sets forth a tell-tale or marking composition which includes a plurality of diverse medicaments, vaccines, or the like. Illustrative of those diverse medicaments, vaccines, or the like contemplated by the invention are those incorporated in Tables 1-9, which are appended hereto. In practice, one or more of said medicaments, vaccines or combinations thereof, which are exemplified by, but not limited to materials selected from the group consisting of steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, hormones, nutrient supplements, antibiotics, medicated premixes and feeds, mammary gland antibiotics, bovine vaccines, ovine vaccines, porcine vaccines and mixtures thereof, are included in therapeutically effective amounts. This invention has utility in treating both humans or animals. The tell-tale marker composition can be formulated in any color, and can be visible under a variety of lighting conditions, e.g. full-spectrum visible light, infra-red light, ultra-violet light, monochromatic light or the like.
In a particularly preferred embodiment, the tell-tale marker color will appear under the hide, in the mouth or on the surface of the skin and also can be seen on the outer layer of the hide, skin or hair.
The marker formulation can exhibit a particular initial coloration and subsequently transform to another visually distinct coloration. It also can be injected or given
Fay Zohreh
Kwon Brian-Yong
McHale & Slavin
LandOfFree
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