Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1999-11-01
2004-07-27
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S625000, C514S629000, C424S043000, C564S192000, C564S217000, C564S218000
Reexamination Certificate
active
06767925
ABSTRACT:
This invention relates to sprayable analgesic compositions.
In another respect, the invention pertains to methods of administering analgesic compounds.
According to another aspect, the invention pertains to compositions and methods for oral administration of analgesic compounds by absorption through the buccal mucosa.
Topical application of analgesic compositions, i.e., by application to and absorption through the skin, is known. For example, the composition for topical application of a salicylate emulsion foot spray is disclosed in a patent to Modderno (U.S. Pat. No. 2,975,097).
BACKGROUND OF THE INVENTION
Sprayable topical analgesic anti-inflammatory compositions for treating skin rashes, etc. are disclosed in the Saitoh, et al. patent (U.S. Pat. No. 4,775,667).
Aerosol compositions for inhalation therapy, containing analgesics which are absorbed in the bronchioles and alveoli are disclosed in the patent to Porush, et al. (U.S. Pat. No. 2,868,691).
Liquid analgesics for oral administration are also known. For example, see the patent to Haas (U.S. Pat. No. 4,861,797) which discloses palatable liquid ibuprofen compositions.
To date, however, analgesic compounds have not been made available for administration by absorption through the buccal mucosa. It would be highly advantageous to provide such compositions in buccal absorption methods for administering analgesics, because such use and methods could be much more convenient for use by the general public, when it is not practical to use tabletted or swallowed liquid compositions. Moreover, compositions and methods for buccal mucosa administration of analgesics would be especially useful to persons who have impaired ability or aversion to swallowing tablets or liquid preparations.
Additionally, it would be advantageous to provide analgesic compositions and methods of administering analgesics which provide a desired physiological effect with the same or lower dosage compared to tabletted or liquid analgesic compositions.
SUMMARY OF THE INVENTION
I have now discovered liquid analgesic compositions and methods of administering analgesic compounds which are conveniently and inexpensively prepared, conveniently administered, and which may provide the desired physiological effect at a lower total dose than that obtained by use of prior tabletted or swallowed liquid compositions. My compositions and methods have been found particularly useful by persons who have a limited ability to use oral ingested tablets or liquids or have an aversion to such products. Further, it appears that a desired physiological result, i.e., alleviation of headaches can be obtained by administration of only approximately {fraction (1/20)}th of the dose normally recommended for tabletted analgesics such as acetaminophen.
DETAILED DESCRIPTION OF THE INVENTION
Briefly, in accordance with my invention, I provide a sprayable analgesic composition comprising an analgesic compound which is capable of introduction into the bloodstream by absorption through the buccal mucosa in a pharmacologically acceptable liquid carrier. The viscosity of the composition is adjusted to permit spray application of the composition to the buccal mucosa. In a preferred embodiment, the analgesic compound is acetaminophen. In another embodiment, the analgesic compound is ibuprofen. In the preferred embodiment, the liquid carrier is an aqueous ethanol liquid.
According to another embodiment of the invention, the above-described composition is contained in a measured dose spray dispenser which delivers a physiologically effective quantity of the composition in one or more, preferably in from 1-5, measured doses.
According to yet another embodiment of the invention, I provide a method of administering an analgesic compound to a subject comprising dispersing a quantity of an analgesic compound which is absorbed by the buccal mucosa in a pharmacologically acceptable liquid carrier to form a sprayable liquid composition, introducing the liquid composition into a measured dose spray dispenser, and applying a physiologically effective quantity of said composition by spraying from said dispenser on the buccal mucosa.
As used herein, the term analgesic is intended to describe any of the several known analgesics, such as acetaminophen, aspirin, ibuprofen, naproxen and the like, some of which also exhibit anti-inflammatory and/or anti-pyretic physiological activity.
The compositions preferably also include, in addition to the analgesic and liquid carrier components, other optional ingredients such as surfactants, humectants, preservatives, flavoring agents and other topical pharmaceutical adjuvants and excipients.
The compositions are prepared by art-recognized techniques which are typically used in the preparation of similar sprayable compositions.
REFERENCES:
patent: 3644626 (1972-02-01), Witzel et al.
patent: 4230688 (1980-10-01), Rowsell et al.
patent: 4250163 (1981-02-01), Nagai et al.
patent: 4671953 (1987-06-01), Stanley et al.
patent: 4704406 (1987-11-01), Stanislaus et al.
patent: 4743588 (1988-05-01), Mirejovsky et al.
patent: 4760087 (1988-07-01), Zimmer et al.
patent: 4775667 (1988-10-01), Saitoh et al.
patent: 4861797 (1989-08-01), Haas
patent: 4910197 (1990-03-01), Beitner
patent: 5143731 (1992-09-01), Viegas et al.
patent: 5331000 (1994-07-01), Young et al.
patent: 5981591 (1999-11-01), Deihl
Bryan Cave LLP
Reamer James H.
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