Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Carbohydrate or lignin – or derivative
Patent
1990-03-08
1992-01-14
Griffin, Ronald W.
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Carbohydrate or lignin, or derivative
106189, 1061971, 514 57, 514 64, 514159, 514163, 514925, 514928, 514969, 514944, C08L 126, A61K 908, A61K 3160, A61K 3169, A61K 3172
Patent
active
050811584
DESCRIPTION:
BRIEF SUMMARY
This invention relates to compositions and methods for in situ treatment of body tissues.
In another respect, the invention pertains to the use of hydroxypropyl cellulose (HPC) in the manufacture of such compositions and the use of such compositions, manufactured from HPC.
According to another aspect, the invention relates to methods of treating skin, mucosal tissue and other moist tissue, by forming an adherent film thereon.
In another respect, the invention relates to compositions and methods for forming films in situ on body tissues, which films are effective sustained release carriers for medicinal and cosmetic components, to maintain such medicaments at and on a treatment site on body tissue.
In the topical treatment of body tissue, problems are encountered in maintaining treatment compositions in contact with the treatment site. The problem arises because normal movement of the treatment site and surrounding tissue, as well as abrasion or irrigation of the treatment site, causes topical compositions to be displaced.
In the case of mucosal tissue, it is considered practically impossible to maintain a treatment composition at the treatment site for more than a few minutes. The mucosal tissues are glaborous and initially wet which interferes with attempts to adhesively secure a treatment composition to these tissues.
The use of topical anesthetics for reducing pain is known. For example, commercially-available preparations containing benzocaine are widely used. However, these do not form coherent films in the mouth and are easily displaced from the ulcer site by saliva and physical movement of the surrounding tissues. An intra-oral ointment base for use in the oral cavity has been proposed which consists essentially of sodium carboxymethyl cellulose and pectin. However, such ointments are not considered sufficiently persistent to solve the basic problem of maintaining a topical analgesic agent in contact with an ulcer for up to several hours.
Topical adhesive dosages for mucosal ulcers have also been proposed in the form of a two-phase tablet having an adhesive peripheral layer of hydroxypropyl cellulose with the medication carried in an oleaginous core of cocoa butter. This device adheres to the mucosa of dogs for thirty minutes to six hours.
Mixtures of hydroxypropyl cellulose (HPC) and polyvinylacetate have been proposed as film-forming carriers for medications, but no use of such systems for intra-oral application of topical medicines has resulted.
Precast films of hydroxypropyl cellulose containing analgesics and antibiotics has been reported anecdotally for the treatment of pain of leukoplakia.
Alkyl cellulose and/or cellulose ether compounds have been used as thickeners or ointment bases for a wide variety of medicaments. For example, an alkyl cellulose, believed to be methyl cellulose, was used as a carrier and ointment base for the topical medicinal composition described in U.S. Pat. No. 4,381,296 to Tinnell. Hydroxyethyl cellulose and/or hydroxypropyl cellulose was used to form a gel for application of the topical acne medications of U.S. Pat. No. 4,244,948 to Boghosian et al. And a water-soluble film formed of hydroxypropyl cellulose was used as the carrier for a bactericide in a teat-dip composition in U.S. Pat. No. 4,434,181 to Marks et al.
Heretofore it was understood that the relief of pain associated with recurrent aphthous stomatitis (RAS) ulcers was temporarily alleviated by the medicinal composition of Tinnell '296 patent in an alcohol-methlcellulose carrier. However, more recently, it has been demonstrated that a principal analgesic effect is due to a protective film which forms, which acts as a barrier to further insults of the ulcer by foods, saliva, etc. Moreover, it is now understood that the barrier film formation is due to chemical reaction of the medicinal compositions of Tinnell '296 and the cellulosic thickener, rather than by simple deposition of the cellulosic material per se, upon vaporization of the alcoholic solvent. Further, it has now been discovered that the cellulos
REFERENCES:
patent: 4226848 (1980-10-01), Nagai et al.
patent: 4244948 (1981-01-01), Boghosian et al.
patent: 4285934 (1981-08-01), Tinnell
patent: 4292299 (1981-09-01), Suzuki et al.
patent: 4381296 (1983-04-01), Tinnell
patent: 4434181 (1984-02-01), Marks et al.
patent: 4765983 (1988-08-01), Takayanagi et al.
patent: 4767612 (1988-08-01), Hagen et al.
patent: 4913897 (1990-04-01), Chvapil et al.
Herpaway, product description, Zila Pharmaceuticals, Inc., Las Vegas, Nev., NDC 0151-2844-67 prior to Jan. 1984.
Zilactin Medicated Gel, product description, Zila Pharmaceuticals, Inc., Phoenix, Az., 12004-893 first use: Aug. 17, 1987.
Zilactin Medicated Ointment, product description, Zila Pharmaceuticals, Inc., Phoenix, Az., NDC 51284-468-02 first use: Jan. 30, 1984.
Griffin Ronald W.
Zila Pharmaceuticals, Inc.
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