Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1999-01-25
2001-02-06
Azpuru, Carlos A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S468000
Reexamination Certificate
active
06183775
ABSTRACT:
The present invention relates to a slowly erodible lozenge having pleasant organoleptic properties, which means that the user has a pleasant feeling in the mouth when sucking it. When an active substance, especially a pharmaceutically active substance, is added to the composition, a buccal delivery system is obtained that releases the active substance slowly in a controlled manner, for example with almost zero order release.
The delivery of drugs through the buccal mucosa is a very well known and convenient way of administering a number of active ingredients for either local or systemic action. Chewable tablets, lozenges and other similar oral dosage forms have been present on the market for many years. These galenical forms often consist of a soluble diluent, such as sugar, lactose, mannitol or sorbitol, and a binder. Lubricants, flavours, sweetening agents, taste correctors and one or more active ingredients are normally added which do not improve the tableting properties of the mixture. These forms dissolve relatively rapidly once in the mouth, within either a few seconds or up to 10 minutes, and deliver both soluble and insoluble active ingredients to the buccal cavity.
Chewing gums are also present on the market. They are often used to increase the time over which the active ingredient is delivered to the buccal cavity—which can be up to more than a half an hour. However, these forms do also have their drawbacks, although they are popular and useful for several drugs, e.g. fluoride supplements, nicotine etc. One major drawback is that normally the taste changes rapidly in the mouth—often after only a few minutes of chewing—due to the rapid release of flavours and sweeteners occurring when the chewing action proceeds. Moreover, a chewing gum is not a discreet form of drug administration, and it can be unpleasant and tiring to chew for a long period of time several times a day.
SUMMARY OF THE INVENTION
The present invention relates to a new buccal delivery system which allows the delivery of a soluble or insoluble active substance to the buccal mucosa over an extended period of time. The delivery occurs in a controlled release manner normally within a period of from 15 minutes up to 90 minutes, or within an even longer period of time.
The buccal delivery system of the invention is in the form of a slowly erodible lozenge and consists essentially of (an insoluble matrix formed from)
(a) a soluble filler in an amount of from 50 up to 99 weight-% of the total composition,
(b) an insoluble film-forming agent which is capable of forming an insoluble matrix,
(c) a swellable polymer,
(d) optionally an active substance and
(e) optionally usual auxiliaries.
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Amer. Pharm. Assoc. and Pharm. Soc. of Great Britain: “Handbook of Pharmaceutical Excipients”, 1988, pp. 41-42; pp. 53-55; pp. 134-140.
Azpuru Carlos A.
Novartis Consumer Health S.A.
Thallemer John D.
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