Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-10-20
2001-10-23
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S440000, C424S479000, C424S489000, C426S660000
Reexamination Certificate
active
06306429
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to centre-filled confectionery compositions, especially liquid centre-filled confectionery compositions, providing an enhanced perception of throat warming or cooling.
BACKGROUND OF THE INVENTION
Products in the form of cough syrups and candy-based cough drops have long been known as vehicles for the delivery of medicaments aimed at soothing sore or irritated throats. Such medicaments include analgesics, antitussives, expectorants, cooling agents such as menthol, and warming agents such as ethanol or gingerol. The material can be administered swallowing a liquid cough mixture or by way of a throat drop or lozenge which releases the active agent upon sucking. Particularly in the case of a volatile active agent, the product can also provide relief from cold symptoms by way of clearing the nasal passages.
EP-A-431,376 describes hard confections for sustained release treatment of sore throats comprising hydrogenated isomaltulose and an active ingredient which can be an antitussive or antihistamine but can also be a volatile oil such as menthol or eucalyptus. The confection normally contains a further flavouring agent such as lemon, honey or cherry but which can also be menthol or eucalyptus.
The art has also described methods of enhancing the effects of volatile oils in cough drops and the like. Thus U.S. Pat. No. 4,762,719, to Forester, published Aug. 9, 1988, describes a cough drop with a hard candy outer shell and a powdered centrefill. The centrefill composition comprises an active ingredient, such as menthol and eucalyptus, and a rapidly dissolving powder, such as sorbitol, xylitol or dextrose monohydrate, which desirably has a negative heat of solution to accentuate the cooling effect of the actives. The shell may further comprise a flavour such as cherry, lemon, orange, lime, etc.
U.S. Pat. No. 4,980,169, to Oppenheimer et al., assigned to the Warner-Lambert Company, published Dec. 25, 1990, describes cough drops in which the flavour is enhanced by incorporation a sensorially undetectable amount of a volatile oil modifying agent, especially capsicum.
It has now been found that the perceived effect of a physiological warming or cooling agent can be enhanced by incorporating a warming or cooling agent into a first composition which is administered along with a second composition which provides for delayed release of a cooling or warming agent. The first and second compositions are suitably provided by a centre-filling confectionery composition in which the shell provides the first composition and the filling provides the second.
It is accordingly an object of this invention to provide medicated confectionery compositions, especially throat drops, delivering enhanced throat and nasal warming or cooling.
SUMMARY OF THE INVENTION
The present invention relates to a throat drop, suitable for the relief of cough and cold like symptoms, comprising a cooling composition and a warming composition in distinct and discrete regions thereof, the cooling and warming compositions being adapted to provide sequential release profiles.
The throat drop provides an enhanced warming or cooling effect, analogous to the way in which an enhanced perception of heat or cold is experienced when one transfers one hand from hot to cold water or vice-versa.
All levels and ratios are by weight, unless otherwise indicated. Percentages are by weight of the throat drop unless otherwise specified.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a throat drop comprising a cooling composition and a warming composition. The compositions are in distinct and discrete regions of the drop, preferably in the shell and filling respectively of a centre-filled drop, so that sequential release of the compositions is obtained when the drop is sucked. Examples of suitable product constructions providing differential release profiles are described in WO97/06695 incorporated herein by reference. Preferred for use herein, however, are centre-filled drops comprising a shell and a filling contained within the shell. The shell comprises a cooling or warming composition, and the filling comprises a warming composition if the shell comprises a cooling composition or a cooling composition if the shell comprises a warming composition.
Cooling compositions
An essential component of the cooling composition is a physiological cooling agent. Suitable levels of the cooling agent are from about 0.001 to about 10%, preferably from about 0.01 to about 5%, more preferably from about 0.05 to about 3% by weight of the cooling composition.
A test for physiological cooling agents is described in GB-A-1,452,291, published Oct. 13, 1976, reproduced herein below for convenience.
The following test procedure can be used as a means to identify compounds having a physiological cooling activity. This test is intended purely as a means for identifying compounds having a physiological cooling agent activity and useful in the present invention and for giving an indication of the different relative activities of the compounds, as between themselves and as compared with menthol, when applied in particular manner to a particular part of the body. The results are not necessarily indicative of the activity of these compounds in other formulations and other parts of the body where other factors come into play. For example, a controlling factor in the onset of cooling effect, its intensity and longevity will be the rate of penetration of the compounds through the epidermis and this will vary in different locations on the human body. The formulation of actual products according to this invention will therefore be done largely on an empirical basis although the test results and other figures given herein will be useful as a guide, particularly in the formulation of products for oral administration, since the test procedure to be described involves oral application of the compound. A similar test may, of course, be devised for the purposes of measuring the relative activities of the compounds of another area of the body, for example, the face or forearm, and this will be a useful guide in the choice of compounds to be used in preparations for external topical usage. It will also be noted that the described test procedure is done on a statistical basis. This is necessary since sensitivity to these compounds will vary not only from compound to compound and from one part of the body to another, but also from one individual to another. Tests of this nature are commonly used in the testing of the organoleptic properties e.g. taste and smell of organic and inorganic compounds, see Kirk-Othmer: Encyclopedia of Chemical Technology, 2nd Ed. (1967) Vol. 14, pages 336-344.
The following test procedure is aimed at determining the minimum quantity of the test compound required to produce a noticeable cooling effect in a person of average sensitivity, this minimum quantity being termed the threshold for that particular compound. The tests are carried out on a selected panel of 6 people of median sensitivity to l-menthol.
To select a test panel of average sensitivity the following procedure is used. Known quantities of 1-menthol in solution in petroleum ether (bp. 40-60° C.) are placed on 5 mm squares of filter paper, whereafter the solvent is allowed to evaporate. A panel of observers is enrolled and asked to place one impregnated square at a time on the tongue and to report on the presence or absence of a cooling effect. The quantity of l-menthol on each impregnated square is gradually reduced from a value substantially above 0.25 &mgr;g. per square to substantially below 0.25 &mgr;g, the precise range being immaterial. Conveniently, one starts with squares containing 2.0 &mgr;g being half that of the preceding square, i.e. the second test square will contain 1.0 &mgr;g, the third 0.5 &mgr;g, and so on. Each quantity is tested on the tongue at least 10 times. In this way, the thresholds to cold receptor stimulus by l-menthol are determined for each individual of the panel, the threshold for each individua
Howell John M.
Page Thurman K.
The Procter & Gamble & Company
Tran S.
White Loy M.
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