Throat soothing compositions

Details Throat soothing compositions Throat soothing compositions

1999-10-20

2002-08-13

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

C424S439000, C424S441000, C424S464000, C426S003000, C426S321000, C426S660000

Reexamination Certificate

active

06432441

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to orally ingestible compositions, especially liquid centre-filled confectionery compositions, for soothing of sore or irritated throats and relief of congested nasal passages.
BACKGROUND OF THE INVENTION
Products in the form of 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 medicament can be administered 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, for example, 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.
One of the problems faced in delivering long-lasting relief from such a product is maintaining the active ingredient in the throat for a sufficiently long period of time. It has now been found, however, that encapsulating the active ingredient within vesicles can act significantly to prolong the throat relief delivered by the active.
Lecithins are well known as food emulsifiers and they have also been disclosed as e.g. humectants. U.S. Pat. No. 4,250,196, for example, discloses a liquid centre-filled chewing gum where lecithin is one of many optional humectants in the centre-fill portion. U.S. Pat. No. 4,466,983 discloses substantially non-aqueous semi-liquid centre-fill products in which one of the examples employs lecithin as an emulsifier. Lecithins have also been used to form vesicles for the delivery of drugs, as disclosed for example in EP-A-140,085. However, it is believed that it has not previously been recognised that vesicles, encapsulating a throat soothing active, can be incorporated into a medicated confectionery composition to deliver a prolonged soothing effect in the throat and nasal passages.
It is accordingly an object of this invention to provide medicated confectionery compositions, especially throat drops, delivering prolonged throat and nasal soothing.
SUMMARY OF THE INVENTION
The present invention relates to a throat drop comprising from 60 to 95%, preferably from 75 to 85%, of an edible shell and from 5 to 40%, preferably from 15 to 25%, of an aqueous filling, by weight of the drop, the filling comprising from 8 to 95% water and from 0.001 to 10% of a vesicle-forming agent which encapsulates the throat relief agent within vesicles which are dispersed within the filling.
All levels and ratios are by weight, unless otherwise indicated. Percentages are by weight of the filling unless otherwise specified.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a throat drop comprising a throat relief agent encapsulated within vesicles. Without wishing to be bound by theory, it is believed that the vesicles acts as a bioadhesive and are able to sustain the throat relief agent within the throat, giving a prolonged throat soothing effect. The vesicles are suspended within an aqueous filling encased in an edible shell. By ‘throat drop’ is meant a medicated confection which is suitable for sucking or chewing within the mouth, thereby releasing the throat relief agent.
The aqueous filling comprises water, generally at a level of from about 8 to about 95%, but preferably from about 8 to about 20%, more preferably from about 10 to about 15% by weight of the filling. Levels of water higher than about 20% are unsuitable for the production of centre-filled hard candies. The filling can be a liquid, gel or paste.
An essential component of the throat drops of the present invention is a throat relief agent. By “throat relief agent” herein is meant any organic compound or mixture of compounds capable of providing relief to a person with a sore or irritated throat or nasal passage. Classes of throat relief agents include, but are not limited to analgesics, antitussives, expectorants, physiological cooling agents, physiological warming agents and mixture thereof. Preferably the throat relief agent is selected from physiological cooling agents, physiological warming agents and mixtures thereof. Suitable levels of the throat relief 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 aqueous composition.
Suitable physiological cooling agents are described in W097/06695, incorporated by reference herein. Preferred for use herein are physiological cooling agents selected from the group consisting of menthol, peppermint oil, N-substituted-p-menthane-3- carboxamides, acyclic tertiary and secondary carboxamides, 3-1-menthoxy propan-1,2-diol and mixtures thereof. Particularly preferred for use herein are menthol and menthol containing oils such as peppermint oil.
The carboxamides found most useful are those described in U.S. Pat. No. 4,136,163, Jan. 23, 1979 to Watson et al., and U.S. Pat. No. 4,230, 688, Oct. 28, 1980 to Rowsell et al. The carboxamides in U.S. Pat. No. 4,136,163 are N-substituted-p-menthane-3-carboxamides. N-ethyl-p-menthane-3-carboxamide, commercially available as WS-3 from Wilkinson Sword, is preferred herein. The carboxamides of U.S. Pat. No. 4,230,688 are certain acyclic tertiary and secondary carboxamides, of which trimethyl isopropyl butanamide, commercially available as WS-23 from Wilkinson Sword is preferred for use herein.
Preferred physiological warming agents are those selected from the group consisting of vanillyl alcohol n-butyl ether, vanillyl alcohol n-propyl ether, vanillyl alcohol isopropyl ether, vanillyl alcohol isobutyl ether, vanillyl alcohol n-amino ether, vanillyl alcohol isoamyl ether, vanillyl alcohol n-hexyl ether, vanillyl alcohol methyl ether, vanillyl alcohol ethyl ether, gingerol, shogaol, paradol, zingerone, capsaicin, dihydrocapsaicin, nordihydrocapsaicin, homocapsaicin, homodihydrocapsaicin, ethanol, iso-propyl alcohol, iso-amylalcohol, benzyl alcohol, chloroform, eugenol, cinnamon oil, cinnanic aldehyde, and phosphate derivatives thereof. The phosphate derivatives are those described in WO 97/02273, incorporated by reference herein.
The throat drops of the present invention also comprise from 0.001 to 10% by weight of the filling of a vesicle-forming agent which acts to form vesicles which are dispersed within the filling and encapsulate the throat relief agent. By ‘vesicle’ is meant an essentially spherical structure comrprising a lipid bilayer encapsulating a central core. The vesicles herein can be uni- or multi-lamellar and have a number average particle size of from about 1 to about 100 &mgr;m, more preferably from about 5 to about 50 &mgr;m. The particle size can be measured using an optical microscope, such as a Nikon Optiphoto 2, linked to an electronic image analysis system such as the Linkam MS100. Measurement can also be made using a graduated graticule in the field of view. EP-A-534,823, which describes anhydrous make-up compositions which can form vesicles on exposure to water gives a comprehensive list of amphiphilic liquids which can be used to form vesicles. For the throat drops herein it is of course preferable that food-grade materials are used and the preferred vesicle forming agents are natural phospholipids such as egg or soy lecithin. The preferred phospholipids of the present invention are plant-derived lecithins and, especially, soybean lecithin. Soybean lecithin can act to form vesicles at very low levels. Preferably the vesicle forming agent is present at a level of from about 0.001 to about 1%, more preferably from about 0.005 to about 0.1% and especially from about 0.01 to about 0.05% by weight of the filli

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