Note: Descriptions are shown in the official language in which they were submitted.
TITLE: TASTE MASKED MEDICATED FLOSS
BACKGROUND OF THE INVENTI ON
This application is a continuation-in-part of
application Serial No. 07/325,643, filed March 20, 1989, which
is a continuation-in-part of application Serial No. 07/283,742,
filed December 13, 1988, in turn a continuation-in-part of
application Serial No. 07/169,838, filed March 18, 1988, which
is a continuation-in-part of application Serial ~o. 07/040,371,
filed April 20, 1987. Application Serial No. 07/325,643 is
also a continuation-in-part of said application Serial
No. 07/169,838 and of application Serial No. 07/169,914, filed
March 18, 1988, which is another continuation-in-part of
application Serial No. 07/040,371.
In the prior applications preceeding Serial
No. 07/283,742, various substances having pharmacological
properties~were combined with a sugar and spun into fibers to
produce a readily water-soluble product. The various examples
enumerated in tbose applications involved the use of water
soluble medicaments and were directed to enhancing the
solubility rate of the different substances. It was discovered
also that spinning a substance with a sugar can alter the
medium in which a particular substance can either dissolve or
become dispersed, the latter while forming a colloid or
colloidal-like dispersion. When the spun sugar products
described in the applications are added to water, the product
disperses autogenously throughout the water and remains
dispersed. In most instances one observes a general cloudiness
associated with a colloidal suspension. But this is not always
the case. Several other novel phenomena have been observed
also.
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The disclosure in application Serial No. 07/283,742
deals with oleaginous substances such as vegetable oil, baby
oil, olive oil, margarine, lanolin, cocoa butter and the like,
and how their lack of affinity for water is altered by mixing
the oleaginous substance with sugar and melt spinning the
mixture in a cotton candy spinning machine or the equivalent.
As so modified the products disperse autogenously in water
forming a colloidal or colloidal-like dispersion.
In application Serial No. 07/325,643 it is explained
that a spun product from a combination of a saccharide and a
hydrophobic ingredient is hydrophillic with low concentrations
of such ingredient but becomes increasingly hydrophobic as the
concentration of the hydrophobic ingredient is increased,
although the end product nevertheless acts hydrophilically when
the water temperature is elevated. Larger ratios of
hydrophobic substance-to-saccharide yields a spun fibrous
product that has increased stability. Similar stabilization
can be attained by adding either beeswax or a petrolatum to the
saccharide either in the presence of or absence of a separate
active ingredient. Control with beeswax can also provide a time
release tablet or the like when swallowed.
Examples set forth in said -643 application
demonstrate the ability of controlling the floss to mask the
taste of a distasteful or unpalatable medicament or the like.
Generally, as explained therein, the medicament or active
ingredient is not absorbed as rapidly in the mouth as the
saccharide. By adding a suitable quantity of beeswax, the
release and absorbtion of the saccharide can be slowed to match
that of the active ingredient whereby any objectionable taste
is successfully masked. Thus, in Example VIII beeswax granules
were mixed with sucrose in the ratio of 1:16, and in Example IX
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the ratio was increased to 1:12. In Example XV where "MA~LOX"
antacid suspension was the medicament, 1/4 tsp. ground beeswax
USP was blended with 1:6 parts "MAALOX" to sucrose. The
resulting floss when placed as a wad on the tongue, sat on the
tongue for about 2 seconds and then was ~one within an
additional 3 seconds. ~o aftertaste of the "MAALOX" antacid
could be detected.
~ ubsequent to filing the -643 application it was
determined that by increasing the ratio of beeswax to sucrose
over that employed in Example XV of that application, and
reducing the ratio of sucrose to MAALOX below that employed in
Example XIV of that application, it was still possible to mask
the taste of "MAALOX". However, with more distasteful
ingredients such as aspirin it has been found that satisfactory
taste masking can not be obtained by merely delaying the
dispersal of sucrose.
SUMMARY OF THE PRESENT lNv~NlION
It is, therefore, an object of the present invention
to provide a floss type oral dosage unit that includes a taste
masking substance other than the saccharide.
Another object of the invention is to provide a
dosage unit containing an effective amount of an ingredient
that functions to inhibit undesirable taste stimulation by an
unpalatable or distasteful medicament.
Other objects will occur to those skilled in the
subject art after reading the present disclosure.
In accordance with one aspect of the present
invention there is provided a pharmaceutic dosage unit
comprising compacted spun fibers of a spinnable, readily water-
soluble material, an effective amount of a medicament, and an
effective amount of an ingredient other than said medicament
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and said material which ingredient, when the dosage unit istaken orally, functions to inhibit undesirable taste
stim~lation by said medicament.
The invention will be better understood after reading
the following detailed description of the presently preferred
embodiments thereof.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
Co-pending application Serial No. 07/169,838
describes methods for combining a medicament with any one or
more of the water soluble melt spinnable sugars and spinning
the combination to produce a readily soluble floss form of the
medicament. The disclosure of such application is incorporated
herein by reference.
Co-pending application Serial No. 07/283,742
discloses that any oleaginous substance that can be mixed with
a melt-spinnable sugar, when spun in a cotton candy spinning
machine, produces a product which, when added to water or has
water added to it, forms, virtually autogenously, a uniform
dispersion having all the appearances of a colloidal
dispersion. The disclosure of such application is incorporated
herein by reference.
Co-pending application Serial No. 07/325,643
discloses that if the ratio of oleaginous material to sugar
(saccharide) exceeds a certain value, the precise crossover
point being a function of the particular oleaginous material
and sugar, the floss product will no longer disperse rapidly in
water at normal room temperature. However, rapid dispersal as
an apparent colloidal system does take place at elevated water
temperatures. Similar results can be obtained by admixing with
the sugar, with or without other ingredients, suitable
quantities of certain semi-solid substances that individually
are practically insoluble in water, such as beeswax or
petrolatum. In general, the fibrous products produced by the
examples set forth in that application give the appearance when
added to water at normal room temperature of being hydrophobic.
Compacted quantities of the fibrous product actually float on -~
the surface of the water. But as soon as the water temperature
is raised above some critical level for the particular fiber
product, the fibrous product disperses rapidly throughout the
body of water forming what appears to be a colloidal
dispersion. The present invention can best be described and
understood from a consideration of certain examples.
For the following examples the floss spinning machine
used was: Econo floss Model 3017 manufactured by Gold Medal
Products Co. of Cincinnati, Ohio. Unless otherwise stated,
reference to sucrose in the examples is to "Gold Medal n
flossugar, lime flavor. Unless otherwise indicated, the
temperature of the grid in the spinning machine was about
180~F. (82.2~C.) while the operating speed was about 3800
R.P.M.
EXAMPLE I
1/4 tsp. of white beeswax by Spectrum of Gardena,
California was placed in a "~raun" chopper having a metal bowl
and blades with clear acrylic top. To this was added 1
"Chlorseptic" lo~enge by Norwich Eaton Pharmaceuticals. Each
lozenge contains as the active ingredients 32.5 mg phenol and
sodium phenolate, with inactive ingredients comprising coloring
agent, corn syrup, flavor and sucrose. The chopper was
operated for about 1 minute until materials were blended into
fine powder. The powder was transferred to a mixing vessel to
which was added 3 tsp. aspirin USP from Valley Biomedical of
Winchester, Virginia, 1/5 tsp. "Crisco" vegetable oil for
~ 3~
binding, and 1/2 cup (24 tsps.) lime flosssugar. The
ingredients were mixed thoroughly with a spoon for about 4
minutes, and the resulting mixture spun using the floss
spinning machine. A nice floss resulted. When a sample of the
floss was added to water at room temperature, the floss was
observed to float. However, when addéd to water at 180~F. the
floss dispersed immediately while a quantity of telltale white
material appeared at the surface. It was concluded that the
white material was the aspirin content.
EXAMPLE II
The procedure set forth in Example I was repeated but
omitting the "chlorseptic" lozenge. A nice floss resulted.
Having produced the two quantities of floss, one with
a phenol content and one without, a quantity of the floss
produced in Example II, about the ~ize of a quarter dollar and
about 1/4" thick, was placed on the tongue of the experimenter.
It dispersed in about 4 to 5 seconds leaving a bitter
aftertaste characteristic of aspirin. About 1 hour later,
having cleared the palate, the experimenter repeated the test
this time using a wad, the same size, of the floss produced in
Example I. Again, it took about 4 to 5 seconds to disperse on
the tongue. But this time the phenol content apparently numbed
slightly the taste buds such that absolutely no aspirin taste
could be detected either during the dispersion or by way of
aftertaste.
The ratio of the "chlorseptic" lozenge to the aspirin
medicament in Example I is believed to be about 1:9. The
actual phenol content is less than that relative to the
medicament and has been estimated as in the ratio of about
1:40. Moreover, the t~st described in Example II revealed that
the beeswax plus sucrose content by itself was ineffective to
cause the sucrose content to mask the taste of the aspirin.
However, the small quantity of phenol in the ratio of 1 part
phenol to 40 parts aspirin to 320 parts sucrose was completely
effective.
Having described the present invention with reference
to the presently preferred embodiment, it should be apparent to
those skilled in the subject art that various changes in
materials and in the process steps can be adopted without
departing from the true spirit of the invention as defined in
the appended claims.
