U.S. patent number 3,902,493 [Application Number 05/469,494] was granted by the patent office on 1975-09-02 for medicated catamenial tampon.
This patent grant is currently assigned to The Procter & Gamble Company. Invention is credited to Kathleen Grieshop Baier, Paul Dennis Trokhan.
United States Patent |
3,902,493 |
Baier , et al. |
September 2, 1975 |
Medicated catamenial tampon
Abstract
A medicated catamenial tampon, comprising a resilient foam
corpus and a medicament-bearing hydrophobic non-woven overwrap
which is permeable to catamenial fluids, adapted for non-menstrual
as well as menstrual delivery of medicant to control and treat
vaginal area disorders.
Inventors: |
Baier; Kathleen Grieshop
(Cincinnati, OH), Trokhan; Paul Dennis (Hamilton, OH) |
Assignee: |
The Procter & Gamble
Company (Cincinnati, OH)
|
Family
ID: |
23864007 |
Appl.
No.: |
05/469,494 |
Filed: |
May 13, 1974 |
Current U.S.
Class: |
604/286 |
Current CPC
Class: |
A61K
9/0036 (20130101); A61F 13/2037 (20130101) |
Current International
Class: |
A61F
13/20 (20060101); A61F 13/24 (20060101); A61K
9/00 (20060101); A61F 013/20 () |
Field of
Search: |
;128/270,285 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Schaeffer; Jack D. Witte; Richard
C. O'Flaherty; Thomas H.
Claims
What is claimed is:
1. A medicated catamenial tampon, comprising: a resilient
mensesphilic polyurethane foam corpus having a dry modulus of
compressibility of from about 0.2 lbs. per. sq. in. to about 0.6
lbs. per sq. in., a wet modulus of compressibility of from 0.1 psi
to about 0.3 psi, a shape modulus of compression of from about 0.05
lbs. to about 1.0 lbs., and a critical surface tension of at least
60 dynes per centimeter; and a medicamentbearing hydrophobic
non-woven overwrap which is permeable to vaginal fluids, wherein
said medicament comprises a safe and effective amount of a
therapeutically active agent for control of vaginal disorders and a
vaginal fluid-soluble binding lubricant having a melting point
within the range of from 42.degree. to about 45.degree.C.
2. A medicated tampon according to claim 1 wherein said overwrap
comprises a hydrophobic non-woven tissue having a wet tensile
strength in the machine direction of at least 250 grams per
inch.
3. A medicated tampon according to claim 1 wherein said
therapeutically active agent is nystatin.
4. A medicated tampon according to claim 1 wherein said binding
lubricant is selected from the group consisting of polyethylene
glycol having an average molecular weight of 1,540, polyethylene
glycol having an average molecular weight of 4,000, polyethylene
glycol having an average molecular weight of 6,000,
polyethylene-4-sorbitan monostearate, polyoxyl 40 stearate,
mixtures thereof, and mixtures thereof with polyethylene glycol
having an average molecular weight of 1,000.
5. A medicated tampon according to claim 4 wherein said binding
lubricant is polyethylene glycol having an average molecular weight
of 1,540.
Description
BACKGROUND OF THE INVENTION
The present invention relates to an improved medicated catamenial
tampon, characterized by enhanced delivery and vaginal retention of
medicament, which may be comfortably inserted and withdrawn for
treatment during both menstrual and non-menstrual periods.
The normal healthy state of the lower female genital organs is
maintained by a delicate balance of hormonal, cytologic and
bacterial factors which develop at puberty. This balance is easily
disrupted, making the vagina and related organs unusually
susceptible to infectious disease. Such infection is generically
known as vaginitis. Although the conditions conducive to vaginitis
are not fully understood, it is believed that the danger of
infection increases during menstruation. At this time during the
female cycle a slightly alkaline pH is frequently established with
attendant sloughing of epithelial tissue. Such conditions favor the
overgrowth of putrefactive microorganisms, introduced, for example,
through careless handling of catamenials, resulting in severe
inflammation.
One of the primary obstacles to effective control and treatment of
vaginitis is the difficulty of delivering adequate dosages of
medicament to the afflicted areas during the non-menstrual period.
Since, as previously discussed, the likelihood of vaginitis
increases during menstruation, the usual approach to treatment
concentrates on controlling the infection at that time. However,
even when controlled during menstruation, potentially infectious
microorganisms continue to survive into the non-menstrual cycle.
These "residual" microorganisms, unless controlled, are free to
cause continuing inflammation or reoccurrence of infection during
subsequent menstrual and non-menstrual periods. The folded
convoluted structure of the vagina makes delivery of medication
difficult and painful, particularly during non-menstrual periods
when the naturally lubricating and spreading catamenial fluids
present during menstruation are nearly absent.
Heretofore, vaginitis has been treated by a variety of medicant
delivery techniques. For example, medicaments in the form of ovules
have been introduced by hand; medicaments in the form of foams or
ointments have been introduced by syringe; and medicaments have
been introduced by impregnation on catamenial devices. Since
vaginitis tends to flare up most noticeably during menstruation,
the use of medicated tampons has received particular attention as a
convenient form of treatment.
The prior art has suggested a variety of medicated, wrapped and
unwrapped, catamenial tampons. The predominant approach has been to
impregnate the tampon corpus with medicament. A less common
approach has been to overwrap the tampon corpus with a
medicament-impregnated covering. U.S. Pat. No. 3,091,241 to W. R.
Kellett exemplifies this latter approach. In any event, previously
known medicated tampons suffer several shortcomings. In particular,
such medicated tampons are fabricated from compressed absorptive
fibers. Accordingly, such tampons are essentially rigid cylindrical
tubes designed to reform in the vaginal cavity when wetted by
absorbed catamenial fluid. Their rigid structure, however, makes
non-menstrual use both painful and ineffective.
Accordingly, it is the primary object of the instant invention to
provide a compliant comfortable medicated tampon, having enhanced
medicament delivery and retention, which can be worn during both
menstrual and non-menstrual periods of the female cycle.
It is a further object of the instant invention to provide a
medicated tampon which can be easily and painlessly inserted, worn,
and withdrawn.
These and other objects are achieved by the instant invention as
will become readily apparent from the following disclosure.
SUMMARY OF THE INVENTION
Objects of the present invention are achieved by providing a
medicament-bearing catamenial tampon, comprising: a resilient foam
corpus having a modulus of compression which allows it to be
reformed following insertion to conform to the irregularities of
the vaginal wall; and a medicament-bearing hydrophobic non-woven
overwrap which is permeable to vaginal fluids, wherein said
medicament comprises a safe and effective amount of a
therapeutically active agent for control of vaginal disorders and a
vaginal fluid-soluble binding lubricant having a melting point of
from about 38.degree. to 50.degree.C.
BRIEF DESCRIPTION OF THE DRAWINGS
The several features of the present invention will become more
readily apparent from the following detailed description taken in
conjunction with the accompanying drawings in which:
FIG. 1 represents a cross sectional view of a preferred medicated
tampon, as described herein, housed in a tubular inserter; and
FIG. 2 represents a cut-away perspective view of a preferred
medicated tampon, as described herein.
DETAILED DESCRIPTION OF THE INVENTION
The instant invention, broadly speaking, is based upon the
unexpected discovery that an improved medicated catamenial tampon
can be prepared by providing a medicament bearing catamenial
tampon, comprising: a resilient foam corpus having a modulus of
compression which allows it to be reformed following insertion to
conform to the irregularities of the vaginal wall; and a medicant
bearing hydrophobic non-woven overwrap which is permeable to
vaginal fluids, wherein said medicament comprises a safe and
effective amount of a therapeutically active agent for control of
vaginal disorders and a vaginal fluid-soluble binding lubricant
having a melting point of from about 38.degree. to about
50.degree.C.
A medicated tampon to be fully satisfactory for present purposes
must be acceptable to the user, and effective in treating vaginal
disorders. To be acceptable to the user, it must be, among other
things, aesthetically pleasing, easily and unobtrusively carried,
comfortably inserted and removed, and absorptive. To be effective
in treating vaginal disorders, the tampon must be able to deliver
medication directly to the afflicted areas during both menstrual
and non-menstrual periods and must promote vaginal retention of the
medication. Since the superlatives of some of these aspects tend to
be mutually exclusive, a consumer acceptable and effective
medicated tampon must be a balance of all of these traits.
To achieve an optimum balance of desirable properties, the
medicated tampon of the present invention comprises two critical
structural components. Referring to FIGS. 1 and 2, the medicated
tampon 15 of the present invention comprises a reslient foam corpus
10 and a medicament-bearing hydrophobic non-woven overwrap 11.
The Foam Corpus
The resilient foam corpus 10 can be prepared from a variety of
materials in a variety of shapes. However, in order to insure
delivery of medication to the afflicted area of the vagina and in
order to conform to the surface of the vagina when worn either
menstrually or non-menstrually, the foams suitable for use herein
should have a modulus of compression which allows the tampon to be
reformed following insertion to conform to the irregularities of
the vaginal wall. In other words, suitable foams will expand, when
dry, to substantially fill the vaginal cross-section. The term
"dry-expansion" as used herein is intended to describe that
property of suitable foams which allows the tampon corpus to
conform to the vagina without relying on the actions of fluids to
release compression set which may have taken place within the
tampon prior to insertion. Dry-expanding foams allow the medicated
tampon to be worn non-menstrually yet achieve adequate vaginal
contact so as to insure delivery of medication to afflicted
areas.
Suitable preferred dry-expanding foams used as tampon corpus 10
should have a dry modulus of compressibility as defined in ASTM
Test D1564, Compression Load Deflection Test (Suffix D), of from
abut 0.2 pounds per square inch to about 0.6 pounds per square
inch, preferably about 0.4 pounds per square inch, and a wet
modulus of compressibility to attain 75 percent of the original dry
thickness ranging from about 0.1 to 0.3 psi, preferably about 0.2
psi. The ASTM Compression Load deflection Test consists of
measuring the load necessary to produce a 25 percent compression
over the entire top area of the foam specimen. In addition,
suitable preferred foams should have a shape modulus of
compression, i.e., the unidirectional pounds force required to
deform the tampon to its collapsed state, such that the tampon will
assume its collapsed state under the forces exerted within the
vagina. The shape modulus should be greater than about 0.05 pounds
so the tampon has some tendency to maintain its shape when
compressed. The shape modulus should not be greater than about 1.0
pound because then the tampon becomes too difficult to deform and
retains its round cross section which is not as good for tampon
performance because the vaginal walls do have some beam strength
and do not drape perfectly; therefore, if the vagina is not fully
distended by a tampon, a greater percentage of the vaginal wall is
in contact with a collapsed, i.e., flattened, tampon than is in
contact with an uncollapsed, i.e., round, tampon, due to the
vaginal wall contilevering beyond the lateral edges of the tampon.
The shape modulus is dependent upon the density and elasticity of
the material and the shape of the tampon.
In addition to the above-described dry-expansion properties,
suitable foams for use herein are preferably mensesphilic, i.e.,
have surface characteristics such that vaginal fluids tend to
spread readily or spontaneously on the surface and in the
capillaries of the foam. As previously discussed, the vagina is
most susceptible to infection during menstruation. Thus, it is
desirable to utilize a vaginal fluid-absorbent tampon corpus as a
convenient vehicle for the medicament-bearing overwrap. Since
vaginal fluids are primarily aqueous solutions, materials onto and
into which it spreads readily could be loosely described as
hydrophilic. Hydrophilicity, and thus mensesphilicity, is fully
detailed in the American Chemical Society publication entitled
Contact Angle, Wettability and Adhesion, edited by Robert F. Gould
(1964), incorporated herein by reference. In general,
hydrophilicity is defined by contact angles, and surface tensions
of the fluids and solids involved.
The contact angle is defined as the angle formed between two planes
as measured in the liquid, i.e., the plane tangent to the liquid
air interface at the point of liquid-air-solid mutual contact and
the plane of liquid-solid contact at the liquid-air-solid mutual
contact. The smaller this angle is, the less is the force required
to spread the liquid and at a contact angle of zero, the fluid
tends to spread spontaneously and without limit on the surface of
the solid. In general, materials having a contact angle between
them of less than 90.degree. can be described as -philic
(attractice toward each other) and those having angles greater than
90.degree. between them as -phobic (repellent toward each other).
Therefore, a mensesphilic material can be definitely but broadly
defined as one with which menstrual fluid makes a contact angle of
less than 90.degree..
The contact angle between a fluid and a solid, and consequently the
philicity or phobicity of the solid for the liquid, is related to
the ratio between the surface tension of the fluid and the solid.
In practice, the method for determining surface tension of the
solid is to compare contact characteristics of the solid against
various liquids. This method is more completely described on p. 12,
et seq., of the above mentioned publication. The value derived from
this method is usually called the critical surface tension of the
solid. If the ratio is greater than 1:1, i.e., the surface tension
of the fluid is greater, the solid is -phobic. If the ratio is less
than 1:1, i.e., the surface tension of the solid is greater, the
solid is -philic. As the ratio becomes smaller, the solid is more
and more -philic.
Menstrual fluid has a surface tension range of about 35 to 60 dynes
per centimeter. It will have a contact angle of less than
90.degree. and will tend to spread spontaneously on a solid which
has a critical surface tension value greater than its surface
tension.
Water has a high surface tension which is about 72 dynes per
centimeter and would be apt to spread spontaneously only on solids
with critical surface tensions higher than 72 dynes per centimeter
unless the solid's surface had changed through an interaction with
the water. Therefore, hydrophilicity is not a precise definition
with respect to the affinity of a solid for menstrual fluid. The
contact angle between menstrual fluid and a solid or the ratio
between the surface tension of the menstrual fluid and the critical
surface tension of the solid is definitive of their mutual affinity
and tendency toward spontaneous wetting. Since the surface tension
of water is higher than that of menstrual fluid, any solid which is
hydrophilic is also usually mensesphilic.
Although flexible polyurethane foams in general can be used herein
to form the tampon corpus 10, there are drastic differences in
performance between tampons having the tampon corpus prepared from
conventional mensesphobic flexible polyurethane foams and
mensesphilic flexible polyurethane foams. The differences are
sufficiently great that mensesphilic polyurethane foams are highly
preferred. Even within mensesphilic polyurethane foams there is a
wide variation in performance; and it is most preferred to use
mensesphilic polyurethane foams having good wet swell properties
since the total volume of vaginal fluids which can be contained by
a tampon corpus is related to its eventual size and yet one prefers
to have a tampon of minimal size for ease of insertion. Minimal
size is especially important where one uses an inserter of the type
that requires the tampon to be pushed out through a cylindrical
portion of the inserter (see FIG. 1). Another desirable quality is
low compression set when radially compressed within an inserter
since dry expansion after insertion provides better bypass control
as well as medicant delivery. It is, of course, desirable to use
foams having a minimum content of extraneous soluble materials
since the product may be retained in the body for a considerable
period of time and retained soluble extraneous materials could
interfere with the desired therapeutic value of the medicated
tampon.
In general, the flexible polyurethane foams used in the preferred
embodiment of this invention will be prepared from a reaction mix
comprising a polyhydroxy compound which will be, at least in part,
a polyether but which may be also, in part, a polyester, and
mixtures of polyester and polyether compounds. The following
patents, all of which are incorporated herein by reference,
disclose mensesphilic polyurethane foams which are especially
desirable. Joerg Smabeth, et al., U.S. Pat. No. 3,586,648, patented
June 22, 1971; Alexis Archipoff, et al., U.S. Pat. No. 3,573,234,
patented Mar. 30, 1971; Joerg Sambeth, et al., U.S. Pat. No.
3,560,416, patented Feb. 2, 1971; Charles H. Hofrichter, et al.,
U.S. Pat. No. 3,463,745, patented Aug. 26, 1969; Stanley I. Cohen,
et al., U.S. Pat. No. 3,457,203, patented July 22, 1969; Joerg
Sambeth, et al., U.S. Pat. No. 3,451,954, patented July 22, 1969;
Joerg Sambeth, et al., U.S. Pat. No. 3,451,953, patented June 24,
1969; Joerg Sambeth, et al., U.S. Pat. No. 3,432,448, patented Mar.
11, 1969; Rudolf Merten, et al., U.S. Pat. No. 3,388,081, patented
June 11, 1968; Bernard Rabussier, U.S. Pat. No. 3,385,803, patented
May 28, 1968; James A. Calamari, U.S. Pat. No. 3,164,565, patented
Jan. 5, 1965; Morris V. Shelanski, et al., U.S. Pat. No. 3,098,048,
patented July 16, 1963; Carl V. Strandskov, U.S. Pat. No.
3,042,631, patented July 3, 1962; Fritz Schmidt, et al., U.S. Pat.
No. 3,007,883, patented Nov. 7, 1961; Harold L. Elkin, U.S. Pat.
No. 2,965,584, patented Dec. 20, 1960; Erwin Windemuth, et al.,
U.S. Pat. No. 2,948,691, patented Aug. 9, 1960; Elekal, British
Pat. No. 1,180,316, patented Feb. 4, 1970, Vereinigt Papierwerke
Schickedanz & Co., French Pat. No. 1,350,709, patented Dec. 23,
1963.
Other mensesphilic polyurethane foams can also be used, including
the foams disclosed in the following patents which are also
incorporated herein by reference. George Shkapenko, et al., U.S.
Pat. No. 3,535,143, patented Oct. 20, 1970; John G. Simon, et al.,
U.S. Pat. No. 3,508,953, patented Apr. 28, 1970; Whitney R. Adams,
et al., U.S. Pat. No. 3,458,338, patented July 29, 1969; John R.
Caldwell, et al., U.S. Pat. No. 3,418,066, patented Dec. 24, 1968;
Joerg Sambeth, et al., U.S. Pat. No. 3,413,245, patented Nov. 26,
1968; Lyle W. Colburn, U.S. Pat. No. 3,404,095, patented Oct. 1,
1968; Fred W. Meisel, et al., U.S. Pat. No. 3,382,090, patented May
7, 1968; Yvan Landler, et al., U.S. Pat. No. 3,326,823, patented
June 20, 1967; Ming Chih Chen, U.S. Pat. No. 3,249,465, patented
May 3, 1966; Sotirios S. Beicos, U.S. Pat. No. 3,149,000, patented
Sept. 15, 1964; John Bugosh, et al., U.S. Pat. No. 3,094,433,
patented June 18, 1963; Karl Goldann, U.S. Pat. No. 2,998,295,
patented Aug. 29, 1961; Marvin J. Hurwitz, et al., U.S. Pat. No.
2,990,378, patented June 27, 1961; John Bugosh, U.S. Pat. No.
2,920,983, patented Jan. 12, 1960; and William R. Powers, et al.,
U.S. Pat. No. 2,900,278, patented Aug. 18, 1959.
In general, it is preferred to prepare the tampon corpus 10 from a
mensesphilic foam which is at least partially mensesphilic by
virtue of the reactants; but it is also desirable in many instances
to add additional mensesphilic materials to the foam to increase
either the mensesphilicity of the foam or the ability of the foam
to hold liquid and resist compressive failure, i.e., squeeze out. A
mensesphilic, polyurethane foam used should have a critical tension
of at least about 60 dynes per centimeter and preferably greater
than about 72 dynes per centimeter.
As stated before, it is especially desirable for the foam to have
good wet swell properties, i.e., undergo wet swell at one
atmosphere of pressure, being at least about 25 percent and
preferably about 100 percent. A minimum wet swell of about 25
percent is necessary to appreciate advantages of wet swell.
Examples of polyurethane foams which have good wet swell properties
include those disclosed in U.S. Pat. No. 3,164,565, referred to
hereinbefore and Morris V. Shelanski, et al., U.S. Pat. No.
3,098,048, patented July 16, 1963; those disclosed hereinafter in
FOAMS I, II, and III; and the product sold commercially as Scott
Hydro-Foam.sup.TM by Scott Paper Company Foam Division, Eddystone,
Pa. As discussed hereinbefore, it is desirable to remove extraneous
materials from these foams, for example, by washing them with
water, to avoid any irritant or toxicity problems that these
extraneous materials may cause.
The following FOAMS I, II, and III are mensesphilic foams which are
preferred for use as the tampon corpus 10 of the medicated tampons
of this invention. They were made from a polyether polyol having an
appreciable level of polyethylene oxide built into the molecule.
For this purpose, a polyether incorporating 40-60 wt. percent
polyethylene oxide and 60-40 percent polypropylene oxide seems to
be about optimum.
FOAM I
An intimate mixture of
INGREDIENT PARTS BY WEIGHT COMMENT
__________________________________________________________________________
Polyether Polyol.sup.1 100.00 Non-ionic Surfactant.sup.2 15.00
Wetting agent n-Ethyl Morpholine 0.10 Foaming catalyst Stannous
Octoate (T-9) 0.40 Polymerization catalyst Silicone
Surfactant.sup.3 4.00 Foam stabilizer Water 4.50 Blowing agent
__________________________________________________________________________
.sup.1 Dow SA-1421 available from Dow Chemical Company, Midland,
Michigan .sup.2 Polyethylene glycol .sup.3 Silicone L-532 available
from Union Carbide, Charleston, West Virginia
was prepared at room temperature. These ingredients were mixed in a
food type blender at high speed for about 1 minute. Then 48.3 parts
by weight of toluene di-isocyanate (TDI), comprising 80 percent 2,4
and 20 percent 2,6 isomers, were quickly added and mixed at high
speed in the blender for 2 to 5 seconds. The entire mixture was
then poured quickly into a form wherein the foaming proceeded. Upon
completion of the foaming, within 90 seconds, the gelled foam was
further cured in an oven at 250.degree.F. for 2 hours. This post
cure is necessary for small batches but not for large batches. The
foam thus formed was flexible, resilient, and mensesphilic.
FOAM II
A polyurethane foam was prepared using the procedure of FOAM I, but
instead of 48.3 parts by weight of TDI, 38 parts by weight were
used. The procedure used for pouring, foaming, and post-foaming
cure was the same as in FOAM I.
The foam thus formed was flexible, resilient, mensesphilic, and wet
swelling.
FOAM III
A polyurethane foam was prepared using the procedure of FOAM I, but
instead of 48.3 parts by weight of TDI, 52 parts by weight were
used. The procedure used for pouring, foaming, and post-foaming
cure was the same as in FOAM I.
The foam thus formed was flexible, resilient mensesphilic, and wet
swelling.
In addition to the above formulations, acceptable foams for use as
tampon corpus 10 can be made in the complete absence of the
non-ionic surfactant, n-ethyl morpholine, and silicone surfactant.
By the same token, the levels of foaming catalyst, polymerization
catalyst, and foam stabilizer may be increased to several times the
values stated while still producing a wet swellable mensesphilic
foam. The amount of water may be varied from 0 to 9 parts per
hundred as a method of varying the density of the foam. Similarly,
an organic blowing agent such as Freon-11 may be used instead of
water/TDI yielding CO.sub.2 as the blowing agent.
Having thus described the principal characteristics of suitable
foams for use as the tampon corpus 10, it is clear that a variety
of tampon corpus configurations may be readily adapted for use
herein. For example, the commonly assigned U.S. Pat. No. 3,815,601
granted June 11, 1974, entitled "Catamenial Aggregate Absorbent
Body", and U.S. Pat. No. 3,794,029, granted 2/26/74 to B. A. Dulle
(incorporated herein by reference) disclose resilient foam tampons
which are suitable for use herein as tampon corpus 10. The
above-mentioned U.S. Pat. No. 3,815,601 dicloses a particularly
preferred tampon corpus configuration, wherein the corpus comprises
a plurality of discrete foam pieces rather than a unitary body.
Various other suitable configurations will be readily apparent to
those skilled in the art.
The Medicament-Bearing Overwrap
The second critical component of the present invention is a
medicament-bearing hydrophobic non-woven overwrap which is
permeable to vaginal fluids. Referring again to FIGS. 1 and 2, the
resilient foam corpus 10 of tampon 15 is wholly encased within the
overwrap 11 which has applied to its surfaces a medicament 12. The
overwrap can be formed from an essentially rectangular piece of
material by bringing two opposite edges of the rectangular piece
together to form a tube having a longitudinal seam which is secured
by any of numerous well-known methods, such as sewing or glueing.
One end of the tube can then be gathered radially inwardly and
fastened to form a closure, such as distal end 13. This closure can
be held by any of many various well-known means such as glueing,
sewing, or tying with a string. At this stage the overwrap is
tubular with distal end 13 closed and proximal end 16 open. The
foam corpus is then placed within the overwrap and the proximal end
16 is gathered radially inwardly and fastened to form a closure.
Thus, the overwrap 11 wholly encases the foam corpus 10.
A withdrawal string 14 is attached to the overwrap of the assembled
tampon. The withdrawal string 14, of course, provides a means of
withdrawing the tampon from the vagina following delivery of the
medicant or when soiled, whichever occurs first.
The fit of overwrap 11 about the tampon corpus 10 is preferably
loose to a degree rather than tight and can be described by a
packing factor or a volume-length factor in conjunction with an
overwrap cross-sectional area. It is advantageous to make the
overwrap 11 somewhat loose about the tampon corpus 10 so that the
overwrap is essentially unstressed. A loose overwrap makes the
tampon look and feel fluffy and soft, i.e., aesthetically pleasing.
A loose overwrap also promotes absorption characteristics and
insertion, wearing, and removal comfort.
The fit of the overwrap 11 about the corpus 10 also affects
ejection force such that, with equal amounts of absorbent material,
the ejection force is generally lower if the packing factor is
higher, i.e., if the overwrap fit is tighter. For this reason and
others explained hereinafter, the looseness of overwrap 11 about
corpus 10, i.e., packing factor, is critical to achieve an optimum
balance of certain desirable tampon characteristics. A loose
overwrap about a tampon corpus of low modulus of compression to
give a packing factor within a range defined infra will promote
removal comfort, i.e., lack of discomfort when the tampon is
removed from a vagina. Removal comfort is enhanced because the
corpus will compress to conform to the introital orifice; thus
dilation of the introitus during removal is gradual and easier due
to the low modulus of the tampon corpus. Thus, since the introitus
is a constricting band of muscles which can be dilated, a soft,
comfortable tampon will take on a wedge shape having a gradually
increasing diameter to gradually dilate the introitus, rather than
sharply dilating the introitus, to enhance the removal comfort of
the tampon. Removal comfort is particularly desirable inasmuch as
the medicated tampons herein are intended for use during
non-menstrual periods.
The looseness of the overwrap can be more precisely defined in
terms of a volume packing factor. The volume packing factor is the
volume of the corpus divided by the maximum volume enclosable by
the overwrap, i.e., cubic inches of foam corpus per cubic inches
within the overwrap. The volume of absorbent material as used in
the packing factor can be calculated for any specific tampon by
dividing the weight of the corpus by the density. A weight packing
factor can also be determined for tampons of this invention by
dividing the weight of the corpus 10 by the maximum volume
enclosable by the overwrap 11.
A tampon which will conform and gradually ease the introitus open
to promote removal comfort should have a packing factor which will
allow some conformation by the corpus to the introital opening, but
not be loose enough to permit the corpus to shift to the rearmost
portion of the overwrap as the tampon is withdrawn. A shift to the
rearmost portion of the overwrap of too much of the corpus 10 could
allow an accumulation at the rear of the tampon which would require
an abrupt dilation of the introitus and increased removal
discomfort.
The material used as the overwrap in this invention preferably is a
soft, flexible, vaginal fluid permeable non-woven material having
small apertures therethrough and a wet tensile strength in the
machine direction of at least 250 grams per inch. A biodegradable
material is desirable for the overwrap because it will enhance the
destructability of disposed tampons. Two nonwoven fabrics which
have functioned well as the overwrap and are believed to be
biodegradable are: Dexter X-2172, a nonwoven fabric consisting of
approximately a 60:40 cotton:rayon blend, saturation bonded with a
mixture of HA8 and HA 24, Rohm & Haas acrylic binders, said
fabric having a measured weight of about 0.6 to 0.7 ounce per
square yard and being hydrophobic and available from C. H. Dexter
& Sons Co., Windsor Locks, Conn., and Viskon, a 100% rayon,
nonwoven, line-bonded material, which is hydrophilic, has a
measured weight of about 0.47 ounce per square yard, and is
available from Chicopee Mills, 1450 Broadway, New York, N.Y.
Reemay, a hydrophobic, spunbonded, low basis weight, polyester
nonwoven fabric having a measured weight of about 0.4 ounce per
square yard and available from E. I. DuPont de Nemours, Wilmington,
Del., is another nonwoven which has performed satisfactorily as an
overwrap for tampons of this invention. Use of a highly hydrophobic
material as the overwrap with a highly absorptive absorbent body
can be advantageous in that it insulates the vaginal wall from
collected menses and thus maintains, during menstruation, the
slightly acidic condition of the vagina which exists during
non-menstrual times.
The above nonwoven fabrics have no noticeable apertures therein,
but some materials having noticeable apertures have been used
satisfactorily. The purpose of keeping the apertures small is to
prevent small pieces of corpus 10 from escaping through the
overwrap 11, and to prevent edges or corners of larger pieces from
projecting through the overwrap. The nominal and potential
apertures, i.e., opened areas or areas encompassed by adjacent
fibers in the overwrap should not exceed a size which will prevent
corpus 10 from escaping from the overwrap or from protruding
therethrough such as to interfere with the ejection force of the
tampon from a tubular inserter. some foam-like materials, e.g.,
polyurethane, have a high coefficient of friction with inserter
materials like polyethylene or paperboard. The static coefficient
of friction of polyurethane with polyethylene is about 1.05.
Therefore, the nominal and potential apertures within the overwrap
should be no greater than the smallest pieces of corpus 10. The
potential apertures can be much larger than the nominal apertures
when the crossover points within the overwrap are not bonded. It
has been found that a woven overwrap having an interfiber distance
of about one-eighth inch in both directions and having no
attachment at the crossover points is not acceptable in that the
ejection force from a telescoping tubular inserter for that tampon
is increased. It has been found that overwraps having apertures
with diameters as large as one-sixteenth inch, when the tampon
corpus 10 is an aggregate of foam pieces of sizes from about
one-sixteenth to about three-eighths inch, do not prove detrimental
to the functioning of the tampon.
It is believed desirable to maintain the exterior surface of the
tampon 15 as smooth and having as low a coefficient of friction as
possible for at least two reasons: to achieve a low ejection force,
i.e., the force required to eject the tampon from a tubular
inserter, and to prevent scraping of the soft, tender tissue within
the vagina during insertion, wearing, and removal. In general, the
resilient foam corpus has a higher coefficient of friction than the
overwrap material and, therefore, any protrusion through the
overwrap would result in an increase in the ejection force and the
scraping of the tissue within the vagina.
The overwrap should have a static coefficient of friction with the
interior of the inserter of less than about 0.40, and preferably
less than about 0.37, to provide acceptable ejection forces with
larger tampons of this invention. Overwraps having a coefficient
substantially higher than 0.40 result in ejection forces which are
substantially higher and prove to be objectionable by users.
The overwrap 11 should have strength characteristics so as to
prevent the nonwoven material from rupturing during removal or from
vaginal pressures while in vivo. The overwrap should have a wet
tensile strength in the machine direction of at least about 250
grams per inch. The minimum wet internal tearing resistance as
measured by TAPPI Standart T 414 ts-65 in the machine direction for
the overwrap should be about 100 grams to tear 16 plies 2 inches to
prevent the overwrap from tearing during removal of the tampon from
the vagina.
A material which has worked well as a withdrawal string 14 is a
waterproofed cotton string having a 5/3 ply and a 9 pound tensile
strength. Such a string is available from Bibb Manufacturing
Company, Macon, Ga., under the name of 5/3 ply Sno-Spun bleach 108
cotton.
Any string sufficiently strong to withstand removal forces can be
used as the withdrawal string 14. The polyester strings generally
have a higher tensile strength and can be used if a stronger string
is desired. Polyester strings are available from UniRoyal Fiber
& Textile, Division UniRoyal, Incorporated, 350 Columbia Road,
Winnsboro, S.C. 29180.
Referring once more to FIGS. 1 and 2, overwrap 11 has applied to
its surface a therapeutically active medicament composition 12
comprising an agent for control of vaginal area disorders, and the
vaginal fluid soluble binding lubricant having a melting point of
from about 38.degree. to about 50.degree. C.
The term "agent for control of vaginal area disorders" is intended
to include any of the wide variety of therapeutic agents which are
suitable as topical treatments for vaginal area disorders. A
complete and thorough survey of suitable agents can be found in
Benign Diseases of the Vulva and Vagina by Gardner, et al. (1968),
incorporated herein by reference. Naturally, the choice of agent is
not critical to the present invention and depends principally upon
the nature of the disorder and the severity of affliction. In
general, suitable agents are antibiotic, antiseptic, and/or
anesthetic.
The following table is intended to exemplify various suitable
agents for control of the three principal forms of vaginitis.
TABLE I ______________________________________ Agents for Control
of Vaginitis Form of Vaginitis Controlling Agent
______________________________________ (1) Candidiasis Gentian
violet Nystatin Candicidin Chlordantoin Amphotericin B Propionic
acid and salts Corticosteroids Hydrocortisone Fluocinolone
acetonide Flurandrenolone (2) Trichomoniasis Metronidazole
Polymyxin B Acetarsone Furazolidone Diiodohydroxyquin (3)
Haemophilus Oxytetracycline vaginalis vaginitis Sulfonamides
Sulfisoxazole Sulfadiazine Nitrofurazone
______________________________________
For purposes of the present invention, the selected therapeutic
agent is adhered to the tampon overwrap 11 by dissolving or
suspending the agent in a binding lubricant, which is in turn
applied to the tampon overwrap. The medicament compositions may be
applied to the overwrap by any of a wide variety of techniques such
as dipping, impregnating, spraying, or painting.
In a preferred embodiment, the medicament composition is applied to
a portion of the overwrap surface, thereby assuring that the
absorptive properties of the tampon are not hindered and that the
tampon will perform adequately when worn during menstruation.
Although longitudinal stripes of medicament, see FIGS. 1 and 2, are
suitable, it is clear that the medicament may be applied to the
tampon in essentially any geometric pattern which will leave a
portion of the overwrap uncoated to assure adequate absorption for
menstrual use. In general, it has been found suitable to apply
medicament to no more than 50% of the overwrap surface area.
As used herein, the term "binding lubricant" is intended to include
various select surface active waxes, uniquely characterized
temperature a high solubility in the physiological fluids of the
vagina and a melting point slightly above the normal body
temeprature of the vagina.
It has been discovered that proper selection of the binding
lubricant is critical to optimum delivery of the therapeutic agent
to the afflicted vagina area. Although not wishing the be bound by
theory, it is believed that by selecting a binding lubricant which
solubilizes in vaginal fluid, it is possible to effect, in essence,
a sustained-release of the active agent. In other words, the
therapeutic agent, being intimately associated with the binding
lubricant, is released from the tampon overwrap 11 in a relatively
continuous flow as the binding lubricant is solubilized in the
vagina. In order to achieve a sustained-release of active, the
binding lubricant should have a solubility in vaginal fluid of from
about 0.5 grams of binding lubricant per cubic centimeter of
vaginal fluid (hereinafter expressed as gm/cc) to about 10 gm/cc,
preferably about 1 gm/cc. As previously noted, vaginal fluid is an
aqueous solution, thus vaginal fluid is analogous to isotonic
saline in solubilization properties. It is therefore acceptable to
assume that solubility of the binding lubricant in isotonic saline,
within the desired range, is a suitable measure of solubility in
vaginal fluid, within the desired range.
In addition to solubility characteristics, suitable binding
lubricants should have a melting point slightly above normal body
temperature in the vagina. As previously noted, non-menstrual use
of the instant medicated tampon, which is essential to efficacious
treatment of vaginal disorders, emphasizes the importance of
comfortable insertion of the tampon. Suitable binding lubricants
when warmed to body temperture exist in an amorphous state between
solid and liquid which enables the binding lubricant to adhere to
the tampon overwrap, yet lubricate vaginal surfaces.
Thus, the medicated tampon of the present invention can be
comfortably inserted during non-menstrual periods to achieve
continuous treatment of the disorder. As is well known, normal body
temperature in the vagina is 37.degree.C. Accordingly, suitable
binding lubricants should have a melting point of from about
38.degree. to about 50.degree.C, preferably 42.degree. to
45.degree.C.
Preferred binding lubricants are innocuous, inert, nonvolatile
materials having a pH in dilute solution near normal non-menstrual
vaginal pH. Vaginal pH generally varies within the range of 3.8 to
4.2. Accordingly, preferred binding lubricants have a pH in dilute
solution of from about 3.5 to about 7.0, preferably about 4.0.
Preferred binding lubricants include, for example, the following
surface active waxes: polyethylene glycol having an average
molecular weight of 1,540; polyethylene glycol having an average
molecular weight of 4,000; polyethylene glycol having an average
molecular weight of 6,000; polyethylene-4-sorbitan monostearate;
polyoxyl 40 stearate; mixtures thereof; and mixtures thereof with
polyethylene glycol having an average molecular weight of 1,000.
Suitable mixtures include, for example, 75 percent by weight
polyethylene glycol having an average molecular weight of 1,000 and
25 percent by weight polyethylene glycol having an average
molecular weight of 4,000; and 70 percent by weight polyethylene
glycol having an average molecular weight of 1,540 and 30 percent
by weight polyethylene glycol having an average molecular weight of
6,000. Polyethylene glycol having an average molecular weight of
1,540 is an especially preferred binding lubricant.
Efficacious concentrations of the agent in the medicament
composition will vary depending upon such considerations as the
disorder being treated, the severity of affliction, and the potency
of the agent. Accordingly, the concentrations of constituents in
suitable medicament compositions cannot be predicted on other than
an individual basis. However, one skilled in the art will readily
perceive suitable medicament composition formulations for
individual circumstances. Thus, the concentration of agent in the
medicant compositions herein is left to routing evaluation and
determination. As a general guideline, the medicant compositions
suitable for use in the present invention comprise from about 0.1
percent to about 10.0 percent by weight of the therapeutic agent,
and from about 90.0 percent to about 99.9 percent by weight of the
binding lubricant.
The tampon of this invention can be inserted into a vagina via a
telescoping tube type inserter, as is well known to those of
ordinary skill in the tampon art. One such inserter having inwardly
tapering flexible segments at the leading end to form a normally
closed, smooth, openable, leading end is shown in FIG. 1 with the
tampon 15 of FIG. 2 held therein. The inserter used with the tampon
of this invention was molded from polyethylene, but can also be
made of other materials well known to men of ordinary skill in the
tampon inserter art. The tampon 15 is resiliently compacted and
maintained in that condition before and during insertion by placing
it in the tubular inserter 17. Resiliently compacted as used herein
means compressed to a degree such that the absorptive body takes on
a readily releasable temporal set, i.e., a set which dissipates in
the absence of fluids after the tampon is ejected from a
constraining means such as an inserter. The overwrap 11 of the
tampon 15 is in contact with the inner surface of the inserter 17.
An ejecting means, such as the ejector 18, removes a tampon from
the inserter. In the embodiment of FIG. 1, ejector 18 pushes
against the rear end of tampon 15 to move it forward in the
inserter, open the closure at the forward end of the inserter and
expel the tampon from the inserter 17.
The tampon, used in the inserter, forces open the segments at the
forward end of the inserter. The inserter 17 is inserted into the
vagina and the tampon 15 is ejected from the outer tube by pushing
the ejector 18 so that it telescopes within the inserter 17. The
inserter 17, with the ejector 18 therein, is removed from the
vagina after the tampon 15 has been fully ejected from inserter 17
and deposited within the vagina.
The following example is intended to illustrate a suitable,
preferred embodiment of the invention concept; and is not intended
to limit the scope of the invention herein.
EXAMPLES
MEDICATED CATAMENIAL TAMPON
A medicament composition was prepared by agitating 2.30 grams of
nystatin of potency 5007 units per milligram of "as is" nondried
powder having a moisture content of 3.9 percent, a therapeutic
agent for control of vaginal area disorders, and 50.0 grams of
polyethylene glycol having an average molecular weight of 1,540 in
a Waring Blender. The resulting composition was applied, in four
equidistant longitudinal stripes one-fourth inch in width, to the
overwrap of a resilient foam catamenial tampon comprising an
aggregate of individual pieces of absorbent foam material, said
aggregate being encased within the flexible fluid permeable
overwrap. The foam material, described hereinbefore as Foam I, was
characterized by a dry modulus of compression at 25 percent
compression in the range of 0.2 to about 2.0 pounds per square
inch. The tampon overwrap consisting of a hydrophobic nonwoven
polyester fabric having a wet tensile strength in the machine
direction of about 250 grams per inch.
The resulting medicated catamenial tampon is used in treating
vaginal area disorders during both the menstrual and non-menstrual
periods of the female cycle with good results.
The following binding lubricants are substituted for polyethylene
glycol having an average molecular weight of 1,540 in the
above-described medicament composition and substantially equivalent
results are achieved: polyethylene glycol having an average
molecular weight of 4,000; polyethylene glycol having an average
molecular weight of 6,000; polyethylene-4-sorbitan stearate;
polyoxyl 40 stearate; a mixture of 70 percent by weight of
polyethylene glycol having an average molecular weight of 1,540 and
25 percent by weight of polyethylene glycol having an average
molecular weight of 4,000; a mixture of 70 percent by weight of
polyethylene glycol having an average molecular weight of 1,540 and
30 percent by weight of polyethylene glycol having an average
molecular weight of 6,000; a mixture of 10 percent by weight of
polyethylene-4-sorbitan monostearate, 15 percent by weight of
polyoxyl 40 stearate, and 75 percent by weight of polyethylene
glycol having an average molecular weight of 1,540; a mixture of 70
percent by weight of polyethylene glycol having an average
molecular weight of 1,000 and 30 percent by weight of polyethylene
glycol having an average molecular weight of 6,000; and the
like.
The following therapeutic agents for control of vaginal disorders
are substituted for nystatin in the abovedescribed medicament
composition with comparable results: gentian violet; candicidin;
chlordantoin; amphotericin B; propionic acid and salts;
corticosteroids such as hydrocortisone, fluocinolone acetonide, and
flurandrenolone; metronidazole, polymyxin B; acetarsone;
furazolidone; diiodohydroxyquin; oxytetracycline; sulfonamides such
as sulfisoxazole and sulfadiazine; and nitrofurazone.
The overwrap of the above described tampon is replaced by overwraps
consisting of Dexter X-2172 and Viskon, respectively, with
substantially equivalent results. The foam employed in this example
is replaced with Foam II and Foam III, respectively, with similar
results.
* * * * *