WO1987001585A2 - Vaginal conditioning for sexual activity - Google Patents

Vaginal conditioning for sexual activity Download PDF

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Publication number
WO1987001585A2
WO1987001585A2 PCT/US1986/001972 US8601972W WO8701585A2 WO 1987001585 A2 WO1987001585 A2 WO 1987001585A2 US 8601972 W US8601972 W US 8601972W WO 8701585 A2 WO8701585 A2 WO 8701585A2
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WO
WIPO (PCT)
Prior art keywords
vaginal
envelope
tract
composition
conditioning
Prior art date
Application number
PCT/US1986/001972
Other languages
French (fr)
Other versions
WO1987001585A3 (en
Inventor
Denny F. Doran
Original Assignee
Affiliated Innovation Management Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Affiliated Innovation Management Inc. filed Critical Affiliated Innovation Management Inc.
Priority to GB8711630A priority Critical patent/GB2191942B/en
Publication of WO1987001585A2 publication Critical patent/WO1987001585A2/en
Publication of WO1987001585A3 publication Critical patent/WO1987001585A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S424/00Drug, bio-affecting and body treating compositions
    • Y10S424/14Topical contraceptives and spermacides

Definitions

  • This invention concerns means and methods for conditioning the vaginal tract for sexual activity, especially adjusting and controlling surface physical-chemical characteristics, including specifically pH, over a desired period of time.
  • Vaginal acidity also may curtail male participation in desired sexual activity, as in accelerating male orgasm, thus reducing the intended duration of sexual intercourse.
  • Higher acidity levels characteristic of some contraceptives, can aggravate such brevity.
  • neither partner is usually able to extend the duration of intercourse as desired.
  • Prior efforts to remedy such an unsatisfactory situation have tended toward reducing penile sensitivity, such as by interposition of a lubricated membrane or topical application of one or another analgesic composition. Either method may 5 prolong sexual engagement, but not usually very pleasurably for either the male or the female (and usually unfavorably for conception).
  • the objectives of the present invention are 0 attained by compensating in benign manner for a frequently encountered biologically dependent mistiming of male sexual reaction, and by means for implementing such compensation.
  • a primary object of this invention is to condition the vaginal tract to favor penile contact of desirable duration.
  • Another object of this invention is to prolong future periods of sexual intercourse, such as between partners with a history of rather brief periods thereof.
  • a further object of the invention is to enhance the human ability to plan for and to control the duration of desired 0 sexual activity, especially enabling the female to do so.
  • Yet another object is to provide compositions to effect such conditioning, also ways of applying such compositions.
  • a still further object of the invention is to accomplish the desired objects economically so as to be amply available.
  • this invention temporarily reduces the acidity of the vaginal tract considerably, about several orders of magnitude (i.e., pH units), usually rendering the tract substantially non-acidic, for a period of time wherein sexual activity is expected, up to several hours or longer. Thereafter the vagina either is allowed to return to its normal acidity via acidic bodily secretions over time or is assisted in doing so by topical application of acidifying material. Frequently the tract is rendered mildly alkaline initially and is rendered acidic after such lapse of time. All this occurs very simply as a consequence of a single action by the user.
  • a suppository, tablet, or the like for insertion into the vagina before some contemplated sexual activity, to adjust and control vaginal pH as desired.
  • a soluble device comprises a releasable alkaline constituent, and preferably a later releasable acidic constituent, quite well tolerated by the various bodily tissues to be contacted thereby.
  • the desired timing is readily aided by providing for successive release of such constituents, by embodying the diverse active components in gradually or successively soluble capsules, compartments, layers, mixtures, or by like measures.
  • Compositions such as astringents, antiseptics, fragrances, emollients, emulsifiers, surfactants, and the like, may be included therewith or may be introduced separately as desired.
  • Fig. 1 is a first set of three graphs of the condition of the vaginal tract in terms of pH units (vertical scale) vs. time units (horizontal scale) of the duration of actual or intended sexual activity, showing relatively long and short instances of unaided activity, and activity according to this invention, characterized by both pH and duration.
  • Fig. 2 is another set of three graphs of pH vs. duration, similarly scaled, of vaginal conditions variously controlled to about neutral pH according to this invention over periods of like duration.
  • Fig. 3 is another set of three graphs of pH vs. duration, scaled like the preceding diagrams: one of acidic vaginal conditions without the benefit of the present invention, and two others of initially alkalin —and then acidic—conditions according to the present invention.
  • - Figs. 4A and 4B are front and side elevations of a vaginal tablet exemplifying an embodiment of the present invention.
  • Fig. 5 is a side sectional elevation of a form of vaginal suppository useful according to this invention.
  • Figs. 6A and 6B are axial and transverse sectional views through another embodiment of suppository according to the invention, wi£h a plurality of compartments therein separated radially.
  • Fig. 7 is a side sectional elevation of another embodiment of vaginal suppository useful according to this invention, having a plurality of compartments separated transversely.
  • Fig. 8 is a side sectional elevation of yet a further embodiment of vaginal suppository useful according to the invention, having a multiplicity of individual beadlike elements together in a compartment therein.
  • the vaginal tract is normally quite acidic. According to the present invention, it beomes substantially non-acidic temporarily. At the end of a given time duration, perhaps a period of intense sexual activity, such as sexual intercourse, the tract is enabled to return to its normally acidic condition, either by natural secretion or is restored promptly to such acidity, according to this invention.
  • the invention does not alter the natural secretion process of the human body but only combines with the existing secretions after the body has completed their formation and exudation. Figs.
  • vaginal alkalinity or acidity conveniently in terms of pH, on an ordinate scale centered at 7 (neutral) and extending downward to a pH of 3 (very acidic) and also extending upward to a pH of 9 (rather alkaline), vs. activity duration on an abscissa (scaled 1 to 10) in arbitrary time units otherwise undesignated—a unit may be any suitably graduated number of minutes (such as 5, 10, 20, or even more).
  • pH is the logarithm of the reciprocal of the hydrogen ion concentratio —or the negative logarithm of the same concentration.
  • Fig. 1 illustrates curves of two diverse uncontrolled examples and a diffuse range of controlled examples: (A1 ) normal conditions with adequate duration, (A2) undesirably brief duration, otherwise normal, and (B) a band encompassing controlled conditions or curves.
  • the initial pH is about 4.6
  • the final pH about 4.4
  • the ending range midpoint of 7 time units approximates both the most frequent (modal) duration and the average (or arithmetic mean) time—for them.
  • Fig. 1 also shows band B (stippled) representing a range of conditions, and of curves, according to this invention. It resembles a scatter chart of measurements as might be made of numerous instances of the practicing of the present invention, at times within the respective instance durations.
  • The. outline of B is not shown in solid lines but fades away in stippling to suggest that conditions attainable by, and acceptable in practicing, this invention can be encountered broadly though the more densely stippled central region can be. expected to be more typical of the invention conditions.
  • Band B is vertically broader at its ends, where it spreads fro ⁇ r. readings of about 4 to about 6 pH, than intermediately, where it mainly occupies a range of about one half pH unit from a pH of nearly 7.0 to about 7.5. Subsequent examples provide more specific curves within this general range.
  • Fig. 2 illustrates two examples of this invention wherein the pH is adjusted initially to essentially neutral, and ultimately is enabled to return gradually to a more normal acidic condition: (C1 ) an improvement upon Example A2 of Fig. 1 obtained by application of an unbuffered alkalizer; and
  • Example C2 a variant of Example C1 , obtained by application of a buffered alkalizer; as well as
  • Example C1 of Fig. 2 the pH curve rises gradually from a mildly acidic pH or about 4.3 to a neutral pH of 7, and overshoots somewhat to a maximum pH of about 7.5, then it gradually diminishes and terminates below a neutral pH after about 6 to 8 time units.
  • This action amounts to a gradual neutralization of the normally acidic condition in the vagina by a mildly alkaline composition, which establishes a mildly alkaline condition there temporarily. Thereafter, the natural bodily secretions gradually neutralize the excess alkalinity and restore the normally acidic condition of the vagina.
  • Example C2 in contrast to C1 , the curve rises from a like beginning at about a 4.3 pH to an essentially neutral pH of 7, where (being buffered) it remains for some half dozen time units and then (broken line) gradually trails off to acidic lower pH readings to end after 6 to 8 time units.
  • the curve of Example D representing dissolution and neutralization of an acid-soluble alkalizing composition, rises (as the normally acidic secretions react with it) to neutrality, and remains there for nearly the full scale of time as it continues to react with and neutralize any further acid secretions as produced.
  • the pH trends slowly downward to increasingly acidic values to end at a pH near 6. This action is also mentioned below.
  • Fig. 3 illustrates a more alkaline alternative to the previous examples, along with examples of undesirably short and satisfactorily long durations in very acidic starting and ending conditions:
  • (G) compensation for F according to this invention.
  • the curve of Example E in contrast to the preceding more neutral maxima, rises to a mildly alkaline pH just under 8, staying there for about a half dozen time units, and then drops abruptly to level out at about 4.5 on the broken line portion of the curve between 7 and 10 time units.
  • the E average duration of at least about 8 time units matches or exceeds the normal A1 duration and satisfactorily doubles the (unsatisfactory) average A2 duration.
  • Curve F of Fig. 3 is characteristic of modification of the B situation by presence of acidic contraceptive composition. It begins at a strongly acidic pH of about 3.5, and also ends there after a duration of only several time units—within the broken line from 2 to 4 units. Such a brief duration is obviously at least as unsatisfactory as was the A2 duration.
  • Remedial Example G shows a curve that begins at an initial very acid pH and rises similarly to the E curve of this invention to about a 7.5 pH, and remains for a handful of time units, then drops promptly through neutral readings and (at about 7 time units) more abruptly.
  • the G curve matches the A1 and E curves at about 4.5 pH and 8 time units, and levels out at about a pH of 3.5 at 10 time units.
  • the midpoint of its broken terminal part at about 8 time units is comparable to that attained in E, notwithstanding that its very low final pH is compatible with presence of a strongly acidic contraceptive.
  • compositions are in the form of an insertable solid object, like a homogeneous tablet or a (usually) non-homogeneous "suppository".
  • Table I matches the Examples and Figures with one another.
  • FIG. 4A and 4B show an acid-soluble tablet embodiment
  • Figs. 5 to 8 show (on an enlarged scale) suppository embodiments, of the invention. It will be understood that any of such physical embodiments may be provided in a non- soluble sheath, wrapper, or the like (not shown) from which it is extracted for insertion into the vagina, where body moisture and temperature act to dissolve it over a given predetermined time period, as desired, and thus to release its constituents or contents.
  • Figs. 4A and 4B show an acid-soluble tablet embodiment
  • Figs. 5 to 8 show (on an enlarged scale) suppository embodiments, of the invention. It will be understood that any of such physical embodiments may be provided in a non- soluble sheath, wrapper, or the like (not shown) from which it is extracted for insertion into the vagina, where body moisture and temperature act to dissolve it over a given predetermined time period, as desired, and thus to release its constituents or contents.
  • 4A and 4B depict solid tablet 4 of this invention in a curvilinear triangular form, viewed first toward front face 5 and then toward edge 9, the latter view also showing part of curved front face 5 and rear face 6.
  • This tablet is also compartment-free, as its constituents are distributed fairly homogeneously throughout.
  • FIG. 5 shows in longitudinal section first suppository 10 according to this invention.
  • This soluble article comprises an elongated thick-walled gelatinous capsule or envelope 11 , with optional hollow core 16 often holding (when present) contents 17.
  • the envelope composition, and in Example C2 the contents is/are alkaline so as to neutralize the vaginal tract upon contact. Return of the vagina to normally acidic condition is enabled passively after the duration of the pH effect from application of the contents.
  • Example D the components or contents comprise not only an alkalizer for like alkalizing purpose, but also added means suitable for actively restoring a naturally acidic condition of the tract—or aiding in its restoration—gradually over an extended period of time, as is explained below in discussing suitable compositions.
  • acidic restoration is not strictly essential to the desired time duration of sexual activity, failure of the vagina to return to a normal acidity would render it unduly susceptible to growth of yeasts and other similarly 5 undesirable infections that flourish in such an environment at high pH levels.
  • This invention undertakes to preclude such conditions by enabling or positively ensuring vaginal acidity after the desired duration of activity.
  • the alkaline envelope dissolves to raise the pH to a mildly alkaline pH and eventually releases acidic contents 17 to restore the vaginal tract to normal acidity.
  • the first 5 released contents (rather than—or in addition to—the surrounding envelope itself) alkalize the surface of the vagina for a desired period of time, and thereafter second released contents (whether in solid, liquid, emulsion, or gel form) neutralize the previously released alkalizer remnant 0 and provide an acidic surplus to restore the vaginal surface to a desirably low pH, approximating its original degree of acidity.
  • Figs. 6A and 6B show, in longitudinal and transverse section, respectively, second embodiment 20 of such a 5 " suppository according to the present invention, comprising elongated thin-walled gelatinous (or otherwise soluble) envelope 21 surrounding smaller elongated gelatinous envelope 25, which is thicker-walled or less readily soluble (or both) than larger envelope 21.
  • the respective envelopes are spaced 0 apart by annulus 23 of alkaline liquid (preferably in an emulsion or gel form), retained by inner wall 22 of the outer envelope. The alkaline liquid is released, during use, upon eventual dissolution of the outer envelope.
  • Hollow core 26 of the inner envelope contains acidic contents 27 (optionally in liquid, in gel or emulsion, or in particulate solid form), which is released into the vagina upon dissolution of the inner envelope after a desired time.
  • the time delay is readily determinable and is dependent upon the thickness of the envelope wall and its solubility, as well as the dissolution rate of the contents, which can be adjusted as needed.
  • Fig. 7 shows, in longitudinal section, third embodiment 30 of a vaginal suppository according to this invention.
  • thin-walled readily soluble envelope 31 and thick-walled and/or less readily soluble envelope 35 form right and left end halves of an integrally formed elongated envelope structure outwardly similar to those illustrated in previous diagrams but divided into such pair of envelopes by transverse partition wall 34.
  • Flat base portions of the respective envelopes in Fig. 7 are contiguous, intermediate the ends of the structure.
  • Hollow core 32 of first envelope 31 contains alkaline liquid 33, which is released first into the vagina upon dissolution of that first envelope.
  • Hollow core 36 of second envelope 35 contains acidic liquid 37, which is released considerably later by reason of the slower dissolution of the second envelope and the intervening partition.
  • Fig. 8 shows in longitudinal section fourth embodiment 40 of suppository, being a modification of those shown previously.
  • elongated thin-walled soluble envelope 41 encloses in its hollow core 42 a multiplicity of beadlike capsules, shown in diverse sizes for the sake of clarity, including at least two types: more readily soluble beads 43 (shown small) comprising alkaline composition, and less readily soluble beads 47 (shown large) comprising acidic composition.
  • tablet 4 measures about one to two centimeters on a side and from several millimeters to about a centimeter in thickness, and the various embodiments of suppository range from about one to a few centimeters in length, and from a few millimeters or so to a couple centimeters in diameter, all depending upon the desired duration of activity and upon the dosage of the contained compositions—and whether such contents are solid or liquid and in what concentration.
  • the soluble material for the suppository wall(s) may be made of innocuous (even edible) material such as cocoa butter, gelatin, or methyl (or carboxymethy) cellulose, for example, with or without addition of other components, such as physical and/or chemical stabilizers, as are well known to minimize effects of unduly high or low temperature, for example.
  • the suppository wall itself is neutralizing it conveniently comprises carboxymethyl cellulose cross-linked to triethanolamine and/or to trimethylolaminomethane.
  • a suppository itself may comprise a neutral gel thereof or of gelatin or cocoa butter, as an envelope enclosing a neutralizing or alkalizing (or acidifying) composition, as the case may be.
  • a solid tablet may mix together its constituent pH-adjusting materials along with an appropriate binder of starch, lactose, etc. with or without a gelatinous coating.
  • Compositions contained within and being released from a device of this invention to adjust and control vaginal pH are innocuous, numerous, and readily available.
  • Examples include weak acids, such as acetic, boric, citric, and lactic; weak bases, such as ammonium, calcium, and magnesium hydroxides, and alkyl and aryl (and mixed) amines; salts of weak acids and bases, such as ammonium acetate and calcium carbonate, salts of strong bases and weak acids, such as sodium citrate and trisodium phosphate; and salts of weak bases and strong acids, such as ammonium or aluminum nitrate or sulfate, for example.
  • weak acids such as acetic, boric, citric, and lactic
  • weak bases such as ammonium, calcium, and magnesium hydroxides, and alkyl and aryl (and mixed) amines
  • salts of weak acids and bases such as ammonium acetate and calcium carbonate, salts of strong bases and weak acids, such as sodium citrate and trisodium phosphate
  • salts of weak bases and strong acids such as ammonium or aluminum nitrate or sulfate, for
  • the constituent alkalizer(s) of tablet 4 in Example D of Fig. 2 may be less readily soluble but reactive with vaginal acid as long as such acid is present, such as a mixture of calcium and magnesium hydroxides.
  • An alternative composition comprises calcium carbonate, with or without such hydroxide(s)
  • a composition also useful in Example D comprises live acidophilus lactobacillus, such as Doerderleini, in suitable starch or equivalent nutrient, much as disclosed by Ibaraga in U.S. Pat. 3,639,566. Gradual growth of the lactobacillus occurs and progressively lowers the pH below an initial neutral level. Other pH-adjusting compositions are more appropriate for the later examples.
  • the alkalizing component in physical embodiments other than those already specified, conveniently comprises a buffering aqueous mixture of 100 parts monopotassium phosphate to 90 parts of sodium hydroxide at one to several tenths molar.
  • Alternatives include like mixtures of 100 parts of of boric acid with 5 parts of sodium hydroxide or 100 parts of disodium phosphate plus 9 parts of citric acid. Concentration and/or quantity, as well as composition, are adjustable to compensate for actual vaginal extent and initial acidity level, as will be apparent to those skilled in the art.
  • the acidifying composition may, but need not, be buffered; it need only be capable of neutralizing all the residual alkalizing component, with enough left over to enable the pH to approach a desired level, such as the starting levels indicated in curves E and G of Fig. 3.
  • Suitable buffered acidifiers comprise 100 parts of potassium acid phthalate:
  • Example G (Fig. 3) alkalizing requirements are very similar to those of Example E except that the more acid initial condition may well require more (if not more alkaline) alkalizing contents.
  • the acidifier such as citric acid
  • the acidifier may include zinc chloride as a spermicide—or alternatively for that purpose p-nonylpheloxypolyethoxyethanol or other equivalent compound.
  • some other means such as systemic chemical dosage ( ' title "pill") or non-chemical method or means may replace or £ supplement such a topical spermicide.
  • a small quantity of malic acid may be utilized instead of (or in addition to) other acid to impart a pleasant scent to the composition generally.
  • An emollient such as glycerine, is also useful in maintaining adequate lubrication, especially if particulate material is present.
  • a compatible antiseptic such as boric acid, may be substituted as an acidifier, if desired.
  • Such a suppository is conveniently "finger-like" in form, with dimensions in ranges already noted. If the envelope wall is of a neutral composition, its volume should be subtracted in determining dosage; but not, of course, if it is alkalizing (or acidifying). The contained volume after total wall volume is deducted may well range from less than half the total volume to ninety percent or even more.
  • the total volume of a pH-adjusting device of this invention will depend upon the absolute quantity of the alkalizing or acidifying composition needed, upon whether such composition is in solid or liquid form, and upon its concentration (which in turn will depend upon any diluent present).
  • Volume and concentration of compositions for accomplishing the objects of this invention are inversely related, of course, as a smaller but more concentrated volume of a given composition is essentially equivalent to a larger but more dilute volume thereof.
  • Solid compositions, when used in other than tablet form, such as in a suppository envelope, are preferably in finely divided particulate form to aid dissolution. Any liquid content helps to maintain the vaginal tract desirably moist.
  • liquid As little as 5 ml of liquid is capable of covering all or most of the vaginal surface to a depth of about a tenth of a mm, that is several thousandths of an inch, especially in the presence of a surfactant (such as sodium lauryl sulfonate) thereby rendering it satisfactorily moist even if solids must be dissolved.
  • a surfactant such as sodium lauryl sulfonate
  • Recommended solids and aqueous or other liquid compositions should not harm the tissues contacted by them regardless of their concentration.
  • its original shape and (in part) size will persist longer than in the instance of the other embodiments, as its thick wall is itself an alkalizer. Solid tablet embodiments often dissolve even more slowly, of course.
  • part or all thereof dissolves much sooner, desirably before the onset of sexual intercourse, and thus releases the usually liquid contents later, as the period of sexual activity tends "1 to a conclusion.
  • Prompt dissolution of an outer envelope as in the second embodiment, or of an end compartment of a twin envelope as in the third embodiment reduces the space occupied by the residue.
  • small beadlike capsules in the fourth embodiment function to like effect. It will be understood that every person (and, thus, every couple) is different and that human complexity reduces the predictability of behavior, especially sexual behavior, so that the foregoing examples are only emblematic of what may, rather than what must, occur. However, if this invention benefitted only a minor fraction of the possible candidates for its use it will have proved to be worthwhile. It also should prove similarly beneficial in animal husbandry, as when it is utilized to improve likelihood of conception.

Abstract

Conditioning of the vaginal tract for sexual activity, by a method including adjusting and controlling its surface pH, with soluble means for accomplishing such conditioning. The specified conditioning favors increased duration of sexual intercourse, as is often desired, and is compatible here with such diverse goals as favoring or discouraging conception. Normally the human vagina is strongly acidic, which may render intercourse with some males unduly brief. Through this invention the vaginal pH is increased about several pH units, by applying thereto a capsule, tablet, or suppository containing an alkalizer, to be released upon dissolution, so that the surface of the vaginal tract nears and preferably reaches or somewhat exceeds a neutral pH of 7 for a desired period of time. Thereafter, the vagina is enabled to return to its normally acidic condition, or is preferably actively returned thereto by subsequent release of an acidifier from such topically applied means.

Description

VAGINAL CONDITIONING FOR SEXUAL ACTIVITY
TECHNICAL FIELD
This invention concerns means and methods for conditioning the vaginal tract for sexual activity, especially adjusting and controlling surface physical-chemical characteristics, including specifically pH, over a desired period of time.
BACKGROUND ART
A frequently expressed cause of dissatisfaction with human sexual intercourse is that it is so brief on occasion as to be disappointing rather than satisfying. It often is further frustrating in that it does not result in conception where that is desired. Though this perspective focuses principally upon human sexual activity, it is well known that failure of bred animals to conceive is a common source of disappointment for humans engaged in such a vocation. Despite emphasis in this text upon human sexual activity, applicability of this invention to animal husbandry is also intended.
Although there may be many contributing reasons, emotional and psychological (presumably more in humans than in animals) as well as physiological, for such undesired outcomes, my present invention considers undue brevity of intercourse in terms of physical-chemical conditions hitherto not very well appreciated in that regard.
Normally the surface condition of a healthy human vagina is acidic; it may even become somewhat more so during sexual activity. Yet an acid environment is known to be deleterious to the survival of spermatozoa. Indeed, if conception is not desired, more strongly acidic contraceptive compositions may be present intentionally at times of expected and actual sexual intercourse, which may further aggravate the brevity thereof as a major cause of dissatisfaction.
Vaginal acidity also may curtail male participation in desired sexual activity, as in accelerating male orgasm, thus reducing the intended duration of sexual intercourse. Higher acidity levels, characteristic of some contraceptives, can aggravate such brevity. In such instances neither partner is usually able to extend the duration of intercourse as desired. Prior efforts to remedy such an unsatisfactory situation have tended toward reducing penile sensitivity, such as by interposition of a lubricated membrane or topical application of one or another analgesic composition. Either method may 5 prolong sexual engagement, but not usually very pleasurably for either the male or the female (and usually unfavorably for conception). Application of oils or other emollients directly to either the male or female organs may be helpful, but more as a palliative than as a solution to the problem. O? Thus, a need exists for a better method of increasing the duration of sexual intercourse, where duration is inadequate .for reasons that can be treated purely physically. It would be desirable to be able to extend the duration regardless of whether a couple may wish to conceive in doing so or wish to 5 avoid conceiving, as determined according to their own views. The present invention provides just such a better method and provides physical means especially designed for practicing it.
DISCLOSURE OF THE INVENTION
In general, the objectives of the present invention are 0 attained by compensating in benign manner for a frequently encountered biologically dependent mistiming of male sexual reaction, and by means for implementing such compensation.
A primary object of this invention is to condition the vaginal tract to favor penile contact of desirable duration. 5- Another object of this invention is to prolong future periods of sexual intercourse, such as between partners with a history of rather brief periods thereof.
A further object of the invention is to enhance the human ability to plan for and to control the duration of desired 0 sexual activity, especially enabling the female to do so.
Yet another object is to provide compositions to effect such conditioning, also ways of applying such compositions.
A still further object of the invention is to accomplish the desired objects economically so as to be amply available. In particular, this invention temporarily reduces the acidity of the vaginal tract considerably, about several orders of magnitude (i.e., pH units), usually rendering the tract substantially non-acidic, for a period of time wherein sexual activity is expected, up to several hours or longer. Thereafter the vagina either is allowed to return to its normal acidity via acidic bodily secretions over time or is assisted in doing so by topical application of acidifying material. Frequently the tract is rendered mildly alkaline initially and is rendered acidic after such lapse of time. All this occurs very simply as a consequence of a single action by the user.
In brief, a suppository, tablet, or the like is provided, for insertion into the vagina before some contemplated sexual activity, to adjust and control vaginal pH as desired. Such a soluble device comprises a releasable alkaline constituent, and preferably a later releasable acidic constituent, quite well tolerated by the various bodily tissues to be contacted thereby. The desired timing is readily aided by providing for successive release of such constituents, by embodying the diverse active components in gradually or successively soluble capsules, compartments, layers, mixtures, or by like measures. Compositions such as astringents, antiseptics, fragrances, emollients, emulsifiers, surfactants, and the like, may be included therewith or may be introduced separately as desired.
Such methods and means for accomplishing the aforementioned and related objects of the invention will be apparent from the following description and the accompanying diagrams, which are presented by way of example rather than limitation.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a first set of three graphs of the condition of the vaginal tract in terms of pH units (vertical scale) vs. time units (horizontal scale) of the duration of actual or intended sexual activity, showing relatively long and short instances of unaided activity, and activity according to this invention, characterized by both pH and duration. Fig. 2 is another set of three graphs of pH vs. duration, similarly scaled, of vaginal conditions variously controlled to about neutral pH according to this invention over periods of like duration. Fig. 3 is another set of three graphs of pH vs. duration, scaled like the preceding diagrams: one of acidic vaginal conditions without the benefit of the present invention, and two others of initially alkalin —and then acidic—conditions according to the present invention. - Figs. 4A and 4B are front and side elevations of a vaginal tablet exemplifying an embodiment of the present invention.
Fig. 5 is a side sectional elevation of a form of vaginal suppository useful according to this invention.
Figs. 6A and 6B are axial and transverse sectional views through another embodiment of suppository according to the invention, wi£h a plurality of compartments therein separated radially.
Fig. 7 is a side sectional elevation of another embodiment of vaginal suppository useful according to this invention, having a plurality of compartments separated transversely.
Fig. 8 is a side sectional elevation of yet a further embodiment of vaginal suppository useful according to the invention, having a multiplicity of individual beadlike elements together in a compartment therein.
; MODES FOR CARRYING OUT THE INVENTION
As noted above, the vaginal tract is normally quite acidic. According to the present invention, it beomes substantially non-acidic temporarily. At the end of a given time duration, perhaps a period of intense sexual activity, such as sexual intercourse, the tract is enabled to return to its normally acidic condition, either by natural secretion or is restored promptly to such acidity, according to this invention. The invention does not alter the natural secretion process of the human body but only combines with the existing secretions after the body has completed their formation and exudation. Figs. 1 to 3 represent vaginal alkalinity or acidity, conveniently in terms of pH, on an ordinate scale centered at 7 (neutral) and extending downward to a pH of 3 (very acidic) and also extending upward to a pH of 9 (rather alkaline), vs. activity duration on an abscissa (scaled 1 to 10) in arbitrary time units otherwise undesignated—a unit may be any suitably graduated number of minutes (such as 5, 10, 20, or even more). As technically defined, pH is the logarithm of the reciprocal of the hydrogen ion concentratio —or the negative logarithm of the same concentration. At the left of the vertical axis, the end portions of some of the curves (in broken lines) begin at times before the onset (at time 0) of the period of defined duration, thus corresponding to the administration of materials of this invention in expectation of sexual activity. The right end portions of the curves appear in broken lines to indicate durations within- that range on the time scale. The curves of these graphs are described first, and then the methods and means whereby the examples of this invention are brought about are specified after intervening description of some physical embodiments of the invention.
Fig. 1 illustrates curves of two diverse uncontrolled examples and a diffuse range of controlled examples: (A1 ) normal conditions with adequate duration, (A2) undesirably brief duration, otherwise normal, and (B) a band encompassing controlled conditions or curves. In the curve of Example A1 , the initial pH is about 4.6, and the final pH about 4.4, with a duration of about 5 to 9 time units (broken line portion) , as an example of normal duration of sexual activity (including intercourse) adequate for a majority of sexual partners. The ending range midpoint of 7 time units approximates both the most frequent (modal) duration and the average (or arithmetic mean) time—for them. In the Curve A2 example, on the other hand, the pH values are similar, beginning at about 4.4 and ending at about 4.3, but such ending occurs after a duration of only 3 to 5 time units, or an average of 4 units, usually deemed inadequate. Fig. 1 also shows band B (stippled) representing a range of conditions, and of curves, according to this invention. It resembles a scatter chart of measurements as might be made of numerous instances of the practicing of the present invention, at times within the respective instance durations. The. outline of B is not shown in solid lines but fades away in stippling to suggest that conditions attainable by, and acceptable in practicing, this invention can be encountered broadly though the more densely stippled central region can be. expected to be more typical of the invention conditions. Band B is vertically broader at its ends, where it spreads froπr. readings of about 4 to about 6 pH, than intermediately, where it mainly occupies a range of about one half pH unit from a pH of nearly 7.0 to about 7.5. Subsequent examples provide more specific curves within this general range.
Fig. 2 illustrates two examples of this invention wherein the pH is adjusted initially to essentially neutral, and ultimately is enabled to return gradually to a more normal acidic condition: (C1 ) an improvement upon Example A2 of Fig. 1 obtained by application of an unbuffered alkalizer; and
(C2) a variant of Example C1 , obtained by application of a buffered alkalizer; as well as
(D) a further neutralizing variant, obtained via a mixture of acid-soluble alkalizer and acid-restoring material. In Example C1 of Fig. 2, the pH curve rises gradually from a mildly acidic pH or about 4.3 to a neutral pH of 7, and overshoots somewhat to a maximum pH of about 7.5, then it gradually diminishes and terminates below a neutral pH after about 6 to 8 time units. This action amounts to a gradual neutralization of the normally acidic condition in the vagina by a mildly alkaline composition, which establishes a mildly alkaline condition there temporarily. Thereafter, the natural bodily secretions gradually neutralize the excess alkalinity and restore the normally acidic condition of the vagina. In Example C2, in contrast to C1 , the curve rises from a like beginning at about a 4.3 pH to an essentially neutral pH of 7, where (being buffered) it remains for some half dozen time units and then (broken line) gradually trails off to acidic lower pH readings to end after 6 to 8 time units. The curve of Example D, representing dissolution and neutralization of an acid-soluble alkalizing composition, rises (as the normally acidic secretions react with it) to neutrality, and remains there for nearly the full scale of time as it continues to react with and neutralize any further acid secretions as produced. Upon exhaustion of alkalizer, the pH trends slowly downward to increasingly acidic values to end at a pH near 6. This action is also mentioned below. Fig. 3 illustrates a more alkaline alternative to the previous examples, along with examples of undesirably short and satisfactorily long durations in very acidic starting and ending conditions:
(E) further compensation for unsatisfactory curve A2 by a sequential combination of buffered alkalizer and acidifier; (F) brief duration in more strongly acidic conditions than in A2;
(G) compensation for F according to this invention. The curve of Example E, in contrast to the preceding more neutral maxima, rises to a mildly alkaline pH just under 8, staying there for about a half dozen time units, and then drops abruptly to level out at about 4.5 on the broken line portion of the curve between 7 and 10 time units. The E average duration of at least about 8 time units matches or exceeds the normal A1 duration and satisfactorily doubles the (unsatisfactory) average A2 duration.
Curve F of Fig. 3 is characteristic of modification of the B situation by presence of acidic contraceptive composition. It begins at a strongly acidic pH of about 3.5, and also ends there after a duration of only several time units—within the broken line from 2 to 4 units. Such a brief duration is obviously at least as unsatisfactory as was the A2 duration. Remedial Example G, as compared with F, shows a curve that begins at an initial very acid pH and rises similarly to the E curve of this invention to about a 7.5 pH, and remains for a handful of time units, then drops promptly through neutral readings and (at about 7 time units) more abruptly. The G curve matches the A1 and E curves at about 4.5 pH and 8 time units, and levels out at about a pH of 3.5 at 10 time units. The midpoint of its broken terminal part at about 8 time units is comparable to that attained in E, notwithstanding that its very low final pH is compatible with presence of a strongly acidic contraceptive.
It will be understood that the illustrated curves are only exemplary, not necessarily typical of any entire population, but represent conditions such as are exhibited by, on the one hand, some of those people who have not experienced relatively brief intercourse duration, and—on the other hand—others who do have such a problem, and also additionally some of the latter under conditions compensated for according to this invention. Compositions suitable for assuring the diverse pH values in the curves of Figs. 2 and 3 are identified below after discussion of structural embodiments (in Figs. 4 to 8) useful in providing such desired compositions. Administration of an alkalizing composition as a douche or, at the other extreme, in the form of a powder is possible, of course. However, such means and methods preclude important benefits of this invention, and the preferred vehicle for such compositions is in the form of an insertable solid object, like a homogeneous tablet or a (usually) non-homogeneous "suppository". Table I matches the Examples and Figures with one another.
TABLE I - Cross-References of Examples and Figures
GRAPH FIG: 1 1 2 2 2 3 3 3
EXAMPLE: A1 A2 C1 C2 D E F G
EMBODIMENT FIG: - — 5 5 4-8 5-8 _ 5-8 Figs. 4A and 4B show an acid-soluble tablet embodiment, and Figs. 5 to 8 show (on an enlarged scale) suppository embodiments, of the invention. It will be understood that any of such physical embodiments may be provided in a non- soluble sheath, wrapper, or the like (not shown) from which it is extracted for insertion into the vagina, where body moisture and temperature act to dissolve it over a given predetermined time period, as desired, and thus to release its constituents or contents. Figs. 4A and 4B depict solid tablet 4 of this invention in a curvilinear triangular form, viewed first toward front face 5 and then toward edge 9, the latter view also showing part of curved front face 5 and rear face 6. This tablet is also compartment-free, as its constituents are distributed fairly homogeneously throughout.
As already noted, the chemical compositions of this Fig. 4A and Fig. 4B embodiment, and also all of the various other embodiments are considered below, after each of the diverse illustrated physical embodiments has been described. Fig. 5 shows in longitudinal section first suppository 10 according to this invention. This soluble article comprises an elongated thick-walled gelatinous capsule or envelope 11 , with optional hollow core 16 often holding (when present) contents 17. In Example C1 , the envelope composition, and in Example C2 the contents, is/are alkaline so as to neutralize the vaginal tract upon contact. Return of the vagina to normally acidic condition is enabled passively after the duration of the pH effect from application of the contents. In Example D, the components or contents comprise not only an alkalizer for like alkalizing purpose, but also added means suitable for actively restoring a naturally acidic condition of the tract—or aiding in its restoration—gradually over an extended period of time, as is explained below in discussing suitable compositions. Although such acidic restoration is not strictly essential to the desired time duration of sexual activity, failure of the vagina to return to a normal acidity would render it unduly susceptible to growth of yeasts and other similarly 5 undesirable infections that flourish in such an environment at high pH levels. This invention undertakes to preclude such conditions by enabling or positively ensuring vaginal acidity after the desired duration of activity.
In Examples E and G, using the first embodiment (Fig. 5) TT: of suppository, the alkaline envelope dissolves to raise the pH to a mildly alkaline pH and eventually releases acidic contents 17 to restore the vaginal tract to normal acidity. However, other physical embodiments (described below) enable sequential release of diverse contents. Preferably the first 5 released contents (rather than—or in addition to—the surrounding envelope itself) alkalize the surface of the vagina for a desired period of time, and thereafter second released contents (whether in solid, liquid, emulsion, or gel form) neutralize the previously released alkalizer remnant 0 and provide an acidic surplus to restore the vaginal surface to a desirably low pH, approximating its original degree of acidity.
Figs. 6A and 6B show, in longitudinal and transverse section, respectively, second embodiment 20 of such a 5" suppository according to the present invention, comprising elongated thin-walled gelatinous (or otherwise soluble) envelope 21 surrounding smaller elongated gelatinous envelope 25, which is thicker-walled or less readily soluble (or both) than larger envelope 21. The respective envelopes are spaced 0 apart by annulus 23 of alkaline liquid (preferably in an emulsion or gel form), retained by inner wall 22 of the outer envelope. The alkaline liquid is released, during use, upon eventual dissolution of the outer envelope. Hollow core 26 of the inner envelope contains acidic contents 27 (optionally in liquid, in gel or emulsion, or in particulate solid form), which is released into the vagina upon dissolution of the inner envelope after a desired time. The time delay is readily determinable and is dependent upon the thickness of the envelope wall and its solubility, as well as the dissolution rate of the contents, which can be adjusted as needed.
Fig. 7 shows, in longitudinal section, third embodiment 30 of a vaginal suppository according to this invention.
Instead of being one inside the other as in the embodiment of Figs. 5 and 6, here thin-walled readily soluble envelope 31 and thick-walled and/or less readily soluble envelope 35 form right and left end halves of an integrally formed elongated envelope structure outwardly similar to those illustrated in previous diagrams but divided into such pair of envelopes by transverse partition wall 34. Flat base portions of the respective envelopes in Fig. 7 are contiguous, intermediate the ends of the structure. Hollow core 32 of first envelope 31 contains alkaline liquid 33, which is released first into the vagina upon dissolution of that first envelope. Hollow core 36 of second envelope 35 contains acidic liquid 37, which is released considerably later by reason of the slower dissolution of the second envelope and the intervening partition.
Fig. 8 shows in longitudinal section fourth embodiment 40 of suppository, being a modification of those shown previously. Here, elongated thin-walled soluble envelope 41 encloses in its hollow core 42 a multiplicity of beadlike capsules, shown in diverse sizes for the sake of clarity, including at least two types: more readily soluble beads 43 (shown small) comprising alkaline composition, and less readily soluble beads 47 (shown large) comprising acidic composition. In size, tablet 4 measures about one to two centimeters on a side and from several millimeters to about a centimeter in thickness, and the various embodiments of suppository range from about one to a few centimeters in length, and from a few millimeters or so to a couple centimeters in diameter, all depending upon the desired duration of activity and upon the dosage of the contained compositions—and whether such contents are solid or liquid and in what concentration. The soluble material for the suppository wall(s) may be made of innocuous (even edible) material such as cocoa butter, gelatin, or methyl (or carboxymethy) cellulose, for example, with or without addition of other components, such as physical and/or chemical stabilizers, as are well known to minimize effects of unduly high or low temperature, for example. In a suppository embodiment wherein the suppository wall itself is neutralizing it conveniently comprises carboxymethyl cellulose cross-linked to triethanolamine and/or to trimethylolaminomethane. Otherwise, a suppository itself may comprise a neutral gel thereof or of gelatin or cocoa butter, as an envelope enclosing a neutralizing or alkalizing (or acidifying) composition, as the case may be. A solid tablet may mix together its constituent pH-adjusting materials along with an appropriate binder of starch, lactose, etc. with or without a gelatinous coating. Compositions contained within and being released from a device of this invention to adjust and control vaginal pH are innocuous, numerous, and readily available. Examples include weak acids, such as acetic, boric, citric, and lactic; weak bases, such as ammonium, calcium, and magnesium hydroxides, and alkyl and aryl (and mixed) amines; salts of weak acids and bases, such as ammonium acetate and calcium carbonate, salts of strong bases and weak acids, such as sodium citrate and trisodium phosphate; and salts of weak bases and strong acids, such as ammonium or aluminum nitrate or sulfate, for example. Others will come to the mind of persons skilled in the art. Alkaline envelope compositions for Example C1 have been noted. The curve illustrated for Example C2 is for the preferred hollow form in which the contents are compositions effective as a neutral (pH=7) buffer. An example utilizes 100 parts of monopotassium phosphate to 60 parts of sodium hydroxide. An alternative neutral buffering composition for C2 consists of 100 parts of disodium phosphate to 43 parts of citric acid, for example.
The constituent alkalizer(s) of tablet 4 in Example D of Fig. 2 may be less readily soluble but reactive with vaginal acid as long as such acid is present, such as a mixture of calcium and magnesium hydroxides. An alternative composition comprises calcium carbonate, with or without such hydroxide(s) A composition also useful in Example D comprises live acidophilus lactobacillus, such as Doerderleini, in suitable starch or equivalent nutrient, much as disclosed by Ibaraga in U.S. Pat. 3,639,566. Gradual growth of the lactobacillus occurs and progressively lowers the pH below an initial neutral level. Other pH-adjusting compositions are more appropriate for the later examples. For Example E, the alkalizing component, in physical embodiments other than those already specified, conveniently comprises a buffering aqueous mixture of 100 parts monopotassium phosphate to 90 parts of sodium hydroxide at one to several tenths molar. Alternatives include like mixtures of 100 parts of of boric acid with 5 parts of sodium hydroxide or 100 parts of disodium phosphate plus 9 parts of citric acid. Concentration and/or quantity, as well as composition, are adjustable to compensate for actual vaginal extent and initial acidity level, as will be apparent to those skilled in the art.
The acidifying composition may, but need not, be buffered; it need only be capable of neutralizing all the residual alkalizing component, with enough left over to enable the pH to approach a desired level, such as the starting levels indicated in curves E and G of Fig. 3. Suitable buffered acidifiers comprise 100 parts of potassium acid phthalate:
(i) to 20 parts of sodium hydroxide for Example E, or (ii) to 15 parts of hydrochloric acid for Example G. Alternative buffered mixtures include 100 parts of citric acid to 40 parts of disodium phosphate for Example E, or to 20. parts of disodium phosphate for Example G. Unbuffered aqueous citric acid can suffice for either example—in lesser amount for Example E than Example G will require. Suitable " alternative compositions and amounts will be apparent.
When conception is desired, release of the re-acidifying material may be further delayed by appropriate modification of its compartment wall, as by greater thickness or lesser solubility—or the acidifier may be omitted and be supplied separately. In Example G (Fig. 3) alkalizing requirements are very similar to those of Example E except that the more acid initial condition may well require more (if not more alkaline) alkalizing contents.
Also, in Example G, the acidifier, such as citric acid, may include zinc chloride as a spermicide—or alternatively for that purpose p-nonylpheloxypolyethoxyethanol or other equivalent compound. Moreover, when conception is not desired, some other means, such as systemic chemical dosage ('title "pill") or non-chemical method or means may replace or £ supplement such a topical spermicide.
A small quantity of malic acid may be utilized instead of (or in addition to) other acid to impart a pleasant scent to the composition generally. An emollient, such as glycerine, is also useful in maintaining adequate lubrication, especially if particulate material is present. A compatible antiseptic, such as boric acid, may be substituted as an acidifier, if desired. Similar additions or substitutions of other suitable compositions for the same or similar reasons will come readily to the minds of persons skilled in the cosmetic arts. Such a suppository is conveniently "finger-like" in form, with dimensions in ranges already noted. If the envelope wall is of a neutral composition, its volume should be subtracted in determining dosage; but not, of course, if it is alkalizing (or acidifying). The contained volume after total wall volume is deducted may well range from less than half the total volume to ninety percent or even more.
In practice, the total volume of a pH-adjusting device of this invention will depend upon the absolute quantity of the alkalizing or acidifying composition needed, upon whether such composition is in solid or liquid form, and upon its concentration (which in turn will depend upon any diluent present). Volume and concentration of compositions for accomplishing the objects of this invention are inversely related, of course, as a smaller but more concentrated volume of a given composition is essentially equivalent to a larger but more dilute volume thereof. Solid compositions, when used in other than tablet form, such as in a suppository envelope, are preferably in finely divided particulate form to aid dissolution. Any liquid content helps to maintain the vaginal tract desirably moist.
As little as 5 ml of liquid is capable of covering all or most of the vaginal surface to a depth of about a tenth of a mm, that is several thousandths of an inch, especially in the presence of a surfactant (such as sodium lauryl sulfonate) thereby rendering it satisfactorily moist even if solids must be dissolved. Recommended solids and aqueous or other liquid compositions should not harm the tissues contacted by them regardless of their concentration. In the first described embodiment of suppository, its original shape and (in part) size will persist longer than in the instance of the other embodiments, as its thick wall is itself an alkalizer. Solid tablet embodiments often dissolve even more slowly, of course. In the thin-walled suppository embodiments, part or all thereof dissolves much sooner, desirably before the onset of sexual intercourse, and thus releases the usually liquid contents later, as the period of sexual activity tends"1 to a conclusion. Prompt dissolution of an outer envelope as in the second embodiment, or of an end compartment of a twin envelope as in the third embodiment, reduces the space occupied by the residue. Alternatively, small beadlike capsules in the fourth embodiment function to like effect. It will be understood that every person (and, thus, every couple) is different and that human complexity reduces the predictability of behavior, especially sexual behavior, so that the foregoing examples are only emblematic of what may, rather than what must, occur. However, if this invention benefitted only a minor fraction of the possible candidates for its use it will have proved to be worthwhile. It also should prove similarly beneficial in animal husbandry, as when it is utilized to improve likelihood of conception.
INDUSTRIAL APPLICABILITY As the methods of the present invention have not been known for such purpose heretofore, they will give rise to new or augmented manufacturing and merchandising operations to meet the demand for means to practice such methods. The influence of this invention on human sexual activity will reduce frustration and increase life satisfaction on the job, thus improving industrial operations, as well as at home. The foregoing specification not only gives a number of specific examples of the practice of this invention but also suggests variants or alternatives to aid an understanding of the present invention in its wide applicability. Other such modifications may be made, as well, as by adding, combining, deleting, or subdividing parts or steps, while retaining at least some of the benefits of this invention, which itself is defined in the following claims.

Claims

THE CLAIMED INVENTION:
1. Method of conditioning a vaginal tract, as for a time period suitable for sexual activity, characterized by increasing the pH of the tract substantially, and thereafter enabling it to return to normal acidity.
2. Vaginal conditioning method according to claim 1 , characterized further in that the pH is increased by topically applying alkalizing material to the tract.
3. Vaginal conditioning method according to claim 1 , characterized further in that the tract is passively enabled to return to normal acidity by refraining from interfering with acidic bodily secretion in the vicinity.
»
4. Vaginal conditioning method according to claim 1 , characterized further in that the tract is actively enabled to return to normal acidity via topical application of acidifying material thereto.
5. Vaginal conditioning method according to claim 1 , characterized further by topically applying an alkalizing material to the tract at about the beginning of such a time period, and topically applying an acidifying material to the tract at about the end of such a time period.
6. Vaginal conditioning method according to claim 1, characterized further in that the pH is increased several pH units above normal for the tract.
7. Vaginal conditioning method according to claim 1 , characterized further in that the pH is increased to about 7, corresponding to approximate neutrality of the tract.
8. Vaginal conditioning method according to claim 1 , characterized further in that the tract is rendered mildly alkaline, corresponding to a pH fractionally above 7.
9. Vaginal conditioning method according to claim 1, characterized further by embodying material for adjusting the vaginal pH in a solid tablet.
10. Vaginal conditioning method according to claim 2, characterized further by embodying material for adjusting the vaginal pH in a soluble envelope.
11. Vaginal conditioning method according to claim 4, characterized further by embodying material for increasing the vaginal pH in a first soluble envelope and by embodying material for reducing the vaginal pH in a second, less soluble envelope accompanying the first envelope.
12. Vaginal conditioning method according to claim 11, characterized further by including acidophilus lactobacillus in the material for reducing the vaginal pH.
13. Vaginal conditioning method according to claim 11, characterized further by including nutrient medium for the acidophilus lactobacillus in the material for reducing the vaginal pH.
14. An insertable soluble device for conditioning a vaginal tract for sexual activity according to claim 5, characterized by a composition for buffering the tract to a pH of about 7 for such period of time, and acidophilus lactobacillus in nutrient medium and thereby adapted to grow and thus to aid in restoring the tract to a lower pH after such period of time.
15. Material for conditioning an acidic vaginal tract for sexual activity, characterized by a first released composition for alkalizing the tract to a desired non-acidic condition for a period of time suited to such activity, and a second released composition for acidifying the tract at about the end of such period.
16. Vaginal conditioning material according to claim 15, characterized further in that the alkalizing composition is buffered to a pH within the range of about 7.5 to about 8.
17. Vaginal conditioning material according to claim 16, characterized further in that the acidifying composition has a pH of at most about 5.
18. Vaginal conditioning material according to claim 17, characterized further in that the acidifying composition comprises a spermicide and is buffered to a pH within the range of about 3 to 4.
19. Vaginal suppository characterized by a first soluble envelope surrounding the first released composition, and a second soluble envelope surrounding the second released composition, of the conditioning material of claim 15.
20. Vaginal suppository characterized by at least one soluble envelope and a plurality of pH-adjusting materials surrounded thereby and including at least a pH-increasing composition.
21. Vaginal suppository according to claim 20, and characterized in that such a soluble envelope is alkaline, and such envelope surrounds an acidifying composition.
22. Vaginal suppository according to claim 21 , and characterized in that such a soluble envelope is non-acidic, and such envelope surrounds an alkalizing composition.
23. Vaginal suppository according to claim 22, and characterized in that such envelope surrounds another soluble envelope, and the latter envelope surrounds an acidifying composition.
24. Vaginal suppository according to claim 20, and characterized in that such envelope surrounds a multiplicity of." beadlike capsules, including more readily soluble capsules comprising alkalizing composition and less readily soluble capsules comprising acidifying composition.
25. Vaginal suppository according to claim 20, and characterized in that such soluble envelope is composed in substantial part of methyl cellulose, carboxymethyl cellulose, or like soluble cellulosic material, including a readily soluble first portion surrounding an alkalizing composition having a pH in the range of about 7.5 to 9 and comprising a salt of a weak acid and a strong base, and including also a less readily soluble second portion surrounding an acidifying composition having a pH of at most about 5 and comprising a weak acid.
26. Vaginal suppository according to Claim 25, and characterized in that the alkalizing composition comprises disodium phosphate, and the acidifying composition comprises citric acid.
27. Vaginal suppository according to Claim 25, and characterized in that it is shaped in elongated configuration having two envelopes, each envelope surrounding a compartment containing one of the compositions, and with the envelope containing the acidifying composition surrounded by and joined to the envelope containing the alkalizing composition.
PCT/US1986/001972 1985-09-23 1986-09-22 Vaginal conditioning for sexual activity WO1987001585A2 (en)

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GB8711630D0 (en) 1987-06-24
US4670256A (en) 1987-06-02
GB2191942B (en) 1989-12-06
AU6377386A (en) 1987-04-07
WO1987001585A3 (en) 1987-05-21
EP0240545A1 (en) 1987-10-14
GB2191942A (en) 1987-12-31

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