GB2125697A - Lubricating suppository - Google Patents

Abstract

A suppository for the vaginal canal, solid at normal ambient temperatures but which melts at body temperature to form a homogeneous liquid having the appearances of a single liquid phase comprises: (a) a continuous phase of a water- soluble polyoxyalkylene polyol component consisting of polyoxyethylene glycol of molecular weight from 400 to 5000, the component being formulated to have a melting range low enough for the formation of a clear molten liquid at less the 75 DEG C; (b) from 10 to 60 parts per 100 (based on the weight of polyol) of a non-ionic surfactant of HLB value greater than 12, the surfactant being uniformly distributed through the continuous phase; (c) from 10 to 40 parts per 100 (based on the weight polyol), of a glyceride of an aliphatic carboxylic acid, distributed throughout the continuous phase with the aid of the non-ionic surfactant. e

Description

SPECIFICATION Lubricating suppository production and use thereof This invention relates to a lubricating suppository, the production and use thereof; more particularly it relates to a lubricant which is intended specifically for the human vagina.

One aspect ofthe present invention relates to a pre-coital lubricant in suppository form. Another aspect ofthe present invention relates to a method for lubricating the human vagina by insertion ofa solid suppository which melts to form a lubricant at human body temperature. A further aspect ofthe present invention relates to a process for producing a lubricant ing suppositoryfrom a plurality of generally solid materials, at least one of which is lubricious at normal ambient temperatures.

Avariety of materials have been suggested as lubricants for human body canals, particularly the vaginal and anal canals. The requirements of such lubricants vary depending upon the reason for lubricating the inside surfaces ofthe canal. Prior to or during coitus, the human body itself provides some natural lubrication. However, there is a well-estab lished marketformaterialswhichsupplementthe function ofthe natural lubricant Theoretically, various lubricious materials which are not harmful to skin could be a pre-coital lubricant, and petroluem jelly, mineral ortriglyceride oils and similar biologically-inert oleophilic materials have been ued forthis purpose.Like oleophilic materials, however, they are capable of staining fabric, are relatively incompatible with natural vaginal moisture and may resist removal from the skin or the interior of the vaginal canal when plain water rinses are used.

Accordingly, the pharmaceutical, cosmetic and personal care industries have made efforts to formulate lubricants which are better suited for pre-coital use and othervaginal canal lubricating purpses. A composition known as "KYJelly" is an example of a sterile, general purpose lubricant with label instruc tionsforuse as a lubricant in obstetrical andgynecolo- gical procedures and to aid in the insertion of thermometersand other instruments inthevagina or rectum. "Ortho Personal Lubricant", on the other hand, is an example of a composition labelled for use specifically for sexual intercourse. Nevertheless, the latter product is somewhat similar in its composition to the sterile general purpose jelly.Both products contain a major amount of water combined with a cellulose derivative and are packaged in collapsible tubes. The predominantly aqueous nature of these products may provide advantages over oleaginous materialsforthe above reason, but, because the water component of both of these formulations appears to play an important role in making the product lubricious, upon evaporation, the lubricity may be lost.

Such evaporation may occur even during coitus.

When insertion of a material into a human body canal (particularlythevagina oranus) is desirable, suppositories have advantages and are often preferred by patients, doctors and other users. The suppository art is a highly developed one, particularly with respect to suppositories which provide a matrix for releasing some medicament. Such suppositories may be made lubricious; see,forexample, U.S. Patent No.

3,776,001. Medicatorsand tampons, for example have also to be made lubricious, at least on the surfaces thereof. The following references are believed to be representative ofthis art: U.S. Patent Nos. 3,756,238; 3,815,600; 3,884,233; 3,886,940; 4,026,292; and 4,140,756.

It has now been found that a pre-coital lubricant may be formulated such that it is suitableforformation into suppositories and is not dependent upon a high water content or moisture to be lubricious, but yet is water-washable to a far greater degree than the common oleaginous lubricants. Indeed,the present lubricants have a high level ofcompatibilitywith plain water and may easily be solvated or uniformly distributed (dissolved andlor dispersed andlorsus- pended) in water.Suppositories in accordance with the present invention are solid at normal ambient temperatures, but melt at human bodytemperature to form a substantially homogeneous liquid having the appearance of a single liquid phase, even though a glycerideofan aliphatic carboxylic acid is distributed through this homogeneous liquid.In eitherthe liquid orthe solid state, the present suppositories comprise: (a) a continuous phase comprising a polyoxyalkylene polyol component consisting essentially of polyethyleneglycols having a molecularweightof from 400 to 5,000, so that this component will have a melting range low enough for the present purposes; (b) from 10to 60 parts, per 100 parts, by weight, of the above polyol component, (typically from 10to 30%, by weight, of the suppository), of a non-ionic surfactant having an HLB value of greater than 12 (typically this surfactant dissolves in the above polyol component); and (c) from 10 to 40 parts, per 100 parts, based on the weight of the above polyol component, of a glyceride (preferably a triglyceride) of an aliphatic carboxylic acid, which glyceride is uniformly distributed throughoutthe continuous phase with the aid of the non-ionic surfactant.

The human vagina may be pre-coitally lubricated using such a suppository by inserting the solid suppository and permitting itto meltwithinthe vaginal canal priorto coitus. The melting is generally complete within averyfewminutes. If desired the insertion may take place upto a few hours before coitus.

Suppositories in accordance with the present invention are made by melting the polyethylene glycols at a moderately elevated temperature, thereby obtaining a homogeneous melt. The preferred non-ionicsurfactant (including surfactant combinations) may be dissolved in the melt. The resulting hot mixture is a suitable medium for distributing the glyceride, which is the primary lubricating substance. When a suitable blend has been formed, it may be cast into the form of suppositories using moulds or a suppository packaging material that serves as both mould and package.

As will be apparent from the foregoing, the present invention is directed specifically to the requirements of pre-coital lubrication, although the presentsuppositories may incidentally facilitate insertion of, for example, medical instruments into human body canals. For coital lubrication, compatabilitywith water or moisture is desirable not only to provide water washability, but also to facilitate combination with natural vaginal moisture and uniform spreading over all the surfaces ofthe vaginal canal. A relatively low viscosity in the molten state also improves the pre-coital lubricating function in accordance with the present invention.Such low viscosity may have one drawback, however: the lubricant may easily pass from the vaginal canal onto clothing or otherfabric. To overcome this drawback, it has been foundthat an extremely high level of water compatibility may be provided without losing the other advantages ofthe present invention. Asolid residue or stain (e.g. on fabric) from such leakage may be removed with plain water because of the extraordinarily high level of dispersion ofthe oleaginous phase or phases of the lubricant and the compatibility ofthe non-ionic surfactants with the polyoxyethylene glycol base.

Compositions in accordance with the present invention need not and preferably do not contain solid material which will not readily disperse of become suspended in water. Even the priorart cellulosic materials are more difficultto suspend ordisperse in waterthanthe presentcompositions. The polyoxyalkylene polyol component, since it consists essentially of polyethylene glycols, is essentially soluble in water.

The non-ionic surfactant component is essentially soluble in the polyethylene glycols, thereby simplifying the phase relationship between the glycols and the glyceride lubricant. The concentration of non-ionic surfactant is sufficiently high to ensure that the glyceride will be well emulsified and may be re emulsified if a spot or stain on fabric results from the application of the present invention.

Even in the absence of natural vaginal moisture, a fully or partially melted suppository orvaginal insert in accordance with the present invention has lubricating properties. The present unique combination of ingredients further allows the melted lubricating substance to become miscible with the vaginal moisture present even in small amounts. As the insert or suppository melts and mixes with any vaginal moisture, it spreads readilythroughoutthe vagina. In addition, the lubricity provided bythe present invention is not reduced due to evaporation of moisture during coitus.

In addition to the glycol, glyceride lubricant and surfactant components ofthe present composition, it may be further modified by a lower aliphatic monomeric hydrophilic polyol which will dissolve in the glycol phase. A preferred monomeric polyol is glycerin. Pigments, fillers, extenders, preservatives and antioxidants may also be included in the composition, but it is generally preferred to avoid the use of fillers, extenders, or pigments which will ieave a visible solid residue. For antioxidant or preservative effects, various FDA-approved compounds are suitable, including the conventional alkylated hydroxy aromatic compounds, such as BHT (butylated hydroxytoluene) or BHA (butylated hydroxyanisole).

The major amount ofthe continuous phase comprises one or more (preferably a blend) of polyoxyethylene or polyethylene glycols. These glycols contain an oxyethylene chain having an extraordinary compatibility with water and a hydroscopicity of at least 0.1%, preferably at least 1% of glycerin.Because these polyethylene glycols comprise such a large proportion ofthe lubricating suppository, it is prefer red that a single such glycol (if used alone) or a combination of such glycols be solid at normal ambienttemperatures (from 20to 25"C) and preferably at moderately elevated temperatures which may inadvertantly be reached during storage, e.g. 30 or 35"C. Onthe other hand, it is desirablethattheglycol component be capable of melting at temperatures close to human bodytemperature (e.g. 37"C). The melting point of the glycol component may of course, be depressed by blending with compatible liquids or low-melting solids.Nevertheless, it is preferable that, in the absence of such liquids or low-melting solids, the glycol component have a melting point or melting range sufficiently low to ensure the formation of a clear molten liquid at less than 75"C., more preferably at lessthan 55Or60 C.Among the low-melting solids and liquids which may provide the melting point depressant effect are low molecular weight polyoxyethylene glycols which are available in molecular weights well below 1,000 (equivalent weights well below 500). It is preferred, however, to keep the molecularweightofthe lowest-melting glycol above 400. A polyethylene glycol having an average molecularweight of about 500 could be a solid at 20"C, but may have the consistency of low-melting petrolatum.

Polyoxyethylene glycols are available in molecular weights above 1,000,000, but most ofthe molecular weight range above 5,000 is of limited utility forthe present purposes because ofthe relatively high melting points or solidification ranges of such mate rials. The optimum average molecular weight range for glycols useful in accordance with the present invention is above 900 and below 2,000, thereby ensuring a solidification range below 60"C. A blend of such glycolswithinthis molecularweight range will generally begin to melt attemperatures no higher than 50"C. With "finetuning" ofthe blend, it may be formulated to begin to melt at 36-38 or39'C,which is approximately the ideal melting range, absent a melting point depressant otherthan a low molecular weight polyoxyehtylene glycol. With a melting point depressant th is range may be extended to 40"C or higher, as explained above. In any event, it is desireablethattheglycol component begin to melt at 3638"Cwithin afew minutes.

A particularly effective way to provide the waterwashability of lubricating compositions in accordance with the present inventtin is to ensure thatthe glyceride (e.g. the glyceryl trialkanoate) is well distributed with a surfactant component which is compatible with the polyethylene glycols in the continuous phase and, perhaps equally important, thatthese glycols have a measurable degree of water solubility, e.g. more than 10%, by weight. A remarkable feature of the polyethyleneglycolsisthateven relatively high polymers of ethylene oxide have water solubility. At relatively low molecular weights, these hydroxy-terminated polymers will dissolve to the extent of about 70%, by weight, (or more) in water. As the molecularweightincreases into the thousands, the water solubility declines, but not drastically.

Polyoxyethylene glycols used in accordance with the present invention, either individually or in combination, typically have a water solubility in excess of 50% on a weight'weight basis. For this reason, mixtures of oxyethylene polymers with oxypropylene of tetramethyleneoxy polymers are not preferred. Among nonionic polymers, i it is difficultto improve upon the water solu bility of the oxyethylene (i.e. ethylene oxide) polymers, and certainlythe water compatibil- ity of propylene oxide orotheroxyalkylene polymers is meagre in comparison to the polyoxyethylenes. In short, the oxyalkylene chains obtained from twocarbon oxyalkylen units are unique among this class of structures, particularly in terms of the compatibility with water thereof.Absent modification with pendant or recurring oxyethylene units, other hydrophilic solids, such as cellulose, also lackthis extraordinarily high degree of water compatibility. Relatively hydrophobic or oleophilic compounds which may detract from the water compatibility ofthe present glycol component are preferably excluded from this compo nent With the exception of very minor amounts of antioxidants and preserrvaives, for example, it will generally be the case that the least hydrophilic ingredient ofthe composition in accordance with the present invention will be the glyceride, which is substantially insoluble in water.

In typical sippository compositions in accordance with the present invention, from 50 to 70%, by weight, ofthe composition is this glycol component.

The total composition contains a non-ionic su rfactant component which may be uniformly distributed (dissolved, dispersed or suspended) through the continuous phase. It is generally preferred thatthis surfactant component be sufficiently compatible with the continuous phase to form a part of it, thereby simplifying the phase relationships within the composition.It is also preferred that the su rfactant have a significant degree of compatibility with water, which may be provided by selecting surfactant compounds or compositions having an HLB value of greaterthan 12, more preferably greater than 14. (The HLBvalue is the "hydrophile-lipophile balance" and is determined in accordance with well known procedures published in the scientific and trade literature; HLB values of below9 are considered generally lipophilic, values of 9-11 are considered intermediate or borderline and value of about 12 are clearly hydrophilic.) Although HLB values of 20 or30 or more have been reported, it isgenerallyunnecessaryto usenon-ionicsurfactants having values significantly above 18.When a combination of surfactants is used (as is particularly preferred in accordance with the present invention), the overall HLBvalue may be determined on a weighted-average basis, as conventional in the detergent art. Some non-ionic emulsifiers and other surfactants will actually dissolve in molten polyoxyethylene glycols, foremost among these su rfactants being those connaining oxyethylene chains, such as the poly(oxyethylene) polyol esters, poly(oxyethylene) polyol ethers and mixtures of these esters and ethers. Some of these compounds, such as polyoxyethylene (20) sorbitan mono-oleate, are also water-soluble. Several series of polyoxyethylene ethers of higher aliphatic alcohols are commercially available, as are the polyoxyethelene derivatives of higher aliphatic carboxylic acids, e.g. the polyoxyethylene polyol alkanoates.Unsaturated aliphatic carboxylic acids and alcohols may also be used to form the desired polyoxyethylene derivatives. A significant degree of higher aliphatic character may be obtained with acids and alcohols containing at least 6 carbon atoms, preferably at least 10 carbon atoms. At C28 and higher, the aliphatic character may become excessive and may even be somewhat excessive at C20 or C22. Relatively hydrophilic nuclei, such as sorbitan and other lower aliphatic monomeric polyols, may help to counterbalance the aliphatic character of carbon chains in the C12 -C20 range. An example of a thus-balanced compound is polyoxyethylene (20) sorbitan mono-oleate.

There may be distinct advantages in adding a lower aliphatic monomeric hydrophilic polyol to the con tinuousphase. Glycerin,for example, is of interest because of its extraordinary affinity for water, from 10 to 100 times as much hygroscopicity as the preferred polyoxyethylene glycols. Glycerin, in fact, is commonly used as a humectant, as well as a solvent, a plasticizer and an emollient.It is a common ingre dientofanal suppositories and is considered safe and effective for a variety of medical uses. (Surfactants generally used in accordance with the present invention are also considered to be safe materials, the particularly preferred ones having been cleared forfoodordrug use.)Although glycerin is an optional ingredient in the present suppositories, it is generally preferred to include from Sto 20%, by weight, based on the total weight ofthe suppository composition of this compound.

The most important ingredient ofthe phase which is emulsified in the continuous phase is a lubricious glyceride, preferably a trig Iyceride generally consi- dered to be safe and effective for lubricating or plasticizing human skin. The glyceryl lower alkanoates, such as triacetin and tributyrin, tend to be high boiling liquids which may have plasticizing properties, but are less effective as lubricants as compared to triglycerides of the aliphatic carboxylic acids having 6 or more carbon atoms. Some of the most preferred lubricants for skin are of coconut origin and contain triglycerides of Ce - C18 carboxylic acids, particularly the saturated aliphatic acids (e.g. capric, caprylic, lauric, palmitic and stearic acids).These triglycerides may be fractionated to shift the content toward eitherthe C6 -C12triglycerides or the C12 -C18 triglycerides, as may be desired. Unfortunately, all of these triglycerides are substantially insoluble in water. Even glyceryl tributyrate (the C4 analogue of the coconut-origin triglycerides) is reported to have a solubility in water of only 0.01%. However, the highly effective emulsifier of su rfactant component in accordance with the present invention provides excellentwaterwashability and the prospect of virtuallytotal removal oftriglyceride residue from clothing or otherfabric with an essentially plain water rinse. In addition, this emulsifier system helps to provide a clear, apparently homogeneous melt within and above the melting range ofthe present suppository. Although the present invention is notto be regarded as bound by a theory, it is believed that the triglyceride is extremely well dispersed in the composition to the point where the composition approachesthe nature of true solution.

The oxyethylene glycols are normallythefirst ingredients charged to a heated mixer since they normally comprise the majoramountofthesupposi- tory composition. Thetemperature within the mixer is maintained at a sufficiently high level to maintain the glycols in the molton state without approaching the flash point of any component of the composition.

Ordinarily, it is not necessary to exceed a temperature of about 75"C in the mixer. The glycols form a clear melt, to which the non-ionic surfactant system may be added, and preferably, dissolved with stirring. The glyceride is also added under constant stirring and from 1 5to 20 minutes will typically be a sufficient period of agitation thoroughlyto disperse or suspend this component. The resu It will be a uniform distribution of all components ofthe composition. The glycerin or other hydrophilic polyol may be added to the composition ata suitable stage during production.

The heated mass may be poured from the mixer into moulds, demoulded and then individually wrapped in foil/laminate packaging material. Cooling of the mould is particularly desired for the purpose of obtaining rapid and complete solidification of the portion of molten material which has been poured into the mould. Alternatively, the heated mass may be cast into a preformed suppository packaging material that serves as both mould and package.

The preferred method of use isto insert the suppository into the vagina at least 5 minutes priorto sexual intercourse. If this procedure is not convenient the suppository may be inserted as much as an hour ortwo before intercourse and a sufficient amount of liquid lubricantwill still be present in the vaginal canal when intercourse is commenced. After thorough melting of the suppository, leakage of the molten lubricant from the vaginal canal will novitiate the effectiveness ofthe present invention, beacuse of the compatibility ofthe triglyceride with natural lubricants, the ease of blending ofthe lubricant with natural moisture which may be present, the spreading ofthe lubricantthroughoutthe canal and the effectiveness of very small residual amounts ofthe lubricant.

The present invention is illustrated by the following Example.

Example Asolid suppositorywas castfrom the following formulation.

Ingredient Parts, by Weight Polyethylene glycol, average 25 molecularweight 1300-1600, solidifying range 40-50"C, soft, white waxy solid, solubility in water at 20"C, approximately70% (weightlweight), pH of a 5% aqueous solution about 6.5 (CARBONWAX (Registered Trade Mark) 1540) Polyethylene glycol, average 25 molecularweight 950-1050, solidifying range 35-40 C, solubility in water at 20"C about 70% on a weig htlweight basis (CARBOWAX 1000) Glycerin 10 Polyoxyethylene (23) lau ryl 10 ether (BRIJ 35) Polyoxyethylene (20) sorbitan 5* mono-oleate (TWEEN (Registered Trade Mark) 80) Polyoxyethylene (40) stearate 5 (MYRJ 52-5) Fractionated triglyceride of 20 coconutorigin (caprylic/ caprictriglyceride NEOBEE M-5) * Alternatively, may be replaced with more BRIJ or MYRJ.

The HLB value of the polyoxyethylene lauryl ether and the polyocyethylene stearate is normally within the range offrom 16.5 to 17. The HLB value ofthe polyoxyethylene sorbitan mono-oleate is normally 15. Accordingly,the average HLB value of the non-ionic surfactant system in accordance with the present invention is above 16. The glycol component was melted and maintained within the temperature range offrom 55-70"C during production of the suppository compositions. Production was carried out on a batch basis, but it may also be done continuously.

1 part of antioxidant, BHT (butylated hydroxy toluene) was added to 10,000 parts ofthe above described composiiti A suppository cast from this composition was 30 mm in length and 13 mm wide at its widest point. (Suppositories from 10 to 50 mm in length and from 2 to 20 mm in width may easily be case and moulded.) Although not generally preferred, medicaments related to coitus, such as spermicides and bacter icides may be added to suppository compositions in accordance with the present invention.

Throughoutthis specification, the terms "polyethylene glycol" and "polyoxyethylene glycol" are used synonymously.

Claims (15)

CLAIMS:

1. A lubricating suppositoryforthe human vagin al canal, which suppository is solid at normal ambient temperatures, but melts at human body temperature to form a substantially homogeneous liquid having the appearance of a single liquid phase, which comprises: (a) a continuous phase comprising a water-soluble polyoxyalkylene polyol component consisting essen tially of polyoxyethylene glycol having a molecular weight of from 400 to 5000, the said component being formulated to have a melting range sufficiently low to ensuretheformation of a clear molten liquid at less than 75"C;; (b) from 10 to 60 parts per 100 based on theweight of the said polyoxyalkylene polyol component, of a non-ionic surfactant having an HLB value of greater than 12, the said non-ionic surfactant being uniformly distributed through the said continuous phase; (c) from 10 to 40 parts per 100 based on the weight of the said polyoxyalkylene polyol component, of a glyceride ofan aliphatic carbocylic acid, the said glyceride being uniformly distributed throughoutthe said continuous phase with the aid ofthe said non-ionic surfactant; the said lubricating supposi tory; in eitherthe solid or molten state, having sufficient compatibility with water to be readily uniformly distributable in water.

2. Asuppository as claimed in claim 1 wherein the said continuous phase further comprises a lower aliphatic monomeric hydrophilic polyol dissolved in the said continuous phase.

3. Asuppository as claimed in claim 2 wherein the said hydrophilic polyol is glycerin.

4. Asuppository as claimed in any of claims 1 to 3 wherein the said non-ionic surfactant comprises a blend of oxyethylene chain-containing ester or ethers, the said blend having an HLB value of above 14, the ester or ether functional groups ofthe said esters or ethers comprising a higher aliphatic residue.

5. Asuppositoryas claimed in claim 4wherein the said HLB value is less than 18.

6. A suppository as claimed in any of claims 1 to 5 comprising: (a) from 50to 70%, by weight, of a blend of polyoxyethylene glycols having a molecularweight of from 900 to 2000, which blend at leastbeginsto melt attemperatures of no higherthan 50"C; (b) dispersed in the said blend of polyoxyethylene glycols, from 10 to 20%, by weight, of a triglyceride of C6 -C18 saturated aliphatic carboxylic acids; (c) dissolved in the said blend of polyethylene glycols,from 10 to 30%, by weight, of a blend of non-ionic surfactants selected from poly(oxyethylene) polyol esters, poly(oxyethylene) polyol ethers and mixtures thereof, the said blend having a weight-average HLB value of at least 14;; and (d) from 0 to 20%, byweight, of glycerin dissolved in the said blend of polyoxyethylene glycols.

7. A suppository as claimed in any of claims 1 to 6 further comprising an effective amount of an antioxidant.

8. A solid, pre-coital, vaginal lubricant suppository as claimed in claim 1 which melts at 37"C, the said suppository having been cast and solidified from a genrally homogeneous motel mass comprising: a continuous phase consisting essentially of: (a) from 50 to 70%, byweight, based on the weight of the suppository, of a blend of g lycols consisting essentially of: (1) a polyoxyethylene glycol having an average molecularweightoffrom 900 to 1100; and (2) a polyoxyethylene glycol having an average molecularweightoffrom 1200 to 1700, the ration of glycol (2)to glycol (1) being from 1:1 to4:1; (b) from Sto 20%, by weight, based on the weight of the suppository, of glycerin; (c) from 10 to 30%, by weight, based on the weight of the suppository, of a combination of non-ionic surfactants having a weighted-average HLB value of from 14to 18, the said combination c6mpnsing polyoxyethylene laurel ether and polyoxyethylene stearate; and (d) as a discontinuous phase emulsified in and distributed uniformly throughout the said continuous phase, a triglyceride of coconut origin containing caprylicandcapricacid residues.

9. Asuppository as claimed in claim 8 comprising: 50%, by weight, ofthe said glycol blend, 20%, by weight, of the said triglyceride, 10%, byweight,of glycerin, from lotto 15%, by weight, of a polyoxyethylene lauryl ether having an HLBvalueoffrom 16.5to 17, from Oto 5%, byweight, of a polyoxyethylene sorbitan mono-oleate having an HLB value of about 15, from 5to 10%, byweight,ofa polyoxyethylene stearate having an HLBvalue of from 16.5 to 17 and an effective amount of an alkylated hydroxyaromatic antioxidant.

10. A suppository as claimed in any of claims 1 to 9 substantially as herein described with particular reference to the Example.

11. A process forthe production of a lubricating suppository as claimed in any of claims 1 to 10 which is solid at room temperature, but melts at human bodytemperature which comprises: (a) melting a blend of solid polyoxyethylene glycols ata temperature above normal ambienttempera- tures, but below700C thereby obtaining a homogeneous melt; (b) dissolving in the meltfrom 10 to 60 parts per 100 based on the weight of the said polyoxyethylene glycols, of a non-ionic surfactant having an HLB value of above 12, while maintaining the melt at a temperature above normal ambient temperature;; (c) distributing throughout the resulting meltfrom 10 to 40 parts per 100 based on the weight ofthe said polyoxyethylene glycols, a solid glyceride of an aliphaticcarboxylicacid, until the said solid glyceride forms a discontinuous phase uniformly distributed through the melt and emulsified in the said melt, while maintaining the resulting emulsified, two- phase melt at a temperature above normal ambient temperature; and (d) casting portions of the resulting two-phase melt intotheform of suppositories and solidifying the thus-cast portions.

12. A process as claimed in claim 11 substantially as herein described with particular reference to the Example.

13. Amethodfor pre-coitally lubricating a human vagina with a liquid lubricant which comprises: (a) inserting a solid suppository as claimed in any of claims 1 to 10 intothevagina; and (b) permitting the said suppository to meltwithin the vagina prior to coitus to form a water-compatible, lubricious liquid coital lubricant.

14. A method as claimed in claim 13 substantially as herein described.

15. A kit which comprises a suppository as claimed in any of claims 1 to 10 and instructionsfor the use thereof.