US4347237A
Expired / Lapsed
US
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Lower fatty acid glyceride high-HLB lubricating suppository and method for making and using the same
Assignee: Upsher Smith Laboratories LLC
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Filing: 1981-03-02
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Granted: 1982-08-31
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Expires: 2001-03-02
Abstract
Abstract The disclosed lubricating suppository is formulated to have properties advantageous for coital use, including extraordinary water washability. The ingredients and phase relationships of the suppository composition provide a high degree of compatibility with water and with naturally-occurring vaginal moisture. The suppository composition contains a glyceride lubricant and can be lubricious with or without the presence of moisture. The suppository, which is solid at room temperature but melts in a short time at body temperature, is made by dissolving, for example, 10-30 parts by weight of high-HLB (e.g. >14) nonionic surfactant in 50-70 parts by weight of a molten, water-soluble polyoxyethylene glycol component and by dispersing or emulsifying 10-20 parts by weight of the glyceride (e.g. a triglyceride of C 6 -C 18 aliphatic carboxylic acids) included in the composition. In use, the suppository can be inserted prior to coitus and permitted to melt to a liquid, which is lubricious even in the absence of moisture, but still has the aforementioned extraordinary water washability.
Inventors
- 👤 Kenneth L. Evenstad
- 👤 Hiep Nguyen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 17:38
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/02; Y; Y10; Y10S; Y10S424/00; Y10S424/14; Y10S424/15
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
191 words
A lubricating suppository for the human vaginal 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, said suppository comprising: (a) a continuous phase comprising a water soluble polyoxyalkylene polyol component consisting essentially of polyoxyethylene glycol having a molecular weight within the range of 400 to 5000, said component being formulated to have a melting range low enough to ensure the formation of a clear molten liquid at less than about 75° C.; (b) about 10-60 parts per one hundred parts by weight of said polyoxyalkylene polyol component, of a nonionic surfactant having an HLB value greater than 12, said nonionic surfactant being uniformly distributed through said continuous phase; (c) about 10-40 parts per hundred, based on the weight of said polyoxyalkylene polyol component, of a C 6 -C 12 aliphatic carboxylic acid glyceride said glyceride being uniformly distributed throughout said continuous phase with the aid of said nonionic surfactant; said lubricating suppository, in either the solid or molten state, having sufficient compatibility with water to be readily uniformly distributable in water.
Claim 2
Dependent Claim
191 words
A lubricating suppository for the human vaginal 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, said suppository comprising: (a) a continuous phase comprising a water soluble polyoxyalkylene polyol component consisting essentially of polyoxyethylene glycol having a molecular weight within the range of 400 to 5000, said component being formulated to have a melting range low enough to ensure the formation of a clear molten liquid at less than about 75° C.; (b) about 10-60 parts per one hundred parts by weight of said polyoxyalkylene polyol component, of a nonionic surfactant having an HLB value greater than 12, said nonionic surfactant being uniformly distributed through said continuous phase; (c) about 10-40 parts per hundred, based on the weight of said polyoxyalkylene polyol component, of a C 6 -C 12 aliphatic carboxylic acid glyceride said glyceride being uniformly distributed throughout said continuous phase with the aid of said nonionic surfactant; said lubricating suppository, in either the solid or molten state, having sufficient compatibility with water to be readily uniformly distributable in water.
Claim 3
Dependent Claim
23 words
A suppository according to claim 1 wherein said continuous phase further comprises a lower aliphatic monomeric hydrophilic polyol dissolved in said continuous phase.
Claim 4
Dependent Claim
12 words
A suppository according to claim 2 wherein said hydrophilic polyol is glycerin.
Claim 5
Dependent Claim
44 words
A suppository according to claim 1 wherein said nonionic surfactant comprises a blend of oxyethylene chain-containing esters or ethers, said blend having an HLB value above about 14, the ester or ether functional groups of said esters or ethers comprising a higher aliphatic residue.
Claim 6
Dependent Claim
15 words
A suppository according to claim 4 wherein said HLB value is less than about 18.
Claim 7
Dependent Claim
131 words
A suppository according to claim 1 consisting essentially of: (a) 50-70% by weight of a blend of polyoxyethylene glycols with a molecular weight within the range of about 900 to about 2000, which blend at least begins to melt at temperatures no higher than about 50° C.; (b) dispersed in said blend of polyoxyethylene glycols, 10-20% by weight of a triglyceride of at least one C 6 -C 12 saturated aliphatic carboxylic acids; (c) dissolved in said blend of polyethylene glycols, 10-30% by weight of a blend of nonionic surfactants selected from the group consisting of poly(oxyethylene) polyol ethers, poly(oxyethylene) polyol ethers, and mixtures thereof, said blend having a weight-average HLB value of at least about 14; and (d) 0-20% by weight of glycerin dissolved in said blend of polyoxyethylene glycols.
Claim 8
Dependent Claim
15 words
A suppository according to claim 6 which further includes an effective amount of an antioxidant.
Claim 9
Dependent Claim
164 words
A solid, pre-coital, vaginal lubricant suppository which melts at 37° C., said suppository having been cast and solidified from a generally homogeneous molten mass comprising: a continuous phase consisting essentially of: (a) 50-70% by weight, based on the weight of the suppository, of a blend of glycols consisting essentially of: (1) a polyoxyethylene glycol having an average molecular weight of 900-1100, and (2) a polyoxyethylene glycol having an average molecular weight of 1200-1700, the ratio of glycol (2) to glycol (1) ranging from about 1:1 to about 4:1; (b) 5-20% by weight, based on the weight of the suppository, of glycerin; (c) 10-30% by weight, based on the weight of the suppository, of a combination of nonionic surfactants having a weighted-average HLB value of about 14 to about 18, said combination comprising polyoxyethylene lauryl ether and polyoxyethylene stearate; and (d) as a discontinuous phase emulsified in and distributed uniformly throughout said continuous phase, a triglyceride of coconut origin containing caprylic and capric acid residues.
Claim 10
Dependent Claim
164 words
A solid, pre-coital, vaginal lubricant suppository which melts at 37° C., said suppository having been cast and solidified from a generally homogeneous molten mass comprising: a continuous phase consisting essentially of: (a) 50-70% by weight, based on the weight of the suppository, of a blend of glycols consisting essentially of: (1) a polyoxyethylene glycol having an average molecular weight of 900-1100, and (2) a polyoxyethylene glycol having an average molecular weight of 1200-1700, the ratio of glycol (2) to glycol (1) ranging from about 1:1 to about 4:1; (b) 5-20% by weight, based on the weight of the suppository, of glycerin; (c) 10-30% by weight, based on the weight of the suppository, of a combination of nonionic surfactants having a weighted-average HLB value of about 14 to about 18, said combination comprising polyoxyethylene lauryl ether and polyoxyethylene stearate; and (d) as a discontinuous phase emulsified in and distributed uniformly throughout said continuous phase, a triglyceride of coconut origin containing caprylic and capric acid residues.
Claim 11
Dependent Claim
85 words
A suppository according to claim 8 comprising: 50% by weight of said glycol blend, 20% by weight of said triglyceride, 10% by weight of glycerin, 10-15% by weight of a polyoxyethylene lauryl ether having an HLB value of about 16.5 to about 17, 0-5% by weight of a polyoxyethylene sorbitan mono-oleate having an HLB value of about 15, 5-10% by weight of a polyoxyethylene stearate having an HLB value of about 16.5 to about 17, and p1 an effective amount of an alkylated hydroxyaromatic antioxidant.
Claim 12
Dependent Claim
48 words
A method for pre-coitally lubricating the human vagina with a liquid lubricant comprising the step of: (a) inserting a solid suppository of claim 1 into the vagina, and (b) permitting said suppository to melt within the vagina prior to coitus to form a water-compatible, lubricitous liquid coital lubricant.
Claim 13
Independent Claim
175 words
A method for making a lubricating suppository which is solid at room temperature but melts at human body temperature, comprising the following steps: (a) melting a blend of solid polyoxyethylene glycols at a temperature above normal ambient temperatures but below about 75° C., thereby obtaining a homogeneous melt; (b) dissolving in the melt about 10-60 parts by weight, per 100 parts by weight of said polyoxyethylene glycols, of nonionic surfactant having a HLB value above 12, while maintaining the melt at a temperature above normal ambient; (c) distributing throughout the melt produced by step (b) about 10-40 parts by weight, per 100 parts by weight of said polyoxyethylene glycols a solid glyceride of at least one C 6-12 aliphatic carboxylic acid, until said solid glyceride forms a discontinuous phase uniformly distributed through the melt produced by step (b) and emulsified in said melt, while maintaining the resulting emulsified, two-phase melt at a temperature above normal ambient; and (d) casting portions of the resulting two-phase melt into the form of suppositories and solidifying the thus-cast portions.
Claim 14
Independent Claim
175 words
A method for making a lubricating suppository which is solid at room temperature but melts at human body temperature, comprising the following steps: (a) melting a blend of solid polyoxyethylene glycols at a temperature above normal ambient temperatures but below about 75° C., thereby obtaining a homogeneous melt; (b) dissolving in the melt about 10-60 parts by weight, per 100 parts by weight of said polyoxyethylene glycols, of nonionic surfactant having a HLB value above 12, while maintaining the melt at a temperature above normal ambient; (c) distributing throughout the melt produced by step (b) about 10-40 parts by weight, per 100 parts by weight of said polyoxyethylene glycols a solid glyceride of at least one C 6-12 aliphatic carboxylic acid, until said solid glyceride forms a discontinuous phase uniformly distributed through the melt produced by step (b) and emulsified in said melt, while maintaining the resulting emulsified, two-phase melt at a temperature above normal ambient; and (d) casting portions of the resulting two-phase melt into the form of suppositories and solidifying the thus-cast portions.
Claim 15
Dependent Claim
11 words
A lubricating suppository made according to the method of claim 11.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1985-08-30 | 1986-03-01 | 1986-08-31 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1989-08-30 | 1990-03-01 | 1990-08-31 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1993-08-30 | 1994-03-01 | 1994-08-31 | $7700.00 | Window Closed / Lapsed |