Feminine hygiene products

Abstract

Disclosed are acidic feminine intimate cleansing compositions having a pH in the range of from 3 to 5, which further necessarily comprises at least: as a primary antimicrobial active constituent, lactic acid, which may optionally be a substituted lactic acid and/or derivative thereof; and which composition further includes an anionic constituent system which boosts the antimicrobial efficacy of the primary lactic acid constituent present; and which compositions feature low irritation, and good antimicrobial efficacy against certain species of bacteria. Treatment processes using the feminine intimate cleansing composition in treatment of the groin area of human females, and vendible products containing the feminine intimate cleansing compositions are also disclosed.

Claims

1. An acidic feminine intimate cleansing composition effective in treating the vaginal region of the female body and the vagina, the composition having a pH in the range of from 3.5 to 5, comprising: as a primary antimicrobial active constituent one or more of: lactic acid and/or a substituted lactic acid and/or a salt and/or a derivative thereof; and a ternary anionic constituent system comprising (a) a secondary alkane sulfonate compound, (b) an N-acyl sarcosinate compound, and (c) an aromatic hydrotrope compound, wherein in the components (a), (b), and (c) of the ternary anionic constituent system are present in relative parts by weight of (a):(b):(c) in the range of : 0.5-4.5:0.025-0.25:1, with the proviso that salicylic acid, salicylic acid salts and salicylic acid derivatives are excluded from the compositions.

2. A composition according to claim 1, wherein in the components (a), (b) and (c) of the ternary anionic constituent system are present in relative parts by weight of (a):(b):(c) in the range of: 0.5-4:0.025-0.25:1.

3. An acidic feminine intimate cleansing composition effective in treating the vaginal region of the female body, and the vagina, the composition having a pH in the range of from 3.5 to 5, comprising: as a primary antimicrobial active constituent one or more of: lactic acid, and/or a substituted lactic acid and/or a salt and/or a derivative thereof; and a binary anionic constituent system which necessarily comprises one comprises (a) a secondary alkane sulfonate and (c) an aromatic hydroptrope compound in relative parts by weight of (a):(c) in the range of: 0.5-4.5:1 or (b) an N-acyl sacrosinate compound and (c) aromatic hydroptrope compound in relative parts by weight of (b):(c) in the range of : 0.025-0.25:1 with the proviso that salicylic acid, salicylic acid salts and salicylic acid derivatives are excluded from the compositions.

4. A feminine intimate cleansing composition according to claim 1, wherein the composition exhibits antimicrobial efficacy against one or more of S.aureus, E.coli, C.albicans and/or K.pneumoniae.

5. A feminine intimate cleansing composition according to claim 3, wherein the composition exhibits antimicrobial efficacy against one or more of S.aureus, E.coli, C.albicans and/or K.pneumoniae.

6. The composition of claim 3, wherein the (c) aromatic hydrotrope compound(s) is a cumene sulfonate compound.

7. A composition according to claim 1 wherein: the (a) secondary alkane sulfonate compound is present in excess of that of the (c) aromatic hydrotrope compound, and at the same time the (b) N-acyl sarconsinate compound, are present in an amount at least about 74% less than the (c) aromatic hydrotrope compound.

8. The composition according to claim 7, which exhibits antimicrobial efficacy against one or more of S.aureus, E.coli, C.albicans and/or K.pneumoniae.

9. The composition of claim 1, wherein the (c) aromatic hydrotrope compound is a cumene sulfonate compound.

10. The composition of claim 1, wherein the composition is not disruptive of the naturally occurring bacterial flora within the vagina.

11. The composition of claim 10, wherein the composition is not disruptive of Lactobacilli already present within the vagina.

12. The composition in claim 1, wherein the composition excludes cationic compounds which independently provide an antimicrobial benefit.

13. The composition of claim 1, wherein the composition exhibits efficacy against microorganisms of the genus Candida.

Description

EXAMPLES

(1) A number of feminine intimate cleansing compositions according to the present invention are disclosed with reference to Tables IA and IB. Compositions according to the invention are identified by the use of the letter “E” prefixing one or more further numerals a/o letters, while comparative compositions are identified by the letter “C” prefixing one or more further numerals a/or letters.

(2) The formulation(s) of Table IA were produced and tested, the formulations of Table IB represent formulae which may be produced. In the compositions reported on Table 1A and 1B, the identified compounds/constituents were supplied by raw materials identified on Table 2 which may have had less than 100% wt. or were 100% wt. “active” of the named compound/constituent, however it is to be understood that the amounts of each identified compound a/o constituent is reported on Table 1 as being “100% wt. active” basis. Additionally, to each of the compositions was included deionized water in “quantum sufficient” (q.s.) in order to provide 100 parts by weight of the specific composition, and in some instances an amount of one or more pH adjusting constituents, e.g., acids and/or bases, such as sodium hydroxide, may have been added in order to establish a desired pH for the composition, which similarly required a “q.s.” amount.

(3) TABLE-US-00001 TABLE 1A E1 sodium secondary 6.66 alkane sultanate (60%) sodium lauroyl 0.70 sarcosinate (30%) sodium cumene 2.50 sultanate (40%) sodium lauryl ether 6.44 sulfate 2EO (70%) cocoamidopropyl 2.25 betaine (30%) lactic acid (90%) 2.50 PEG-4 0.90 rapeseedamide (95%) NaOH (aq. soln.) 0.10 (30%) sodium chloride 5.00 tetrasodium 0.20 glutamate diacetate (47%) preservative1 1.00 fragrance 0.25 d.i. water q.s. pH 4.19

(4) TABLE-US-00002 TABLE 1B E2 E3 E4 E5 E6 sodium secondary 6.66 2.5 — 6.66 6.66 alkane sulfonate (60%) sodium lauroyl 0.7 0.7 0.7 0.22 — sarcosinate (30%) sodium cumene 2.5 2.5 2.5 2.5 2.5 sulfonate (40%) sodium lauryl ether 6.44 6.44 6.44 6.44 6.44 sulfate 2EO (70%) cocoamidopropyl 2.25 2.25 2.25 2.25 2.25 betaine (30%) lactic acid (90%) 2.5 2.5 2.5 2.5 2.50 PEG-4 0.9 0.9 0.9 0.9 0.90 rapeseedamide (95%) glycerine 5.0 5.0 5.0 5.0 5.0 NaOH (aq. soln.) 0.1 0.1 0.1 0.1 0.10 (30%) sodium chloride 2.0 2.0 2.0 2.0 2.0 tetrasodium 0.2 0.2 0.2 0.2 0.2 glutamate diacetate (47%) preservative2 0.9 0.9 0.9 0.9 0.9 fragrance 0.1 0.1 0.1 0.1 0.1 d.i. water q.s. q.s. q.s. q.s. q.s. pH 4.2 4.2 4.2 4.2 4.2

(5) TABLE-US-00003 TABLE 2 sodium secondary secondary alkane sulfonate, sodium salt alkane sulfonate (60%) (60% wt. actives) supplied by Hostapur SAS- 60 (ex. Clariant or Nease Performance Chem.) sodium lauroyl lauroyl sarcosinate, sodium salt (30% wt. sarcosinate (30%) actives) supplied by Crodasinic LS30 NP (ex. Croda) sodium cumene sodium cumene sulfonate, sodium salt sulfonate (40%) (40% wt. actives), supplied by Eltesol SC 40 (ex. Huntsman Co.) or Naxonate 40SC (ex. Nease Performance Chemicals) sodium lauryl ether sodium lauryl ether sulfate 2EO (70% wt. sulfate 2EO (70%) actives) supplied by Texapon N70A (ex. BASF) cocoamidopropyl cocoamidopropyl betaine (30% wt. actives) betaine (30%) supplied by Mackam-35 (ex. Rhodia) lactic acid (90%) lactic acid, (90% wt. actives) supplied by lactic acid PEG-4 rapeseedamide PEG-4 rapeseedamide (95% wt. actives) (95%) supplied by Amedent-N (ex. KAO) glycerine glycerine, USP or technical grade (98-100% wt. actives) NaOH (aq. soln.) (30%) aqueous sodium hydroxide solution, (30% wt. actives) technical grade NaOH sodium chloride anhydrous sodium chloride (99-100% wt. actives), laboratory grade tetrasodium glutamate tetrasodium glutamate diacetate (47% wt. diacetate (47%) actives) supplied by Dissolvine GL-47 (ex. AkzoNobel) preservative 1 mixture of caprylyl glycol and ethylhexylglycerin supplied as Sensivia SC10 (ex. Schulke+ Mayr) and used “as supplied” preservative2 proprietary blend of benzyl alcohol, benzoic acid and sorbic acid supplied as Microcare SBB (ex. Thor Specialties Inc.) and used “as supplied” fragrance proprietary composition(s) of its respective supplier d.i. water deionized water

(6) The compositions of Tables 1A and 1B were formed, or may be formed by adding measured amounts of the identified constituent to a mixing vessel, e.g. a laboratory beaker of suitable capacity supplied with a mixing device, e.g. a motorized stilTer and mixing allowed to continue until a homogenous composition is formed. Preferably however the compositions of Table 1A and 1B are formed by adding to a beaker the water, at room temperature and under moderate stirring measured amounts of the indicated constituents, and preferably the lactic acid is the final constituent to be added, unless a minor amount of sodium hydroxide is required to adjust the final pH of the composition. Stirring is maintained until the resultant composition is homogenous, and thereafter it may be stored in a suitable container or vessel until used, or may be used immediately if so desired.

(7) Preferred embodiments of the inventive compositions are stable upon storage at room temperature (20° C.-25° C.) for at least 90 days, preferably even longer without exhibiting an undesired degradation in physical or antimicrobial properties.

(8) Antimicrobial Testing:

(9) A sample of the composition El of Table IA was tested for antimicrobial efficacy against one or more of: Staphylococcus aureus (ATTC 6538), Escherichia coli (ATCC 10536)), C. albicans (ATCC#10231), and K. pneumoniae (ATCC#4352) in accordance with the protocols of British Standard EN 1276, a quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional environments—Test Method and requirements (phase 2, step 1) Ref. No. EN 1276: 1997E the contents of which are herein incorporated by reference. The data obtained from the EN 1276 test was then used in subsequent calculations.

(10) The Log.sub.10 Average CFU/mL and the Average CFU/mL of the average of the plate counts for the Initial Population, Final Population, and Post-Exposure Populations versus each test product dilution were calculated according to the following equations:
CFU/mL=(C.sub.i×10−.sup.D)
Log.sub.10 Average=log.sub.10(C.sub.i×10−.sup.D) where: C.sub.i=Average of the plates counted D=Dilution Factor of the plates counted
The Log.sub.10 Reduction attributable to each test product dilution at each timed exposure was calculated according to the following equations:
Log.sub.10 Reduction=Log.sub.10 Average (IP)−Log.sub.10 Average (PEX) where: IP=Average CFU/mL of the Initial Population PEX=Average CFU/mL of the Post-Exposure Population
The results of the testing and calculations are reported on the following Table 3 where several Log 10 Reduction are reported for a particular formulation it is to be understood that two or more replicates of the identified formula were tested.

(11) TABLE-US-00004 TABLE 3 Micro (EN 1276) E1 S. aureus >5.22, >5.22 E. coli >5.42, >5.42 C. albicans 0.73, 0.88 K. pneumoniae >5.12, >5.12

(12) As is seen from the foregoing reported results, the inventive compositions exhibited excellent antimicrobial efficacy against the identified species of challenge organisms.

(13) The composition of Table 1A also demonstrated a low degree of topical irritation, which is of particular importance with regard to consumer acceptance of