Abstract: Alcohol-free and paraben-free waterless (dry) body bath compositions are disclosed, said compositions consisting of 87% to 95% of water, 1% to 2% of caprylyl/carpryl glucoside, 1% to 2% of cocamidopropyl betaine, 0.5% to 1.7% of phenoxyethanol, 0.5% to 1.9% of sodium benzoate, 1.6% to 2.9% of propylene glycol, 0.36% to 0.69% of disodium EDTA, 0.29% to 0.8% of citric acid, 0.001% of limonene, 0.001% of linalool, 0.001% of citronellol and 0.001% of butylphenyl methyl propional. The alcohol-free and paraben-free waterless (dry) body bath compositions leave behind no residue, maintain the smoothness and the pH of the skin, do not cause skin dryness, completely cleanse the skin by removing dirt, sweat, germs and odour, provide excellent moisturizing effect and reduce the microbiological count.
Generally, t
he present disclosure relates to
body bath
compositions
. Particularly, it relates to
waterless (dry)
body bath
composition
s
.
More particula
rly, it relates to alcohol
-
free
and
5
paraben
-
free
waterless (dry)
body bath
composition
s
.
BACKGROUND OF THE INVENTION
Bathing forms an essential part of daily routine for cleansing the body and removing dirt and
germs. Bathing soaps and body baths are widely used worldwide for this purpose. Body baths
can broadly be classified into two types: w
et body baths which requires rinsing with water
10
and waterless (dry) body baths which do not require rinsing.
While wet body baths are quite efficient, they require the use of water, which is an extremely
precious resource. Further, wet body baths compositi
ons generally contain alcohol and other
harsh chemicals
such as parabens
, which
may
cause skin
dryness and
adverse health effects
(depending on the concentration)
.
15
Waterless body bath, on the other hand, are a great way to reduce the use of water in
cleansing the skin and other body parts. Since no water is required, waterless (dry)
body
baths can be used even by people living in areas where water is scarce, including campers,
backpackers, defence personnel in remote areas, and the like. These are als
o very useful in
hospitals
for p
roviding
a warm, comfortable patient
-
friendly bathing
or sponging
alternative
20
(especially useful for bedridden patients).
However, existing waterless (d
ry
)
body baths are largely inefficient in removing body odour,
dirt, swe
at, and germs. Further, unlike wet body baths, they leave behind residue that is
difficult to remove. Moreover, the presence of harsh chemicals may cause skin rashes, itching
and pH imbalance, leading to other skin problems. Also the existing waterless (dr
y) body
25
bath compositions contain strong fragrance and make the skin dry, which may not be suitable
for use on patients and the like. Due to these reasons, waterless (dry) body baths have not
become popular with consumers.
There is the
refore, a need in th
e art for a waterless (dry)
body bath composition that does not
contain alcohol
or paraben
and cleanses the skin and body parts completely without leaving
30
behind any undesirable residue.
There is the
refore, a need in the art for a waterless (dry)
body bath
composition that does not
contain strong fragrance, is gentle on the skin (especially sensitive skin), moisturizes the skin,
and makes the skin clean and soft.
SUMMARY OF THE INVENTION
35
In order to overcome
the above mentioned drawbacks, alcoh
ol
-
free
and paraben
-
free
waterless (dry)
body bath
compositions are
disclosed, said alcohol
-
free
and paraben
-
free
3
waterless (dry)
body bath
composition
s
consisting of
87% to 9
5
%
of
water as a solvent
,
1%
to 2
%
of a
primary
surfactant,
1
%
to 2
%
of a secondary surfactant,
0.5% to 1.7%
of a first
preservative,
0.5% to 1.9%
of a second preservative,
1
.6
%
to 2.9
%
of a moisturizer, 0.36% to
0.69
% of a
chelating
agent
, 0.29% to 0.8% of a modifier,
0.
00
1
% of a
first
fragrance
, 0.001%
of a second fragran
ce, 0.001% of a third fragrance and 0.001% of a fourth fragrance
.
5
The
primary
surfactant is selected from the group consisting of
caprylyl
/
c
arpryl glucoside
,
decyl glucoside and coco glucoside.
The secondary surfactant is selected from the group consisting
of c
ocamidopropyl betaine
,
coco betaine, lauryl hydroxypropyl sultaine, coco hydroxypropyl sultaine, disodium
cocoamphodiacetate, cocamide MEA and decyl glucoside
.
10
The first preservative
and
the second preservative are
selected from the group consisting o
f
phenoxyethanol, sodium benzoate, DMDM
-
Hydantoin and
isothiazolinone
.
The moisturizer is selected from the group consisting of propylene glycol, glycerine, plant
oils and panthenol.
The chelating agent is selected from the group consisting of
disodium EDT
A, polyaspartic
15
acid and ethylene diamine
-
disuccinic acid.
The modifier is selected from the group consisting of citric acid and sodium hydroxide.
The first fragrance, the second fragrance, the third fragrance and the fourth fragrance are
selected from the
group consisting of
l
imonene
, l
inalool
, c
itronellol
and butylphenyl methyl
p
ropional
.
20
DETAILED DESCRIPTION OF THE INVENTION
Unless otherwise specified, all the percentages disclosed are
in
w/v.
A
lcohol
-
free
and paraben
-
free
waterless (dry)
body bath
composition
s
are disclosed, said
composition
s consisting
of
87% to 9
5
% of water as a solvent, 1% to 2% of a primary
surfactant, 1% to 2% of a secondary surfactant, 0.5% to 1.7% of a first preservative, 0.5% to
25
1.9% of a second preservative, 1.6% to 2.9%
of a moisturizer, 0.36% to 0.69% of a chelating
agent, 0.29% to 0.8% of a modifier, 0.001% of a first fragrance, 0.001% of a second
fragrance, 0.001% of a third fragrance and 0.001% of a fourth fragrance.
In a preferred
embodiment of the present disclosure
, the solvent is water.
In
an
embodiment of the present disclosure, the
primary
surfactant is selected from the group
30
consisting
of
caprylyl/c
arpryl glucoside
, decyl glucoside and coco glucoside.
In another
preferred
embodiment of the present disclosure, t
he
primary
surfactant is
caprylyl/c
arpryl glucoside
.
In another embodiment of the present disclosure, the secondary surfactant is selected from the
group consisting of
c
ocamidopropyl betaine
, coco betaine, lauryl hydroxypropyl sultaine,
35
4
coco hydroxypropyl
sultaine, disodium cocoamphodiacetate, cocamide MEA and decyl
glucoside.
In yet another
preferred
embodiment of the present disclosure, the secondary surfactant is
c
ocamidopropyl betaine
.
In yet another embodiment of the present disclosure
, the first preservative is selected from the
5
group consisting of
phenoxyethanol, sodium benzoate, DMDM
-
Hydantoin and
isothiazolinone
.
In yet another
preferred
embodiment of the present disclosure, the first preservative is
phenoxyethanol
.
In yet another e
mbodiment of the present disclosure, the second preservative is selected from
10
the group consisting of
phenoxyethanol, sodium benzoate, DMDM
-
Hydantoin and
isothiazolinone
.
In yet another
preferred
embodiment of the present disclosure, the second preservativ
e is
sodium benzoate
.
In yet another embodiment of the present disclosure, the moisturizer is selected from the
15
group consisting of propylene glycol, glycerine, plant oils and panthenol.
In yet another
preferred
embodiment of the present disclosure, the mo
isturizer is propylene
glycol.
In yet another embodiment of the present disclosure, the chelating agent is selected from the
group consisting of disodium EDTA, polyaspartic acid and ethylene diamine
-
disuccinic acid.
20
In yet another preferred embodiment of t
he present disclosure, the chelating agent is
disodium EDTA.
In yet another embodiment of the present disclosure, the modifier is selected from the group
consisting of citric acid and sodium hydroxide.
In yet another preferred embodiment of the present dis
closure, the modifier is citric acid.
25
In yet another embodiment of the present disclosure, the first fragrance, the second fragrance,
the third fragrance and the fourth fragrance are selected from the group consisting of
l
imonene
, l
inalool
, c
itronellol
and
butylphenyl methyl p
ropional
.
In yet another preferred embodiment of the present disclosure, the first fragrance is limonene.
In yet another preferred embodiment of the present disclosure, the second fragrance is
30
linalool.
In yet another preferred embodi
ment of the present disclosure, the third fragrance is
c
itronellol
.
8
The pH was determined potentiometrically
b
y
means of
a
glass elec
trode and a suitable pH
meter (d
igital).
After setting t
he pH
meter at
25ºC
,
the pH meter
was standardized
using
standard buffer solutions of pH
value 6.0 and 7.0.
The
pH
of the
body bath
was then
measured.
The microbial limits were determined
using the below mentioned protocol
.
5
Pre
-
treatment of the sample:
10 g of the preparation under examination
was suspended
in buffered sodium chloride
-
peptone solution
(
pH 7.0
)
or any other suitable medium shown to ha
ve no antimicrobial
activity.
T
he volume
was adjusted to
100 ml with the same.
A s
uitable surface active agent
such as 0.1% w/v solution of Polysorbate 80
was added (where required)
to assist
with
the
10
suspension of
poorly wettable substances.
Inactivation of antimicrobial activity:
For
test specimen
s
known to contain
antimicrobial
substances
,
a corresponding
inactivating agent
was used
to neutralize the antimicrobial
activity. The inactivating agent (Polysorbate 80)
was added to the
chosen diluent preferably
before sterilization.
15
A
ll th
e necessary items required
for the testing were
kept under a laminar air flow (LAF)
.
T
he pre
-
sterilized petri dish
was labelled
with glass marker,
to
show the media name
(
soyabean casei
n digest
agar (SCDA) for bacterial count or
Sabouraud Dextrose agar (SDA)
for fungal count
)
,
the name of the product
,
the batch number
and
the
date of analysis.
E
ach of 1 ml of pre
-
treated sample
was carefully pipetted
on
to
previously labelled
p
etri dish
20
in duplicate, said petri dish being maintained under a laminar air flow
.
Positive control:
K
nown volume of cells (10
-
10 cells) of
E.coli/ S.aureus
was added in
SCDA plate and allowed to solidify for 30 minutes s. Likewise, known volume of cells of
Candida
albicans
was added
in SDA plate
allowed to solidify for 30 minutes
.
Negative Control:
SCDA/ SDA media
was poured
in pre
-
sterilized and labeled plates and
25
allow to solidify.
T
he plates
were incubated
at respective temperature
s
(SCDA
–
35
0
C
-
37
0
C/ SDA 20
0
C
–
25
0
C) for 1
20 hours
(5 days).
The incubate
d
plates
were
monitored every 2
4 hours
.
Calculation
:
30
Average No. of colonies X Dilution factor
CFU / g =
-----------------------------------------------------------
Weight
of sample
It was ensured that the n
egative control
did
not show any growth at the end of the incubation
period.
35
9
Pathogens test:
The pathogens mainly comprise
of
E.coli
,
Salmonella
,
S.aureus
and
P.aeruginosa
.
Sample prep
aration
: 10 gm sample
was aseptically transferred
into sterile 90 ml SCDM
broth.
T
he media
was labelled
with
the
media name,
the product batch number
and
the
incubation
5
date and incubate
d
at 30
0
C
–
35
0
C for 18
-
24 hours
. After
the
incubation
,
if the media was
clear
,
it was
conclud
ed that
pathogens are absent. If
turbidity was
observed
,
then
specific
testing of
pathogens
was carried out
as described below:
E.coli
:
Primary test:
0.1ml of enrichment media
was transferred
into 10ml of MacConkey’s
broth
10
containing inverted Durham’s tube and incubate
d
at 30
0
C
–
37
0
C for 24 hours to 48 hours
.
T
he tube
was labelled to
show enrichment transfers (SCDM to MacConkey broth), sample
n
umber
and
the
date of enrichment and
incubate
d
at 30
0
C
–
37
0
C for 24 hours
.
After i
ncubation, if Durhams tube showed
gas and
if a
colour change to yellow
occurred
, then
a loopful of the same
was streaked
on MacConkey agar plate and incubate
d for 24
–
72 hours
15
at 30
0
C
–
37
0
C. If no change
was observed, then the testing was stopped
.
Upon incubation,
the plate was observed
for
typical culture characteristics of
E.coli
. If typical
characteristics were found, then secondary test was conducted.
If
no typical characteristics were found,
the result was recorded
as
‘
Absent
’
for
E.coli.
20
Secondary test (Indole test):
0.5 ml kovac’s reagent
was added
in to pre
-
incubated 5 ml
peptone water (1%).
After shaking, it was a
llow
ed to stand for 1 minute
,
the formation of a pink colo
u
red ring was
interpreted as a positive result
.
The presence of acid and gas and of indole in the secondary test indicates the presence of
25
E.coli.
Cultural characteristics of
E.coli
in MacConkey agar is as follows:
MacConkey agar plate
Brick red, colonies may have surrounding
zone of precipitated bile.
Salmonella
:
0.1 ml of primary enrichment from SCDM
was aseptically transferred
into 10 ml of sterilized
30
Selenite
-
F
-
Broth or 10 ml of Tetrathionate Brilliant green Broth tube.
10
T
he tube
was labelled to
show the enrichment transfers (SCDM to SFB/ SCDM to
TT
BGB),
product identification and d
ate of Enrichment
and
incubate
d
at 35
0
C
–
37
0
C for 24 h
ou
rs.
After the incubation period,
if the SFB tube showed
tur
bidity and the TTBGB tubes showed
disappearance of green colour with white precipitate
,
the
n loopful
of
enrichment
was picked
up
and streak
ed
on surface of pre
-
incubated Bismuth sulfite agar (BSA)/ Brilliant Green Agar
5
(BGA) Media plates/ Xylose lysine Deoxycholate agar/ Deoxycholate agar plate.
T
he plate
was labelled to
show
e
nrichment transfers, (SFB to
BG
A/ SFB to BSA/ TTBGB to BSA)
product identification and d
ate of streak
ing
.
Upon i
ncubation,
if the plate showed
typical cultural characteristics of
Salmonella
,
b
iochemical identification test
was conducted to confirm the same
.
10
Secondary test (TSI test):
A
n
y colonies showing the
typical
characteristics
were sub
-
cultured
in triple sugar iron agar
by first inoculating the surface of the slope with inoculating needle and then making a stab
cultures with the same inoculating needle.
T
hese two tubes
were incubate
d
at 35
0
C
–
37
0
C for 18
-
24 h
ou
rs.
15
After incubation, yellow butt (acidic) with pink slant (alkaline)
,
with or without
concomitant
blackening of butt from H
2
S p
roduction in TSI tubes indicated
the presence of
Salmonella
.
The
cultural
characteristics of
Salmonella
in media plates are
as follows:
Sr. No.
Medium
Description of colony
1
Bismuth Sulphite agar
Black or green
2
Brilliant green agar
Small
, transparent and colourless or opaque,
pinkish or white (frequently surrounded by a
pink or red zone)
3
Deoxycholate citrate agar
Colourless and opaque with or without black
centres.
4
Xylose
-
lysine Deoxycholate agar
Red with or without black centres.
20
Test for
Staphylococcus aureus
(
S. aureus
):
Upon incubation
,
the growth
was observed
in tube.
Loopful of
e
nrichment
was picked up
and
streak
ed
on the surface of pre
-
incubated Mannitol Salt agar (MSA) media plate. Finally, the
plate
s were incubated
at 35
0
C
–
37
0
C for 24
–
48 h
ou
rs.
11
After the incubation period, the colony morphology
was observed for
typical cu
ltural
characteristics of
S.aureus
.
If typical characteristics were observed, then the presence of
S.aureus
was confirmed by biochemical identification test.
Secondary test:
T
he typical colony of
S.aureus
was streaked
from Mannitol salt agar to
Baired Parker agar
and i
ncubate
d
at 35
0
C
–
37
0
C for 24
-
48 h
ou
rs.
5
After Incubation
,
the growth was examined for black colouration.
If growth showed black
colouration, it was interpreted to as a positive result
.
C
ultural characteristics of
S.aureus
in
MSA/ Baired parker agar plates are
as follows:
MSA plate
Yellow colonies with yellow surrounding
zone
Baired Parker agar plate
Black colonies surrounded by clear zone
Test for
Pseudomonas aeruginosa
(
P.aeruginosa
)
:
10
L
oopful of enriched SCDM broth
was picked up
and streak
ed
on the surface of pre
-
incubated Cetrimide Agar (CA) media plate.
The plate was labelled to
show the enrichment transfer, (SCDM to CA) product identification
and date of streak
ing
. Finally
,
the
plate was incubated
at 35
0
C
–
37
0
C for 24
-
72 h
ou
rs.
Upon examination,
if none of the colonies conformed
to the description given in following
15
table,
it confirmed the absence
of
Pseudomonas
.
Medium
Description of colony
Cetrimide
Greenish
If any
colonies conform
ed
to the description given in above table,
oxidase test was carried out
to confirm the presence of
Pseudomonas
.
Oxidase test:
20
An
isolated colony
was spread well
on oxidase disc from
Cetrimide
agar plate.
The production of
p
urple colour
within 5 to 10 seconds
indicated a positive result.
12
It will be apparent to a person skilled in the art that the above description is for illustrative
purposes only and should not be considered as limiting. Various modifications, additions,
alterations an
d improvements without deviating from the spirit and the scope of the
disclosure
may be made by a person skilled in the art.
Such modifications, additions,
alterations
and improvements
are to
be construed as being within the scope of this disclosure
Claims:1. An alcohol-free and paraben-free waterless body bath composition, consisting of:
water as a solvent;
a primary surfactant selected from the group consisting of caprylyl/carpryl glucoside, decyl glucoside and coco glucoside;
a secondary surfactant selected from the group consisting of cocamidopropyl betaine, coco betaine, lauryl hydroxypropyl sultaine, coco hydroxypropyl sultaine, disodium cocoamphodiacetate, cocamide MEA and decyl glucoside;
a first preservative and a second preservative, said first preservative and said second preservative being selected from the group consisting of phenoxyethanol, sodium benzoate, DMDM-Hydantoin and isothiazolinone;
a moisturizer selected from the group consisting of propylene glycol, glycerine, plant oils and panthenol;
a chelating agent selected from the group consisting of disodium EDTA, polyaspartic acid and ethylene diamine-disuccinic acid;
a modifier selected from the group consisting of citric acid and sodium hydroxide and
a first fragrance, a second fragrance, a third fragrance and a fourth fragrance,
wherein the composition consists of:
of 87% to 95% of water, 1% to 2% of the primary surfactant, 1% to 2% of the secondary surfactant, 0.5% to 1.7% of the first preservative, 0.5% to 1.9% of the second preservative, 1.6% to 2.9% of the moisturizer, 0.36% to 0.69% of the chelating agent, 0.29% to 0.8% of the modifier, 0.001% of the first fragrance, 0.001% of the second fragrance, 0.001% of the third fragrance and 0.001% of the fourth fragrance.
2. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the primary surfactant is caprylyl/carpryl glucoside.
3. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the secondary surfactant is cocamidopropyl betaine.
4. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the first preservative is phenoxyethanol.
5. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the second preservative is sodium benzoate.
6. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the moisturizer is propylene glycol.
7. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the chelating agent is disodium EDTA.
8. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the modifier is citric acid.
9. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein said first fragrance, said second fragrance, said third fragrance and said fourth fragrance are selected from the group consisting of limonene, linalool, citronellol and butylphenyl methyl propional.
10. An alcohol-free and paraben-free waterless body bath composition according to claim 1, wherein the first fragrance, the second fragrance, the third fragrance and the fourth fragrance are produced by compounds that are derived from natural sources.
11. An alcohol-free and paraben-free waterless body bath composition according to claim 1, said composition consisting of 92% of water.
12. An alcohol-free and paraben-free waterless body bath composition according to claim 2, said composition consisting of 1.5% of caprylyl/carpryl glucoside.
13. An alcohol-free and paraben-free waterless body bath composition according to claim 3, said composition consisting of 1.5% of cocamidopropyl betaine.
14. An alcohol-free and paraben-free waterless body bath composition according to claim 4, said composition consisting of 1% of phenoxyethanol.
15. An alcohol-free and paraben-free waterless body bath composition according to claim 5, said composition consisting of 1% of sodium benzoate.
16. An alcohol-free and paraben-free waterless body bath composition according to claim 6, said composition consisting of 2% of propylene glycol.
17. An alcohol-free and paraben-free waterless body bath composition according to claim 7, said composition consisting of 0.5% of EDTA.
18. An alcohol-free and paraben-free waterless body bath composition according to claim 8, said composition consisting of 0.5% of citric acid.
, Description:FIELD OF THE INVENTION
Generally, the present disclosure relates to body bath compositions. Particularly, it relates to waterless (dry) body bath compositions. More particularly, it relates to alcohol-free and paraben-free waterless (dry) body bath compositions.
BACKGROUND OF THE INVENTION
Bathing forms an essential part of daily routine for cleansing the body and removing dirt and germs. Bathing soaps and body baths are widely used worldwide for this purpose. Body baths can broadly be classified into two types: wet body baths which requires rinsing with water and waterless (dry) body baths which do not require rinsing.
While wet body baths are quite efficient, they require the use of water, which is an extremely precious resource. Further, wet body baths compositions generally contain alcohol and other harsh chemicals such as parabens, which may cause skin dryness and adverse health effects (depending on the concentration).
Waterless body bath, on the other hand, are a great way to reduce the use of water in cleansing the skin and other body parts. Since no water is required, waterless (dry) body baths can be used even by people living in areas where water is scarce, including campers, backpackers, defence personnel in remote areas, and the like. These are also very useful in hospitals for providing a warm, comfortable patient-friendly bathing or sponging alternative (especially useful for bedridden patients).
However, existing waterless (dry) body baths are largely inefficient in removing body odour, dirt, sweat, and germs. Further, unlike wet body baths, they leave behind residue that is difficult to remove. Moreover, the presence of harsh chemicals may cause skin rashes, itching and pH imbalance, leading to other skin problems. Also the existing waterless (dry) body bath compositions contain strong fragrance and make the skin dry, which may not be suitable for use on patients and the like. Due to these reasons, waterless (dry) body baths have not become popular with consumers.
There is therefore, a need in the art for a waterless (dry) body bath composition that does not contain alcohol or paraben and cleanses the skin and body parts completely without leaving behind any undesirable residue.
There is therefore, a need in the art for a waterless (dry) body bath composition that does not contain strong fragrance, is gentle on the skin (especially sensitive skin), moisturizes the skin, and makes the skin clean and soft.
SUMMARY OF THE INVENTION
In order to overcome the above mentioned drawbacks, alcohol-free and paraben-free waterless (dry) body bath compositions are disclosed, said alcohol-free and paraben-free waterless (dry) body bath compositions consisting of 87% to 95% of water as a solvent, 1% to 2% of a primary surfactant, 1% to 2% of a secondary surfactant, 0.5% to 1.7% of a first preservative, 0.5% to 1.9% of a second preservative, 1.6% to 2.9% of a moisturizer, 0.36% to 0.69% of a chelating agent, 0.29% to 0.8% of a modifier, 0.001% of a first fragrance, 0.001% of a second fragrance, 0.001% of a third fragrance and 0.001% of a fourth fragrance.
The primary surfactant is selected from the group consisting of caprylyl/carpryl glucoside, decyl glucoside and coco glucoside.
The secondary surfactant is selected from the group consisting of cocamidopropyl betaine, coco betaine, lauryl hydroxypropyl sultaine, coco hydroxypropyl sultaine, disodium cocoamphodiacetate, cocamide MEA and decyl glucoside.
The first preservative and the second preservative are selected from the group consisting of phenoxyethanol, sodium benzoate, DMDM-Hydantoin and isothiazolinone.
The moisturizer is selected from the group consisting of propylene glycol, glycerine, plant oils and panthenol.
The chelating agent is selected from the group consisting of disodium EDTA, polyaspartic acid and ethylene diamine-disuccinic acid.
The modifier is selected from the group consisting of citric acid and sodium hydroxide.
The first fragrance, the second fragrance, the third fragrance and the fourth fragrance are selected from the group consisting of limonene, linalool, citronellol and butylphenyl methyl propional.
DETAILED DESCRIPTION OF THE INVENTION
Unless otherwise specified, all the percentages disclosed are in w/v.
Alcohol-free and paraben-free waterless (dry) body bath compositions are disclosed, said compositions consisting of 87% to 95% of water as a solvent, 1% to 2% of a primary surfactant, 1% to 2% of a secondary surfactant, 0.5% to 1.7% of a first preservative, 0.5% to 1.9% of a second preservative, 1.6% to 2.9% of a moisturizer, 0.36% to 0.69% of a chelating agent, 0.29% to 0.8% of a modifier, 0.001% of a first fragrance, 0.001% of a second fragrance, 0.001% of a third fragrance and 0.001% of a fourth fragrance.
In a preferred embodiment of the present disclosure, the solvent is water.
In an embodiment of the present disclosure, the primary surfactant is selected from the group consisting of caprylyl/carpryl glucoside, decyl glucoside and coco glucoside.
In another preferred embodiment of the present disclosure, the primary surfactant is caprylyl/carpryl glucoside.
In another embodiment of the present disclosure, the secondary surfactant is selected from the group consisting of cocamidopropyl betaine, coco betaine, lauryl hydroxypropyl sultaine, coco hydroxypropyl sultaine, disodium cocoamphodiacetate, cocamide MEA and decyl glucoside.
In yet another preferred embodiment of the present disclosure, the secondary surfactant is cocamidopropyl betaine.
In yet another embodiment of the present disclosure, the first preservative is selected from the group consisting of phenoxyethanol, sodium benzoate, DMDM-Hydantoin and isothiazolinone.
In yet another preferred embodiment of the present disclosure, the first preservative is phenoxyethanol.
In yet another embodiment of the present disclosure, the second preservative is selected from the group consisting of phenoxyethanol, sodium benzoate, DMDM-Hydantoin and isothiazolinone.
In yet another preferred embodiment of the present disclosure, the second preservative is sodium benzoate.
In yet another embodiment of the present disclosure, the moisturizer is selected from the group consisting of propylene glycol, glycerine, plant oils and panthenol.
In yet another preferred embodiment of the present disclosure, the moisturizer is propylene glycol.
In yet another embodiment of the present disclosure, the chelating agent is selected from the group consisting of disodium EDTA, polyaspartic acid and ethylene diamine-disuccinic acid.
In yet another preferred embodiment of the present disclosure, the chelating agent is disodium EDTA.
In yet another embodiment of the present disclosure, the modifier is selected from the group consisting of citric acid and sodium hydroxide.
In yet another preferred embodiment of the present disclosure, the modifier is citric acid.
In yet another embodiment of the present disclosure, the first fragrance, the second fragrance, the third fragrance and the fourth fragrance are selected from the group consisting of limonene, linalool, citronellol and butylphenyl methyl propional.
In yet another preferred embodiment of the present disclosure, the first fragrance is limonene.
In yet another preferred embodiment of the present disclosure, the second fragrance is linalool.
In yet another preferred embodiment of the present disclosure, the third fragrance is citronellol.
In yet another preferred embodiment of the present disclosure, the fourth fragrance is butylphenyl methyl propional.
In yet another embodiment of the present disclosure, the first fragrance, the second fragrance, the third fragrance and the fourth fragrance are natural fragrances (fragrant compounds that are derived from natural sources).
In yet another embodiment of the present disclosure, the fragrance is a synthetically produced fragrance.
In a more preferred embodiment of the present disclosure, the disclosed alcohol-free and paraben-free waterless (dry) body bath compositions consist of 87% to 95% of water, 1% to 2% of caprylyl/carpryl glucoside, 1% to 2% of cocamidopropyl betaine, 0.5% to 1.7% of phenoxyethanol, 0.5% to 1.9% of sodium benzoate, 1.6% to 2.9% of propylene glycol, 0.36% to 0.69% of disodium EDTA, 0.29% to 0.8% of citric acid, 0.001% of limonene, 0.001% of linalool, 0.001% of citronellol and 0.001% of butylphenyl methyl propional.
In a most preferred embodiment of the present disclosure, the disclosed alcohol-free and paraben-free waterless (dry) body bath compositions consist of 92% of water, 1.5% of caprylyl/carpryl glucoside, 1.5% of cocamidopropyl betaine, 1% of phenoxyethanol, 1% of sodium benzoate, 2% of propylene glycol, 0.5% of disodium EDTA, 0.5% of citric acid, 0.001% of limonene, 0.001% of linalool, 0.001% of citronellol and 0.001% of butylphenyl methyl propional.
The disclosed alcohol-free and paraben-free waterless (dry) body bath compositions are to be used as given below:
1. Apply onto skin and other body parts until the area is completely wet;
2. Gently massage onto the body parts;
3. Dry the body parts thoroughly by wiping it with a soft towel;
4. Repeat the above steps for heavily soiled areas and skin folds.
The alcohol-free and paraben-free waterless (dry) body bath compositions disclosed herein leave behind no residue, maintain the smoothness and the pH of the skin, do not cause skin dryness, completely cleanse the skin by removing dirt, sweat, germs and odour, provide excellent moisturizing effect and reduce the microbiological count.
The process by which the compositions are manufactured consists of mixing the primary surfactant and the secondary surfactant first in a vessel. The solvent, the first preservative and the second preservative are mixed in a separate vessel. The two mixtures are subsequently mixed together and cooled down. Finally, the first fragrance, the second fragrance, the third fragrance and the fourth fragrance are added.
For the examples disclosed below, the viscosity was tested using the below described procedure:
A quantity of oil (200C + 0.10) was placed in a filling tube and transferred to a capillary tube by gentle suction, taking care to prevent bubble formation in the liquid by keeping the air vent tube closed. The meniscus of the column of liquid in the capillary tube was adjusted to the level of the top graduation line. Both the vent and the capillary tubes were opened in order to permit the liquid to flow into the reservoir against atmospheric pressure. The time, in seconds, for the liquid to flow from the upper mark to the lower mark in the capillary tube was recorded.
The viscometer constant, k, was calculated from the equation:
k = v/dt
where,
v is the known viscosity of the liquid in centipoise,
d is the specific gravity of the liquid tested at 200C, and
t is the time in seconds for the liquid to pass from the upper mark to the lower mark.
Example 1:
A composition consisting of 90% of water, 6% of triethanolamine lauryl sulfate, 1% of cocamidopropyl betaine, 0.05% of citric acid, 1% of propylene glycol and 1.95% of glycerine did not produce the required amount of foam for it to be user-friendly.
Example 2:
A composition consisting of 90% of water, 5% of triethanolamine lauryl sulfate, 1% of cocamidopropyl betaine, 0.5% of disodium EDTA, 0.05% of citric acid 2% of propylene glycol and 1.45% of glycerine produced a good amount of foam. However, the composition was found to possess a high viscosity.
Example 3:
A composition consisting of 91% of water, 5% of triethanolamine lauryl sulfate, 1.45% of cocamidopropyl betaine, 0.5% of disodium EDTA, 0.05% of citric acid and 2% of propylene glycol produced a good amount of foam. However, the primary surfactant and the secondary surfactant could not be wiped off.
Example 4:
A composition consisting of 93% of water, 2.5% of triethanolamine lauryl sulfate, 1.5% of cocamidopropyl betaine, 0.5% of disodium EDTA, 0.5% of citric acid and 2% of propylene glycol produced a good amount of foam. However, the composition was found to possess a low viscosity.
Example 5:
A composition consisting of 92% of water, 1.5% of caprylyl/carpryl glucoside, 1.5% of cocamidopropyl betaine, 0.5% of disodium EDTA, 0.5% of citric acid, 1% of sodium benzoate, 1% of phenoxyethanol and 2% of propylene glycol was found to be yield a clean and clear liquid.
Example 6:
A composition consisting of 92% of water, 1.5% of caprylyl/carpryl glucoside, 1.5% of cocamidopropyl betaine, 0.5% of disodium EDTA, 0.5% of citric acid, 1% of sodium benzoate, 1% of phenoxyethanol and 2% of propylene glycol was found to be yield a clean and clear liquid. The subsequent addition of 0.001% of limonene, linalool, citronellol and butylphenyl methyl propional yielded a clean and clear liquid with baby powder fragrance.
The results of stability tests conducted on the composition disclosed in Example 6 over one month are summarized below:
Attribute Acceptable Result Initial Result Result after a month
Appearance Clean, Clear Liquid with Baby Powder Fragrance Clean, Clear Liquid with Baby Powder Fragrance Clean, Clear Liquid with Baby Powder Fragrance
Viscosity About 1.6 centipoise (cps) at room temperature 1.60 cps 1.58 cps
pH at 25ºC 6.5 to 7.5 6.9 6.8
Microbial limits
• Total Aerobic microbial Count
• Total Mould and yeast count
• E.coli
• Salmonella
• Pseudomonas
NMT 100 cfu/ml
NMT 10 cfu/ml
Absent
Absent
Absent
< 19cfu/ml
< 1cfu/ml
Absent
Absent
Absent NA
The pH was determined potentiometrically by means of a glass electrode and a suitable pH meter (digital). After setting the pH meter at 25ºC, the pH meter was standardized using standard buffer solutions of pH value 6.0 and 7.0. The pH of the body bath was then measured.
The microbial limits were determined using the below mentioned protocol.
Pre-treatment of the sample:
10 g of the preparation under examination was suspended in buffered sodium chloride- peptone solution (pH 7.0) or any other suitable medium shown to have no antimicrobial activity. The volume was adjusted to 100 ml with the same. A suitable surface active agent such as 0.1% w/v solution of Polysorbate 80 was added (where required) to assist with the suspension of poorly wettable substances.
Inactivation of antimicrobial activity: For test specimens known to contain antimicrobial substances, a corresponding inactivating agent was used to neutralize the antimicrobial activity. The inactivating agent (Polysorbate 80) was added to the chosen diluent preferably before sterilization.
All the necessary items required for the testing were kept under a laminar air flow (LAF).
The pre-sterilized petri dish was labelled with glass marker, to show the media name (soyabean casein digest agar (SCDA) for bacterial count or Sabouraud Dextrose agar (SDA) for fungal count), the name of the product, the batch number and the date of analysis.
Each of 1 ml of pre-treated sample was carefully pipetted onto previously labelled petri dish in duplicate, said petri dish being maintained under a laminar air flow.
Positive control: Known volume of cells (10-10 cells) of E.coli/ S.aureus was added in SCDA plate and allowed to solidify for 30 minutes s. Likewise, known volume of cells of Candida albicans was added in SDA plate allowed to solidify for 30 minutes.
Negative Control: SCDA/ SDA media was poured in pre-sterilized and labeled plates and allow to solidify.
The plates were incubated at respective temperatures (SCDA – 350C-370C/ SDA 200C – 250C) for 120 hours (5 days).
The incubated plates were monitored every 24 hours.
Calculation:
Average No. of colonies X Dilution factor
CFU / g = -----------------------------------------------------------
Weight of sample
It was ensured that the negative control did not show any growth at the end of the incubation period.
Pathogens test: The pathogens mainly comprise of E.coli, Salmonella, S.aureus and P.aeruginosa.
Sample preparation: 10 gm sample was aseptically transferred into sterile 90 ml SCDM broth.
The media was labelled with the media name, the product batch number and the incubation date and incubated at 300C – 350C for 18- 24 hours. After the incubation, if the media was clear, it was concluded that pathogens are absent. If turbidity was observed, then specific testing of pathogens was carried out as described below:
E.coli:
Primary test: 0.1ml of enrichment media was transferred into 10ml of MacConkey’s broth containing inverted Durham’s tube and incubated at 300C – 370C for 24 hours to 48 hours.
The tube was labelled to show enrichment transfers (SCDM to MacConkey broth), sample number and the date of enrichment and incubated at 300C – 370C for 24 hours.
After incubation, if Durhams tube showed gas and if a colour change to yellow occurred, then a loopful of the same was streaked on MacConkey agar plate and incubated for 24 – 72 hours at 300C – 370C. If no change was observed, then the testing was stopped.
Upon incubation, the plate was observed for typical culture characteristics of E.coli. If typical characteristics were found, then secondary test was conducted.
If no typical characteristics were found, the result was recorded as ‘Absent’ for E.coli.
Secondary test (Indole test):
0.5 ml kovac’s reagent was added in to pre- incubated 5 ml peptone water (1%).
After shaking, it was allowed to stand for 1 minute, the formation of a pink coloured ring was interpreted as a positive result.
The presence of acid and gas and of indole in the secondary test indicates the presence of E.coli.
Cultural characteristics of E.coli in MacConkey agar is as follows:
MacConkey agar plate Brick red, colonies may have surrounding zone of precipitated bile.
Salmonella:
0.1 ml of primary enrichment from SCDM was aseptically transferred into 10 ml of sterilized Selenite-F-Broth or 10 ml of Tetrathionate Brilliant green Broth tube.
The tube was labelled to show the enrichment transfers (SCDM to SFB/ SCDM to TTBGB), product identification and date of Enrichment and incubated at 350C – 370C for 24 hours.
After the incubation period, if the SFB tube showed turbidity and the TTBGB tubes showed disappearance of green colour with white precipitate, then loopful of enrichment was picked up and streaked on surface of pre-incubated Bismuth sulfite agar (BSA)/ Brilliant Green Agar (BGA) Media plates/ Xylose lysine Deoxycholate agar/ Deoxycholate agar plate. The plate was labelled to show enrichment transfers, (SFB to BGA/ SFB to BSA/ TTBGB to BSA) product identification and date of streaking.
Upon incubation, if the plate showed typical cultural characteristics of Salmonella, biochemical identification test was conducted to confirm the same.
Secondary test (TSI test):
Any colonies showing the typical characteristics were sub-cultured in triple sugar iron agar by first inoculating the surface of the slope with inoculating needle and then making a stab cultures with the same inoculating needle.
These two tubes were incubated at 350C – 370C for 18 - 24 hours.
After incubation, yellow butt (acidic) with pink slant (alkaline), with or without concomitant blackening of butt from H2S production in TSI tubes indicated the presence of Salmonella. The cultural characteristics of Salmonella in media plates are as follows:
Sr. No. Medium Description of colony
1 Bismuth Sulphite agar Black or green
2 Brilliant green agar Small, transparent and colourless or opaque, pinkish or white (frequently surrounded by a pink or red zone)
3 Deoxycholate citrate agar Colourless and opaque with or without black centres.
4 Xylose-lysine Deoxycholate agar Red with or without black centres.
Test for Staphylococcus aureus (S. aureus):
Upon incubation, the growth was observed in tube. Loopful of enrichment was picked up and streaked on the surface of pre- incubated Mannitol Salt agar (MSA) media plate. Finally, the plates were incubated at 350C – 370C for 24 – 48 hours.
After the incubation period, the colony morphology was observed for typical cultural characteristics of S.aureus. If typical characteristics were observed, then the presence of S.aureus was confirmed by biochemical identification test.
Secondary test: The typical colony of S.aureus was streaked from Mannitol salt agar to Baired Parker agar and incubated at 350C – 370C for 24 - 48 hours.
After Incubation, the growth was examined for black colouration. If growth showed black colouration, it was interpreted to as a positive result. Cultural characteristics of S.aureus in MSA/ Baired parker agar plates are as follows:
MSA plate Yellow colonies with yellow surrounding zone
Baired Parker agar plate Black colonies surrounded by clear zone
Test for Pseudomonas aeruginosa (P.aeruginosa):
Loopful of enriched SCDM broth was picked up and streaked on the surface of pre- incubated Cetrimide Agar (CA) media plate.
The plate was labelled to show the enrichment transfer, (SCDM to CA) product identification and date of streaking. Finally, the plate was incubated at 350C – 370C for 24 - 72 hours.
Upon examination, if none of the colonies conformed to the description given in following table, it confirmed the absence of Pseudomonas.
Medium Description of colony
Cetrimide Greenish
If any colonies conformed to the description given in above table, oxidase test was carried out to confirm the presence of Pseudomonas.
Oxidase test:
An isolated colony was spread well on oxidase disc from Cetrimide agar plate.
The production of purple colour within 5 to 10 seconds indicated a positive result.
It will be apparent to a person skilled in the art that the above description is for illustrative purposes only and should not be considered as limiting. Various modifications, additions, alterations and improvements without deviating from the spirit and the scope of the disclosure may be made by a person skilled in the art. Such modifications, additions, alterations and improvements are to be construed as being within the scope of this disclosure.
| # | Name | Date |
|---|---|---|
| 1 | 201711031389-FORM FOR SMALL ENTITY(FORM-28) [05-09-2017(online)].pdf | 2017-09-05 |
| 2 | 201711031389-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [05-09-2017(online)].pdf | 2017-09-05 |
| 3 | 201711031389-EVIDENCE FOR REGISTRATION UNDER SSI [05-09-2017(online)].pdf | 2017-09-05 |
| 4 | 201711031389-DECLARATION OF INVENTORSHIP (FORM 5) [05-09-2017(online)].pdf | 2017-09-05 |
| 5 | 201711031389-COMPLETE SPECIFICATION [05-09-2017(online)].pdf | 2017-09-05 |
| 6 | 201711031389-Form 5-180917.pdf | 2017-09-26 |
| 7 | 201711031389-OTHERS-231017.pdf | 2017-10-31 |
| 8 | 201711031389-Correspondence-231017.pdf | 2017-10-31 |
| 9 | 201711031389-RELEVANT DOCUMENTS [02-05-2018(online)].pdf | 2018-05-02 |
| 10 | 201711031389-Changing Name-Nationality-Address For Service [02-05-2018(online)].pdf | 2018-05-02 |
| 11 | 201711031389-RELEVANT DOCUMENTS [03-05-2018(online)].pdf | 2018-05-03 |
| 12 | 201711031389-Changing Name-Nationality-Address For Service [03-05-2018(online)].pdf | 2018-05-03 |
| 13 | 201711031389-Power of Attorney-100518.pdf | 2018-05-16 |
| 14 | 201711031389-Correspondence-100518.pdf | 2018-05-16 |
| 15 | 201711031389-FORM 18 [16-07-2021(online)].pdf | 2021-07-16 |
| 16 | 201711031389-FER.pdf | 2021-10-17 |
| 1 | 201711031389E_18-08-2021.pdf |