Formulation and Characterization of Herbal cream

containing Fenugreek seed extracts

Abstract- The aim of present study was formulation of a stable W/O emulsion containing fenugreek
seeds extract using olive oil as a base. Extract of Fenugreek seeds was obtained by using methanol as a
solvent and the extract of fenugreek seeds, was entrapped in the inner aqueous phase of W/O emulsion.
The formulation was prepared in internal aqueous phase (W/O emulsion) containing the extract of
fenugreek seeds. The herbal formulation showed good spreadibilty, good consistency, homogeneity, pH,
non greasy and no evidence of phase separation

INTRODUCTION-

Emulsions are a class of disperse systems consisting of two immiscible liquids. The liquid droplets (the
disperse phase) are dispersed in a liquid medium (the continuous phase). To disperse two immiscible
liquids, one needs a third component, namely, the emulsifier which is a surface active agent. Emulsifiers
reduce interfacial tension between two immiscible liquids. The choice of the emulsifier is crucial in the
formation of the emulsion and its long-term stability. In cosmetics, emulsions are the delivery vehicle for
many hair and skin conditioning agents. Oil in Water (O/W) emulsions are the most commonly used
cosmetic delivery systems which supply moisture to skin and improve the skin condition by forming the
occlusive barrier on the skin. Anionic and non-ionic emulsions are used to deliver various oils and waxes
which provide miniaturization, smoothness and softness to hair and skin. Emulsions formed with
cationic emulsifiers are themselves effective conditioning agents since their positive charge is attracted
to the negative sites on the hair, thus allowing them to resist rinse off.

MATERIALS AND METHODS-

Material: Fenugreek seeds and Olive oil were purchased from local market of Matunga, Mumbai. Span
80, Tween 80, Guar gum (additive) were ordered from TCI Chemicals(India )Pvt. Ltd.

Methods:

Preparation of plant extracts:

Dried and fresh batches of fenugreek seeds were purchased from local market, Matunga, Mumbai.
Seeds were washed with distilled water to get rid of extraneous matter. Fenugreek seeds (10 g) were
dried in oven at 50oC. After drying, they were ground into a fine powder in a mixer. Methanol (250 ml)
was used for extraction by Soxhlet extraction method for six hours. The extracts were filtered. The
residue was re-extracted twice under the same condition to ensure complete extraction. The extracts
were combined, filtered and evaporated to dryness under reduced pressure at 65oC by a rotary
evaporator. Extract was stored at dry place. 10 ml of the extract was measured into a preweighed
aluminum dish and kept in an oven at 85°C for 24 hours then followed by placing in desiccator for 14
hours. The weight difference was calculated and percentage yield as well as weight expressed in mg/10
ml was determined.

Emulsion preparation :

Oil phase that consisted of olive oil and calculated quantity of Span 80 (HLB No. 4.5) and Tween 80 (HLB
No. 15) was prepared. At the same time, aqueous phase was prepared by adding the fenugreek seeds
extract and natural polymer in water. After that, oil phase was added to the aqueous phase drop by
drop at 2500 rpm stirring to get the O/W emulsion based emulsion and further stirred for 30 minutes.

Preparation of base:

The procedure was continued exactly as described above for preparation of cream without using the
fenugreek seeds extract. This is the emulsion of olive oil and water.

Standardization of cream parameters:

The effect of various parameters like surfactant content, oil content, fenugreek seeds extract, HLB
number of surfactant blend and additive content on emulsion stability was studied by trial and error
method.

Characterization of emulsions and stability tests:

Rheological properties of an emulsion are important. These properties decide the physical stability, skin
feel, ease of application on skin and its overall performance. The factors like oil content, amount of
additive are the controlling factors of viscosity of an emulsion. The viscosity of emulsion and base was
measured at 20±0.1ºC over a shear rate-range of 0 to 600 s-1 , using a rotational viscometer RV-2.
Stability tests were performed under different conditions for the emulsion and base. These tests were
performed on samples kept at 8 ± 0.1OC (in refrigerator), 25± 0.1OC (in incubator), 40 ± 0.1OC (in
incubator) and 40 ± 0.1OC (in incubator with 75% relative humidity).

Dermatological tests and product evaluation on skin:

Evaluation Test: pH: 10% w/v suspension of the cream was prepared with water and the pH was
measured using pH meter. Homogeneity: The formulations were tested for the homogeneity by visual
appearance and by touch. Appearance: The appearance of the cream was judged by its color,
pearlscence and roughness and graded.

Dilution method: Fixed amount of cream was diluted with water and mineral oil separately
Filter paper method: A streak of the cream was applied on the filter paper
Ash: Product was taken in a flat –bottom platinum dish and ashing was done at 600 ˚C in muffle furnace
feel: Emolliency, slipperiness and amount of residue left after the application of fixed amount of cream
was checked.
Type of smear: After application of cream, the type of film or smear formed on the skin were checked.
Uses & Effectiveness

Possibly Effective for

 Diabetes Some research shows that consuming fenugreek seed, mixed with food during a meal,
lowers blood sugar levels after the meal in people with type 2 diabetes. However, while taking 5-50
grams of fenugreek seed once or twice daily seems to work, lower doses of 2.5 grams don't seem to
work. In people with type 1 diabetes, taking 50 grams of fenugreek seed powder twice daily seems
to reduce the amount of sugar in the urine.
 Painful menstrual periods (dysmenorrhea). Taking 1800-2700 mg of fenugreek seed powder three
times daily for the first 3 days of a menstrual period followed by 900 mg three times daily for the
remainder of two menstrual cycles reduces pain in women with painful menstrual periods. The need
for painkillers was also reduced.

Insufficient Evidence for

 Exercise performance. Some research shows that consuming fenugreek seed, mixed with
food during a meal, lowers blood sugar levels after the meal in people with type 2
diabetes. However, while taking 5-50 grams of fenugreek seed once or twice daily
seems to work, lower doses of 2.5 grams don't seem to work. In people with type 1
diabetes, taking 50 grams of fenugreek seed powder twice daily seems to reduce the
amount of sugar in the urine.

 Dysmenorrhea Taking 1800-2700 mg of fenugreek seed powder three times daily for the first 3 days
of a menstrual period followed by 900 mg three times daily for the remainder of two menstrual
cycles reduces pain in women with painful menstrual periods.
 Heartburn. There are conflicting results regarding the effects of fenugreek on exercise performance.
Some early research shows that taking 500 mg of fenugreek supplement (Indus Biotech, India) for 8
weeks decreases body fat and increases testosterone levels, but does not change muscle strength or
endurance in young men. However, other research shows that taking 500 mg of fenugreek extract
(Torabolic, Indus Biotech) daily for 8 weeks reduces body fat and increases leg and bench press
performance in a similar group of young men.

 Heartburn. Research shows that taking a specific fenugreek product (FenuLife, Frutarom Belgium)
before the two biggest meals of the day reduces symptoms of heartburn.
 High cholesterol. There is conflicting evidence about the effects of fenugreek on cholesterol levels.
Early research shows that taking fenugreek seed reduces total and low-density lipoprotein (LDL or
"bad") cholesterol. But the effects of fenugreek seed on high-density lipoprotein (HDL or "good")
cholesterol and triglycerides are inconsistent.
 Breast milk production. There are some reports that taking powdered fenugreek seed daily increases
milk production in breastfeeding women. But evidence confirming this is limited. Some early research
shows that drinking tea containing fenugreek, alone or along with other ingredients, increases milk
volume. But other research suggests that taking capsules containing fenugreek three times daily for
21 days starting 5 days after giving birth does not affect breast-milk production.
  Male infertility. Early research suggests that taking fenugreek seed oil drops by mouth three times
daily for 4 months improves sperm count in men with a low concentration of sperm. But taking the
other parts of the fenugreek seed does not seem to have this effect.
 Weight loss. Early research shows that a fenugreek seed extract can reduce daily fat intake in
overweight men when taken by mouth at a dose of 392 mg three times daily for 2-6 weeks. But a
lower dose does not appear to have this effect. Neither dose affects weight, appetite, or fullness.
Adding 4 or 8 grams of fenugreek fiber to breakfast seems to increase feelings of fullness and reduce
hunger at lunchtime. But it's not clear if this increases weight loss.
 Parkinson's disease. Research suggests that taking fenugreek seed extract (Indus Biotech Private
Limited, Pune) twice daily for 6 months does not improve symptoms in people with Parkinson's
disease.
 Ovarian cysts (polycystic ovary syndrome). Research suggests that taking fenugreek seed extract
(Goldarou Pharmaceutical Co. Isfahan Iran) daily for 8 weeks does not improve symptoms for women
with ovarian cysts.
 Stomach upset.
 Constipation.
 "Hardening of the arteries" (atherosclerosis).
 Kidney disease.
 Hernias.
 Mouth ulcers.
 Chronic cough.
 Chapped lips.
 Cancer.
 Eczema.
 Gout.
 Sexual problems (erectile dysfunction, ED).
 Fever.
 Baldness.
 Other conditions.

Side Effects & Safety

Fenugreek is LIKELY SAFE for people when taken by mouth in amounts normally found in foods. It
is POSSIBLY SAFE when taken by mouth in amounts used for medicinal purposes (amounts larger than
normally found in food) for up to 6 months. Side effects include diarrhea, stomach upset, bloating, gas, and a
"maple syrup" odor in urine. Fenugreek can cause nasal congestion, coughing, wheezing, facial swelling, and
severe allergic reactions in hypersensitive people. Fenugreek might lower blood sugar.

Special Precautions & Warnings:

Pregnancy: Fenugreek is LIKELY SAFE in pregnancy when used in amounts greater than those in food. It
might cause early contractions. Taking fenugreek just before delivery may also cause the newborn to have an
unusual body odor, which could be confused with "maple syrup urine disease." It does not appear to cause
long-term effects.
Breast-feeding: Fenugreek is POSSIBLY SAFE when taken by mouth to increase breast-milk flow in the short-
term. Some research shows that taking 1725 mg of fenugreek three times daily for 21 days does not cause
any side effects in infants.
Children: Fenugreek is POSSIBLY SAFE when taken by mouth in children. Some reports have linked
fenugreek tea to loss of consciousness in children. An unusual body odor resembling maple syrup may also
occur in children drinking fenugreek tea.
Allergy to plants in the Fabaceae family: People who are allergic to other plants in the Fabaceae, including
soybeans, peanuts, and green peas might also be allergic to fenugreek.
Diabetes: Fenugreek can affect blood sugar levels in people with diabetes. Watch for signs of low blood sugar
(hypoglycemia) and monitor your blood sugar carefully if you have diabetes and use fenugreek.

Interactions:

!
 Medications for diabetes (Antidiabetes drugs) interacts with FENUGREEK

Fenugreek might decrease blood sugar. Diabetes medications are also used to lower blood sugar.
Taking fenugreek along with diabetes medications might cause your blood sugar to go too low.
Monitor your blood sugar closely. The dose of your diabetes medication might need to be
changed.<br/><br/> Some medications used for diabetes include glimepiride (Amaryl), glyburide
(DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia),
chlorpropamide (Diabinese), glipizide (Glucotrol), tolbutamide (Orinase), and others.

 Medications that slow blood clotting (Anticoagulant / Antiplatelet drugs) interacts with
FENUGREEK

Fenugreek might slow blood clotting. Taking fenugreek along with medications that also slow clotting
might increase the chances of bruising and bleeding.<br/><br/> Some medications that slow blood
clotting include aspirin, clopidogrel (Plavix), diclofenac (Voltaren, Cataflam, others), ibuprofen (Advil,
Motrin, others), naproxen (Anaprox, Naprosyn, others), dalteparin (Fragmin), enoxaparin (Lovenox),
heparin, warfarin (Coumadin), and others.

 Warfarin (Coumadin) interacts with FENUGREEK

Warfarin (Coumadin) is used to slow blood clotting. Fenugreek might also slow blood clotting. Taking
fenugreek along with warfarin (Coumadin) might increase the chances of bruising and bleeding. Be
sure to have your blood checked regularly. The dose of your warfarin (Coumadin) might need to be
changed.

Dosing :
The following doses have been studied in scientific research:
BY MOUTH:
  For diabetes: 5-50 grams of powdered fenugreek seed added to one or two meals daily for 4 days
to 24 weeks has been used. A dose of 1 gram daily of an extract of fenugreek seeds has been used.
 For painful menstruation (dysmenorrhea): 1800-2700 mg of fenugreek seed powder three times
daily for the first 3 days of menstruation, followed by 900 mg three times daily for the remainder of
two menstrual cycles, has been used.

RESULTS AND DISCUSSION :

The pH of human skin typically ranges from4.5 to 6.0 and 5.5 is considered to be average pH of the skin.
Therefore, the formulations intended for application to skin should have pH close to this range The pH
values of the formulation remained constant with slight decrease in values.

CONCLUSION :

The emulsion of aqueous extract of fenugreek seeds and olive oil can be prepared. The rheological
parameters and storage stability of each formulated cream were found to be identical with marketed
product. The formulation was found to be superior to the marketed product for long term effect and
spreadability. Due to no adverse effect of the formulation on skin and good moisturizing properties, the
formulation can be used as a skin care product and an effective moisturizer.