Natural Humectants in Formulation of Calamine Lotion: Its Evaluation and Comparison

Harsha Solanki1, Vinay Sagar Verma1, Mukesh Sharma1, Ajay Singh2, Garima Sharma1, ManishaMajumdar1, Sujata Gupta1, Sandhya1, Vandana Sahu1, Kalyani Dewangan1,

D.K. Tripathi1, Amit Alexander1, Ajazuddin1*

1Rungta College of Pharmaceutical Sciences and Research, Kurud Road Kohka, Bhilai, Chhattisgarh, India, 490024

2GD Rungta College of Science and Technology, Kurud Road Kohka, Bhilai, Chhattisgarh, India, 490024

*Corresponding Author E-mail: ajazuddin@rungta.ac.in

 

ABSTRACT:

Herbal cosmetics are formulated, using different cosmetic ingredients to form the base in which one or more herbal ingredients are used to cure various skin ailments. The name itself suggests that herbal cosmetics are natural and free from all the harmful synthetic chemicals which otherwise may prove to be toxic to the skin. Compared to other beauty products, natural cosmetics are safe to use. Cosmeceuticals are cosmetic-pharmaceutical hybrid products intended to improve the health and beauty of the skin by providing a specific result, ranging from acne-control and anti-wrinkle effects, to sun protection. Calamine lotion is widely used as an antiseptic and protective for its cooling and soothing effect in various skin disorders. Instead of traditional synthetic products different plant parts and plant extracts are used in this study to procure calamine lotion having natural humectants, e.g. aloe-vera gel and honey. Herbal cosmetics are the preparations used to enhance the human appearance. The purpose of this study is to compare the semi synthetic activity of glycerin with other humectants in terms of their emollient properties to ensure whether calamine lotion can be formulated using natural humectants or not.

 

KEYWORDS: Humectants, Emollient, Antiseptic, Calamine Lotion.

 

 


INTRODUCTION:

The concept of beauty and cosmetics dates back to ancient mankindand civilization. Generally herbal cosmetics are also referred to as natural cosmetics.1,2 Herbal cosmetics are formulated, using different cosmetic ingredients to form the base in which one or more herbal ingredients are used to cure various skin ailments. The name itself suggests that herbal cosmetics are natural and free from all the harmful synthetic chemicals which otherwise may prove to be toxic to the skin. Instead of traditional synthetic products different plant parts and plant extracts are used in these products,

e.g. aloe-vera gel and coconut oil. They also consist of natural nutrients like Vitamin E that keeps skin healthy, glowing and beautiful. For example, Aloe-vera is a herbal plant species belonging to liliaceae family and is naturally and easily available. There are a rising number of consumers concerned about ingredients such as synthetic chemicals, mineral oils who demand more natural products with traceable and more natural ingredients, free from harmful chemicals and with an emphasis on the properties of botanicals.3,4

 

Skin irritation during cast immobilisation is a common complaint, especially for patients in humid tropical regions. It may lead to patient and caretaker stress, cast breakdown, and skin complications.1 Calamine lotion is a widely used topical agent to soothe skin irritation. Liquid dosage forms used in pharmacy are either monophasic or biphasic. Monophasic liquid dosage forms are classified into two groups: (1). Liquids for internal application5, (2). Liquids for external application Ex; Lotions6. Lotions are liquids for cutaneous application that are intended to be applied to the unbroken skin without friction. They are aqueous, alchohol or polyols based solution or suspension containing topically active therapeutic agent. Calamine lotion7 and amphotericin B lotion8 are examples of lotions. The label states 1).The names and concentration of the active ingredients. 2). Lotion is intended for external application only. 3). Lotion should be shaken well before use. 4). The date after which the lotion is not intended to be used. 5). The conditions under which the lotion should be stored. 6). The directions for using the lotion and 7). Any special precautions associated with the use of the lotion10,11. Calamine lotion is a liquid preparation meant for external application without friction. They are directly applied with the help of cotton. Calamine lotion falls in the category of Antiseptic and protective. The container should be labelled “For external use only”. Sometimes on long standing calamine lotion have a tendency to separate out. Therefore the container must be labelled “Shake well before use”.12,13,14The purpose of this study is to compare the semi synthetic activity of glycerin with other humectants in terms of their emollient properties to ensure whether calamine lotion can be formulated using natural humectants with required stability and efficacy.

 

MATERIAL AND METHOD:

All the ingredients used were of analytical grade procured from pharmaceutical laboratory of RCPSR.

 

Table 1: Description of ingredients used Calamine lotion preparation

S.

NO.

INGREDIENTS

COMPANY

CATEGORY

1

Calamine (extra pure confirming to B.P)

Loba chemie

Astringent

2

Zinc oxide (confirming to I.P)

Loba chemie

Protective

3

Bentonite (Aluminium silicate hydrate)

CDH Laboratory reagent

Suspending agent

4

Tri sodium citrate (Dihydrate extra pure)

Loba chemie reagent and pure chemicals

Chelating agent

5

Liquefied phenol (Carbolic acid crystals)

CDH Laboratory regent

Antiseptic/Preservative.

6

Glycerin

Purified CDH

Soothing effect

7

Purified water

-

Vehicle

 

Calamine lotions were prepared in motor pestle by trituration method with different humactants. Required quantity of calamine, zinc oxide and bentonite with a solution of tri sodium citrate in about 70% of water was triturated and at last liquefied phenol along with the humectant used was added to the mixture with sufficient purified water to produce 100ml.15,16

 


 

 

Table 2: Description of  Humactants used.

Humactants

Synthetic/ Natural

Source

Chemical Constituents

Properties

Uses

Glycerin

Synthetic

Semi-Synthetic

It’s a compound containing polyols. The backbone of glycerin is triglycerides.

It is a colourless, odourless viscous liquid which is sweet in taste and hygroscopic in nature.

Cleanser, Toner, Moisturizer, Acne treatment, Blackhead treatment, Effective sunscreen, Scar removal, Treat cracked heels, skin lightening etc.

Honey

Natural

Honey comb of apismellifera (Apidae)

Sucrose, glucose, fructose, proteins, enzymes etc.

It is a pale yellow to golden brown coloured, characteristic odour, viscous liquid which is sweet in taste and hygroscopic in nature.

Natural antibacterial, Acne prevention, Antioxidants, slows down aging, complexion boost, Moisturizer, soothing effect, natural humectant, create natural glow etc.

Aloe Vera Gel

Natural

It is found in the inner parenchymal cells of aloe barbadensis miller (liliaceae)

Anthraquinone glycosides, aloesin etc.

Greenish brownviscous liquid with characteristic odour and slightly bitter in taste.

Prevents signs of aging, Moisturizer, Reduces acne and lightens blemishes, Reduces sunburns and tans, Heals wounds and reduces inflammation.

 

 

Table 3: Formulation table.

Sr. No.

Ingredients

F1

F2

F3 (IP)

Marketed Preparation

1

Calamine

15 gm

15 gm

15 gm

15 gm

2

Zinc oxide

5 gm

5 gm

5 gm

5 gm

3

Bentonite

3 gm

3 gm

3 gm

3 gm

4

Tri sodium citrate

0.5 gm

0.5 gm

0.5 gm

0.5 gm

5

Liquefied phenol

0.5 gm

0.5 gm

0.5 gm

0.5 gm

6

Glycerin

_

_

5 mL

5 mL

7

Honey

_

5 mL

_

_

8

Aloevera Gel

5 mL

_

_

_

9

Purified water

100 mL (qs)

100 mL (qs)

100 mL (qs)

100 mL (qs)

 

 


Evaluation

Test for thermal stability

Thermal stability of the formulation was determined by the humidity chamber controlled at 60- 70% RH and 37 ± 1°C.17,18

 

 

Determination of pH

5 ± 0.01g of the lotion was weighed accurately in a 100ml beaker. 45ml of water was added anddispersed the lotion in it. The pH of the suspension was determined at 27oC using the pH meter.

Figure 1: pH meter

 

Patch test

About 1-3gm of material to be tested was placed on a piece of fabric or funnel and applied to the sensitive part of the skin e.g. skin behind ears. The cosmetic to be tested was applied to an area of 1sq.m.of the skin. Control patches (of similar cosmetic of known brand) were also applied. The site of patch is inspected after 24 hrs. As there was no reaction the test was repeated three times. As no reaction was observed on third application, the person may be taken as not hypersensitive.19,20

 

Accelerated stability testing

Accelerated stability testing of prepared formulations were conducted at 40 ± 2°C temperature and 75± 5% relative humidity and studied for 10 days.

 

 

 

Visual appearance

The visual appearance of the formulation at each stability test condition was assessed by comparing the color of the lotion to the initial color and appearance of the C. niloticus oil lotion. Photos were taken of each formulation, placed at the same location in the laboratory each time that appearance was evaluated. A digital camera was placed approximately 15 cm away from the formulations.21

 

Viscosity test

Test for rheological property of lotion was carried out by viscosity measurement using Brookfield viscometer.

A Brookfield Viscometer (Model DV II+, Middleboro, MA, USA),mounted on a Helipath D20733 stand and fitted with a T-bar spindle was used to determine the viscosity of the lotion at each storage condition. The lotion was placed in a pre-heated water bath to reach a temperature of 25 ◦C. The viscosity reading was measured every10 s for the duration of 5 min. Approximately thirty-two readings were generated and the average viscosity determined.22

 

Determination of water content

10g of the material was weighed and transferred it into the flask. 200ml of toluene and few pieces of pumice stone was added and connected the apparatus with condenser. The flask was heated until toluene was begin to boil and refluxed. When the H2O was distilled over source of heat was removed.23

 

Water % by mass = V X D x 100/ M

 

Where, V = volume of water in ml at room temperature collecting in receiving tube

D = density of water at room temperature

M = Mass in gm of the material taken for the test

 

Microbial examination of lotion

1g of material was weighed and aseptically transferred into the conical flask containing 50ml of dil. phosphate buffer at pH 7.2 and pipette out 1ml portion into 3 sterile plates. Melted soyabean casein digest agar (SCDA) medium was poured over it (at 45oC) and cooled. After that plates were rotated to mix properly. Then the plates were incubated at 30 ± 40oC for 74 hrs in an inverted portion. Average number of colonies was determined by multiplying the dilution factor.24

              

 


 

 

 

RESULT AND DISCUSSION:

Table 4: Evaluation of different calamine lotion

Sr. No.

Parameters

F1

F2

F3 (IP)

Marketed Preparation

1

Colour

Pink

Pink

Pink

Pink

2

pH

7.9

7.85

8.13

6.74

3

Viscosity

44.2

2.4

1.4

44.5

4

CP

95

48

28

890

5

Skin Sensitivity

Does not cause any allergies, rashes etc.

Does not cause any allergies, rashes etc.

Does not cause any reactions

Does not cause any reactions

6

Thermal Stability

Stable

Stable

Stable

Stable

7

Water content

90%

87%

88%

88%

8

Herbal residue

Nil

Nil

Nil

Nil

9

Total aerobic microbial count

1x102

 

1x102

1x102

1x102

 

10

Mould and yeast count

0x102

0x102

1x102

0x102

 

 

 

Figur 2: (A) lotion containing glycerine                     (B) lotion containing aloe vera                                (C) lotion containing honey

 

 


The pH of the lotion was found to be in range of 6-7 which is good for skin pH. 25 All the formulations were shown pH nearer to skin required. The lotion applied on skin was easily removed by washing with tap water Emolliency, slipperiness and amount of residue left after the application of fixed amount of lotion was found. When formulations were kept for long time, it was found that no change in colour of lotion. The results of water content and total fatty matter value of both formulations F1 and F2 showed satisfactory values.  All the formulations show no redness, edema, Inflammation and irritation during irritancy studies. These formulations are safe to use for skin. The result of total aerobic microbial count and Mould and yeast count were presented in table and showed satisfactorily values. Stability studies of the lotion were studied and confirmed that the both formulation (F1 and F2) found to be stable when stored for 10 days.

 

CONCLUSION:

Here in the work done it has been concluded that calamine lotion can be prepared from herbal natural extract like honey and aloe-vera. Formulation F4 showed best results when compared with other formulations. It showed a pH similar to skin pH and no skin sentivity with greater stability.

 

ACKNOWLEDGMENT:

The authors want to acknowledge the management and library of Rungta College of Pharmaceutical Sciences and Research, Kohka-Kurud road Bhilai, for providing necessary infrastructure and literature for the compilation of the work.

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Received on 04.07.2016                    Accepted on 20.08.2016  

©A&V Publications all right reserved

Research J. Topical and Cosmetic Sci. 2016; 7(2):41-45.

DOI: 10.5958/2321-5844.2016.00007.8