INTRODUCTION:

Over the last decades the treatment of illness have been accomplished by administrating drugs to human body via various roots namely oral, sublingual, rectal, parental, topical, inhalation etc. Topical delivery can be defined as the application of a drug containing formulation to the skin to directly treat Cutaneous disorder or the cutaneous manifestations of a general disease (eg: psorisis) with the intent of containing the pharmacological or the effect of drug to the surface of the skin or within the skin semi solid formulations in all their diversity dominate the system for topical delivery,¹ but foams, spray , medicated powders, solutions and even medicated adhesive systems are in use. Creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base.² This term has conventionally been applied to semisolids that possess a relatively fluid consistency formulated as either water-in-oil (e.g., Cold Cream) or oil-in-water (e.g., Fluocinolone Acetonide Cream) emulsions. However, more recently the term has been limited to products consisting of oil-in-water emulsions or aqueous microcrystalline dispersions of long-chain fatty acids or alcohols that are water washable and more cosmetically and aesthetically acceptable.³

Type of cleansing cream:

I.) Anhydrous type⁴: It contains mixture of hydrocarbon, oils and waxes. It also contains cetyl alcohol, spermaceti, cocoa butter, fatty acid esters etc.

Mineral oil................................80 gm

Petroleum jelly........................15gm

Ozokerite wax ........................5 gm

Preservative and perfumes .....q.s

II.) Emulsified type⁵:

They can be either o/w or w/o type.

Common Ingredients:

Oil phase.......................Spread easily

Waxes..........................Give appropriate thixotropy

Emollient material likes cetylalcohol, spermaceti, and lanolin Water phase with preservative

Vanishing cream⁶:

These are named so as they seem to vanish when applied to the skin. High quantity of stearic acid as oil phase use. This provides an oil phase which melts above body temperature and crystallizes in a suitable form, so as to imperceptible in use and gives a non greasy film. Main component is emollient esters, stearic acids Part of stearic acid is saponified with an alkali and rest of stearic acid is emulsified this soap in big quantity of water. The quality of cream depends on the amount of acid saponified and nature of alkali used⁷. NaOH makes harder cream than KOH. Borax makes cream very white but product has tendency to grain. Pearliness can be attained using liq. paraffin, cocoa butter, starch, castor oil, almond oil. Ammonia solution has a tendency to discolor creams made with it after some time. Cetyl alcohol improves touch and stability at low temperature without affecting sheen

Typical formulation^8,9

Stearic acid..................................15gm

Glycerin.......................................5gm

KOH.............................................0.5 gm

Water............................................75.82 gm

NaOH...........................................0.18 gm

Cetyl alcohol................................0.50 gm

Propylene glycol..........................3.0gm

Preservative andperfume..............q.s

Type:

a) Liquid cream:- Consistency is of liquid nature

b) Solid creams: - Consistency is higher

c) Nonaqueous type:- Not containing any aqueous medium

Evaluation of cream as per the requirements for skin creams specified, following parameters are used for evaluation of cream

Evaluation parameters^10,11:

Thermal stability

For thermal stability testing, a humidity chamber and clear glass container of around 30ml capacities with screw cap are used. With the help of spatula cream is inserted in the glass containers and tapped to settle to the bottom and plug is inserted and tightens the cap. The packed bottle is kept inside the incubator at 450± 1 0C for 48h. On removal from the incubator, it is noted that no oil separation or any other phase separation will not observed, than formulated cream is stable at 450C.

Determination of pH of formulated Cream^12,13:

The digital pH meter is calibrated using buffer solution of pH 4.01, 7.0 and 9.2. Cream is taken in a beaker and the pH of the cream is determined.

Appearance:

The appearance of the cream is judged by its color, pearl scence and roughness and graded

After feel:

Emolliency, slipperiness and amount of residue left after the application of fixed amount of cream is check

Type of smear:

After application of cream, the type of film or smear formed on the skin are check removal: The ease of removal of the cream applied is examined by washing the applied part with tap water

Acid value¹⁴:

Take 10 gm of substance dissolved in accurately weighed, in 50 ml mixture of equal volume of alcohol and solvent ether, the flask is joined to reflux condenser and slowly heated, until sample is dissolved completely, to this 1 ml of phenolphthalein added and titrated with 0.1N NaOH, until faintly pink color appears after shaking for 30 seconds

Acid value = n X 5.61/w

n = the number of ml of NaOH required.

w = the weight of substance.

Saponification value:

Introduce about 2 gm of substance refluxed with 25 ml of 0.5 N alcoholic KOH for 30 minutes, to this 1 ml of phenolphthalein added and titrated instantly, with 0.5 N HCL.

Saponification value¹⁵= (b-a) X 28.05/w

The volume in ml of titrant = a

The volume in ml of titrant =b

The weight of substance in gm = w

Irritancy test:

Mark an area (1sq.cm) on the left hand dorsal surface. The cream is applied to the specified area and time is noted. Irritancy, erythema, edema, is checked if any for regular intervals up to 24 hrs and reported.

Determination of total fatty substance content^16,17:-

About 2g of the exactly weighed formulated cream is taken into a conical flask, Dilute Hydrochloric acid (25ml) is added and a reflux condenser is fixed into the flask and the solution is boiled until it completely cleared. Then contents of the flask are poured into a 300ml-separating funnel and it is cooled to room temperature. In portion of 10ml the conical flask is rinsed with 50 ml of petroleum ether and poured into the separating funnel, separating funnel is then shaked well and left until the layers are separated. An aqueous phase is separated and all ether extract is then washed with water. This petroleum ether extract is then filtered through a filter paper and dried the material in the flask at a temperature 90 ± 2 0C of to constant mass

Formula:

Total fatty substance = 100 M1/ M2

Where, M1= mass (g) of the residue , M2 = mass (g) of the cream

Determination of residue:-

About 5g of the cream is taken in a weighed, clean and dry squat form weighing bottle and dried to constant mass at 105 ± 1 0C. Cooled in a desiccator and weighted

Formula:

Residue = 100 M1/ M2

Where,

M1 = mass (gm) of the residue, M2 = mass (gm) of the cream¹⁸.

Test for lead:

Standard lead solution is prepared by using 1.600gm of the lead nitrate taken in water and the solution is made to 1000ml. solution (10ml) is Pipette out and diluted to 1000ml with water. 1 ml of this solution contains 0.01mg of lead (Pb). About 2.00gm of cream is taken in a crucible and heated on a hot plate and then taken in a muffle furnace to ignite it at 600 0C to constant mass. Dilute hydrochloric acid 3ml (5N) is added and warmed and volume is made to 100ml. solution is then filtered^19,20. In the second Nessler' s cylinder, 2 ml of dilute acetic acid (1N) is added, volume is made with water to 25ml. standard hydrogen sulphide(10ml) solution is added to each Nessler’s cylinder and volume is made with water (50ml) mixed and allowed to stand for 10min and the colour produced in two Nessler’s cylinders is compared. The colored produced with hydrogen sulphide is matched against that obtained with standard lead solution.

Spreadability²¹:

Spreadability of cream is measured with the glass slide apparatus, overkill of cream is placed between two slides and 1 kg weight is placed on slide for 5 min. to compress the sample to uniform thickness, time in seconds to separate two slides is taken as measure of spreadability

S = w l / t

Where, S = spreadability (g cm/sec) , w = weight on upper slide (g), l = length of Slide (cm),t = time taken in sec (sec).

Homogeneity:

The developed cream is tested for homogeneity by visual inspection, after the cream have been set in the container, spread on the glass slide for the appearance, tested for the presence of any lumps, flocculates or aggregates.

Microbial evaluation:

Microbial evaluation of herbal formulations is essential to check the limits of microbial contamination and extents of pathogencity^22,23. This evaluation has direct correlation with the quality of products. For the evaluation of total microbial count details of different count media are used, nutrient agar medium used for the growth of bacteria and Potato dextrose agar medium is used for the growth of fungi.

In aseptic conditions cream equivalent to 1 gram is dissolved in 10ml of sterile water and is serially diluted. The medium and apparatus required for experimental are sterilized in an autoclave at 121 0C for 15min. In aseptic conditions, 1ml of test sample is transferred to petridish containing melted agar medium at about 42 0C and mixed well by rotating the petridish. It is allowed to solidify and then incubated at 37 0C for 24h for detection of bacteria. After incubation period, colonies are counted

Formula:

No. of Microorganism = No. of colonies × dilution factor /Volume of sample

Stability testing of formulated cream^24,25:

For assessing the stability of formulated creams following parameters are taken into consideration like Thermal stability testing, pH, Total fatty substance content, Total residue, General test for lead, Consistency, Spreadability. These studies are essential to ensure that product is stable over its designated shelf life. The stability study is carried out for three months as per ICH norms, at three different temperatures such as at room temperature, 450C and 8 to 100C.

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Received on 24.02.2016 Accepted on 30.04.2016

Research J. Topical and Cosmetic Sci. 7(1): Jan.-June 2016 page 19-22

DOI: 10.5958/2321-5844.2016.00004.2