INTRODUCTION:

In ancient times cosmetics were only used as a beauty fix. These were derived from various natural sources. In the present scenario beauty along with personal care is the trend. Cosmeceuticals ^[2] combination of cosmetics and drugs has come into picture, which imparts decorative, attractive and eye appealing impressions along with therapeutic activity. These products not only add glamorous touch to an individual but also heal different pathological conditions such as inflammation, cracking, chapping and dryness of the skin. Face is the important part which is exposed to the environment and one must take a great care of it.

Lips are the most important part in the face. It needs proper nourishment and hydration as it is the only part in our body which lacks pores. Cosmeceuticals like lip balms, lip serum, lip rouge, lip oils, lip masks, lip scrubs^[4], lipsticks^[5], and exfoliators have evolved which protects the lip skin from dehydration, hyperpigmentation, inflammation etc. Out of all lipsticks is the integral part of daily make up routine. Lipsticks are cosmetic formulations for the modification or accentuation of lip color and are prepared by molding a dispersion of colors in a waxy base, in the form of stick/crayon. Any preparations used in beauty treatments for lip make-up also known as sticks or more commonly known in beauty treatments by the name of lipsticks. When these preparations contain active ingredients, they are also known as medicated lipsticks or medisticks^[6] which may contain synthetic drugs or herbal dugs^[7].. Many medicated lipsticks, lip balms, micro sponges were formulated by using allantoin^[8] benzoyl peroxide, terbinafine hydrochloride, flubiprofen, and natural antifungal ingredient curcumin^[9][10] acyclovir^[11], etc. In the present study we tried to formulate a medicated lipstick using salicylic acid which is a keratolytic agent with mild antiseptic action. Salicylic acid^[13] facilitates desquamation by solubilizing the intercellular cement that binds scales in the stratum corneum, thereby loosening the keratin. This keratolytic effect may provide an antifungal action because removal of the stratum corneum suppresses fungal growth; it also aids in the penetration of other antifungal agents. Instead of synthetically derived colors which may show side effects upon longer usage, we used naturally extracted colour from annatto seeds^[12], which imparts orange red colour and is slightly peppery with a hint of nutmeg. Bixin and nor bixin are the important chemical constituents which has carotenoid pigment. The more norbixin in an annatto color, the more yellow it is; a higher level of bixin gives it a more orange shade. The fat-soluble color in the crude extract is called bixin, which can then be saponified into water-soluble norbixin. This dual solubility property of annatto is rare for carotenoids. The seeds contain 4.5–5.5% pigment, which consists of 70–80% bixin. Unlike beta-carotene, another well-known carotenoid, annatto-based pigments are not vitamin. Other excipients include beeswax, hard paraffin, and castor oil.

Beeswax (Cera alba) is a natural wax produced by honey bees of the genus Apis. The wax is formed into "scales" by eight wax-producing glands in the abdominal segments of worker bees, who discard it in or at the hive. The hive workers collect and use it to form cells for honey-storage and larval and pupal protection within the beehive. Beeswax is used in lip balm, lip gloss, hand creams, salves, and moisturizers^[15]; and in cosmetics such as eye shadow, blush, and eye liner. Beeswax is also an important ingredient in moustache wax and hair pomades, which make hair look sleek and shiny. In the preparation of lipstick beeswax is used as glazing agent for giving a glossy look to the lipstick and also it is used for the hardening of the final preparation of lipstick. Paraffin wax is a white or colourless soft solid derivable from petroleum, coal or oil shale, that consists of a mixture of hydrocarbon molecules containing between twenty and forty carbon atoms. It is solid at room temperature and begins to melt above approximately 37 °C (99°F); its boiling point is >370°C (698°F), used as moisturiser in toiletries and cosmetics such as vaseline, though potentially comedogenic. In this case it is used as a glossary for the finished product. Castor oil is a vegetable oil obtained by pressing the seeds of the castor oil plant (Ricinuscommunis). The common name "castor oil", from which the plant gets its name, probably comes from its use as a replacement for castoreum, a perfume base made from the dried perineal glands of the beaver (castor in Latin).Castor oil is a colorless to very pale yellow liquid with a distinct taste and odor once first ingested. Its boiling point is 313°C (595°F) and its density is 961kg/m³. It is a triglyceride in which approximately 90 percent of fatty acid chains are ricinoleates. Oleate and linoleates are the other significant components. Castor oil is not a drying oil, meaning that it has a low reactivity toward air compared to other oils such as linseed oil and tung oil. Dehydration of castor oil gives linoleic acids, which do have drying properties.

METHOD:

Melting and Mixing:

First, the raw ingredients for the lipstick are melted and mixed separately because of the different types of ingredients used. One mixture contains the solvents, a second contains the oils, and a third contains the fats and waxy materials. These are heated in separate stainless steel or ceramic containers.

The solvent solution and liquid oils are then mixed with the color pigment that is extracted from annatto seeds. After the pigment mass is ground and mixed, it is added to the hot wax mass until a uniform color and consistency is obtained. The fluid lipstick can then be strained and molded.

Molding:

Once the lipstick mass is mixed and free of air, it is ready to be poured into the tube.

The melted mass is dispensed into a mold, which consists of the bottom portion of the metal and a shaping portion that fits snugly with the tube. Lipstick is poured "up-side down" so that the bottom of the tube is at the top of the mold. Any excess is scraped from the mold.

The lipstick is cooled and separated from the mold, and the bottom of the tube is sealed.

Extraction of Annatto Color

The coloring agent used in the formulation is annatto. It is extracted by first drying the seeds of annatto. These seeds are the heated with ethanol solution and the ethanol solution is allowed to evaporate until the color is concentrated and then the color is extracted. The ethanolic solution is directly used for coloring.

Evaluation methods of Medicated Lipstick

It is very essential to maintain a uniform standard for medicated lipstick, keeping this view in mind the formulated medicated lipsticks was evaluated on the parameters such as melting point, breaking point force of application, surface anomalies etc.

Melting point:

The melting point of formulated lipstick was determined by capillary tube method, the capillary was filled and keep in the capillary apparatus and firstly observed the product was slowly-slowly milted. After sometimes observed product was completely melted. The above procedure was done in 3 times and the melting point ratio was observed in all formulations.

Breaking point:

Breaking point was done to determine the strength of lipstick. The lipstick was held horizontally in a socket inch away from the edge of support. The weight was gradually increased by a specific value (10gm) at specific interval of 30 second and weight at which breaks was considered as the breaking point.

Force of application:

It is test for comparative measurement of the force to be applied for application. A piece of coarse brown paper kept on a shadow graph balance and lipstick was applied at 45º angle to cover a 1 sq. Inch area until fully covered. The pressure reading is an indication of force of application.

Surface anomalies:

This was studied for the surface defects, such as no formation crystals on surfaces, no contamination by moulds, fungi etc.

Aging stability:

The products were stored in 40ºC for 1 hrs. Various parameters such as bleeding, crystallization of on surface and ease of application were observed.

Skin irritation test:

It is carried out by applying the product on the skin for 10 min.

EVALUATION:

The following parameters were evaluated for the formulated herbal salicylic acid medicated lipstick and results were reported as follows

Table1: Evaluation parameters of salicylic acid medicated lipstick

S. No.	Test	Standard	Observation
1	Melting point	45-50 °C	47 °C
2	Breaking point	10 gm -30 sec	30 gm- 90 sec
3	Force of application	45 °C	good
4	Surface anomalies	No anomality	None
5	Aging stability	Good	Good
6	Skin irritation test	none	None
7	Spreadability	Good	Good
8	Colouring	good good+	Good

RESULTS AND DISCUSSION:

Method of preparation:

Without the use of color and drug:

The preparation was done in three stages where the first stage involved the formulation of lipstick without the color and the drug. This trial was successful where the formulation obtained was satisfying in the shape and its consistency.

Using the Color but no Drug:

This was the second trial attempt where the consistency of color and the stability of lipstick were observed. The second attempt of preparation also was successful in getting the required preparation. The final trial in an attempt to formulate the lipstick. It was done using all the planned requirements of the natural coloring agent and the drug, salicylic acid. This final preparation was observed for all the parameters of the formulation, consistency of color and also the drug. This also was successful in obtaining the required formulation and the final obtained product was visually compelling.

Further results of evaluation are given below:

Meltingpoint:

The melting point of this prepared lipstick was found to be 47°C

Breaking point:

The given lipstick was tested for its breaking point and it was found to be at 30grams for 90 seconds

Surface anomalies:

The lipstick was found free from any surface anomalies like the crystals and other formation microorganisms.

Stability studies:

The lipstick was tested for stability. It was placed in refrigerator for 2 hours at 0-4°C. The sweating action of lipstick was observed after 6 minutes of exposure to room temperature. Later it was placed in an oven at 45^OC where the formulation started melting after 20 min of exposure.

Skin irritation:

The prepared lipstick was not found to have any irritation on skin.

Figure 1: Extraction of colour from annatto seeds

Figure 2: Lipstick prepared with no colur and drug(top) and with colour and drug(bottom)

Figure 3: The final product

CONCLUSION:

A lipstick formulation was attempted to prepare using a natural coloring agent and a drug. The attempt was proved to be successful as the prepared formulation passed all the required evaluations of stability, consistency of color, good withstand towards the temperature and also the color consistency of the lipstick was really good as it was tested for this for about a month and the formulation was able to produce good color with the use of natural coloring agent, annatto color.

REFERENCES:

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2. Schneider, Günther et al "Skin Cosmetics" in Ullmann's Encyclopedia of Industrial Chemistry, Wiley-VCH, Weinheim (2005).

3. "Cosmetics and Your Health – FAQs". Womenshealth.gov. November 2004. Archived from the original on 2013-03-12.

4. Lewis, Carol "Clearing up Cosmetic Confusion." FDA Consumer Magazine (2000).

5. Schaffer, Sarah (2006), Reading Our Lips: The History of Lipstick Regulation in Western Seats of Power, Digital Access to Scholarship at Harvard, Retrieved 2014-06-05

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11. Rajyalakshmi SV, vinaya OG. Formulation and optimization of medicated lip rouge contining niosomal acyclovir for the management of recurrent herpes liabialis. International Journal of Applied Pharmaceutics 2017; 9(6): 21-27.

12. Swati Deshmukh, Manisha Chavan, Manisha Sutar and Sonia Singh. Preparation and evaluation of medicated lipstick from Bixaorellana seeds. International Journal of pharma and bio sciences. 2013; 4 (3):139-144

13. Sathish.S, Mahesh.Ch, Saikat Das, Lavanya.V, Suresh.B Preparation and evaluation of salicylic acid medicated lipstick. Journal of Advanced Pharmaceutical Sciences. 2012; 2(2): 289-294.

14. Tejashri AG, Priya Rodge. Formulation and Evalution of herbal Lipstick containing Anti-Fungal agent. Indo American Journal of Pharmaceutical Research. 2018; 8(1):1298-1310.

15. Lauren Dooley B.S., Lexicon Development for Lip products using descriptive sensory analysis California Polytechnic State University, San Luis Obispo, 2004.

Received on 27.01.2020 Accepted on 18.02.2020

Research J. Topical and Cosmetic Sci. 2020; 11(1):20-23.

DOI: 10.5958/2321-5844.2020.00005.9