Development of Cosmeceutical Cream for Dermatitis and Acne vulgaris

 

Kishan L. Jadhav1*,Priyanka R. Kapare1*, Divya V Khairmode1, Nayana Vhatkar1, Shraddha Raut1, Akash S Mali2,3

1Gourishankar Institute of Pharmaceutical Education and Research limb Satara, Maharashtra India

2Vytautas Magnus University, Lithuania

3University of Wurzburg, Germany

*Corresponding Author E-mail: kishanjadhav31@gmail.com, akashmit97@gmail.com

 

ABSTRACT:

Dermatitis and Acne vulgaris is common skin disorders, occurring in about 85–95% of adolescents. It is associated withfilaggrin gene andPropionibacterium acnes infection respectively. Our aim of present research is to design new cream which relieve Itching due to Dermatitis and act on Acne Vulgaris.Following cream is complex mixture of Salicylic acid and retinol which benefits as superb skin treatment.The patch test for sensitivity testing has also been done and no evidence of skin irritation and allergic signs also Accelerated stability testing of cream sample has been conducted in the environmental chamber with temperature 25 ± 10C and humidity 60 ± 10% RH. The products no sign of phase separation and no change in the color. The work mainly focuses on microbial quality control and Dermatitis activity of formulated cream. In future this formulated cream will give promises to Skin care and Anti –Itching with therapeutic effects.

 

KEYWORDS: Dermatitis ,Acne Vulgaris, Itching, Salicylic acid, Vitamin A.

 


 

 

 

INTRODUCTION:

Acne is the most common type of skin disorder. it required new skin care formulation. Presented Cream is complex mixture of Salicylic acid, Retinol and calamine. Recent studies show that mutation observed in outermost layer of skin result in a topic dermatitis. More than around 45 million peoples suffering from Acne and 80% of people in USA will get affected at one point in their life. Due to combination of both calamine and salicylic acid it is easy to negotiate the side effect of retinoids. Prevention of Acne will reduce risk factors. However Salicylic acid and retinol both drugs will relieve the skin problems. As calamine acts as anti- itching agent helps in relieve irritation occur due to dermatitis and Eczema. In USA nearly 10% to 20% infants and some children are infected. The patients of eczema are at high risk of viral infection. Salicylic acid act as Keratolytic agent and bacteriostatic agent. Which cause opening of clogged pore on skin and prevent them from clogging up again. Retinol exact mechanism of action is not known but Several studies shows that it induce apoptosis (programmed cell death) various cells in body isomer of tretinoin used orally for severe acne.[1,6]

 

 

Fig 1.1– Mechanism of action of Retinol and salicylic acid on Acne Vulgaris.

 

Atopic dermatitis is inflammatory disease of skin, which involve the hyperactivity of cutaneous layer. Recent studies show that dermatitis related with immunological and inflammatory reaction. This is major public health problem will affect 1-20% person worldwide also during lifetime it occur to 10 -20% in children and 1-3% in adults. Nationalsurvey in US state approximately in 17.2% children's suffering from AD last 17 years. mainly develop on dry skin and produce non-lesioned skin. According to twin studies of atopic dermatitis in several patients it indicates in 0.72-0.86% in monozygotic and 0.21-0.23% in dizygotic patient genetic factor play vital in development of this disease. Mutation in FLG gene develop sign of dermatitis.Recent approaches suggest that biologics can be implemented as new therapy for AD in future[1].

 

Salicylic acid act by mechanism through reducing lesion formation by unclogging pore. However, it does not affect the sebum production and bacterial growth. Also, retinol is most effective drug against Acne vulgaris, act by same mechanism as that of salicylic acid. topical application of this cosmeceutical cream it spread on skin layer and penetrate through the skin. retinol also helps by unclog the pore it allows to work better action of salicylic acid on acne. Recent studies on retinol shows that it helps to decrease the oil production and act as antibacterial thus prevent bacterial growth in acne. since this cream also contain small amount of calamine it will repair damaged tissue.

 

 

Fig 1.2 – Mechanism of calamine with Salicylic acid on Atopic Dermatitis.

 

Calamine act on dermis layer of skin and denatured bacterial growth. Salicylic acid used to treat eczema due its keratolytic property on epidermis layer of skin,also reduce rough dark spot and plaque effectively. Due to its ability as keratolytic agent it soften the keratin and help to loosen dry skin[2].

 

MATERIALS AND METHODS:

Chemicals

Retinol and Salicylic acid was obtained gift sample (Lasons, India. Pvt. Ltd), other chemicals such as Calamine, Preservatives ,emollients all the materials were obtained commercially and used as such.

 

Formulation Method

Firstly added Salicylic acid, water and  calamine in to heat resistance glass beaker and stirred well (Phase I), on other hand mixture of Paraffin wax and Lanoleic acid melted in other beaker(Phase II) and stirred well to make cream base .phase I becomes viscous with heating at 650C-750C, constantly stirring ,after that used homogenizer for mixing to above prepared emulsion with little drop of Rose water when it goes hand warming or lower than 400C and mixed well until we got smooth and uniform texture. Stored at room temperature.(Table no.2)

 

Evaluations parameters

Take 5 gm of cream in clean platform and observe visually

A.   Physical Characteristics

The formulated creams were observed visually for their color, homogeneity, phase separation, consistency, spread ability. The pH was measured with help of pH meter. (Table no.1)

 

B.   Patch Test

1-3gm cream to be tested was placed on a piece of fabric 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 were also applied. The site of patch is inspected after 24 hrs.

 

C.   Microbiological studies

The designed creams were inoculated on the plates of agar media by streak plate method and a control was prepared by omitting the cream. The plates were placed in to the incubator and are incubated at 370C for 24 hours. After the incubation period, plates were taken out and check the microbial growth by comparing it with the control. (Figure.2)

 

D.   Spreadability studies

A major test for semisolids is that it possesses better spreadability which is a term expressed to denote the extent of area to which the cream readily spreads on application to the skin Spreadability is expressed in terms of time in seconds taken by two slides to slip off from the formulation, placed between, under the application of a certain load. Lesser the time taken for the separation of the two, better the spreadability. Two glass slides of standard dimensions were selected. The formulation whose spreadability had to be determined was placed over one of the slides. The other slide was placed on top of the formulations was sandwiched between the two slides across the length of 5 cm along the slide. 100 g weight was placed up on the upper slide so that the formulation between the two slides was pressed uniformly to form a thin layer. The weight was removed and the excess of formulation adhering to the slides was scrapped off. One of the slides was fixed on which the formulation was placed. The second movable slide was placed over it, with one end tied to a string to which load could be applied by the help of a simple pulley and a pan. A 30g weight was put on the pan and the time taken for the upper slide to travel the distance of 5.0cm and separate away from the lower slide under the direction of the weight was noted. The spreadability was then calculated from the following formula[1,3]

 

Spreadability= m ×l /t

m = weight tied to the upper slide (30g) l =length of glass slide (5cm) t =time taken in seconds.

 

E.   Stability studies

The stability studies were carried out as per ICH guidelines. The cream filled in bottle and kept in humidity chamber maintained at 30 ± 2°C/ 65 ± 5 % RH and 40 ± 2°C / 75 ± 5 %  RH for three months. At the end of studies, samples were analyzed for the physical properties and viscosity.[4].

 

RESULT AND DISCUSSION:

Formulated 10 gm cream has bright Golden yellow color with smooth texture. pH of formulation found to be 6. The stability studies of the various parameters like visual appearance, nature, pH of the formulations showed that there was no significant variation after three months of the study period.(table no 5)The formulation shows no redness, edema, inflammation and irritation during Patch Test studies. These formulations are safe to use for skin. The formulated creams were tested for the presence of pathogenic microorganisms by culturing it with agar medium. There were no signs of microbial growth after incubation period of 24 hours at 370C and having  antimicrobial property.(Figure 2) We  didn’t found any allergic conditions but we advise to consult with physician or pharmacist and should be prescribed in case of pregnant women or who are planning to pregnancy[5,6]

 

 

TABLE NO. 1 PHYSICAL CHARACTERISTICS

Sr.No.

Properties

Formulation

1

Color

Golden yellow

2

Odor

Characteristics

3

Appearance

Semi-Solid

4

Texture

Smooth

 

TABLE NO.2FORMULATION AND ROLES (10 GM)

Ingredients

Role

Quantity

Retinol

Active ingredient

0.6 gm

Salicylic acid

Antimicrobial agent

1.5 gm

Calamine

Anti -Itching agent

0.5 gm

Paraffin

Moisturizer

2.5 gm

Lanoleic acid

Emulsifying agent

2.0 gm

Rose water

Perfuming agent

0.02 ml

Methyl Paraben

Preservative

0.02 ml

Distilled water

Diluent

3.36 ml

 

TABLE NO.3 PH DETERMINATION AND THERMAL STABILITY

Sr.No

Parameters

Formulation

1

Thermal Stability

(RH 65% and 30 ± 40oC)

Stable, No oil Separation

2

pH (27oC ± 2oC)

6

 

TABLE NO.4 SPREDABILITY TEST

Formulations

Time (Min)

Spread ability

(g cm/sec)

New Research

16

11.4

Marketed Cream

18

11.5

 

 

TABLE NO. 5 ACCELERATED STABILITY STUDIES

Months/ Tests

Formulation

After one month       

After second month       

After third month

Physical appearance

Semi-solid

Semi-solid

Semi-solid

Texture

Smooth

Smooth

Smooth

color

Golden yellow

Golden yellow

Golden yellow

Odor

Characteristic

Characteristic

Characteristic

pH value

6

6

6

Thermal stability

ok

ok

ok

Degradation of product

nil

nil

nil

consistency

ok

ok

ok

 

 

 

FIGURE NO. 2 MICROBIOLOGICAL ASSAY

A)Ciprofloxacin (Standard) and Formulation with gram (+) bacteria; B)Ciprofloxacin (Standard) and Formulation with gram (-) bacteria

 

CONCLUSION:

Acne vulgaris is severe skin disorders that afflict people in their adolescence. Acne vulgaris or known as acne is a human skin disease characterized by skin with scaly red skin, blackheads and whiteheads, pinheads, large papules, pimples and scarring. Acne vulgaris is a disease of pilosebaceous considered by the formation of open and closed comedones, papules, pustules, nodules and cysts. Acne affects skin having dense sebaceous follicles in areas including face, chest and back. Acne is not life threatening but severe acne can affect psychological status and social activities. The present review focuses on an epidemiology, etiology, pathogenesis, diagnosis, differential diagnosis and management of acne with the pharmaceutical dosage forms of oral and topical administrations.Present research focuses on development of medicationwith highly therapeutic effect, uses of vitamins for nourishing ,anti-acne ,and reduce itching which give beneficial effects to dermatology,this medication will reducing problems in adolescence for skin care in future. The prepared formulations showed good spreadability, no evidence of phase separation and good consistency during the study period. Stability parameters like visual appearance, nature and fragrance of the formulations showed that there was no significant variation during the study period.

 

ACKNOWLEDGEMENT:

The Authors is highly thankful to Nikam S.N., Lab Assistant Gourishankar Institute of Pharmaceutical Education and Research Limb, Satarafor valuable help in current project.

 

REFERENCE:

1.     Akash S. Mali, Karekar P, Dr. Yadav A. V, "Formulation and Evaluation of Multipurpose Herbal Cream", International Journal of Science and Research (IJSR), Ijsr.Net, Volume 4 Issue 11, November 2015, 1495 – 1498

2.     Zhu, Wenyuan, And Jie Gao. "The Use of Botanical Extracts as Topical Skin-Lightening Agents for The Improvement of Skin Pigmentation Disorders."Journal Of Investigative Dermatology Symposium Proceedings. Vol. 13. No. 1. Nature Publishing Group, 2008

3.     Yaar, M., And B. A. Gilchrest. "Ageing and Photoageing Of Keratinocytes and Melanocytes." Clinical and Experimental Dermatology 26.7 (2001): 583-591.

4.     Ebanks, Jody P., R. Randall Wickett, And Raymond E. Boissy. "Mechanisms Regulating Skin Pigmentation: The Rise and Fall of Complexion Coloration." International Journal of Molecular Sciences 10.9 (2009): 4066-4087.

5.     Roy, Ram Kumar, Mayank Thakur, And V. K. Dixit. "Development and Evaluation of Polyherbal Formulation for Hair Growth–Promoting Activity."Journal of Cosmetic Dermatology 6.2 (2007): 108-112.

6.     Nayana Vhatkar, Shraddha Raut, Manali Pore, SiddhikaDhope, Igor Foscolo and Akash S Mali, Design and development of cosmeceutical cream for hyperpigmentation and anti-aging, Inter J. Adv. Community Medicine 2018; 1(1): 27-31

 

 

 

Received on 21.05.2018                    Accepted on 22.06.2018

©A&V Publications all right reserved

Research J. Topical and Cosmetic Sci. 9(1): Jan.-June 2018 page 33-36.

DOI:10.5958/2321-5844.2018.00007.9