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PREPARATION OF ANTIDERMATITIS OINTMENT WITH WIDER-SPECTRUM

ACTIVITY

Article · January 2007

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 PREPARATION OF ANTIDERMATITIS OINTMENT WITH WIDER-SPECTRUM
ACTIVITY

O.C. ENEH
Research Fellow, Institute for Development Studies, University of Nigeria, Enugu Campus
Lecturer, Department of Pure & Industrial Chemistry, University of Nigeria, Nsukka

ABSTRACT
A topical antidermatitis ointment that exhibits a wider-spectrum of and additional activities than
familiar preparations has been successfully prepared, using over 90% local substitutes for
foreign raw materials. The water-free oily cream product, which contains benzoic acid, salicylic
acid and sulphur as active ingredients, paraffins as vehicle and body and solidifier, as well as
colourant and perfume additives, showed 0.02% cases of skin irritation and hypersensitivity
reactions. It prevents and treats eczema, dandruff, psoriasis, acne, ringworm, after-shave
rashes, heat rashes, napkin and urinary rashes, dermatitis, seborrhea, African beauty spots, and
craw-craw. It also treats bruises, burns and cuts, proving antipyretic, anti-inflammatory and
preventive of post-healing skin discolouration. It does not treat pimples. It was more acceptable
in harmattan. But, moisturizing lotion was preferred to it as a cosmetic.
Keywords: Preparation, antidermatitis ointment, wider-spectrum activity

INTRODUCTION
Different dermatological preparations have been indicated for topical application for the
prevention and treatment of various skin disorders and infections. Notable among these are
Benzoic acid Ointment, Compound, containing benzoic acid and salicylic acid in emulsifying
ointment and indicated for skin infection due to Tinea Spp., e.g. Ringworm. Another one is
Salicylic acid and Sulphur Ointment, containing salicylic acid and precipitated sulphur in
hydrous ointment (oily cream) and indicated for acne, eczema, psoriasis, and dandruff [1]. The
raw materials and the products are imported into Nigeria.
So far, no single topical preparation has been reported for all the above-named skin
disorders and infections [2]. This work, therefore, aims at compounding with sizeable proportion
of local raw materials a topical water-free oily cream that prevents and treats most skin disorders
and infections. This will reduce dependence on foreign products and raw materials as well as
save foreign exchange.
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MATERIALS AND METHODS

The materials used for this preparation were the industrial grade paraffins, benzoic acid,
salicylic acid, sulphur powder, colourant, fragrance and cans (glass or plastic) purchased from
Onitsha Market. Physical and chemical tests commonly found in literature were carried out to
ascertain the quality of the active ingredients (benzoic acid, salicylic acid and sulphur) as
outlined in Table 1. The quality of the petroleum jelly was ascertained following NIS 371:1997
[3]. Local sulphur powder and the paraffins are 90% of the raw materials used.
Table I: Physical and Chemical Tests for Benzoic Acid, Salicylic Acid and Precipitated Sulphur Powder
S/NO MATERIAL PHYSICAL INSPECTIONS CHEMICAL REACTIONS
.

1. Benzoic acid, C 1. White crystalline solid 1. Dissolves in hot water, but

2. Melting point: 1210C separates as shining whites
3. Sparingly soluble in cold flakes on cooling
water, but fairly soluble in 2. Its natural solution gives a
hot water, alcohol and white precipitate with silver
ether nitrate, AgNO3
4. Faint aromatic odour 3. Gives effervescence with
 5. Readily sublimes
6. Volatile in steam
2. Salicylic acid, E 1. White crystalline solid
2. Melting point: 1550C
3. Sparingly soluble in cold
water, but fairly soluble in 2. Gives effervescence with
hot water, alcohol and
ether
4. Poisonous in nature
5. Readily sublimes
6. Volatile in steam
3. Sulphur 1. Yellow powder solid
2. Melting point: 113-119 0C odour
sodium bicarbonate, NaHCO3
4. Gives a buff-colour
precipitate with ferric
chloride, FeCl3
1. Dissolves in hot water, but
separates as shining whites
flakes on cooling
sodium carbonate, Na2CO3, or
sodium bicarbonate, NaHCO3,
releasing carbon dioxide, CO2,
to form sodium salt, sodium
salicylate
3. Gives a violet colour with
ferric chloride, FeCl3, in
aqueous solution
4. Gives 2,4,6-tribromophenol
with bromine water, this
reaction forming the basis of
quantitative estimation of the
acid in medicinal
preparations
1. Gives characteristic sulphide

with Mg as MgS is formed.

2. Vapour from melted sample

gives

pale yellow solid on contact

with a

cold surface.

A common method for preparing water-free oily cream was used as follows:
Hard and soft paraffins were melted on a mild heat. Benzoic acid, salicylic acid and
precipitated sulphur powder were dissolved in liquid paraffin together with colourant
(yellow, oil-soluble) and added to the melted paraffins while stirring. Fragrance was
added when the temperature of the mixture had come down to 40-50oC. The product
was canned warm and liquid in plastic (pvc) or glass bottle.
Varied concentrations of the active ingredients, drawn from preparations earlier reported
[1], were used to get three preparations which were applied topically on different portions of
approximately the same size of eczema of a patient to select the best of the three preparations for
further investigations. Application in this preliminary test was done twice daily (after morning
and night baths) for 15 consecutive days. Consent of the patient was sought and obtained.
The preparation with the selected concentrations of active ingredients was
analyzed/examined for suitability as cosmetic product by a public analyst at the Department of
Pharmacology, University of Nigeria Teaching Hospital, Enugu.
The consent of users/testers was obtained prior to the issuing of the product samples to
5,000 students and parents (staff) of some secondary schools in Enugu and Nsukka metropolis
with a wide range of dermatological differences assumed among them. Sixteen most common
skin disorders and infections were clearly explained to the literate sample recipients. They were
instructed to apply the preparation after morning bath and after evening bath daily for six weeks.
They were to carry out daily observations of the prevention and treatment of eczema, dandruff,
psoriasis, acne, ringworm, after-shave rashes, heat rashes, napkin and urinary rashes, dermatitis,
seborrhea, African beauty spots, pimples, and craw-craw. Also to be noted were its effects on
cuts, bruises and burns, its effects on and compatibility with the skin during and after treatment
of a skin disorder or infection as well as its prevention of post-healing skin discolouration.
Report sheets were given out together with the samples.
Although, not all recipients of samples turned in reports, some recipients turned in
multiple reports from using the samples on households with various disorders and infections.
These made up for those who failed to report their findings. The use of samples on households
also brought babies and children into the tests, besides the youth and adult male and female
people with age variations who received the samples. A summary of the first 5,000 reports
turned in is given in Table 3, where a factor not applicable to a particular skin infection or
disorder is marked “n.a.”
The preparation was stored on the shelf for observation/analysis and used for treatment at
intervals for three (3) years.

RESULTS AND DISCUSSION

After his analysis/examination of the sample of the ointment preparation, the public
analyst remarked, “The product is deemed suitable to be sold as cosmetic” (Table 2).
Table 2: Results of the Public Analyst’s Examination of the Sample
Appearance: Yellow coloured oily cream with tiny air space.
Odour: Perfumed
Specific Gravity: 0.9246
Colour: Yellow
Texture: Soft to touch
CHEMICAL COMPOSITION:
Mineral oil: 77.50%
Benzoic acid: 6.00%
Paraffin wax: 5.80%
Petroleum jelly: 4.20%
Salicylic acid: 3.00%
Sulphur: 3.00%
Fragrance 0.42%
Colourant 0.08%

REMARKS: The product is deemed suitable to be sold as cosmetic.

 Table 3: Summary of Sample Users’ Report
Secondary schools involved: 1. Urban Girls Secondary School, Enugu
2. St. Cyprain’s Girls Secondary, Nsukka
3. College of the Immaculate Conception, Enugu.
Number of Sample Users: 5,000 (male, female, youth, children, and infants)

S/NO. Skin Infection/ Number Number that reported effective Post-healing skin Number that Soothing Anti- Soothing Number that Average
Disorder of users and satisfactory performance discolouration reported skin effect inflammatory effect reported healing period
reported irritation reported effect reported reported compatibility (Days)
1. Acne 18 16 - - n.a. n.a. n.a. 18 21
2. After-shave 23 21 - 1 22 22 22 23 2
rashes
3. Napkin/Urinary 96 88 - - 92 n.a. 83 93 3
Rashes
4. Heat Rashes 121 119 - - 104 n.a. 109 117 3
5. Craw-craw 247 243 - - 236 219 244 223 28
6. Dandruff 498 481 - - n.a. n.a. n.a. 467 3
7. Eczema 487 481 - - n.a. n.a. n.a. 482 17
8. Psoriasis 9 8 - - 6 7 8 8 31
9. Ringworm 394 389 - - 387 305 333 358 4
10. Seborrhea 8 6 - - 7 8 7 7 23
11. African beauty 4 3 - - 3 3 3 4 41
spots
12. Dermatitis 6 5 - - 4 4 4 4 29
13. Pimples 787 - - - 777 778 - 768 -
14. Burns 367 312 - - 347 298 358 343 16
15. Bruises 297 292 - - 246 267 288 288 9
16. Cuts 178 183 - - 167 141 152 163 11
 From Table 3, the preparation had smoothening, soothing, pain-relieving and anti-
inflammatory effects on cuts, bruises and burns, resulting in their healing within 9-16 days. This
agrees with earlier reports that water-free oily creams incorporating benzoic acid and/or salicylic
acid have a mild anti-inflammatory effects, are more occlusive than creams (hydrous ointments),
soothe and smoothen the skin, and are indicated for dry scaling disorders, such as eczematous
disorders and psoriasis [1]. Skin problems treated with nine similar products healed between 8.2
and 15.7 days [4].
Benzoic acid, salicylic acid, and sulphur have disinfecting effect, while salicylic acid has,
in addition, antipyretic and analgesic effects [5-6]. This disinfecting effect must have been
responsible for the enhanced healing of cuts, bruises and burns [7], as well as the prevention of
post-healing skin discolouration. These findings support other reports on the medical and
medicinal uses of the active ingredients in the preparation [8-9].
Psoriasis, ringworm, napkin and urinary rashes, craw-craw, heat rashes, and acne cleared
between 3 and 31 days. This agrees with earlier reports [10-11].
Dandruff on shaven scalp cleared in 2-4 days, but returned when scalp was overgrown
with hair such that contact with preparation was difficult. Topical preparations are not expected
to have a therapeutic effect [1] on dandruff, eczema, etc.
Eczema cleared within 9-31 days but re-appeared 3 months after the applications was
discontinued. It cleared again when treatment was restored for 9-31 days. This was not only
cheaper than, but saved the discomforting side-effect of most systemic treatments of skin
disorders and infections [6,12-14].
Applying the preparation after shaving prevented the development of after-shave rashes.
Continued application till the next shaving exercise might be necessary. The application on the
developed rashes got them cleared within 3 days.
African beauty spots took longest duration, 41 days, to be treated. And, there was no
report of successful treatment of pimples.
Products containing the same active ingredients at the chosen concentrations are non-
toxic, and the skin irritation and hypersensitivity reactions reported by one (1) out of 5,000 users
is acceptable [1].
There was no change in the concentration, colour and potency of the preparation for the
three (3) years of investigation. Expiry date of three (3) years from date of manufacture is,
therefore, recommended.
The preparation was found compatible, confirming the report of earlier workers [4-5].
The preparation, however, was cosmetically less acceptable than hydrous lotions [1],
even though it is more desirable in harmattan season, when paraffin-base water-free oil creams
are often in demand, and for scaling disorders [1]. Thus, further work aimed at basing the
preparation in hydrous lotion is recommended.

CONCLUSION AND RECOMMENDATIONS

About five (5) different skin infections and disorders are prevented and treated with both
familiar water-free ointments, Benzoic Ointment and Salicylic acid and Sulphur Ointment
hitherto made outside Nigeria with foreign raw-materials and imported into the country. This
work has successfully prepared a single water-free ointment for the prevention and treatment of
all the five (5) skin infections and disorders, plus eleven (11) others. Over 90 % of the materials
used are local. This will preserve a huge sum of foreign exchange earnings spent on the
 importation of topical anti-dermatitis preparations and their raw materials as well as create
wealth, generate employment and reduce poverty in Nigeria.
From the bench-scale production, economic viability of the commercial-scale production
could easily be established to make for the commercialization of the product. Further work to
establish the longest shelf-life is also recommended.

ACKNOWLEDGMENTS
My wife’s encouragement, Prof. P.A. Akah’s advice and Professor J.C. Okaka’s criticisms are gratefully
acknowledged. My thanks go to Cobaxy International Limited, Enugu for sponsoring the research.

REFRERENCES
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British National Formulary, 13: 186-226, 352-388.
2. N.I. Pasternak (1986). Review of Articles on the subject of Psoriasis, Eczema and
Neurodermatitis in “Vestnik dermatologii I Venerologii”, 1950-1982. Vestn Dermatol
Venerol 12, 35-38.
3. Standard Organization of Nigeria, SON (1997). Nigeria Industrial Standard, NIS
371:1997 – Standard for Petroleum Jelly, 6-15.
4. D. Tkac (1990). House Remedies. Rodale Press Emmaus, Pennsylvania, 105-107.
5. K.S. Tewari; S.K. Mehrotra and N.K. Vishnoi (1977) A Textbook of Organic Chemistry,
Vikas Publishing House, New Delhi, 2:1148, 1157-1161..
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Industrial Products. John Wiley & Sons, New York, 432.
7. J.J. Leydon (1990). Home Remedies. Rodale Press, Emmaus, Pennsylvania, 173.
8. R.E. Kirk and D.E. Othmer (1972). Encycpaedia of Chemical Technology. 2ed. Wiley,
New York.
9. E.C. Large (1940). The Advance of the Fungi. Jonathan Cape, London.
10. J. Auld (1986). Topical therapy of acne. Australas. J. Dermatol, 27, 3: 118-1124.
11. A.W. Lucky (1987). Update on Acne Vulgaris. Pediatr Ann, 16, 1: 29-38.
12. A. Burger (1970). Medicinal Chemistry, 3ed. Wiley-Interscience, New York.
13. C.F. Liptrot (1978). Modern Inorganic Chemistry. The English Language Book Society
and Mills & Boon Limited, London, 320.
14. S.E. Wolverton (1991). Systemic drug therapy for psoriasis, the most critical issues. Arch
Dermatol, 127, 4: 511-514, 565-568.

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