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Ashish et al. World Journal of Pharmacy and Pharmaceutical Sciences

FORMULATION, DEVELOPMENT AND EVALUATION OF

ANTIACNE DAPSONE GEL

Ashish Gorle* and Kashiram Pawara

Department of Pharmaceutics, R C Patel Institute of Pharmaceutical Education and

Research Shirpur, Dhule, Maharashtra 425405, India.

ABSTRACT

The present study has been undertaken with the aim to formulate and

evaluate antiacne gel containing Dapsone drug. Acne vulgaris is a most

common skin disorder of pilosebaceous unit that affect areas

containing the largest oil glands, including the face, back, and trunk. It

is generally characterized by formation of seborrhea, comedone,

inflammatory lesions. Propionibacterium acnes and Staphylococcus

epidermidis have been recognized as pus-forming bacteria triggering

an inflammation in acne. The formulations were prepared by carbopol

971P and triethanolamine. Compatibility study between drug and

physical mixture was performed by FT-IR and DSC. The formulations

were characterized for various physiochemical properties such as,

physical appearance, viscosity, pH, spread ability, antimicrobial

activity, in-vitro drug release and stability. Compatibility study showed no any kind of

interaction between ingredients used. It was observed that concentration of polymer showed

effects on physical parameter and dissolution time of formulation. Gel formulations were

found to have 1-2 fold enlarge in the skin deposition than conventional cream hence

representing gels forms depots on skin layers and thus providing best choice to deal with

acne. The results showed that the developed Gels had the ability to release the drug for the

duration of about 90 minutes. Among different storage conditions the gels stored at were

found to most stable, as compare to room temperature. Dapsone 5% gel was found to

effective and well tolerated in non-inflammatory as well as inflammatory acne lesions.

KEYWORDS: Dapsone Gel, anti-acne, physical characterization, in-vitro release, stability

study

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

SJIF Impact Factor 6.647

Volume 6, Issue 8, 1664-1679 Research Article ISSN 2278 – 4357

Article Received on

03 June 2017,

Revised on 23 June 2017, Accepted on 13 July 2017,

DOI: 10.20959/wjpps20178-9802

*Corresponding Author

Dr. Ashish Gorle

Department of

Pharmaceutics, R C Patel

Institute of

Pharmaceutical Education

and Research Shirpur,

Dhule, Maharashtra

425405, India.


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INTRODUCTION

The skin is the huge organ of the body, accounting for more than 10% of body mass and the

one that enables the body to interact most closely with its evvironment. The skin consists of

four layes the stratum corneum, epidemis, demis and subcutaneous tissue. Number of

function of the skin can be classified as necessary to survival of the body but of mammals

and humans in a relatively hostile environment. In general context these functions may be

classified as protective, maintaining homeostasis especially interms of composition, or

sensing the environmental influences, such as heat, pressure, pain, allergen and

microorganism entry.[1]

Topical delivery is one that uses a drug for formulation to the skin

which directly cures cutaneous disorder or the cutaneous manifestations of a general disease

(e.g psoriasis) with the target of containing the pharmacological or the effect of drug to the

exterior of the skin. Semi-solid formulations in all their diversity govern the system for

topical as well as local delivery, but foams, spray, medicated powders, solutions and even

medicated adhesive systems are also in use but they did not show significant actions as they

not restrain for longer period. Topical drug administration is a localized drug delivery system

anywhere in the body through ophthalmic, rectal, vaginal and skin as topical routes. Skin is

one of the most readily and easily accessible organs of human body for external

administration and are the major route of topical delivery of drugs. Drugs are applied

topically for their action at the site of application or for systemic effect. Dermatological

formulatins are applied to skin are varied in dosage forms and series in consistency from

liquid to powder but the most accepted products are semisolid products.[2]

Acne vulgaris is the most common chronic inflammatory disease of the skin to affect

humans. Most of patients fail to improve with the current anti-acne therapy due to the cost of

therapy, adverse effects leading to noncompliance or lack of therapeutic benefits of current

antibiotics (resistance). Acne vulgaris is the most common skin condition affecting late

adolescents across the globe. Even though previous studies have been evaluated

epidemiologic model of acne vulgaris in various ethnicities and regions, adequate

understanding of the worldwide burden of the disease associated with patients in their late

adolescence (15–19-year olds) remains lacking. According to the Global Burden of Disease

(GBD) study, acne vulgaris affects ~85% of young adults aged 12–25 years. Acne

consistently corresponds to the top three most prevalent skin conditions in the universal

population, as found in large studies within the UK, France, and the USA. Similar numbers

are reported for young adults in various countries throughout the world. The production of


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androgens during puberty explains, in part, why acne vulgaris is so prevalent in this

population regardless of socioeconomic status, nationality, or sex. As of now, the rising

incidence of acne vulgaris in late adolescence is a global issue; however, it is unknown

whether this increase is a result of higher prevalence of the Western diet, earlier onset of

puberty, genetic drift, or a byproduct of unknown environmental factors.[3]

Topical gel is a localized drug delivery system, intended for administration into eye, rectum,

vaginal and skin. The gels are semisolid formulations which consists of dispersion made up

of solute enclosing and interpenetrated by liquid. The gel will range in appearance from

entirely clear to opaque. Pharmaceutical Gels are semisolid preparations, which have an

external solvent phase, may be hydrophobic or hydrophilic in nature.[2]

Advantages of Topical Drug Delivery Systems[4,5]

a) Avoid first pass metabolism.

b) It is suitable and easy to apply.

c) Avoidance of the risks and inconveniences of intravenous therapy and of the varied

conditions of absorption, like pH changes, presence of enzymes

d) Accomplishment of efficacy with minimum total daily dosage of drug

e) Stay away from fluctuation in drug levels, inter and intra-patient variations.

f) It can be easily removed when irritation begins

g) A relatively large area of application in comparison with buccal or nasal cavity

h) Ability to distribute drug more presizely to a site.

i) It prevents GIT irritation

j) Providing utilization of drugs with short biological half-life, narrow therapeutic window.

k) Improving Improved patient compliance. Suitability for self-medication

Pharmaceutical preparations are applied topically via the skin fall into two general categories,

those applied for local action and those for systemic effects. Local actions include those at or

on the surface of the skin, those that exert their actions on the stratum corneum and those that

modulate the function of the epidermis and/or the dermis. There are various dosage forms are

available in market which may include creams, gels, ointments, pastes, suspensions, lotions,

foams, sprays, aerosols, and solutions. Creams, ointments and gels usually well accepted as

semisolid dosage forms. The most common drug products applied to the skin for systemic

effects are referred to as self adhering transdermal drug delivery systems (TDS) or

transdermal patches.


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Gels are a relatively newer class of dosage form created by entrapment of large amounts of

aqueous or hydroalcohalic liquid in a network of colloidal solid particles which may consist

of inorganic substances, such as aluminum salts or organic polymers of natural or synthetic

origin. Depending upon the nature of colloidal substances such as carbomers and the liquid in

the formulation, which impart an aesthetically pleasing, clear, sparkling appearance to the

pharmaceutical product, and are easily washed off the skin. Gel is two-component system of

a semisolid nature rich in liquid.[6]

Dapsone is an antibacteial and used from 1940s for the betterment of leprosy and skin

disorders such as dermatitis herpetiformis and nodulocystic acne. Dapsone (Aczone) 5% gel

is approved by the U.S. Food and Drug Administration (FDA) for the treatment of acne

vulgaris in adults and children older than 12 years. Although dapsone has antibacterial and

anti-inflammatory activity, the mechanism of action in the treatment of acne is unknown. The

prevalence of acne vulgaris reported from various countries ranges to 87% of adolescents and

up to 54% of adults.1 Though acne is self limiting disease, the presence of active acne lesions

impacts the physical appearance and creates negative effects on psycho-social function for

individual.[7]

Orally administered dapsone is known to cause hematologic reactions, including met-

hemoglobinemia; hemolysis, especially in patients with glucose-6-phosphate dehydrogenase

(G6PD) deficiency; and agranulocytosis.[8]

In present research work, topical delivery of Dapsone as a drug of choice towards acne

treatment and Gel was formulated using polymer carbopol 971P along with different

excipients. API is an second generation antibacterial, antiacne and anti-inflammatory drug,

approved for the treatment of adjunctive treatment for acne. Two types of tests, product

quality tests and product performance tests are carry out with drug formulations so as to

provide assurances of batch-to-batch quality, reproducibility, reliability, and performance.

Product quality tests are performed to assess attributes such as assay, identify- cation, content

uniformity, pH, microbial limits, zone of inhibition are part of the study. Developed products

performance tests are conducted so as to assess release of drug from the finished dosage

form. Hence it may seem to serves the purpose of release drug from formulations at

appropriate manner.


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MATERIALS AND METHOD

MATERIAL

Dapsone drug was received as a gift sample from Glenmark pharmaceutical, Ltd. Mumbai,

India carbopol 971P and methyl paraben, triethanolamine, methanol was obtained from Loba

chemicals, Mumbai and other chemicals utilized (Loba chemicals Pvt. Ltd., Mumbai) was

purchased from local supplier. All the other reagents were used of analytical grade were used

in the development of the topical gels.

EXPERIMENTAL

Preformulation study

Preformulation study is one of the important pre-requisite in development of any drug

delivery system. It gives the information needed to define the nature of the drug substance

and provide a framework for the drug combination with pharmaceutical excipients in the

dosage form. Hence, Preformulation studies on the obtained sample of drug were carried out.

Confirmation of Drug: Confirmation of drug was carried out by Melting Point

determination method, UV Spectrophotometer, Infrared spectroscopy (IR) and by DSC.[9]

Melting point method

Melting point determination is prime confirmation of drug. In this method, melting point was

determined by melting point apparatus. The temperature range at which the drug starts

melting and complete melting was noted.

FTIR Spectroscopic Analysis

The pure drug (Dapsone), a mixture of Dapsone with polymers carbopol 971P were mixed

separately with IR grade KBr in the ratio of 1:100 and corresponding pellets were prepared

by applying 10 metric ton of pressure in hydraulic press. The pellets were then scanned over

a wave range of 4000 to 500 cm-1. in FT-IR instrument (8400 S Shimadzu).

Differential scanning Calorimetry (DSC)

The DSC measurements were performed on a differential scanning calorimeter (DSC

822c, Mettler Toledo) with a thermal analyzer. Under nitrogen flow of 20 ml/min, 2 mg of

Dapsone were placed in a sealed aluminum pan, and heated at a scanning rate of 50 ºC /min

from 20ºC to 200ºC. An empty aluminum pan was used as reference.


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Preparation of Gel: Carbopol 971P accurately weighed was dissolved in distilled water. by

using magnetic stirrer at room temp for 20 min, by continuously stirred on magnetic stirrer

until uniform was formed solution A .Then separately methyl paraben and menthol dissolve

in small quantity of water by using magnetic stirred and heat apply to form clear solution B.

after pure drug are dissolve in small quantity of methanol to form solution C. Then solution

B and solution C are mixed, in solution A continuously stirring add drop by drop

triethanolamin to formation of final gel.[10]

Table 1: Composition of acne gel formulations containing Dapsone

Ingredient F1 F2 F3 F4 F5 F6 F7 F8

Dapsone 1.5g 1.5g 1.5g 1.5g 1.5g 1.5g 1.5g 1.5g

Carbopol 971P 0.5g 0.4g 0.4g 0.5g 0.4 0.5g 0.5g 0.4g

Methyl paraben 0.2g 0.2g 0.3g 0.2g 0.3g 0.4g 0.3g 0.3g

Menthol 0.3g 0.3g 0.5g 0.3g 0.4g 0.2g 0.1g 0.2g

Methanol 3ml 6ml 2ml 4ml 3ml 2ml 5ml 4ml

Triethanolamin q.s q.s q.s q.s q.s q.s q.s q.s

Distilled water 30ml 30ml 30ml 30ml 30ml 30ml 30ml 30ml

Homogeneity: After the gels have been set in the container, all developed gels were tested

for homogeneity by visual inspection. They were tested for their appearance and presence of

any aggregates.[11]

Measurement of pH: pH of various gel formulations was determined by using digital pH

meter. The measurement of pH of each formulation was done in triplicate and average value

was calculated.[11]

Viscosity: Viscosity of the gel should be such that the preparation should be easily removed

from the container and can be easily applied to the skin. The measurement of viscosity of the

prepared topical gels was done with Brookfield viscometer (model LV-DV-II). Viscosity was

determined using spindle no. S-7 at 60 rpm.[12]

Spreadability: One of the criteria for a gel to get together the ideal quantity is that it should

possess excellent spread ability. It is the term expressed to denote the extent of area to which

gel readily spreads on application to skin or affected part. The beneficial efficacy of a

formulation also depends upon its spreading value. Spread ability is expressed in terms of

time in seconds taken by two slides to slip off from gel and placed in between the slides

under the way of certain load. Smaller the time taken for separation of two slides better will

be the spread ability of the formulations.[13]

It is then calculated by using the formula:


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S = M L / T

Where, • M = Wt. tied to upper slide

L = Length of glass slides

T = Time taken to separate the slides.[10]

Drug content studies: 1.0 gm of each gel formulation were taken in 100 ml of volumetric

flask containing 20 ml of phosphate buffer saline (pH 5.5) and stirred for 30 minute. The

volume was made up to 100 ml & 1ml of the above solution was further diluted to 50 ml with

phosphate buffer saline (pH 5.5). The resultant solution was filtered through membrane filter.

The absorbance was recorded by using UV spectrophotometer at respective absorption

maxima i.e. 293 nm. Drug content was determined from the standard calibration curve.[14]

Gelation & Gel melting temperature

Typically, the determination of the boundary between the sol and gel phases depends on the

selected experimental method. In this study a simple test-tube inverting method was

employed to roughly determine the phase boundary. Gelation and gel melting temperatures

were assessed using a modification of the Miller and Donavan technique. A 5 mL aliquot of

gel was transferred to test tubes and immersed in a thermostat water bath at 4°C and sealed

with aluminium foil. The temperature was increased with the increments of 1°C and left to

equilibrate for 1 minute at each new setting. The samples were then examined for gelation,

which was said to have occurred when the meniscus would no longer move upon tilting

through 90°. The gel melting temperature, the temperature at which a gel started flowing

upon tilting through 90° was recorded.[15]

Permeability studies (diffusion cell): Phosphate buffer of pH 5.5 was used for in vitro

release study as a receptor medium. The pretreated skin cellophane membrane was used in

diffusion cell. The gel sample was applied on the cellophane membrane and then fixed in

between donar and receptor. The receptor compartment contained phosphate buffer of pH

5.5. The temperature of diffusion medium was thermostatically controlled at 37º±2º by

surrounding water in jacket and the medium was agitated by magnetic stirrer. The sample at

predetermined intervals were withdrawn and replaced by equal volume of fresh fluid. The

samples withdrawn were uv-spectrophotometrically estimated at 293nm against their

respective blank.[16]


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Anti-Bacterial activity testing: The developed formulations of Gel were utilized for their

antibacterial activity against Propronibacterium Acnes, using the micro dilution broth

procedure. Clindamysin was used as the reference antibacterial agent. Antibacterial activity

of the was performed in Mueller– Hinton broth medium at a pH of 7.0 with an inoculums of

(1–2) × 103 cells/Mr. The chemical compounds, broth medium serial tube dilutions

inoculated with each bacterium were incubated on a rotary shaker at 37°C for 18 hours at 150

rpm.[17]

Stability study All the selected formulations were subjected to a stability testing for the

period of three months as per ICH norms at a temperature of 40 ± 2ºC and 75±5% RH. The

gels were stored in 40ºC/ 75% RH in collapsible tube for 3 months. The samples were

withdrawn on 0 day and after period of 1 month, 2 months and 3 months. All selected

formulations were analyzed for in appearance, pH and drug content by procedure stated

earlier.[18,19]

RESULT AND DISCUSSION

Aforesaid mentioned methods were described in the methodology for the development and

evaluation of gel containing dapsone as a drug. These formulations were intended to produce

immediate release of drugs. The result and discussion are described under different heading

as follows. Antiacne gel of dapsone was evaluated for various parameters. In the present

study, eight formulations were prepared by varying the polymer concentration, and by using

different polymers.

As described in the methods, FT-IR studies were carried out on pure drugs and along with the

polymer. There were no any kind of interaction was observed between drug and excipients

used in the development of gel. IR spectra of dapsone and overlay of carbopol 971P, physical

mixture combinations are shown Figure 1 & 2 respectively and their observed peaks are

given in table 2.


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Figure 1: Infrared spectra of Dapsone

Figure 2: Infrared spectra of Overlay

Table 2: Interpretation of Pure drug by FT-IR

INTERPRETATION OF

CHEMICAL GROUP

OBSERVED

PEAKS

STANDARD

RANGES

C-C Aromatic 1633.76 1600-1680

N-H stretch 3344.68 3100-3500

N-H bending 1633.76 1640-1550

S=O stretch 1433.16 1140-1445


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DSC thermograph of Dapsone

Melting point of Dapsone was measured by Differential scanning Calorimetry at scanning

rate of 100C/min. It exhibits melting endothermic peak at temperature of 179.86

0 C as shown

in Figure 3.

Table 3: Interpretation of DSC Thermogram of Dapsone

PARAMETERS OBSERVED RESULTS

Melting point determination 1820

C

DSC method 179.860

C

Reference range 178-83 0

C

Figure 3: DSC Study of Pure Drug

Figure 4: DSC study of Physical Mixture


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After the gels have been set in the container, all developed gels were tested for homogeneity

by visual inspection and appearance. Homogeneity depend on polymeric concentration

Results shown in Table 4.

The drug content of the formulations was found to be in the range of 93% to 99%. Drug was

found to be uniformly distributed throughout the formulation, Formulation F2 batch was

found to be 99% of drug content and results are shown in table 4.

The pH study of various gel formulations was determined by using digital pH meter. The

measurement of pH of each formulation was done in triplicate average value was considered.

All the formulations were found to be compatible with skin pH, F2 batch was found to be pH

7.0 as neutral show in Table 4.

Viscosity of the gel should be such that the preparation can be easily removed from the

container and can be easily applied to the skin. The measurement of viscosity of the prepared

topical gels was done with Brookfield viscometer (model LV-DV-II). Viscosity was

determined using spindle no. S-7, at 60 rpm F2 batch was found to be 4050 cp, All the batch

of viscosity depend on polymeric concentration shown in Table 4 and figure 5.

Figure 5: Viscosity (cp) Study of Formulated Gel Preparation

One of the criteria for a gel to get together the ideal quantity is that it should possess excellent

spreadability. It is the term expressed to denote the extent of area to which gel readily spreads

on application to skin or affected part. The beneficial effectiveness of a formulation also

depends upon its spreadability by increasing the concentration of any of the gelling agents

upto certain extent was always linked with a decrease in the spredability as expressed by the

lesser centimetre of the spreaded circle, better the spreadability, F2 batch was found to be


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11.6 gm cm2 shown in Table 4. Gelation and Gel melting temperature of formulations was

found to be in the ranges of 48 to 64 respectively.

Table 4: Physicochemical Parameter of Development Batch

Batches Viscosity

(cp) pH Homogeneity

Spreadability

(gm.cm2)

% Drug

content

Gel Melting

(Mean ±SD)

F-1 3680 5.4 Clear 10 96 ± 0.18 64.7 ± 0.3

F -2 4250 7.0 Clear 11.2 99 ± 0.2 55.2 ± 0.6

F-3 3780 6.8 Clear 12 97 ± 0.20 54.5 ± 0.2

F-4 3400 6.0 Clear 10.9 95 ± 0.17 62.8 ±0.3

F-5 3660 6.9 Clear 11 94 ± 0.20 50.5 ± 0.2

F6 3440 6.7 Clear 11.2 97 ± 0.20 49.4 ± 0.5

F-7 2900 6.18 Clear 10.3 93 ± 0.2 48.5 ± 0.4

F-8 3460 6.9 Clear 11.1 94 ± 0.2 60.3 ± 0.4

In vitro release studies of formulations were performed using the diffusion cell apparatus

with dialysis membrane. PBS pH 5.5 was used as diffusion media. The initial rate of drug

release was found to be rapid due to incomplete gel formation, but as the time progresses the

release rate decreases due to the complete formation of gel batch result was found to be for

F1 86.78%, F2 97.9% F3-90.42%, F4 83.22%, F5-85.7%, F6 94.05%, F7 79.8%, F8 96% and

Marketed Gel formulation it was around 94.14 % at the end of 90 min. The results showed

that the developed Gels had the ability to release the drug for the duration of about 90

minutes. In vitro release study indicated that the release of drug varied according to the type

and concentration of polymer utilized in development of gel formulations. The amount of

drug release from F2 Batch was found to be maximum 97.92% at the end of 90 minute.

Results are shown in figure 6.

Table 5: Physicochemical Characterization of Formulated Gel & Marketed Gel

Time

(min) F1 F2 F3 F4 F5 F6 F7 F8

Marketed

Gel

0 0 0 0 0 0 0 0 0 0

15 21.96 18.36 24.48 21.96 21.24 19.02 23.76 21.24 17.00

30 35.4 31.42 36.5 35.76 36.2 35.3 35.52 34.31 29.21

45 46.99 43.37 50.6 54.19 55.1 45.1 45.1 46.96 44.15

60 57.86 60.5 61.48 68.7 68.8 68.9 55.5 64.06 66.24

75 72.32 78.7 75.94 75.98 78.89 78.8 72.02 84.36 78.92

90 86.78 97.92 90.42 83.22 85.7 94.05 79.8 96 94.14


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Figure 6: In-vitro drug release profile of formulated Gels

Table 6: Comparision between optimized batch and marketed Gel Formulation

Experiment Viscosity (cp) pH Homogeneity Spreadability

(gm.cm2)

Drug

content %

Marketed Gel 4000 6.9 Clear 11.1 97 ± 0.2

F2 4050 7.0 Clear 11.2 98 ± 0.2

The results of the study showed that the antiacne gel indicates the presence of potent

antibacterial activity; antimicrobial activity was based on measurement of inhibition zones

formed around the disc. From the observation of the agar plate containing Dapsone against

Propronibacterium Acnes gave a sufficient zone of inhibition similar to that of the standard

drug Clindamysin. So it can be concluded that Acozone showed a sufficient anti-acne activity

in the antibacterial test performed. As it proved the anti-acne activity, this was formulated in

a gel to treat acne by topical action.

Table 7: Comparision of Marketed Gel and Optimized Batch Zone of Inhibition

Experiment No Vitro diffusion Skin irritation Zone inhibition in mm

OptimizeBatch: F2 97.9 % No irritation 1.8 ± 0.12

Marketed gel 94.14 No irritation 2.5± 0.1


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Figure 7: Comparision of Marketed Gel formulation and Optimized Batch

The optimized formulation F2 was evaluated at the time interval of 30,60 and 90 days for all

the parameters like Appearance, vitro drug release and % drug content. The observations of

stability studies of optimized formulation F2 are shown in table 8 and it did not show any

significant change in these parameters after stability studies. This confirms the stored gel

formulation were stable for the storage period.

Table 8: Characterization of Optimized Batch After Stability Study

SR.

NO. PARAMETERS

STORAGE PERIOD (DAYS)

AT 40±2O

C TEMPERATURE AND 75±5% RH

0 30 60 90

1 Appearance transperant transperant transperant transperant

2 Drug content (%) 99±0.5 98.74 +

1.27

97.02 +

1.34 96.48±20

4 In vitro drug

release (%) 98.9 97.80 97.14 97.5

CONCLUSION

Acne vulgaris is a big task to treat because of its chronicity and continuation which builds

adolescent and young adult psychologically distressed. A range of systemic and topical drugs

are available which targets the different phase of pathogenesis of acne. Inflammation is also

measured to be key factor in pathogenesis of acne vulgaris. Systemic antibiotic and other

anti- inflammatory drugs are being utilised in management of acne vulgaris. In conclusion,

the formulated gel as a topical drug delivery system promising the approach which are

utilised for improving efficacy of dapsone in the treatment of acne. FTIR and DSC study

indicated that there is no interaction between the drug and excipients. On the basis of in-vitro


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drug diffusion study optimize batch F2 was selected showing 98.9 % drug release at the end

of 90 min. This gel was clear, transparent. the pH was neutral and its viscosity was easily

remove from container and spreadability is excellent and easily spread, gave antimicrobial

activity high effectiveness in inhibiting the growth of P. acne bacteria. The gel was stable at

room temperature. The quality control tests results were within the acceptable limits. Hence

in future such type of topical drug delivery may utilise for the acne treatment.

ACKNOWLEDGEMENT

The authors would like to acknowledge the Principal, R C Patel Institute of Pharmaceutical

Education and Research Shirpur, for providing the necessary facilities to carry out the

research work.

Conflict of Interest: Nil.

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