INTRODUCTION:

Psoriasis is a long-term inflammatory skin and joint condition that is autoimmune and non-communicable. Psoriasis is derived from the Greek words "psora," which means itchy, and "iasis," which means a disease¹. The frequency of the condition is 2% worldwide, with affluent nations having a greater prevalence of roughly 4.6%².

Psoriasis is a skin condition where skin cells multiply ten times faster than usual. As a result, red, bumpy patches with white scales occur on the scalp, lower back, elbows, and knees, but they can also appear on other areas. Psoriatic arthritis, another name for psoriasis, is an inflammation of the joints. Unfortunately, psoriasis is associated with some types of arthritis and dandruff³. Plaque psoriasis, psoriatic arthritis, scalp psoriasis, flexural psoriasis, guttate psoriasis, pustular psoriasis, nail psoriasis, and erythrodermic psoriasis are among the different kinds of psoriasis that have been documented. Clinical findings like skin biopsies can be used to diagnose these conditions⁴.

The most popular and fundamental method of treating psoriasis is topical therapy. One of the human body's most accessible organs for topical administration, the skin serves as the primary conduit for topical medication delivery systems. Patients find them to be safe and well-tolerated. The biggest obstacle to topical therapy efficacy may be patient adherence^5,6. A submicron colloidal dispersion of medicine particles stabilized by surfactants is called a nanosuspension. Another way to describe them is as a biphasic system made up of pure drug particles scattered over an aqueous medium with a suspended particle diameter of less than 1μm⁷. The preparation of nano suspension of topical corticosteroid to overcome challenges with drug solubility, penetration, stability, and controlled release which improves management of psoriasis and overcome the side effects^8,9. Clobetasol-17-propionate is mainly used in dermatology to treat skin conditions such as psoriasis by reducing inflammation of the skin. Their anti-inflammatory, anti-proliferative, immunosuppressive, and vasoconstrictive properties are responsible for their clinical success in the treatment of psoriasis¹⁰.

MATERIALS AND METHODS:

Materials:

Clobetasol-17-Propionate was purchased from (Yarrow Chemical Products Pvt. Ltd Mumbai, India). SLS, Methanol obtained from (Loba Chemie Pvt. Ltd). β-CD, HPMC K4M is obtained from (Research Lab Fine Chem Industries, Mumbai). Poloxamer 188 obtained from Hi-Media Laboratories Pvt. Ltd. Thane. Citric acid is received from Sisco Chem Lab Pvt. Ltd.

Methods:

Solubility of drug:

The solubility of Clobetasol-17-Propionate was determined in different solvents such as in distilled water, methanol, ethanol, phosphate buffer. The samples were added to each test tube containing 20mL of different solvents with continuous shaking for 30min to prepare saturated solution. All mixtures were allowed to equilibrate at room temperature for 24h. The samples were filtered through Whatman filter and aliquots were suitably diluted and assayed spectroscopically at 239nm. Each value for solubility was determined in triplicate and average values were reported¹¹.

Determination of UV absorption maxima;

Take 0.1g of the drug and dissolve it in 100ml of phosphate buffer (pH 7.4): ethanol to prepare a stock solution of 100mg/ml respectively. From this solution, 0.1ml was withdrawn and the volume was made up to 10 ml with phosphate buffer (pH 7.4): ethanol (1:1) ratio The solution containing a concentration of 10µg/ml clobetasole-17-propionate was scanned over the range of wavelength 200-400nm in a UV-Vis spectrophotometer to determine the wavelength of maximum absorbance^12,13.

Standard Calibration Curve of in Clobetasole-17-Propinate Phosphate Buffer (pH-7.4):

Weigh 10mg Clobetasol-17-Propinate accurately and transferred it into a 10ml volumetric flask and the volume was made up to 10ml using PBS pH 7.4 and Ethanol (1:1) ratio to get concentration of 1000µg/ml. from stock solution 1ml was taken and volume was made up to 10ml using PBS 7.4 to get concentration 100µg/ml. From 100µg/ml prepared solution 1, 2, 3, 4, 5 and 6ml of solutions were withdrawn separately and transferred into 10ml volumetric flasks, and volume was made up to 10ml to get a concentration of 10, 20, 30, 40, 50 and 60µg/ml respectively. Then take the absorbance of each dilution at the 239nm¹⁴.

Differential Scanning Calorimetry:

DSC analysis of the was Clobetasol-17-Propinate carried out using a DSC instrument (Shimadzu). A precisely weighed (5mg) test sample was kept in an aluminium pan and an empty pan as a reference for the analysis. The thermal behavior of samples was measured between 30-300⁰C at 100C/min¹⁵.

Drug and Excipients Interaction Study by FTIR:

The compatibility of the Clobetasol-17-Propinate drug with sodium lauryl sulfate and β-cyclodextrin was studied by FTIR analysis. FTIR spectral analysis of the clobetasol-17-propinate and excipient combination was carried out to investigate the changes in the chemical composition of the drug after combining it with the excipient. The study was done on Shimadzu FT-IR spectra of pure clobetasol-17-propinate and compatibility of drug with excipients¹⁶.

Method of Preparation of Nanosuspension:

Nano-precipitation Method:

The drug used to be molten in methanol to prepare an organic solution and fixed amount. The HPMC K4M, Poloxamer 188, β-CD and SLS, Methyl paraben was dissolved in a 50ml of water it is the aqueous phase. The aqueous water was kept on magnetic stirrer add organic solution drop-wise through a syringe to the aqueous solution for 30min. Then this solution kept under a high-speed homogenizer at room temperature at a rotation speed of 20,000 Rpm with different timing as per DoE¹⁷.

Table No.1: Dependent and independent variables:

Selection of independent and dependent variable for Box Behnken design
Independent variables (factors)	Dependant variable (response)
X₁= β-CD	Y₁ = Particle size
X₂ = SLS	Y₂= Entrapment efficiency
X₃=Sonication time	Y3=Zeta potential

Table No. 2: Formulation batches of Nanosuspension

Ingredients
Sr. No	Batch	CP (mg)	β-CD (mg) (X1)	SLS (mg) (X2)	ST (min) (X3)	HPMC K4M (mg)	Methyl paraben (mg)	Ethanol (ml)	Poloxamer 188(mg)	DW (ml)
1	T1	12.5	25	50	45	450	0.1	2	100	50
2	T2	12.5	37.5	25	60	450	0.1	2	100	50
3	T3	12.5	37.5	50	30	450	0.1	2	100	50
4	T4	12.5	37.5	25	30	450	0.1	2	100	50
5	T5	12.5	50	37.5	60	450	0.1	2	100	50
6	T6	12.5	50	37.5	30	450	0.1	2	100	50
7	T7	12.5	25	25	45	450	0.1	2	100	50
8	T8	12.5	25	37.5	30	450	0.1	2	100	50
9	T9	12.5	37.5	50	60	450	0.1	2	100	50
10	T10	12.5	50	25	45	450	0.1	2	100	50
11	T11	12.5	25	37.5	60	450	0.1	2	100	50

Evaluation of Nanosuspension:

Viscosity Determination:

Using the Brookfield viscometer, spindle No. 60 was adjusted to 100rpm for the nanosuspension, and the results were made in triplicate¹⁸.

Particle size and Zeta potential:

Using a technique known as Dynamic Light Scattering, the particle size and dispersion were ascertained using a particle sizer and Zetasizer Nano ZS. The total charge that a particle gains in a given medium is known as its zeta potential¹⁹.

Field Emission Scanning electron microscopy (FE-SEM):

An aluminum stub was adhered to with double-sided carbon adhesives. The nanosuspensions were deposited onto the tape and then placed in a desiccator to dry. Ten minutes in a row, they were gold-sputtered. A scanning electron microscope with a vacuum chamber was used to place the aluminum stub. The surface properties of the particles were examined²⁰.

Determination of Entrapment Efficiency (%EE):

Nanosuspensions of different ratios were centrifuged for 30 minutes at 6ºC and roughly 10,000rpm using a cooling ultracentrifuge. The amount of free drug present was ascertained by measuring the absorbance of a properly diluted sample of supernatant at 239nm using a UV spectrophotometer. Each formula was tested four times, and the average was calculated^19,20. (EE) could be calculated with the following formula:

Total amount of drug – amount of free drug

% Entrapment efficiency = ––––––––––––––––– ×100

Total amount of drug

Drug content:

One milliliter of each preparation was used to dissolve in ten milliliters of isotonic solution, which was then centrifuged after being stirred magnetically for half an hour. Once centrifugation is complete, remove 1 milliliter of the solution from the centrifuge tube and dilute it with solvent in a 10-milliliter volumetric flask. A UV spectrophotometer set to 239 nm²¹ was used to determine the homogeneity of the content of these dilutions.

Drug concentration in formulation

Drug content = –––––––––––––––––––––––×100

Actual drug use

In-vitro diffusion study:

The Franz diffusion apparatus was used to investigate the drug release of nanosuspensions in vitro. As the diffusion medium, freshly made phosphate buffer with a pH of 7.4 was employed. On one end of a specially made glass cylinder, a cellophane membrane that had been soaked in phosphate buffer 7.4 for the previous night was tied. One milliliter of precisely measured nanosuspension was added to this assembly. The cylinder, which held 25 milliliters of diffusion medium kept at 37±0.5 degrees Celsius, was attached to a stand and hung above the receptor so that the membrane barely brushed the surface of the receptor medium. A magnetic stirrer was used to agitate the diffusion medium at 50 rpm. A UV-Visible Spectrometer was used to detect absorbance at 239nm after aliquots of 1 ml volume were extracted and diluted²².

Stability study:

In addition to determining the recommended storage conditions and the retest period for a drug substance or drug product, stability testing also provides evidence of how environmental factors like temperature, humidity, and light affect the quality of a drug substance or drug product over time. (ICH guideline Q1A (R2)).

In compliance with the recommendations of the International Conference on Harmonization (ICH), stability tests were conducted on nanosuspension compositions. The nanosuspension samples' particle size and entrapment effectiveness were assessed every six months²³.

RESULTS:

Solubility study:

Table No.3: Solubility of Clobetasole-17-Propionate

Sr. No.	Solvents	Solubility
1	Water	Insoluble
2	Ethanol	Soluble
3	Methanol	Freely soluble
4	Acetone	Freely soluble

The solubility of sample can vary significantly depending on the solvent used. It was soluble in ethanol, freely soluble in methanol and acetone, and insoluble in water.

UV Spectroscopy Maximum Wavelength (λ max) of Clobetasol-17-Propinate:

Table No.4: Maximum Wavelength (λ max) Clobetasol-17-Propinate Drug

Sr.

Identification Test

λ max (nm)

Reported Standard

Observed Peak

Phosphate buffer pH 7.4

240nm

239nm

Fig No 1: UV-Spectra of Clobetasol-17-Propionate in Phosphate Buffer (7.4): Ethanol

Calibration curve of Clobetasol-17-Propionate in Phosphate Buffer (pH-7.4)

Fig No. 2: Standard Calibration Curve of Clobetesol-17-Propinate in Phosphate Buffer (pH 7.4)

Table No. 5: Standard Calibration Curve of Clobetasol-17-Propinate in Phosphate Buffer (pH 7.4)

Sr. No	Concentration (μg/ml)	Absorbance
1	10	0.205
2	20	0.339
3	30	0.459
4	40	0.528
5	50	0.654
6	60	0.793

Differential Scanning Calorimetry

Fig No.3: DSC of Clobetasol-17-Propionate

DSC is used to understand the thermal behaviour of Clobetasol-17-Propionate used in the nanosuspension as well as detect phase transition like melting and crystallization. The DSC thermogram (Fig No.3) revealed sharp endothermic peak at 198.2⁰C which represent the corresponding melting temperature of Clobetasol-17-Propionate.

Drug and Excipients Compatibility Study FTIR:

FTIR analysis of CP+β-CD+SLS+ Poloxamer 188+HPMC K4M (Fig No.4) confirms the presence of characteristic functional groups without significant shifts, indicating no chemical interaction between drug and excipient. The observed peaks match the standard ranges of functional groups. This suggests compatibility.

Fig No.4: FTIR of CP+ β-CD+ SLS+ Poloxamer 188+HPMC K4M

Table No.6: Formulation development and optimization

Batch	Independent factor			Dependent factor
Batch	(X1) mg	(X2) mg	(X3) min	(Y1) nm	(Y2) %	(Y3) mV
T1	25	50	45	1154.0	83.77	-19.54
T2	37.5	25	60	803.16	82.13	-31.69
T3	37.5	50	30	897.1	82.61	-30.00
T4	37.5	25	30	689.94	85.47	-31.00
T5	50	37.5	60	759.68	77.85	-30.89
T6	50	37.5	30	1200.0	81.2	-28.64
T7	25	25	45	371.6	90.00	-34.21
T8	25	37.5	30	389.02	89.5	-33.13
T9	37.5	50	60	1172.1	80.08	-23.78
T10	50	25	45	1042.6	80.96	-26.00
T11	25	37.5	60	1215.6	83.54	-26.01

The independent variables selected to optimize the nanosuspension were β -CD (X1, mg), SLS (X2, mg), and sonication time (X3, min) with their low and high levels. The dependent variables were particle size (Y1, nm) entrapment efficacy (%, Y2), and Zeta potential (mV, Y3). From the response given in the above table, further analysis was conducted by a design expert.

Contour plot and 3D plot of particle size

Fig No.5: Contour plot and 3D plot of PS

Contour plot and 3D plot of Entrapment Efficiency

Fig No.6: Contour plot and 3D plot of EE

Contour plot and 3D plot of zeta potential:

Fig No.7: Contour plot and 3D plot of zeta potential

Evaluation of Nanosuspension:

Particle size and PDI:

Fig No.8: PS of optimized batch of nanosuspension

The nanosuspension particle size is crucial for drug distribution and cleanliness. the average size of Clobetasol-17-Propionate nanosuspension was found in the range of 371.6nm as shows in Figure. The degree of polydispersity in the nanosuspension formulation was relatively lower (0.532).

Zeta potential:

Fig No.9: Zeta potential of nanosuspension

The zeta potential value for this formulation was found to be -34.21 mV which indicated that the formulation was stable.

Field Emission Scanning Electron Microscopy (FE-SEM)

Fig No.10: FE-SEM of nanosuspension

The FE-SEM range of nanosuspension of Clobetasole-17-Propionate shows that nanosuspension was in shape and they have diameter range 0.3µm.

pH, Viscosity and Drug Content of Nanosuspension:

pH- The pH of different nanosuspension formulations (batches T1 to T11) was evaluated using a digital pH meter. The pH values ranged from 5.5±0.15 to 6.4±0.05. Most batches exhibited pH values close to neutral, indicating good compatibility with skin physiology. These results suggest that the developed nanosuspension formulations are safe and suitable for topical delivery in psoriasis treatment.

Viscosity of nanosuspension:

The viscosity of nanosuspension formulations (batches T1 to T11) was evaluated using a viscometer, and the results are presented in Table. The viscosity values ranged from 856cps to 965cps. All formulations exhibited viscosities within an acceptable range (approximately 850-1000cps), which is suitable for topical application, ensuring proper spreadability and adherence to the skin surface without causing run-off or discomfort. The optimized batch T7 showed a viscosity of 856cps, which is within the ideal range for nanosuspension intended for skin application, offering a balance between good skin retention and ease of application.

Drug content of nanosuspension:

The drug content of all nanosuspension formulations (T1 to T11) was determined using a UV-Visible spectrophotometric method at 239nm. The results showed that the drug content varied between 89.74% and 96.00% across all batches, as shown in Table. from all the batches T7 exhibited the highest drug content of 96.00±0.58%

Table No. 7: pH, Viscosity and Drug Content of Nanosuspension

Sr. No.	Batch	pH	Viscosity(cps)	Drug content (%)
1	T1	6.3 ± 0.1	860	90.59±0.03
2	T2	5.5 ± 0.15	900	89.88±0.03
3	T3	6.2 ± 0.1	965	90.00±0.01
4	T4	6.3 ± 0.05	870	92.93 ±0.02
5	T5	6.4 ± 0.05	905	93.16±0.02
6	T6	5.6 ± 0.05	875	92.55±0.04
7	T7	5.5 ± 0.15	856	96.00±0.58
8	T8	5.8 ± 0.05	934	95.99±0.37
9	T9	5.7 ± 0.13	896	89.74±0.02
10	T10	6.3 ± 0.05	907	90.55±0.02
11	T11	6.3 ± 0.05	885	91.22±0.04

The in-vitro drug release profiles of Clobetasol-17-Propionate nanosuspension formulations (T1 to T11) were evaluated in phosphate buffer pH 7.4 over a period of 240 minutes. The cumulative drug release (%CDR) for all formulations is depicted in Fig 11. All batches showed a gradual increase in drug release with time, indicating a controlled release behavior. Among all formulations, batch T7 demonstrated the highest cumulative drug release throughout the study period, achieving nearly complete release (96.08%) by the end of 240 minutes.

Stability study:

Stability study of nanosuspension was performed for optimized batch (T7). Solution was kept in stability chambers at 40±2⁰C, 75±5% RH for accelerated study of 6 months. There were no more significant changes noted in particle size and entrapment efficiency. The storage of nanosuspension led to slightly increase in particle size and decrease in entrapment efficiency in 6 months which was significant.

Table No.8: Stability study of optimized batch (T7)

Time	Appearance	Particle size(nm)	Entrapment efficiency (%)
Initial	White liquid	371.6	90.00±0.58
1 months	White liquid	373.2	89.68±0.56
2 months	White liquid	376.9	89.00±0.54
3 months	White liquid	379.5	88.56±0.52
4 months	White liquid	379.0	88.50±0.52
5 months	White liquid	380.5	86.41±0.52
6 months	White liquid	380.0	86.41±0.52

DISCUSSION:

The present study aimed to improve the topical delivery of Clobetasol-17-propionate, a potent corticosteroid used in the treatment of psoriasis, by formulating it into a nanosuspension. Conventional topical formulations often suffer from poor drug solubility, limited skin penetration, and systemic side effects, reducing their therapeutic effectiveness. To overcome these limitations, a nanosuspension approach was utilized. using the nanoprecipitation method and Box–Behnken statistical design, the formulation was successfully optimized. Among all the batches, formulation T7 exhibited optimal characteristics including a small particle size of 371.6 nm, high entrapment efficiency of 90.00%, and a zeta potential of −34.21mV. These parameters suggest good physical stability, efficient drug loading, and potential for enhanced dermal delivery. A stable zeta potential further indicated resistance to aggregation and prolonged shelf life. FTIR and DSC studies confirmed the chemical compatibility between the drug and excipients, with no significant interactions detected. Morphological analysis through FE-SEM revealed uniformly distributed spherical nanoparticles within the desired submicron range. These features are critical for improved drug dissolution, surface area, and penetration into the skin. the pH of the optimized formulation was found to be 5.5, which is within the skin’s physiological range and ensures minimal irritation. The viscosity of 856 cps supports ease of application and good skin adherence. A high drug content (96.00%) indicated effective incorporation and homogeneity of the nanosuspension. In-vitro diffusion studies demonstrated a controlled drug release profile, with cumulative drug release reaching 96.08% in 240 minutes. This extended-release behavior is desirable for chronic conditions like psoriasis, as it may reduce application frequency and enhance patient compliance. Additionally, the six-month accelerated stability study confirmed that the formulation remained physically and chemically stable over time, with only negligible changes in particle size and entrapment efficiency. overall, the developed nanosuspension significantly improved the delivery profile of Clobetasol-17-propionate. It addresses key challenges of conventional topical therapy by offering better solubility, enhanced skin permeation, sustained release, and improved stability. These findings support the nanosuspension as a promising and patient-friendly approach for the effective treatment of psoriasis.

CONCLUSION:

This study successfully designed and evaluated a nanosuspension formulation of Clobetasol-17-propionate for improved topical treatment of psoriasis. The optimized formulation, developed through scientific and statistical methodology, exhibited ideal physicochemical properties, including nanometric particle size, high drug entrapment efficiency, sustained drug release, and excellent physical stability. The nanosuspension significantly improved the solubility and skin permeability of Clobetasol-17-propionate, enabling better therapeutic effect with reduced dosage and minimized side effects. Compared to traditional formulations, the nanosuspension approach provides enhanced targeting, reduced systemic exposure, and improved patient compliance. The controlled release profile ensures longer drug residence time on the skin, which is crucial for chronic conditions like psoriasis. The findings demonstrate that nanosuspension is a promising delivery platform for poorly soluble drugs in dermatological applications.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

FUTURE SCOPE:

The formulation can be proceed to clinical trials for safety and efficiency, leading to market ready topical therapy. Nanosuspension can be adapted for other chronic condition like eczema or dermatitis. Future studies can be explore combining clobetasol propionate with other anti-psoriatic agents (e.g. Vitamin D analogues) in nanosuspension form for synergetic effects. Nanosuspension can be incorporate into gels, creams and spray.

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Received on 06.08.2025 Revised on 22.09.2025

Accepted on 31.10.2025 Published on 02.01.2026

Available online from January 05, 2026

Asian J. Res. Pharm. Sci. 2026; 16(1):1-8.

DOI: 10.52711/2231-5659.2026.00001

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