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Nanocarrier-based hydrogel of betamethasone dipropionate and salicylic acid for treatment of psoriasis.

ABSTRACT: INTRODUCTION:Betamethasone dipropionate (BD) has anti-inflammatory, immunomodulatory, and antiproliferative activity. The aim of the current work was to test the hypothesis that the addition of corticosteroid such as BD and a keratolytic agent such as salicylic acid in nanocarrier based microemulsions formulation would result in enhancement and sustaining of corticosteroid delivery rate leading to better anti-psoriatic activity. Clinical use of BD is restricted to some extent due to its poor permeability across the skin. So to increase its permeation across the skin, microemulsion-based gel formulations were prepared and characterised. MATERIALS AND METHODS:Microemulsions were prepared by aqueous phase titration method, using oleic acid:sefsol (1.5:1), Tween 20, isopropyl alcohol, and distilled water as the oil phase, surfactant, cosurfactant and aqueous phase, respectively. Selected formulations were subjected to physical stability studies and consequently in vitro skin permeation studies. Surface studies of optimized formulation were done by transmission electron microscopy. In vivo anti-inflammatory activity was done by carageenan-induced raw paw edema method. RESULTS:The droplet size of microemulsions ranged from 60 to 190 nm. The optimized formulation exhibited viscosity 28.55 ± 2.03 mP, refractive index 1.409, pH 6.4, and conductivity 10(-4) scm(-1). The optimized microemulsion was converted into hydrogel using carbopol 934, and salicylic acid was incorporated into it. Drug deposition in skin was found to be 29.73 ?g/mg. Assessment of skin permeation was done by histopathology studies which indicated changes in the structure of epidermal membrane of skin. In vivo anti-inflammatory activity indicated 72.11% and 43.96% inhibition of inflammation in case of developed microemulsion gel and marketed gel, respectively. CONCLUSIONS:The developed microemulsion gel containing BD and salicylic acid provided sustained and good anti-inflammatory activity for the treatment of psoriasis.

SUBMITTER: Baboota S

PROVIDER: S-EPMC3465136 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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Nanocarrier-based hydrogel of betamethasone dipropionate and salicylic acid for treatment of psoriasis.

Baboota Sanjula S Alam Md Sarfaraz MS Sharma Shrestha S Sahni Jasjeet K JK Kumar Anil A Ali Javed J

International journal of pharmaceutical investigation 20110701 3

<h4>Introduction</h4>Betamethasone dipropionate (BD) has anti-inflammatory, immunomodulatory, and antiproliferative activity. The aim of the current work was to test the hypothesis that the addition of corticosteroid such as BD and a keratolytic agent such as salicylic acid in nanocarrier based microemulsions formulation would result in enhancement and sustaining of corticosteroid delivery rate leading to better anti-psoriatic activity. Clinical use of BD is restricted to some extent due to its ...[more]

PMID: 23071936

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Project description:BackgroundPlaque psoriasis has significant impact on patients' quality of life. Topical therapy is considered the treatment mainstay for mild-to-moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability and therapeutic options; particularly decisions on transition from topical to non-biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions.ObjectiveTo compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non-biologic systemic treatments based on aggregated patient characteristics and treatment outcomes.MethodsIndividual data from four Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching-adjusted indirect comparisons. Literature review identified non-biologic systemic treatment trials where methods, populations and outcomes align with Cal/BD foam trials. Of 3090 screened publications, four studies of apremilast, methotrexate, acitretin or fumaric acid esters (FAE) were included.ResultsAfter baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P < 0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P < 0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 vs. 12 weeks of methotrexate (50.8% vs. 33.5%; P < 0.001) or acitretin (50.9% vs. 31.7%; P = 0.009), and comparable response to FAE (42.4% vs. 47.0%; P = 0.451).ConclusionsDespite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate or acitretin, and comparable efficacy to FAE.

Project description:Treatment non-adherence is a complex problem encountered in all therapy areas, particularly in chronic diseases such as psoriasis vulgaris. To address adherence issues, focus is turning towards developing interventions tailored to individual patient needs. Topical therapies remain the mainstay of psoriasis treatment; however, these are associated with additional challenges where preparations may be perceived as messy, inconvenient and time-consuming. Once-daily fixed-combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) topical suspension is a convenient and effective first-line topical psoriasis therapy. To improve the patient experience with this treatment, we undertook a program-in collaboration with patients and healthcare professionals-to develop a topical treatment delivery system that further caters to the unmet needs of psoriasis patients. The finalized Applicator comprises: an easy to operate pump-action lever providing consistently accurate dose delivery (0.05 g of Cal/BD topical suspension/pump); a single-tip nozzle allowing for targeted, precise application to body and scalp psoriasis plaques; two spreading surfaces designed to disperse treatment evenly across both large and small affected skin areas; and a protective cover. Patients listed the following as key Applicator attributes: ease of use, 'less messy' treatment, precise application, consistent accurate dosing, 'no touch' treatment, reduction of wasted treatment and extended length of reach for awkward areas. Although these attributes were well received by most patients and healthcare professionals, some patients did not perceive them all as improvements over their current treatment; this highlights the need to tailor treatment for each individual patient's requirements. For patients who prefer using the Applicator, it has the potential to provide greater control over their daily psoriasis management by providing a simple, convenient treatment option, with minimal impact on their lives. The Applicator may represent a more acceptable treatment delivery system for some patients with psoriasis vulgaris and may, therefore, promote long-term treatment adherence.FundingLEO Pharma.

Project description:IntroductionThe phase 3 PSO LONG study (NCT02899962) demonstrated superior efficacy of proactive (PM) versus reactive management (RM) using calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis. Here, we evaluated whether certain baseline parameters had an effect on time to first relapse (TTFR), number of relapses, and assessed interactions between treatment effect.MethodsPSO LONG included an initial 4-week open-label phase (once-daily Cal/BD foam) and a 52-week maintenance phase where patients were randomized to twice-weekly Cal/BD (PM) or vehicle foam (RM), with a 4-week once-daily Cal/BD foam rescue treatment for relapse. Baseline parameters analyzed using a stepwise variable selection procedure included body surface area, modified Psoriasis Area Severity Index (mPASI), Physician Global Assessment (PGA), body mass index, age, sex, Dermatology Life Quality Index, and duration of psoriasis. Continuous variables were divided into groups based on standard criteria.ResultsOverall, the effect of treatment on TTFR did not vary across any baseline parameters. Variables with a statistically significant effect on TTFR were: treatment group (PM vs. RM hazard ratio [HR]: 0.56; p < 0.001); PGA (moderate vs. mild HR: 1.42; severe vs. mild HR: 2.32; overall p = 0.009); mPASI (moderate vs. mild HR: 1.19; severe vs. mild HR: 1.77; overall p = 0.009); and sex (women vs. men HR: 1.26; p = 0.030). Variables with a significant effect on the number of relapses were: treatment group (PM vs. RM, rate ratio [RR] 0.52; p < 0.001); PGA at baseline (moderate vs. mild, RR 1.38; severe vs. mild, RR 2.22; overall p < 0.001); and mPASI (moderate vs. mild, RR 1.25; severe vs. mild, HR 1.70; overall p = 0.002).ConclusionAll patients benefitted from long-term PM versus RM with Cal/BD foam regardless of baseline characteristics, and the benefit of treatment increased with greater disease severity.Trial registrationClinicalTrials.gov identifier, NCT02899962.

Dataset Information

Nanocarrier-based hydrogel of betamethasone dipropionate and salicylic acid for treatment of psoriasis.

Publications

Nanocarrier-based hydrogel of betamethasone dipropionate and salicylic acid for treatment of psoriasis.

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