Abstract
Psoriasis is a chronic autoimmune skin disease impacting the population globally. Pharmaceutical products developed to combat this condition commonly used in clinical settings are IV bolus or oral drug delivery routes. There are some major challenges for effectively developing new dosage forms for topical use: API physicochemical nature, the severity of the disease state, and low bioavailability present challenges for pharmaceutical product developers. For non-severe cases of psoriasis, topical drug delivery systems may be preferred or used in conjunction with oral or parenteral therapy to address local symptoms. Elastic vesicular systems, termed “niosomes”, are promising drug delivery vehicles developed to achieve improved drug delivery into biological membranes. This study aimed to effectively incorporate a corticosteroid into the niosomes for improving the drug bioavailability of desoximetasone, used to treat skin conditions via topical delivery. Niosomes characterization measurements were drug content, pH, spreadability, specific gravity, content uniformity, rheology, and physicochemical properties. Formulations used a topical gelling agent, Carbomer 980 to test for in vitro skin permeation testing (IVPT) and accelerated stability studies. The developed niosomal test gel provided approximately 93.03 ± 0.23% to 101.84 ± 0.11% drug content with yield stresses ranging from 16.12 to 225.54 Pa. The permeated amount of desoximetasone from the niosomal gel after 24 h was 9.75 ± 0.44 µg/cm2 compared to 24.22 ± 4.29 µg/cm2 released from the reference gel tested. Furthermore, a drug retention study compared the test gel to a reference gel, demonstrating that the skin retained 30.88 ng/mg of desoximetasone while the reference product retained 26.01 ng/mg. A controlled drug release profile was obtained with a niosomal formulation containing desoximetasone for use in a topical gel formulation showing promise for potential use to treat skin diseases like psoriasis.
Highlights
The human integumentary system is the most readily accessible organ system and contains the skin, which is the largest human organ serving the purpose of protecting and isolating the internal organs while being the focus of some novel pharmaceutical dosage forms for drug delivery [1,2,3,4]
980 was selected as the thickening agent for the test gel due to the similarity observed with Topicort® gel 0.05% based on the rheological evaluation
Semisolid dosage forms offer practical benefits for delivering therapeutically acceptable drug therapies directed to treating various skin diseases locally in the skin
Summary
The human integumentary system is the most readily accessible organ system and contains the skin, which is the largest human organ serving the purpose of protecting and isolating the internal organs while being the focus of some novel pharmaceutical dosage forms for drug delivery [1,2,3,4]. Most people will require pharmaceutical intervention for skin diseases and infections at least once in their expected lifetime [5]. Psoriasis and eczema are some of the most common dermatological conditions requiring treatment in patients [6]. The former is a distressing, immune-mediated, chronic inflammatory disorder. The latter is a chronic inflammatory disease of the pilosebaceous unit, having a significant negative impact on patients’ quality of life [7,8,9,10,11]. Psoriasis manifests clinically as excessive growth of the stratum corneum (SC) cells with epidermal thickening, which often appears scaly on the surface with hyperkeratosis, itching, and painful, inflamed skin lesions [9,14,15]
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