Topical preparations and their use in dermatology

Summary The challenges of everyday clinical routine require dermatologists to have a basic knowledge of the composition of topical preparations as well as the regulatory background associated with their prescription. Proper selection, prescription, and application of topical preparations, depending...

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Published in:Journal der Deutschen Dermatologischen Gesellschaft Vol. 14; no. 11; pp. 1061 - 1070
Main Author: Wohlrab, Johannes
Format: Journal Article
Language:English
Published: Germany Blackwell Publishing Ltd 01-11-2016
Wiley Subscription Services, Inc
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Summary:Summary The challenges of everyday clinical routine require dermatologists to have a basic knowledge of the composition of topical preparations as well as the regulatory background associated with their prescription. Proper selection, prescription, and application of topical preparations, depending on the respective indication, are key to professional and responsible medical practice. Problems commonly arise with respect to regulatory classifications (medicinal products, medical devices, or cosmetics), eligibility for reimbursement by the statutory health insurances (GKV), and insufficient declaration of vehicle systems. Apart from selecting the appropriate active substance and its proper concentration, choosing a suitable pharmaceutical (galenic) formulation – and thus utilizing the intrinsic effects thereof – is pivotal in enhancing the intended therapeutic effects. When prescribing individual formulations, dermatologists should, to the greatest extent possible, always resort to standardized extemporaneous preparations. Given the multitude of potential ingredients available for pharmaceutical formulations as well as the complexity resulting therefrom, arbitrary changes in quality or quantity of individual components are associated with a high risk of instability, thus jeopardizing safety and the rationale behind any given formulation. Optimal use of topical preparations also requires basic knowledge in pharmacokinetics as well as evidence‐based treatment planning.
Bibliography:ark:/67375/WNG-TKHC18S8-1
ArticleID:DDG13151
istex:8AA44DDD67F61950208C81F5DB5FB07C1D9B82F0
Pharmacokinetics are determined by the interaction of physicochemical characteristics of the active ingredient, characteristics of the vehicle system, and the condition of the skin.
Liberation of the active ingredient is followed by a distribution process within numerous microcompartments.
Creams are three‐phase systems consisting of an aqueous, an oily, and an emulsifying phase.
As regards the differentiation of multiphase systems, the following categories have been tried and tested: ointments, creams, gels, and pastes.
The planning process includes various pharmacological, physical, physiotherapeutic, cosmetic, as well as possibly other options.
Extemporaneous formulations are an excellent option to modify both the application interval as well as the initial concentration of the active ingredient.
Gels are composed of a matrix builder, which – dispersed in water or oil – results in a semi‐solid preparation of variable viscosity.
Vehicle system in accordance with the therapeutic objective (indication).
In order to be able to optimize a therapeutic intervention according to medical, economic and practical aspects, conceptual planning is necessary and useful.
nanoparticles
Arguments in favor of a fixed combination of two (rarely more) active pharmaceutical ingredients include clinical efficacy through additive effects or improved patient adherence.
From a regulatory perspective, topical agents are divided into the categories medicinal products, medical devices, and cosmetics.
Following epicutaneous application of a topical agent, the active ingredient dissolved or suspended therein as well as other ingredients are released (liberated) from the preparation.
Modern vehicle systems have a colloidal phase.
Microemulsions
Pastes contain an insoluble (particle) component suspended in ointment, oil or cream.
Fick's laws of diffusion
It is important to provide patients with written instructions for use.
Intercellular passage is the most important route.
On principle, anhydrous systems are subsumed under the term ointment.
The professional use of topical preparations is one of the core competencies in dermatology.
In finished medicinal products, variable dosage may primarily be achieved by adjusting the amount applied or the application frequency.
Intrinsic effects of the base through its direct interaction with the skin
The multitude of pharmaceutical formulation variants, including officinal bases, require special knowledge, which is one of the core competencies of pharmacists.
Today, medicinal products, medical devices, and cosmetics are validated and manufactured according to high quality standards.
The permeation rate signifies that proportion of the active ingredient that has passed through any given or all skin layers; the process itself is referred to as permeation.
The therapeutic effects of topical agents are determined by the choice of the active ingredient(s), their concentration, and the choice of the galenic base.
The choice of a pharmaceutical (galenic) concept is primarily based on the requirements of the physicochemical properties of the active ingredient to be applied.
Liposomes
The fixed combination of active pharmaceutical ingredients in topical preparations is suitable for only a limited number of clinical treatment scenarios.
The communication between doctor and patient has a decisive impact on patient adherence and, consequently, therapeutic success.
The indiscriminate use of nonspecific polyvalent preparations without clear indication should be avoided.
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ISSN:1610-0379
1610-0387
DOI:10.1111/ddg.13151