Overview
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ABSTRACT
Semi-solid materials are solid at rest and flow under mechanical stress. They are semi-solid on a macroscopic scale but liquid on a microscopic one, allowing the topical administration of therapeutic molecules. They must meet complex specifications and comply with the technical standards of the various pharmacopoeias. The main semi-solid preparations for cutaneous application are described and classified by type of galenic form (gels, emulsions, ointments, pastes, poultices) in this article. The composition of the preparations is explained in relation to their physicochemical and therapeutic properties. Illustrative examples of drugs are given.
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Read the articleAUTHORS
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Marie-Alexandrine BOLZINGER: Professor - Université Claude Bernard Lyon 1 – Laboratoire d'Automatique, de Génie des Procédés et de Génie Pharmaceutique, - LAGEP, UMR CNRS 5007, France
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Stéphanie BRIANÇON: Professor - Université Claude Bernard Lyon 1 – Laboratoire d'Automatique, de Génie des Procédés et de Génie Pharmaceutique, - LAGEP, UMR CNRS 5007, France
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Yves CHEVALIER: CNRS Research Director - Université Claude Bernard Lyon 1 – Laboratoire d'Automatique, de Génie des Procédés et de Génie Pharmaceutique, - LAGEP, UMR CNRS 5007, France
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Marie-Emmanuelle MILLION: Senior Lecturer - Université Claude Bernard Lyon 1 – Laboratoire de Chimie Thérapeutique, - Faculty of Pharmacy, Lyon, France
INTRODUCTION
"Praeparationes semi solidae ad usum dermicum
Semi-solid preparations for cutaneous application are defined by the monograph (07/2021:0132) of European Pharmacopoeia supplement 10.7 as "preparations intended to be applied to the skin to deliver active substances for local or systemic action, or to exert an emollient or protective action. They are homogeneous in appearance. [...]. Semi-solid preparations for cutaneous application consist of a base, simple or compound, in which one or more active substances are usually dissolved or dispersed. Depending on its composition, this base can influence the activity of the preparation. The base used may be monophase or multiphase, and depending on its nature may impart hydrophilic or hydrophobic properties to the preparation. The preparation may contain preservatives and other suitable excipients such as antioxidants, stabilizers, emulsifiers, thickeners and penetrants. These excipients do not interfere with the desired medicinal action and, at the concentrations chosen, do not cause toxic effects or noticeable local irritation". There are several categories of semi-solid preparations for cutaneous application: ointments, creams, gels, pastes and poultices. Until supplement 10.5 of the European Pharmacopoeia (effective July 2021), medicated plasters were included in this monograph. They are now the subject of their own monograph (07/2021:3032) and are not covered in this document. Another form of the system-on-a-support type is the cutaneous device, which corresponds to transdermal systems (patches) which, unlike plasters, provide a systemic effect. These are also described in a separate monograph (07/2021:1011) and therefore not covered in this article. Paste systems are galenic forms in a physical state intermediate between a solid and a liquid. They have properties close to those of solids at rest, but can nevertheless be transformed into viscous liquids by the application of sufficient mechanical stress to enable them to be manipulated, deformed and spread during use.
A definition can be given in line with the common sense associated with practical applications: a pasty system is a viscous, self-supporting material. The term semi-solid sums up this combination of mechanical properties: the material is a solid that can undergo large-scale irreversible (viscous) deformation. In the field of pharmaceutical and cosmetic applications, pasty systems are the galenic forms of choice for the topical administration of pharmaceutical or cosmetic active substances. In short, the appeal of pasty forms lies in their two fundamental properties: these materials are deformable and adherent.
The range of possible physico-chemical properties is varied, adjusted by the type of formulation and the choice of excipients...
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KEYWORDS
state of the art | semi-solid preparations for cutaneous application | pharmaceutical technology | dosage forms
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Pasty systems or semi-solid preparations
Bibliography
Bibliography
Standards and norms
European Pharmacopoeia, 10.8, 2022
Websites
European Directorate for the Quality of Medicines & Healthcare http://www.edqm.eu/fr/ (accessed July 14, 2014)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
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