Source: http://basiscreme.com/english/corneotherapy/microcosm-of-modular-skin-care-formulations.html
Timestamp: 2018-11-20 05:46:36
Document Index: 353922055

Matched Legal Cases: ['§ 7', '§ 8', '§ 11', '§ 13', '§ 1', '§ 13', '§ 11']

Microcosm of modular skin care formulations
corneotherapy imprint sitemap German
Lecture held at the 18th annual meeting of the Society of Dermopharmacy at Berlin on April 9, 2014
With the last amendment of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung - ApBetrO) taking effect on 1st March 2013, the requirements for the formulation (§ 7) and small scale production of medical drugs (§ 8), their ingredients (§ 11) and containers (§ 13) have partly been redefined. In § 1a (10) of ApBetrO, besides the medical products also body care products now are counted among customary pharmacy articles, however no regulations have been issued regarding their manufacturing in pharmacies. In this respect, also essential references to the European Cosmetic Directive (KVO) are missing. The European Cosmetic Directive however is relevant in cases where pharmacies
1) bottle skin care products - in their own containers
2) mix and bottle skin care products - in their own containers
3) mix and bottle skin care products - in ready-made containers
Even the obviously uncomplicated item (1) has complex implications since the CPNP registration1 as well as the container compatibility have to be considered. With regard to the containers, § 13 of ApBetrO only provides fragmentary information since recent and formerly unknown problems such as the use of recycling materials and the related risks are not addressed.
Modular components, i.e. (cosmetic) base creams2,3 and gels as well as pre-dissolved agents or active agents encapsulated in carriers4,5 including certificated containers fall under categories (2) and (3). Efforts are minimal and product safety is ensured. The manufacturing of
(1) dispensing drugs formulated with cosmetic bases and pharmaceutical active agents
(2) dispensing drugs formulated from pharmaceutical bases and cosmetic active agents
has been subject of controversial discussions since certain district pharmacists' chambers refuse to accept cosmetic components without certified GMP conform production although § 11 of ApBetrO has not explicitly mentioned this requirement for ingredients that are not counted among active agents. Particularly lamellar base creams of modular concepts that are formulated on the model of the skin barrier structure6 with a tolerance and broad application far superior to conventional emulsions belong to this group. A number of typical issues of modular lamellar systems7 are discussed such as
structure of aqueous systems
physical plausibility and stability
chemical plausibility and compatibility
metabolization and bioavailability8
tolerance and safety reports
Based on the formulation of "moisturizing creams", the interaction between individual skin condition, modular components (emollients, barrier active components, moisturizers, film-forming agents) and environmental conditions is illustrated in detail9. The example shows both the complex context of the subsequent cream application and the way how the pharmacist can respond to individual needs and provide professional advice.
A further example on "acne" outlines the effective transition from the dermatological treatment to a cosmetic prevention10.
Concluding, the overview on different indications illustrates the potential synergy between dermatology and skin care11,12,13.
Valenta C, Salbengrundlagen; Österreichische Apothekerzeitung 2005;16:770-773
H. Lautenschläger, Huckepack - Übersicht Trägersysteme, medical Beauty Forum 2013;1:16-18
Iwai I et al. The human skin barrier is organized as stacked bilayers of fully extended ceramides with cholesterol molecules associated with the ceramide sphingoid moiety. J Invest Dermatol (2012), doi: 10.1038/jid. 2012.43, 1-11
H. Lautenschläger, Biodegradable lamellar systems in skin care, skin protection and dermatology, SOFW-Journal 2013;139;8:2-8
H. Lautenschläger, Übersicht: Freisetzung und Bioverfügbarkeit - Kosmetik & Pflege 2013;1:36-37 und 2013;2:38-39
Wasserhaushalt der Haut - Moisturizer & Co., medical Beauty Forum 2014 (1), 18-20
Applied Corneotherapy
Corneotherapy - current stage of development
Corneotherapy - what is it?
Indications for nanodispersions
Lamellar preparations
Lamellar systems - application and limitations
Studies on the efficacy
Revision: 23.10.2014