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
- bottle skin care products - in their own containers
- mix and bottle skin care products - in their own containers
- 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
- dispensing drugs formulated with cosmetic bases and pharmaceutical active agents
- 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
- microbiological stabilization
- chemical plausibility and compatibility
- metabolization and bioavailability8
- tolerance and safety reports
- shelf life information
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.
- Lautenschläger H, Universelle Basiscremes mit Membran-Struktur für Hautpflege, Hautschutz und Dermatika, Österreichische Apothekerzeitung 2002;56;14:679
- Valenta C, Salbengrundlagen; Österreichische Apothekerzeitung 2005;16:770-773
- Lautenschläger H, Liposomes, Handbook of Cosmetic Science and Technology (Barel AO, Paye M and Maibach HI), CRC Press Taylor & Francis Group, Boca Raton 2006:155-163
- 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 shingoid 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
- Lautenschläger H, Synergien nutzen - Wie Wirkstoffe und Cremebasen Kosmetik und Pharmazie verbinden, Kosmetische Praxis 2010;3:10-12
- Lautenschläger H, Grenzgänger - Kosmetische Pflege auf den Punkt gebracht, Beauty Forum 2010;8:27-29
- Lautenschläger H, Gegenüberstellung - kosmetische und pharmazeutische Wirkstoffe, Kosmetik International 2010;10:32-36
- Lautenschläger H, Korneotherapie - Bindeglied zwischen Dermatologie und Kosmetik (ISBN 978-3-00-035755-8), 2011:269-270
Dr. Hans Lautenschläger