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  Documentation on manufacturing - news from the galenics of advanced lamellar base creams
 
Lecture held at the 20th annual meeting of the Society of Dermopharmacy in Berlin on March 16, 2016

Lamellar cream bases1 modelled on the structure of the skin barrier2 are suitable for dermatological formulations3, for skin care4 and for skin protection purposes5 6. They have been integral part of the SOS preparations for occupational skin protection of the professional associations for a long time.

Topical lamellar systems usually are oriented towards the plasma membranes of cells and the bilayer principle of the skin barrier. Accordingly, they use phosphatidylcholine7, ceramides, sterines and fatty acids as structuring elements8. Besides the liposomes with low lipid absorbing capacity, creams consisting of a gel body and finely dispersed droplets of skin care oils stabilized by liposomes ("semisomes"9) were initially developed. Next step in the development, apart from the oil-loaded biodegradable nanodispersions, were creams in which native phosphatidylcholine was substituted by hydrogenated phosphatidylcholine (PC-H); they were specified as creams with Derma Membrane Structure10 and are characterized by planar bilayers. The fatty acid composition of PC-H in this case consists of palmitic and stearic acid. Another application field besides skin care is skin protection, as already mentioned.

Cosmetic and pharmacopoeia-adjusted lamellar base creams are manufactured by means of high pressure homogenization under varying conditions. Compared with alternative manufacturing processes such as jet mixer and rotor stator technologies with compulsory passage, both also applicable in the pharmacy11, the high pressure homogenization allows for the production of cream bases with varying consistency and haptic, and simultaneously excellent long-term stability with practically the same composition at varyingly high pressures. Conventional techniques as known from emulsifier containing base creams do not lead to adequate results. This, among others, is related to an extremely low critical micelle concentration (CMC) of about 4.6 x 10-10 mol/l of hydrogenated phosphatidylcholine which is comparable with dipalmitoylphosphatidylcholine (DPPC).

Besides hydrogenated phosphatidylcholine with a phase transition temperature of 42ºC (crystalline/liquid-crystalline), the phytosterines of shea butter (butyrospermum parkii butter) and N-octadecanoyl-sphingosine (ceramide 3 alias ceramide NP) also are structuring components of the lamellar base creams. Together with long-chained fatty acids, the similar lamellar structure of ceramides and cholesterol constitutes the most important barrier function of the stratum corneum.

The lamellar structures in all the creams could be verified with the electron microscope. Besides the planar, also vesicular lamellar elements can be observed. They mostly are oligolamellar and about the size of 100-200 nm. It is presumed that also metastable states can be found in this context, yet they do not influence the macroscopic features such as long-term stability and consistency.

Depending on the production parameters, creams with a shiny surface can form during the manufacturing process which indicates that mainly the lipid phase of the lamellar creams builds up the interface with atmosphere, and that the surface tension is at a minimum. Superficial lipid phase and increased consistency cause a retarded penetration into the skin which is beneficial in cases where the consumer prefers a "rich" product. Interesting aspect of this particular technology: there is no need for an additional consistency agent. Studies still are under way to find out whether and up to what extent liquid-crystalline phases or packs with hexagonal and orthorhombic crystalline arrays and their transitions into each other play a role within the individual processes.

Safety reports for all components of the formulations, also relating to the metabolisms relevant for the physiological tolerance, are available.

 

References

  1. H. Lautenschläger, Biodegradable lamellar systems in skin care, skin protection and dermatology, SOFW-Journal 2013;139;8:2-8
  2. 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
  3. Monographie dermaviduals® lamellare Basiscremes, Ausgabe 02-2016, KOKO Kosmetikvertrieb GmbH & Co. KG
  4. H. Lautenschläger, Übersicht: Freisetzung und Bioverfügbarkeit - Kosmetik & Pflege 2013;1:36-37 und 2013;2:38-39
  5. Lautenschläger H, Albrecht M, Bohn M, Weisser M, Hautschutzpräparate zur Prävention von Hautschäden, DE 19857490
  6. Lautenschläger H, Übersicht: Behandlung von Problemhäuten, Kosmetik International 2012;8:16-18
  7. Lautenschläger H, Phospholipide - Multitalente, medical Beauty Forum 2014 (3), 18-20
  8. Lautenschläger H, Liposomes, Handbook of Cosmetic Science and Technology (Barel AO, Paye M and Maibach HI), 155-163, CRC Press Taylor & Francis Group, Boca Raton 2006
  9. Lautenschläger H, Liposomes in Dermatological Preparations, Part II, Cosmetics & Toiletries 105 (7), 63-72 (1990)
  10. Derma Membran Struktur®: Fortschritt im betrieblichen Hautschutz, Symposium Medical 2001;12;5:37
  11. Lautenschläger H, Albrecht M, Bohn M, Weisser M, Wasserhaltige Hautschutzpräparate zur Prävention von Hautschäden, DE 19857492

Dr. Hans Lautenschläger

 
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Applied Corneotherapy
Corneotherapy - current stage of development
Corneotherapy - what is it?
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Indications for nanodispersions
International Association for Applied Corneotherapy
Lamellar preparations
Lamellar systems - application and limitations
Microcosm of modular skin care formulations
Studies on the efficacy
 
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Revision: 01.05.2016