Liposomology / Drug Delivery

Liposomes protect, transport and release your drug at the right place and time. By this, a reduced dose achieves better efficacy and avoids side effects with a non-invasive application.

Polymun′s technology enables the industrial realization of pharmaceutical and cosmetic products for liposomal drug formats. The production technology is suitable for a broad range of substances formulated by passive entrapment, active loading or membrane incorporation.

Main characteristics of our technology are:

Scalability
The injection module is the heart of the liposome production. The process parameters determine the size of the liposomes regardless of the scale. The production of 100 liters of liposome preparation takes only 40 minutes. Large scale also can be achieved by using several injection modules in parallel.

Sterility
A closed system is used for production. All components can be added via sterile filtration. Subsequent concentration by crossflow filtration is also possible. Thereby, residual ethanol is reduced far below the limit of 0.5% according the European Pharmacopoeia (01/2005:50400).

Homogeneous, Uniform Vesicles
The size of the liposomes is determined by the process parameters, as well as the raw materials. All parameters can be controlled exactly. This results in a very narrow size distribution, necessary for reliable targeting and transport characteristics.

Entrapment of Several Product Classes with High Efficiency
Different techniques are used depending on the nature of the drug. Hydrophilic substances are passively entrapped. An excellent example is Polymun′s liposomal SOD. Amphiphilic substances are actively loaded and hydrophobic drugs or membrane proteins are incorporated into the membrane of the liposomes.

Batch to Batch Consistency
High quality of raw materials and precisely controllable process parameters guarantee excellent reproducibility - essential for pharmaceutical grade products.

Mild Procedure ­ Stability
The crossflow injection technique is a very mild procedure that allows the processing of sensitive drugs. Together with the high quality of raw materials and narrow size distribution, we achieve long term stability of liposomes even at room temperature.

Meet us at:

Liposomes 2010, 4-7 August 2010, Vancouver, Canada: Dr. Andreas Wagner

CPhI 2010, October 5-7 2010, Paris, France: Dr. Dietmar Katinger

Patents:

Method and device for producing lipid vesicles
granted by: AU 2002215987; CA 2,427,640; EP 1 337 322 (AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR); US 6,843,942


Superloaded liposomes for drug delivery
granted by: EA 200602172; CN 1960706A
pending in: AU, CA, EP, IN, JP, KR, US, international stage WO2005115337

Publications:

Wagner A, Stiegler G, Vorauer-Uhl K, Katinger H, Quendler H, Hinz A, Weissenhorn W (2007) One Step Membrane Incorporation of Viral Antigens as a Vaccine Candidate Against HIV. J Liposome Res 17(3):139-54

Wagner A, Platzgummer M, Kreismayr G, Quendler H, Stiegler G, Ferko B, Vecera G, Vorauer-Uhl K, Katinger H (2006) GMP Production of Liposomes-A New Industrial Approach. J Liposome Res 16(3):311-9

Wagner A, Vorauer-Uhl K, Katinger H (2006) Nebulization of liposomal rh-Cu/Zn-SOD with a novel vibrating membrane nebulizer. J Liposome Res 16(2):113-25

Lenz O, Dittmar MT, Wagner A, Ferko B, Vorauer-Uhl K, Stiegler G, Weissenhorn W (2005) Trimeric membrane anchored gp41 inhibits HIV membrane fusion. J Biol Chem 280(6):4095-101

Vorauer-Uhl K, Wagner A, Katinger H (2003) Large Scale Produktion von Liposomen als typische Vertreter partikulärer Trägersysteme. Chemie Ingenieur Technik 75:619-23

Vorauer-Uhl K, Wagner A, Borth N, Katinger H (2002) Long term stability of rh-Cu/Zn-SOD-liposomes prepared by the crossflow injection technique following ICH-guidelines. European Journal of Pharmaceutics and Biopharmaceutics 54:77-81

Wagner A, Vorauer-Uhl K, Kreismayr G, Katinger H (2002) Enhanced protein loading into liposomes by the multiple injection technique. Journal of Liposome Research 12(3):271-83

Wagner A, Vorauer-Uhl K, Kreismayr G, Katinger H (2002) The crossflow injection technique - an improvement of the ethanol injection method. Journal of Liposome Research 12(3):259-70

Wagner A, Vorauer-Uhl K, Katinger H (2002) Liposome produced in a pilot scale: production, purification and efficiency aspects. European Journal of Pharmaceutics and Biopharmaceutics 54:213-9

Vorauer-Uhl K, Wagner A, Borth N, Katinger H (2000) Determination of liposome size distribution by flow cytometry. Cytometry 39(2):166-71