Dr. Klaus Lehmann

D-64380 Roßdorf
bei Darmstadt
Brunnersweg 12
Tel/Fax +49 6154 82984
e-Mail drkl.lehmann@t-online.de

Drug Dosage Form – New Design - Innovative !
 

Process for Laminar Pharmaceutical Compositions:

Laminar drug formulations have an unique microstructure, which can be produced using highly developed production technology of microelektronic components. The forms may have controlled release properties and can be applied as rolled or folded foils directly or filled into gelatine capsules. Laminar drug compositions open new fields of  application with special actives and may create new marketing possibilities.
The figure at the top right showes the new drug design,a rolled film in a hard gelatine capsule is shown on the right hand together with a commercial electrolyte condenser (left) to compare the size and the laminar structure inside. Click on the picture for higher magnification to see more details of the rolled drug film inside the capsule. The microstructure is also shown below in higher magnification and contrast in the electron scanning microphoto below.

 

The Patent:

The german patent application “Laminar Drug Dosage Form and Process of its Production” DE 19715794 
is now available as a licence. I offer it together with an introduction into the new production technology from my own knowledge in the field of controlled release pharmaceutical dosage forms.

 

 

 

The figure obove left shows the basic design of a role prepared from a polymer film with embedded drug. Other possibilities are rolled or folded, drug containing layers in form of cylinders, discs or similar from a single film or multi layered structures. Forms can be filled into hard gelatine capsules size 3 as seen in the first picture above on the right.
The picture above right is a electron scanning microphoto of a section in a rolled cylinder. It shows the microstructure of the carrier film and intermediate layers in the range of nanometers.Area in the picture appr. 1,2 x 1,8 mm.

 

The Author:

As the Head of Pharmaceutical Research and Development Laboratories in Darmstadt/ Germany, I developed polymers for pharmaceutical applications on the basis of Polymethacrylates. The product line named „Eudragit” was well intruduced
wordwide for enteric coating and sustained release dosage forms. For many years I have worked out the application technology in technicum scale and for production in direct contact with pharmaceutucal companies. Recently my company has been reorganized  in the Degussa- Group. I am member of the “International Association for Pharmaceutical Technology” APV- Mainz since 1985.



The internal structure:

The high degree of structural order is determined by two factors: First by the microstructure inside  the film after incorporation of the drug molecules in the polymer network. Using polymer dispersions, the dimensions of the latex particles are in the range of 10 – 100 nanometers.
The second factor is the laminar aggregation of the film layers in the rolled or folded design. Many variations of multiple structure and layer arrangements are possible and can be formed in reproducible processes.


Active drug substances:

High accuracy of dosing can be achieved, this is essential for actives of high potency. Processing at low temperature is possible, useful for sensitive drugs as biological actives or similar. Actives and excipients can be incorporated as solutions, fluids or pastes. No powder technology involved to exclude dust contamination.

Formulation:
composition (mg) options higher dosis
active drug substances 50-300 500
polymers 50-150 250
other excipients 50-150 250
     
weight of the forms (mg) 200-400 750
diameter (mm) 4-8 10
height (mm) 2-6 10

Drug release pattern:

Controlled drug release by diffusion, disintegration or/and dissolution of the laminar dimensions and microstructures.
Additional possibilities for controlled release by:
Selection of film formers, embedding of the actives,
Intermediate layers and adhesives,
Concentrations of drugs and excipients.

Examples for controlled release in the graph below.

 

Specific advantages:

Layering drug melts, suspensions or solutions on foils, rolling and cutting is working at low temperature with no dust release. Small amounts of experimental samples can be prepared in original design. Highly reproducible quality as used wordwide in microelectronics technology.

 

e-Mail- contact for more details: drkl.lehmann@t-online.de