Drug Formulation & Characterization

//Drug Formulation & Characterization
Drug Formulation & Characterization 2018-03-13T09:42:43+00:00

Turning an active compound into a drug product

Bioneer:FARMA is a business unit of Bioneer located at the Department of Pharmacy, University of Copenhagen with many years’ experience in all aspects of drug development and characterization.

We provide analysis, pre-formulation, formulation, as well as in vitro and in vivo evaluation, of both biological and small moleculare drugs. We specialize in oral drug delivery and have developed a range of in vitro models simulating the behavior of drugs and drug products in the gastro-intestinal tract. We use cell culture models to assess drug permeability and absorption mechanism.

For further information, please contact Head of Bioneer:FARMA, Anette Müllertz by email or BD Vibeke Dalhoff by email, or by phone +45 45160444 .

Small Molecules

Bioneer:FARMA specializes in pre-formulation and strategic formulation development of small molecular compounds. All studies are tailored to the specific needs of the client.

When considering right drug delivery strategy for a molecule, factors such as solubility, intrinsic dissolution rate, supersaturation propensity and solid state properties need to be investigated. Bioneer:FARMA has extensive experience in characterizing small molecular drug candidates with regard to these parameters.

Bioneer:FARMA offers permeability assessments of drugs using

  • Caco-2 cell cultures
  • Other relevant cell culture models, including mucus secreting cell models
  • Cell models of the Blood Brain Barrier

Bioneer:FARMA apply physiologically relevant media when relevant for e.g. solubity, dissolution and Caco-2 cell transport studies. This includes media simulating the fluids relevant for the desired administration route, e.g. simulated gastro-intestinal fluids.

For further information, please contact Head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

Bioneer:FARMA develops and characterizes formulations of small molecular drugs. This covers both conventional pharmaceutical formulations as well as enabling drug delivery systems for problem drugs.

Bioneer:FARMA has long experience with oral drug delivery and all needed equipment to develop e.g. coated tablets and liquid filled capsules is available.

Formulations are evaluated and characterized by state-of-the-art in vitro characterization tools simulating the in vivo situation as close as possible. One example is the dynamic Gastric Model (DGM), which for example can simulate food effect on drug products. Simpler models, like biorelevant dissolution and in vitro digestion models, are also applied.

For further information, please contact head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

Biologics

Bioneer:FARMA understands the complexity of biologics and the challenges met during a pre-clinical development from early characterization to formulation.

Characterization and stability of peptides and proteins

Bioneer:FARMA has extensive experience in quantifying and determining the structure and stability of peptide or protein drugs.

Using state-of-the-art analytical equipment, Bioneer:FARMA characterizes peptide and protein drugs, e.g. molecular size, secondary or tertiary structure etc. Furthermore, we conduct studies to determine the peptide or protein tendency to aggregate or fibrillate during storage, as a consequence of elevated temperature or due to mechanical stress.

For further information, please contact Head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

Permeability studies of biological drug compounds 

Bioneer:FARMA has a strong track record within drug transport over biological barriers. The absorption or permeability of biologics, such as peptides, are assessed by use of cell culture models of e.g. the small intestine or the blood brain barrier (BBB).

For further information, please contact head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

Through participation in European projects Bioneer:FARMA has designed and implemented development strategies for oral delivery of peptides and proteins. This includes compatibility with simulated gastro-intestinal media, assessment of protease degradation, efficiency of permeation enhancers, using cell culture models, and more.

For further information, please contact Head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

Bioneer:FARMA develops parenteral formulations of peptide and protein drugs, taking into account the conformation of the drug, in order to evaluate the formation of aggregation and other issues, which could lead to reduced activity.

For further information, please contact Head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

Gastro-Intestinal Models

Bioneer:FARMA has a variety of GI models for investigation of different gastro-intestinal analyses.

In preparation.

For further information, please contact Head of Bioneer:FARMA Anette Müllertz by phone +45 45160444 or email.

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