Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP

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Pharmaceutical Technology

The innovation area Pharmaceutical Technology offers expertise in formulation development of drugs and drug candidates, with a focus on oral and parenteral dosage forms, with over 50 years of experience, more than a dozen patents and extensive consulting to the pharmaceutical industry.

 

Core competencies:

  • Refined Development Classification System (rDCS)
  • Biowaivers
  • Design of enabling formulations for oral drug delivery
  • Biorelevant dissolution testing
  • Transfer model
  • Physiologically based pharmcokinetic modeling (PBPK)
  • Nanoparticular formulations
  • Liposome formulations
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Preformulation

  • Drug characterization
  • Classification according to the refined Developability Classification Scheme for oral dosage forms
  • Formulation feasibility studies including evaluation  of various enabling technologies

Formulation

  • Formulation selection
  • Assessment of development and scale-up risks
  • Biorelevant release studies tailored to the formulation type

PBPK modeling and simulation to predict performance in target patient population(s)

InPharma

Together with four universities and leading pharmaceutical companies, an end-to-end animal-free, computational approach to formulation and development of drugs for oral administration is being designed.

Muco-RSV

With Fraunhofer partner institutes we are creating a lipsomal formulation for vaccination against respiratory infections. 

Partner: Fraunhofer ITEM, IZI, IPA, FEP

Additional information

Biorelevant media to assess drug interactions with acid-reducing agents

In cooperation with a pharmaceutical company we have developed specialized dissolution tests to assess risks associated with co-administration of drugs with acid-reducing agents. 

Rosenberger J, Butler J, Dressman J.
A Refined Developability Classification System.
J Pharm Sci. 2018 Aug;107(8):2020-2032
doi: 10.1016/j.xphs.2018.03.030

Price DJ, Nair A, Kuentz M, Dressman J, Saal C.
Calculation of drug-polymer mixing enthalpy as a new screening method of precipitation inhibitors for supersaturating pharmaceutical formulations.
Eur J Pharm Sci. 2019 Apr 30;132:142-156
doi: 10.1016/j.ejps.2019.03.006

Litou C, Turner DB, Holmstock N, Ceulemans J, Box KJ, Kostewicz E, Kuentz M, Holm R, Dressman J.
Combining biorelevant in vitro and in silico tools to investigate the in vivo performance of the amorphous solid dispersion formulation of etravirine in the fed state.
Eur J Pharm Sci. 2020 Mar 7;149:105297
doi: 10.1016/j.ejps.2020.105297

Segregur D, Flanagan T, Mann J, Moir A, Karlsson EM, Hoch M, Carlile D, Sayah-Jeanne S, Dressman J.
Impact of Acid-Reducing Agents on Gastrointestinal Physiology and Design of Biorelevant Dissolution Tests to Reflect These Changes.
J Pharm Sci. 2019 Nov;108(11):3461-3477
doi: 10.1016/j.xphs.2019.06.021.

Loisios-Konstantinidis I, Cristofoletti R, Fotaki N, Turner DB, Dressman J.
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling case example: Naproxen.
Eur J Pharm Sci. 2020 Feb 15;143:105170
doi: 10.1016/j.ejps.2019.105170