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Special Patients

Focus Group "Special Patients"


  • Laura Falkenstein
  • Anja Göbel
  • Clara Grawe
  • Valentine Elezaj
  • Marcel Kokott
  • Jennifer Kuck
  • Romana Wils

Recent topics:

  • Child-appropriate drug formulations and their characterization
  • Senior-friendly drug formulations and their characterization
  • Advanced medical devices for patient-appropriate drug delivery
  • Formulations and medical devices for personalized medicine
  • Drug formulations for veterinary use

Lura, G. Tardy, P. Kleinebudde, J. Breitkreutz
Tabletting of mini-tablets in comparison with conventionally sized tablets: Tabletting properties and tablet shapes
Int. J. Pharm. X, im Druck (2020)

El Aita, J. Rahman, J. Breitkreutz, J. Quodbach
3D-Printing with precise layer-wise dose adjustments for paediatric use via pressure-assisted microsyringe printing
Eur. J. Pharm. Biopharm. 157: 59-65 (2020)

D. Kottke, A. Lura, D.J. Lunter, J. Breitkreutz
Manufacturing and characterisation of a novel composite dosage form for buccal drug administration
Int. J. Pharm. 589: 119839 (2020)

O. Kiefer, J. Breitkreutz
Comparative investigations on key factors and print head designs for pharmaceutical inkjet printing
Int. J. Pharm. 586: 119561 (2020)

V. Klingmann, C.E. Pohly, T. Meissner, E. Mayatepek, A. Möltner, K. Flunkert, J. Breitkreutz, H.M. Bosse
Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized clinical trial
Eur. J. Pharm. Biopharm. 151: 239-245 (2020)

D. Kottke, H. Majid, J. Breitkreutz, B.B. Burckhardt
Development and evaluation of mucoadhesive buccal dosage forms of lidocaine hydrochloride by ex-vivo permeation studies
Int. J. Pharm. 581: 119293 (2020)

El Aita, J. Breitkreutz, J. Quodbach
Investigation of semi-solid formulations for 3D printing of drugs after prolonged storage to mimic real-life applications
Eur. J. Pharm. Sci. 146: 105266 (2020)

J.C. Visser, L. Wibier, O. Kiefer, M. Orlu, J. Breitkreutz, H.J. Woerdenbag, K. Taxis
A paediatrics utilization study in the Netherlands to identify active pharmaceuticals ingredients suitable for inkjet printing on orodispersible films
Pharmaceutics 12: 164 (2020)

Van Hecken, B.B. Burckhardt, F. Khalil, J. de Hoon, I. Klingmann, M. Herbots, S. Laeer,  F.B. Lagler, J. Breitkreutz
Relative bioavailability of enalapril administered as orodispersible minitablets in healthy adults
Clin. Pharmacol. Drug Devel. 9: 203-213 (2020)

Lura, O. Luhn, J. Suarez Gonzales, J. Breitkreutz   
New orodispersible mini-tablets for paediatric use – A comparison of isomalt with a mannitol based co-processed excipient
Int. J. Pharm. 572: 118804 (2019)

Y. Tian, M. Orlu, H.J. Woerdenbag, M. Scarpa, O. Kiefer, D. Kottke, E. Sjöholm, H. Öblom, N. Sandler, W.L.J. Hinrichs, H.W. Frijlink, J. Breitkreutz, J.C. Visser
Oromucosal films: from patient centricity to production by printing techniques
Exp. Opin. Drug Deliv. 16: 981-993 (2019)

M. Faisal, W. Cawello, B.B. Burckhardt, J. de Hoon, S. Laer, A. van Hecken, M. Herbort, J. Breitkreutz, W. Wiedey, I. Klingmann, L. Spatenkova, F. Lagler, A. Moder, F. Khalil
Simultaneous semi-mechanistic population pharmacokinetic modeling analysis of enalapril and enalaprilat serum and urine concentrations from child appropriate orodispersible minitablets
Frontiers in Paediatrics 7: 281 (2019)

M. Faisal, W. Cawello, B.B. Burckhardt, S. Laer, J. de Hoon, A. van Hecken, M. Herbort, J. Breitkreutz, W. Wiedey, I. Klingmann, L. Spatenkova, F. Lagler, A. Moder, F. Khalil
Model-dependent pharmacokinetic analysis of enalapril administered to healthy adult volunteers using orodispersible minitablets for use in pediatrics
Drug Design, Development and Therapy 13: 481-490 (2019)

M. Bajcetic, S.N. de Wildt, M. Dalinghaus, J. Breitkreutz, I. Klingmann, F.B. Lagler, A. Keatley-Clarke, J.M.P.J. Breur, C. Male, I. Jovanovic, A. Szatmári, L. Ablonczy, B.B. Burckhardt, W. Cawello, K. Kleine, E. Obercanin, L. Spatenkova, V. Swoboda, M. van der Meulen, P. Wagner, J. Walsh, S. Läer
Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study,
Contemporary Clinical Trials Communication 15: 100393 (2019)

S. Niese, J. Breitkreutz, J. Quodbach           
Development of a dosing device for individualized dosing of orodispersible warfarin films
Int. J. Pharm. 561: 314-323 (2019)

J. Quodbach, I. El Aita, J. Breitkreutz
On-demand manufacturing of immediate release levetiracetam tablets using pressure-assisted microsyringe printing
Eur. J. Pharm. Biopharm. 134: 29-36 (2019)

I. Speer, V. Lenhart, M. Preis, J. Breitkreutz
Prolonged drug release from orodispersible films by incorporation of diclofenac-loaded micropellets
Int. J. Pharm. 554: 149-160 (2019)

Y. Thabet, V. Klingmann, J. Breitkreutz
Drug formulations: Standards and novel strategies for drug administration in pediatrics
J. Clin. Pharmacol. 58: S26-S35 (2018)

V. Klingmann, H. Linderskamp, T. Meissner, E. Mayatepek, A. Moeltner, J. Breitkreutz, H.M. Bosse
Acceptability of multiple uncoated mini-tablets in infants and toddlers: a randomized controlled trial
J. Pediatr. 201: 202-207 (2018)

F.P. Fernandes, A.C. Fortes, S.G. Fonseca, J. Breitkreutz, H.G. Ferraz
Manufacture and characterization of mucoadhesive buccal films based on pectin and gellan gum containing triamcinolone acetonide
Int. J. Polym. Sci., Article ID 2403802 (2018)

Y. Thabet, D. Lunter, J. Breitkreutz
Continuous ink-jet printing of enalapril maleate onto orodispersible film formulations
Int. J. Pharm. 546: 180-187 (2018)

Y. Thabet, D. Lunter, J. Breitkreutz
Continuous manufacturing and analytical characterization of fixed-dose, multilayer orodispersible films
Eur. J. Pharm. Sci. 117: 236–244 (2018)

Y. Thabet, J. Walsh, J. Breitkreutz
Flexible and precise dosing of enalapril maleate for all paediatric age groups utilizing orodispersible minitablets
Int. J. Pharm. 541: 136-142 (2018)

Y. Thabet, M. Slavkova, J. Breitkreutz
10 years EU regulation of paediatric medicines – Impact on cardiovascular drug formulations
Exp. Opin. Drug Deliv. 15: 261-270 (2018)

G.F. Petrovick, P. Kleinebudde, J. Breitkreutz
Orodispersible tablets containing taste-masked solid lipid pellets with metformin hydrochloride: Influence of process parameters on tablet properties
Eur. J. Pharm. Biopharm. 122: 137-145 (2018)

M. Münster, C. Schoch, C. Schmidt, J. Breitkreutz
Multiparticulate system combining taste masking and immediate release properties for the aversive compound praziquantel
Eur. J. Pharm. Sci. 109: 446-454 (2017)

S. Lindert, J. Breitkreutz
Oromucosal multilayer films for tailor-made, controlled drug delivery
Expert Opin. Drug Deliv. 14: 1265-1279 (2017)

M. Münster, A.H.A. Mohamed-Ahmed, L.I. Immohr, C. Schoch, C. Schmidt, C. Tuleu, J. Breitkreutz
Comparative in vitro and in vivo taste assessment of liquid praziquantel formulations
Int. J. Pharm. 529: 310-318 (2017)

M. Preis, J. Breitkreutz
Pediatric Drug Development and Dosage Form Design
AAPS PharmSciTech 18: 239-240 (2017)

V. Klingmann, Y. Thabet, J. Breitkreutz
Arzneiformen für Kinder
Pharmakon 4: 134-140 (2016)

L.H.E. Leithold, N. Jiang, J. Post, N. Niemietz, E. Schartmann, T. Ziehm, J. Kutzsche, N. J. Shah; J. Breitkreutz; K.J. Langen, A. Willuweit, D. Willbold
Pharmacokinetic properties of tandem D-peptides designed for treatment of Alzheimer's disease
Eur. J. Pharm. Sci. 89: 31-38 (2016)

G.F. Petrovick, J. Breitkreutz, M. Pein
Taste-masking properties of solid lipid based micropellets obtained by cold extrusion-spheronization
Int. J. Pharm. 506: 361-370 (2016)

E.J. Laukamp, K. Knop, M. Thommes, J. Breitkreutz
Micropellet-loaded rods with dose-independent sustained release properties for individual dosing via the Solid Dosage Pen
Int. J. Pharm. 499: 271-279 (2016)

R. Krampe, D. Sieber, M. Pein, J. Breitkreutz
A new biorelevant dissolution method for orodispersible films
Eur. J. Pharm. Biopharm. 98: 20-25 (2016)

V. Klingmann, A. Seitz, T. Meissner, J. Breitkreutz, A. Moeltner, H.M. Bosse
Acceptability of uncoated minitablets in neonates – a randomized controlled trial
J. Pediatr. 167: 893-896 (2015)

M. Preis, J. Breitkreutz, N. Sandler
Perspective: Concepts of printing technologies for oral film formulations
Int. J. Pharm. 494: 578-84 (2015)

N. Jiang, L.H.E. Leithold, J. Post, T. Ziehm, J. Mauler, K.-J. Langen, J. Breitkreutz, D. Willbold, A. Willuweit
Preclinical pharmacokinetic studies of the tritium labelled D-enantiomeric peptide D3 developed for the treatment of Alzheimer´s disease
PLoS One 10(6): e0128553 (2015)

J. Walsh, M.C. Math, J. Breitkreutz, T. Zerback, H. Wachtel
Devices for oral and respiratory paediatric medicines: What do healthcare professionals think?
Int. J. Pharm. 492: 304-315 (2015)

M. Preis, L. Grother, P. Axe, J. Breitkreutz
In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates
Int. J. Pharm. 491: 8-16 (2015)

M. Slavkova, J. Breitkreutz
Orodispersible drug formulations for children and elderly
Eur. J. Pharm. Sci. 75: 2-9 (2015)

M. Guhmann, M. Preis, F. Gerber. N. Pöllinger, J. Breitkreutz, W. Weitschies
„Design, development and in vitro evaluation of diclofenac taste-masked orodispersible tablet formulations”
Drug Dev. Ind. Pharm. 41: 540-551 (2015)

J.C. Visser, W.M.C. Dohmen, W.L.J. Hinrichs, J. Breitkreutz, H.W. Frijlink, H.J. Woerdenbag
Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films?
Int. J. Pharm. 485: 70-76 (2015)

G. Petrovick, M. Pein, M. Thommes, J. Breitkreutz
Spheronization of solid small lipid extrudates: an innovative approach in process control
Eur. J. Pharm. Biopharm. 92: 15-21 (2015)

B. Coulibaly, M. Pritsch, M. Bountogo, P.E. Meissner, E. Nebié, C. Klose, M. Kieser, N. Berens-Riha, A. Wieser, S.B. Sirima, J. Breitkreutz, R.H. Schirmer, A. Sié, F.P. Mockenhaupt, C. Drakeley, T. Bousema, O. Müller
Efficacy and safety of triple combination therapy with artesunate-amodiaquine- methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso
J. Infect. Dis. 211: 689-697 (2015)

E M. Laukamp, A.K. Vynckier, J. Voorspels, M. Thommes, J. Breitkreutz
Development of sustained and dual drug release co-extrusion formulations for individual dosing
Eur. J. Pharm. Biopharm. 89: 357-364 (2015)

J.C. Visser, H.J. Woerdenbag, S. Crediet, E. Gerrits, M.A. Lesschen, W.L.J. Hinrichs, J. Breitkreutz, H.W. Frijlink
Orodispersible films in individualized pharmacotherapy: the development of a formulation for pharmacy preparations
Int. J. Pharm. 478: 155-163 (2015)

C. Eckert, M. Pein, J. Breitkreutz
Lean production of taste masked lipidic sodium benzoate formulations
Eur. J. Pharm. Biopharm. 88: 455-461 (2014)

Pein, M., Preis, M., Eckert, C., Kiene, F. E.
Taste-masking assessment of solid oral dosage forms–A critical review
Int. J. Pharm., 2014; 465, 1-2, 239-254

E M. Laukamp, M. Thommes, J. Breitkreutz
Hot-Melt Extruded Drug-Loaded Rods: Evaluation of the Mechanical Properties for Individual Dosing via the Solid Dosage Pen
Int. J. Pharm. 275: 344-350 (2014)

M. Preis, D. Gronkowsky, D. Grytzan, J. Breitkreutz
Comparative study on novel test systems to determine disintegration time of orodispersible films
J. Pharm. Pharmacol. 66: 1102-1111 (2014)

M. Preis, O. Häusler, J. Breitkreutz
Electronic tongues in preformulation studies - Application of electronic tongues in preformulations studies to evaluate taste-masking capacities of maltodextrins
Pharm. Ind. 76: 957-962 (2014)

J. Walsh, A. Cram, C. Tuleu, G. Winzenburg, R. Turner, K. Woertz, J. Breitkreutz
Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients
Adv. Drug Deliv. Rev. 73: 14-33 (2014)

M. Preis, C. Woertz, K. Schneider. J. Kukawka, J. Breitkreutz
Bilayer oromucosal film preparations for local administration of lidocaine hydrochloride
Eur. J. Pharm. Biopharm. 86: 552-561 (2014)

S. Lindert, A. Below, J. Breitkreutz
Performance of dry powder inhalers with single dosed capsules in preschool children and adults using improved upper airway models
Pharmaceutics 6: 36-51 (2014)

M. Preis, C. Eckert, O. Häusler, J. Breitkreutz
A comparative study on solubilizing and taste-masking capacities of hydroxypropyl-ß-cyclodextrin and maltodextrins with high amylose content
Sensors & Actuators B 193: 442-450 (2014)

M. Preis, K. Knop, J. Breitkreutz
Mechanical strength test for orodispersible and buccal films
Int. J. Pharm. 461: 22-29 (2014)

N. Genina, E.M. Janßen, A. Breitenbach, J. Breitkreutz, N. Sandler
Evaluation of different substrates for inkjet-printing of rasagiline mesylate substrates
Eur. J. Pharm. Biopharm. 85: 1075-1083 (2013)

C. Woertz, M. Preis, J. Breitkreutz, P. Kleinebudde
Assessment of test methods evaluating mucoadhesive polymers and dosage forms: an overview
Eur. J. Pharm. Biopharm. 85: 843-853 (2013)

V. Klingmann, N. Spomer, C. Lerch, I. Stoltenberg, C. Frömke, H.M. Bosse, J. Breitkreutz, T. Meissner
Favourable acceptance of mini-tablets compared with syrup: a randomised controlled trial in infants and preschool children
J. Pediatr. 163:1728-1732 (2013)

A. Zajicek, M.J. Fossler, J.S. Barrett, J.H. Worthington, R. Ternik, G. Charkoftaki, S. Lum, J. Breitkreutz, M. Baltezor, P. Macheras, M. Khan, S. Agharkar, D.D. MacLaren
A report from the Pediatric Formulations Task Force: Perspectives on the state of child-friendly oral dosage forms
AAPS J. 15: 1072-1081 (2013)

M. Haupt, M. Thommes, A. Heidenreich, J. Breitkreutz
Lipid-based intravesical drug delivery systems with controlled release of trospium chloride for the urinary bladder
J. Control. Rel. 170: 161-166 (2013)

M. Preis, C. Wörtz, P. Kleinebudde, J. Breitkreutz
Characterization of oromucosal film preparations
Exp. Opin. Drug Deliv. 10: 1303-1317 (2013)

M. Pein, C. Eckert, M. Preis, J. Breitkreutz
New protocol for Astree electronic tongue enabling full performance qualification according to ICH Q2 using caffeine citrate as model substance
J. Pharm. Biomed. Anal. 83: 157-163 (2013)

C. Eckert, M. Pein, J. Reimann, J. Breitkreutz
Taste evaluation of multicomponent mixtures using a human taste panel, electronic taste sensing systems and HPLC
Sensors and Actuators B 182: 294-299 (2013)

A. Below, D. Bickmann, J. Breitkreutz
Assessing the performance of two dry powder inhalers in preschool children using an idealized upper airway model
Int. J. Pharm. 444: 169-174 (2013)

Tuleu C., Breitkreutz J.
Educational paper: Formulation related issues in paediatric clinical pharmacology
Eur. J. Pediatr. 172, 717-720 (2013)

Below A., Bickmann D., Breitkreutz J.
Assessing the performance of two dry powder inhalers in preschool children using an idealized upper airway model
Int. J. Pharm. 444, 169-174 (2013)

Janßen E.M., Schliephacke R., Breitenbach A., Breitkreutz J.
Drug-printing by Flexography – a new manufacturing process for orodispersible films
Int. J. Pharm. 441, 818-825 (2013)

Guffon N., Kibleur Y., Coppalu W., Tissen C., Breitkreutz J.
Studies of a new formulation of sodium phenylbutyrate
Arch. Dis. Child. 97, 1081-1085 (2012)

Wening K., Laukamp E.J., Thommes M., Breitkreutz J.
Individual oral therapy with immediate release and effervescent formulations delivered by the Solid Dosage Pen
J. Pers. Med. 2, 217-231 (2012)

Preis M., Pein M., Breitkreutz J.
Development of a taste-masked orodispersible film containing dimenhydrinate
Pharmaceutics 4

Ernest T., Craig J., Nunn A., Salunke S., Tuleu C., Breitkreutz J., Alex R., Hempenstall J.
Preparation of medicines for children – a hierachy of classification
Int. J. Pharm. 435: 124-130 (2012)

Stegemann S., Gogol M., Breitkreutz J.
Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy
Int. J. Pharm. 430, 197-206 (2012)

Spomer N., Klingmann V., Stoltenberg I., Lerch C., Meissner T., Breitkreutz
Acceptance of uncoated mini-tablets in young children – Results from a prospective exploratory cross-over study
Arch. Dis. Child. 97, 283-286 (2012)

Woertz K., Tissen C., Kleinebudde P., Breitkreutz J.
Development of a taste masked generic ibuprofen suspension - Top down approach guided by electronic tongue measurements.
J. Pharm. Sci. 100, 4460-4470 (2011)

Tissen C., Woertz K., Breitkreutz J., Kleinebudde P.
Development of mini-tablets with 1 mm and 2 mm diameter.
Int. J. Pharm. 416, 164-170 (2011)

Stoltenberg I., Breitkreutz J.
Orally disintegrating mini-tablets (ODMTs) - A novel solid dosage form for paediatric use.
Eur. J. Pharm. Biopharm. 78, 462-469 (2011)

Walsh J., Bickmann D., Breitkreutz J., Chariot-Goulet M.
Delivery devices for the administration of paediatric formulations: Overview of current practice, challenges and recent developments.
Int. J. Pharm. 415, 221-231 (2011)

Wening K., Breitkreutz J.
Oral drug delivery in personalized medicine: Unmet needs and novel approaches.
Int. J. Pharm. 404, 1-9 (2011)

Stegemann S., Ecker F., Maio M., Kraahs P., Breitkreutz J., Zimmer A., Bar-Shalom D., Hettrich P.
Geriatric drug therapy: neglecting the inevitable majority.
Ageing Res. Rev. 9, 384-398 (2010)

Hermes M., Barnscheid L., Garsuch V., Schoettler P., Breitkreutz J.
Arzneimittelversorgung von Kindern - Ergebnisse einer Studie zur praktischen Auswirkung der EU-Verordnung 1901/2006 'Better Medicines for Children' seit dem Inkrafttreten im Januar 2007.
Pharm. Ind. 72, 1334-1344 (2010)

Stoltenberg I., Winzenburg G., Breitkreutz J.
Solid oral dosage forms for children - formulations, excipients and acceptance issues.
J. Appl. Ther. Res. 7, 141-146 (2010)

Woertz K., Tissen C., Kleinebudde P., Breitkreutz J.
Rational development of taste masked oral liquids guided by an electronic tongue.
Int. J. Pharm. 400, 114-123 (2010)

Wening K., Breitkreutz J.
Novel delivery device for monolithical solid oral dosage forms for personalized medicine.
Int. J. Pharm. 395, 174-181 (2010)