Focus Group "Extrusion / Coating"

Leader:

Members:

  • Rebecca Chamberlain
  • Anja Göbel
  • Lena Hoffmann
  • Olga Kiefer
  • Stefan Klinken
  • Hanna Ponsar
  • Hellen Windolf

Recent topics:

  • Improvement of oral bioavailability by hot melt extrusion
  • Taste masking by solid lipid extrusion
  • Formation of novel dosage forms by extrusion techniques
  • Preparation of filaments via extrusion
  • Coating on tablets, PAT with Raman spectroscopy
  • Solvent film casting of orodispersible dosage forms

Publications:

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)

I. Speer, M. Preis, J. Breitkreutz
Dissolution testing of oral film preparations: experimental comparison of compendial and non-compendial methods
Int. J. Pharm. 561: 124-134 (2019)

I. Speer, M. Preis, J. Breitkreutz
Novel dissolution method for oral film preparations with modified release properties
AAPS Pharm Sci. Tech. 20(1): 7 (2019)

I. Speer, D. Steiner, Y. Thabet, J. Breitkreutz, A. Kwade
Comparative study on disintegration methods for oral film preparations
Eur. J. Pharm. Biopharm. 132: 50-61 (2018)

Y. Thabet, R. Sibanc, J. Breitkreutz
Printing pharmaceuticals by inkjet technology: Proof of concept for stand-alone and continuous in-line printing on orodispersible films
J. Manuf. Process. 35: 205-2015 (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)

I. Speer, M. Preis, J. Breitkreutz
Prolonged drug release properties for orodispersible films by combining hot-melt extrusion and solvent casting methods
Eur. J. Pharm. Biopharm. 129: 66-73 (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)

Barimani S., Sibanc R., Kleinebudde P.
Optimization of a semi-batch tablet coating process for a continuous manufacturing line by design of experiments.
Int. J. Pharm. 539, 95-103 (2018)

Barimani S., Kleinebudde P.
Monitoring of tablet coating processes with colored coatings.
Talanta 178, 686-697 (2018)

Y. Thabet, J. Breitkreutz
Orodispersible films: Product transfer from lab-scale to continuous manufacturing
Int. J. Pharm. 535: 285-292 (2018)

I. Speer, M. Preis, J. Breitkreutz
Prolonged drug release properties for orodispersible films by combining hot-melt extrusion and solvent casting methods
Eur. J. Pharm. Biopharm. 129: 66-73 (2018)

G.F. Petrovick, J. Breitkreutz
Spheronization of solid lipid extrudates: Elucidation of spheroid formation mechanism
Eur. J. Pharm. Biopharm. 125: 148-158 (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)

E. Lenz, K. Löbmann, T. Rades, K. Knop and P. Kleinebudde
Hot melt extrusion and spray drying of co-amorphous indomethacin-arginine with polymers.
J. Pharm. Sci. 106 (2017) 302-312.

D. Hegyesi, M. Thommes, P. Kleinebudde, T. Sovány, P. Kása Jr., A. Kelemen, K. Pintye-Hódi and G. Regdon Jr.
Preparation and physicochemical characterization of matrix pellets containing APIs with different solubility via extrusion process.
Drug Dev. Ind. Pharm. 43 (2017) 458-464.

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

Hisazumi J., Kleinebudde P.
In-line monitoring of multi-layered pellet film-coating using Raman spectroscopy by MCR and PLS analyses.
Eur. J. Pharm. Biopharm. 114, 194-201 (2017)

Boehling P., Toschkoff G., Dreu R., Just S., Kleinebudde P., Funke A., Rehbaum H., Khinast J.G.
Comparison of video analysis and simulations of a drum coating process.
Eur. J. Pharm. Sci. 104, 72-81 (2017)

Boehling P., Toschkoff G., Just S., Knop K., Kleinebudde P., Funke A., Altmeyer A., Djuric D., Khinast J.G.
Analysis of large-scale tablet coating: Modeling, simulation and experiments.
Eur. J. Pharm. Sci. 90, 14-24 (2016)

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

Dreu R., Toschkoff G., Funke A., Altmeyer A., Knop K., Khinast J.G., Kleinebudde P.
Evaluation of the tablets’ surface flow velocities in pan coaters.
Eur. J. Pharm. Biopharm. 106, 97-106 (2016)

Boehling P., Toschkoff G., Just S., Knop K., Kleinebudde P., Funke A., Rehbaum H., Rajniak P. , Khinast, J.G.
Simulation of a tablet coating process at different scales using DEM.
Eur. J. Pharm. Sci. 93, 74-83 (2016)

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

Folttmann F., Knop K., Kleinebudde P., Pein M.
In-line spatial filtering velocimetry for particle size and film thickness determination in fluidized-bed pellet coating processes
Eur. J. Pharm. Biopharm. 88, 931-938 (2014)

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

Knop K., Kleinebudde P.
PAT-tools for process control in pharmaceuticl film coating applications
Int. J. Pharm. 457, 527-536 (2013)

Preis M., Woertz C., Kleinebudde P., Breitkreutz J.
Oromucosal film preparations: Classification and characterization methods
Expert Opinion on Drug Delivery 10, 1303-1317 (2013)

Brock D., Zeitler J.A., Funke A., Knop K., Kleinebudde P.
Evaluation of critical process parameters for intra-tablet coating uniformity using terahertz pulsed imaging
Eur. J. Pharm. Biopharm. 85, 1122-1129 (2013)

Just S., Toschkoff G., Funke A., Djuric D., Scharrer G., Khinast J., Knop K., Kleinebudde P.
Optimization of the inter-tablet coating uniformity for an active coating process at lab and pilot scale
Int. J. Pharm. 457, 1-8 (2013)

Brock D., Zeitler J.A., Funke A., Knop K., Kleinebudde P.
Critical factors in the measurement of tablet film coatings using terahertz pulsed imaging
J. Pharm. Sci. 102, 1813-1824 (2013)

Just S., Toschkoff G., Funke A., Djuric D., Scharrer G., Khinast J., Knop K., Kleinebudde P.
Experimental analysis of tablet properties for discrete element modeling of an active coating process
AAPS PharmSciTech. 14, 402-411 (2013)

Wirges M., Funke A., Serno P., Knop K., Kleinebudde P.
Development and in-line validation of a Process Analytical Technology to facilitate the scale up of coating processes
J. Pharm. Biomed. Anal. 78-79, 57-64 (2013)

Wirges M., Funke A., Serno P., Knop K., Kleinebudde P.
Monitoring of an active coating process for two-layer tablets-model development strategies
J. Pharm. Sci. 102, 556-564 (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)

Wirges, M., Pein M., Knop K., Kleinebudde P., Boeggering A., Funke A., Serno P.;
Raman vs. NIR - Echtzeit-Überwachung von Prozessen zum Wirkstoffüberzug auf Tabletten in der pharmazeutischen Industrie,
TechnoPharm 3, 98-10 (2013)

C. Mühlenfeld, B. Kann, M. Windbergs and M. Thommes
Solid Dispersions Prepared by Continuous Cogrinding in an Air Jet Mill
Journal of Pharmaceutical Sciences, 2013. 102(11): p. 4132–4139.

C. Krüger, M. Thommes and P. Kleinebudde
Influence of MCC II Fraction and Storage Conditions on Pellet Properties
European Journal of Pharmaceutics and Biopharmaceutics, 2013. 85(3B): p. 1039-1045.

M. Haupt, M. Thommes, A. Heidenreich and J. Breitkreutz
Lipid-based Intravesical Drug Delivery Systems with Controlled Release of Trospium Chloride for the Urinary Bladder
Journal of Controlled Release, 2013. 170(2): p. 161-166.

E. Reitz, H. Podhaisky, D. Ely, M. Thommes
Residence Time Modeling of Hot Melt Extrusion Processes
Journal of Pharmaceutics and Biopharmaceutics, 2013. 85(3B): p. 1200-1205.

S. Just, F. Sivert, M. Thommes and J. Breitkreutz
Improved Group Contribution Parameter Set for the Application of Solubility Parameters to Melt Extrusion
European Journal of Pharmaceutics and Biopharmaceutics, 2013. 85(2): p. 1191-1199.

T. Sakai, M. Thommes
Investigation into Mixing Capability and Solid Dispersion Preparation using the DSM Xplore Pharma Micro Extruder.
Journal of Pharmacy and Pharmacology, 2013. 66(2) p. 218-231.

M. Guhmann, M. Thommes, F. Gerber, N. Pöllinger, S. Klein, J. Breitkreutz and W. Weitschies
Design of Biorelevant Test Setups for the Prediction of Diclofenac in vivo Features after Oral Administration
Pharmaceutical Research 2013. 30(6): p. 1483-1501.

M. Köster and M. Thommes
Analysis of Particle Kinematics in Spheronisation via Particle Image Velocimetry
European Journal of Pharmaceutics and Biopharmaceutics, 2013. 83 (2): p. 307-314.

C. Krüger and M. Thommes
Multiple Batch Manufacturing of Theophylline Pellets using the Wet-Extrusion/Spheronisation Process with kappa-Carrageenan as Pelletisation Aid
Pharmaceutical Development and Technology, 2013. 18(1): p. 225-235.

E. Reitz, C. Vervaet, R.H.H. Neubert and M. Thommes
Grinding in Hot Melt Extrusion – Manufacturing of Solid Crystal Suspensions
European Journal of Pharmaceutics and Biopharmaceutics, 2013. 83 (2): p. 193-202.

C. Krüger, M. Thommes and P. Kleinebudde
Spheronisation Mechanism of MCC II-based pellets.
Powder Technology 2013. 238: p. 176-187.

Russe I.S., Brock D., Knop K., Kleinebudde P., Zeitler J.A.
Validation of terahertz coating thickness measurements using X-ray microtomographyg.
Mol. Pharmaceutics 9, 3551-3559 (2012)

Preis M., Pein M., Breitkreutz J.
Development of a taste-masked orodispersible film containing dimenhydinate
Pharmaceutics 4, 551-562 (2012)

Brock D., Zeitler J.A., Funke A., Knop K., Kleinebudde P.
A comparison of quality control methods for active coating processes.
Int. J. Pharm. 439, 289-295 (2012)

Suhrenbrock L., Radtke G., Knop K., Kleinebudde P.
Pellet layering: scale-up considerations using different kinds of processing equipments.
Drug Dev. Ind. Pharm. 38, 1494-1503 (2012)

Müller J., Brock D., Knop K. Zeitler J.A., Kleinebudde P.
Prediction of dissolution time and coating thickness of sustained release formulations using Raman spectroscopy and terahertz pulsed imaging.
Eur. J. Pharm. Biopharm. 80, 690-697 (2012)

Wirges M., Müller J., Kása Jr. P., Regdon Jr. G., Pintye-Hódi K., Knop K., Kleinebudde P.
From mini to micro scale - Feasibility of Raman spectroscopy as a process analytical tool (PAT). 
Pharmaceutics 3, 723-730 (2011)

Suhrenbrock L., Radtke G., Knop K., Kleinebudde P.
Suspension pellet layering using PVA-PEG graft copolymer as a new binder.
Int. J. Pharm. 412, 28-36 (2011)

Hoffmann E.M., Breitenbach A., Breitkreutz J.
Advances in orodispersible films for drug delivery.
Exp. Opin. Drug Deliv. 8, 299-316 (2011)

Zhong S., Shen Y.-C., Ho L., May R., Zeitler J.A., Evans M., Taday P.T., Pepper M., Rades T., Gordon K.C., Müller R., Kleinebudde P.
Non-destructive quantification of pharmaceutical tablet coatings using terahertz pulsed imaging and optical coherence tomography.
Opt. Laser Eng. 49, 361-365 (2011)

S. Güres, J. Siepmann, F. Siepmann & P. Kleinebudde
Modeling dissolution from solid lipid extrudates containing hydrophilic components.
Eur. J. Pharm. Biopharm. 80 (2012) 122-129.

R. Witzleb, V.-R. Kanikanti, H.-J. Hamann & P. Kleinebudde
Influence of drug particle shape on the solid lipid extrusion process.
Powder Technol. 207 (2011) 407-413.

S. Güres & P. Kleinebudde
Dissolution from solid lipid extrudates containing release modifiers.
Int. J. Pharm. 412 (2011) 77-84.

D. Ghanam & P. Kleinebudde
Suitability of a flat die press for the manufacture of pharmaceutical pellets by extrusion/ spheronization.
Drug Dev. Ind. Pharm. 37 (2011) 456-464.

R. Witzleb, V.-R. Kanikanti, H.-J. Hamann & P. Kleinebudde
Influence of drug particle shape on the solid lipid extrusion process.
Powder Technol. 207 (2011) 407-413.

R. Witzleb, V.-R. Kanikanti, H.-J. Hamann & P. Kleinebudde
Solid lipid extrusion with small die diameters - Electrostatic charging, taste masking and continuous production.
Eur. J. Pharm. Biopharm. 77 (2011) 170-177.

H. Yano & P. Kleinebudde
Improvement of dissolution behavior for poorly water-soluble drug by application of cyclodextrin in extrusion process: Comparison between melt extrusion and wet extrusion.
AAPS PharmSciTech 11 (2010) 885-893.

Thommes M., Ely D. R., Carvajal M. T. und Pinal R.;
Improvement of the Dissolution Rate of Poorly Soluble Drugs by Solid Crystal Suspensions;
Molecular Pharmaceutics; 2011; 8; 721-735.

M. Windbergs, S. Gueres, C.J. Strachan & P. Kleinebudde
Two-step solid lipid extrusion as a process to modify dissolution behaviour.
AAPS PharmSciTech 11 (2010) 2-8.

M. Windbergs, M. Haaser, C. McGoverin, K. Gordon, P. Kleinebudde & C.J. Strachan
Investigating the relationship between drug distribution in solid lipid matrices and dissolution behaviour using raman spectroscopy and mapping.
J. Pharm. Sci. 99 (2010) 1464-1475.

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

Köster M. und Thommes M.; 
New Insights into the Pelletization Mechanism by Extrusion/Spheronization; 
AAPS PharmSciTech; 2010; 11.

Köster M. und Thommes M.; 
Inline Dynamic Torque Measurement in Twin Screw Extrusion Process; 
Chemical Engineering Journal; 2010; 164; 371-375.

Krüger C., Thommes M. und Kleinebudde P.; 
MCC SANAQ burst - A New Type of Cellulose and its Suitability to Prepare Fast Disintegrating Pellets; 
Journal of Pharmaceutical Innovation; 2010; 5; 45-57.

Mendyk A., Kleinebudde P., Thommes M., Yoo A., Szlek J. und Jachowicz R.; 
Analysis of pellet properties with use of artificial neural networks; 
European Journal of Pharmaceutical Sciences; 2010; 41; 421-429.

Thommes M., Baert L. und Rosier J.; 
800 mg Darunavir Tablets Prepared by Hot Melt Extrusion; 
Pharmaceutical Development and Technology; 2010; posted online on 23 Aug. 2010; 1-6.

Kristó K., Bajdik J., Kleinebudde P., Pintye-Hódi K.
Effect of lubricant on spreading of coating liquid on surface of tablets containing pancreatin.
Pharm. Dev. Technol. 15, 354-359 (2010)

Ho L., Müller R., Krüger C., Gordon K.C., Kleinebudde P., Pepper M., Rades T., Shen Y.C., Taday P.F., Zeitler J.A.
Investigating dissolution performance critical areas on coated tablets: A case study using terahertz pulsed imaging.
J. Pharm. Sci. 99, 392-402 (2010)

Müller J., Knop K., Wirges M., Kleinebudde P.
Validation of Raman spectroscopic procedures in agreement with ICH guideline Q2 with considering the transfer to real time monitoring of an active coating.
J. Pharm. Biomed. Anal. 53, 884-894 (2010)

Baki G., Bajdik J., Djuric D., Knop K., Kleinebudde P., Pintye-Hódi K.
Role of surface free energy and spreading coefficient in the formulation of active agent-layered pellets.
Eur. J. Pharm. Biopharm. 74, 324-331 (2010)

Müller J., Knop K., Thies J., Uerpmann, C., Kleinebudde P.
Feasibility of Raman spectroscopy as PAT tool in active coating.
Drug Dev. Ind. Pharm. 36, 234-243 (2010)

Garsuch V., Breitkreutz J.
Comparative investigations on different polymers for the manufacturing of fast-dissolving oral films.
J. Pharm. Pharmacol. 62, 539-545 (2010)

Theses:

Isabell Speer (2019)
Development and characterization of oral film preparations for controlled drug delivery

Svenja Niese (2019)
Development of a dosing system for individualized therapy with oral films

Shirin Barimani  (2018)
Integration eines Coaters mit in-line Raman Spektroskopie in eine kontinuierliche Tablettenproduktion

Yasmin Thabet (2018)
Novel technologies enabling flexible drug dosing of enalapril maleate and hydrochlorothiazide for paediatric use

Lindert, S.  (2016)
Entwicklung und Charakteriserung filmförmiger Zubereitungen zur oromukosalen Anwendung von Peptiden

Folttmann F.  (2015)
Filmdickenbestimmung mittels in-line-Raman-Spektroskopie während der Pelletbeschichtung

Krampe R.  (2015)
Orodispersible Filme mit schwerlöslichem, hochdosiertem Arzneistofff: Herstellungstechniken und biorelevante Beurteilung

Just S.   (2013)
Optimierung der Gleichförmigkeit des Wirkstoffüberzuges von OROS-Tabletten

Brock D.   (2013)
Terahertz Pulsed Imaging for Quality by Design Driven Development of Active-Coated OROS Tablets

Wirges M.  (2012)
Wirkstoffüberzug von OROS-Tabletten - In-line Prozessüberwachung mittels Raman Spektroskopie und ihr Transfer vom Labor- zum Produktionsmaßstab 

Hoffmann E.   (2012)
Flexible Arzneistoffbeladung orodispersibler FIlme durch Bedrucken 

Suhrenbrock L.  (2011)
Effizienz und Geschwindigkeit von Prozessen zur Wirkstoffbeschichtung von Pellets - ein Technologievergleich

Contact:

send email

Verantwortlich für den Inhalt: E-Mail sendenDr. K. Knop