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Publikationen des Arbeitskreises Kleinebudde

C. Köster & P. Kleinebudde.
Evaluation of binders in twin-screw granulation – Optimization of tabletability. 
Int. J. Pharm.
659 (2024) 124290.
https://doi.o/10.1016/j.ijpharm.2024.124290

M. Leane, K. Pitt, G. Reynolds, S. Andersen, J. Bartsch, B. Carlin, A. Crean, J. Gamble, M. Gamlen, B. Gururajan, Y. Khimyak, P. Kleinebudde, S. Koynov, M. Kuentz, Z. Misic, C. Moreton, S. Peter, S. Sheehan, E. Stone, H. Suzuki, A. Tantuccio & B. Van Snick.
Ten Years of the Manufacturing Classification System: A review of literature applications and an extension of the framework to continuous manufacture.
Pharm. Dev. Technol.
29 (2024) 395-414.
https://doi.org/10.1080/10837450.2024.2342953

C. Köster & P. Kleinebudde
Evaluation of binders in twin-screw granulation – Optimal combination of binder and disintegrant.
Eur. J. Pharm. Biopharm. 186 (2023) 55-64. https://doi.org/10.1016/j.ejpb.2023.03.003

H.D. Grumann, S. Klinken & P. Kleinebudde
Evaluation of in-die compression data for a deeper understanding of altered excipient properties upon temperature rise.
AAPS PharmSciTech 24 (2023) 89. https://doi.org/10.1208/s12249-023-02554-3

S. Berkenkemper, S. Klinken & P. Kleinebudde
Multivariate data analysis to evaluate commonly used compression descriptors.
Int. J. Pharm. 637 (2023) 122890. https://doi.org/10.1016/j.ijpharm.2023.122890

S. Berkenkemper, S. Klinken & P. Kleinebudde
Investigating compressibility descriptors for binary mixtures of different deformation behavior.
Powder Technol. 424 (2023) 118571. https://doi.org/10.1016/j.powtec.2023.118571

K. Kiricenko & P. Kleinebudde
Drying behavior inside a continuous vibrated fluidized bed dryer.
Pharm. Dev. Technol. 28 (2023) 440-451. https://doi.org/10.1080/10837450.2023.2205932

M. Franke, T. Riedel, R. Meier, C. Schmidt & P. Kleinebudde
Comparison of scale-up strategies for twin-screw granulation.
Int. J. Pharm. 641 (2023) 123052. https://doi.org/10.1016/j.ijpharm.2023.123052

P. Bawuah, M. Evans, A. Lura, D. Farrell, P.J. Barrie, P. Kleinebudde, D. Markl & J.A. Zeitler
At-line porosity sensing for non-destructive disintegration testing in immediate release tablets.
Int. J. Pharm. X 5 (2023) 100186. https://doi.org/10.1016/j.ijpx.2023.100186

M. Jelsch, Y. Roggo, M. Brewer, P. Heger, Z.-A. Geczi, P. Kleinebudde & M. Krumme
MPC development on a pharmaceutical continuous wet granulation line: from solid feeders to dryer.
Powder Technol. 429 (2023) 118936. https://doi.org/10.1016/j.powtec.2023.118936

H.D. Grumann & P. Kleinebudde
Investigating the heat sensitivity of frequently used excipients with varying particle sizes.
Eur. J. Pharm. Biopharm. 192 (2023) 1-12. https://doi.org/10.1016/j.ejpb.2023.09.010

H.D. Grumann & P. Kleinebudde
Effect of tableting temperature on tablet properties and dissolution behavior of heat sensitive formulations.
Int. J. Pharm. 648 (2023) 123602. https://doi.org/10.1016/j.ijpharm.2023.123603

M. Franke, T. Riedel, R. Meier, C. Schmidt & P. Kleinebudde
Scale-up in twin-screw wet granulation: Impact of formulation properties.
Pharm. Dev. Technol. 28 (2023) 948-961. https://doi.org/10.1080/10837450.2023.2276791

K. Kiricenko, F. Hartmann, A. Altmeyer & P. Kleinebudde
Loss-on-drying prediction for a vibrated fluidized bed dryer by means of mass and energy balances.
J. Pharm. Innov. 18 (2023) 2429-2446. https://doi.org/10.1007/s12247-023-09802-w

F.N. Santamaria Alvarez, P. Kleinebudde & J. Thies
Influence of refilling on dosing accuracy of loss-in-weight powder feeders in continuous manufacturing.
Powder Technol. 436 (2024) 119501.  https://doi.org/10.1016/j.powtec.2024.119501

M. Lück, S. Klinken & P. Kleinebudde
Laser triangulation based in-line elastic recovery measurement for the determination of ribbon solid fraction in roll compaction.
J. Pharm. Sci. 113 (2024) 1020-1028. https://doi.org/10.1016/j.xphs.2023.10.013

S. Berkenkemper & P. Kleinebudde
Evaluation of alternative methods to derive particle density from compression data.
Int. J. Pharm. 632 (2023) 122582. https://doi.org/10.1016/j.ijpharm.2023.122582

S. Barimani, R. Sibanc, D. Tomaževič, R. Meier & P. Kleinebudde
100% visual inspection of tablets produced with continuous direct compression and coating.
Int. J. Pharm. 614 (2022) 121465

P. Kleinebudde
Improving process understanding in roll compaction.
J. Pharm. Sci. 111 (2022) 552-558

S. Bollmann, B. Fischer & P. Kleinebudde
Evaluation of the transferability of an image analysis approach of X-ray micro-computed tomography images for the application with a new validation concept for in silico tools.
J. Drug Del. Sci. Technol. 70 (2022) 103163

J. Hansen & P. Kleinebudde
Increasing the batch size of a QESD crystallization by using a MSMPR crystallizer.
Pharmaceutics 14 (2022) 1227

A. Wilms, R. Meier & P. Kleinebudde
Implementing feedback granule size control in a continuous dry granulation line using controlled impeller speed of the granulation unit, compaction force and gap width.
J. Pharm. Innov. 17 (2022) 449-459

M. Jelsch, Y. Roggo, A. Mohamad, P. Kleinebudde & M. Krumme
Automatic system dynamics characterization of a pharmaceutical continuous production line.
Eur. J. Pharm. Biopharm. 180 (2022) 137-148

H.D. Grumann, S. Klinken & P. Kleinebudde
Influence of temperature on the compression behavior of pharmaceutical excipients.
Int. J. Pharm. 628 (2022) 122305

M. Lück & P. Kleinebudde
Influence of roll speed during roll compaction and its effect on the prediction of ribbon solid fraction.
Pharmaceutics 14 (2022) 2399

J. Hansen & P. Kleinebudde
Towards a better understanding of the role of stabilizers in QESD crystallizations.
Pharm. Res. 39 (2022) 3123-3136

J. Hansen & P. Kleinebudde
Impoving flowability and reducing storage agglomeration of metformin hydrochloride through QESD crystallization.
Eur. J. Pharm. Biopharm. 159 (2021) 170

S. Bollmann & P. Kleinebudde
Evaluation of different pre-processing methods of X-ray micro computed tomography images
Powder Technol. 381 (2021) 539

A.L. Skelbæk-Pedersen, T. Kvistgaard Vilhelmsen, J. Rantanen & P. Kleinebudde
The relevance of granule fragmentation on reduced tabletability of granules from ductile or brittle materials produced by roll compaction/dry granulation.
Int J. Pharm. 592 (2021) 120035

S. Bollmann & P. Kleinebudde
Evaluation of different pre-processing methods of X-ray micro computed tomography images.
Powder Technol. 381 (2021) 539-550

J. Hansen & P. Kleinebudde
Improving flowability and reducing storage agglomeration of metformine hydrochloride through QESD crystallization.
Eur. J. Pharm. Biopharm. 159 (2021) 170-176

C. Köster, S. Pohl & P. Kleinebudde
Evaluation of binders in twin-screw wet granulation.
Pharmaceutics 13 (2021) 241

A. Wilms & P. Kleinebudde
Optimization of residence time distribution in roll compaction/ dry granulation and a critical asessment of its importance in continuous manufacturing.
Particuology 56 (2021) 43-49

A. Wilms, R. Meier & P. Kleinebudde
Development and evaluation of an in-line and on-line monitoring system for granule size distributions in continuous roll compaction/dry granulation based on laser diffraction.
J. Pharm. Innov. 16 (2021) 247-257

J. Hansen & P. Kleinebudde
Enabling the direct compression of metformin hydrochloride through QESD crystallization.
Int. J. Pharm. 605 (2021) 120796

S. Bollmann & P. Kleinebudde
Evaluation of different segmentation methods of X-ray micro computed tomography images.
Int. J. Pharm. 606 (2021) 120880

S. Bollmann & P. Kleinebudde
A new validation methodology for in silico tools based on X-ray computed tomography images of tablets and a performance analysis of one tool.
Pharmaceutics 13 (2021) 1488

J. Radtke, R. Wiedey & P. Kleinebudde
Alternatives to titanium dioxide in tablet coating.
Pharm. Dev. Technol. 26 (2021) 989-999

S. Bollmann & P. Kleinebudde
Predictive selection rule of favourable image processing methods for X-ray micro-computed tomography images of tablets.
Int. J. Pharm. 610 (2021) 121207

 

S. Barimani, R. Sibanc, D. Tomaževič, R. Meier & P. Kleinebudde
100% visual inspection of tablets produced with continuous direct compression and coating.
Int. J. Pharm. 614 (2022) 121465

P. Kleinebudde
Improving process understanding in roll compaction.
J. Pharm. Sci. 111 (2022) 552-558

S. Bollmann, B. Fischer & P. Kleinebudde
Evaluation of the transferability of an image analysis approach of X-ray micro-computed tomography images for the application with a new validation concept for in silico tools.
J. Drug Del. Sci. Technol. 70 (2022) 103163

J. Hansen & P. Kleinebudde
Increasing the batch size of a QESD crystallization by using a MSMPR crystallizer.
Pharmaceutics 14 (2022) 1227

A. Wilms, R. Meier & P. Kleinebudde
Implementing feedback granule size control in a continuous dry granulation line using controlled impeller speed of the granulation unit, compaction force and gap width.
J. Pharm. Innov. 17 (2022) 449-459

M. Jelsch, Y. Roggo, A. Mohamad, P. Kleinebudde & M. Krumme
Automatic system dynamics characterization of a pharmaceutical continuous production line.
Eur. J. Pharm. Biopharm. 180 (2022) 137-148

H.D. Grumann, S. Klinken & P. Kleinebudde
Influence of temperature on the compression behavior of pharmaceutical excipients.
Int. J. Pharm. 628 (2022) 122305

M. Lück & P. Kleinebudde
Influence of roll speed during roll compaction and its effect on the prediction of ribbon solid fraction.
Pharmaceutics 14 (2022) 2399

J. Hansen & P. Kleinebudde
Towards a better understanding of the role of stabilizers in QESD crystallizations.
Pharm. Res. 39 (2022) 3123-3136

A. Wilms, & P. Kleinebudde
Towards better understanding of the influence of process parameters in roll compaction/dry granulation on throughput, ribbon microhardness and granule failure load.
Int. J. Pharm. X (2020) 2, 100059

V. Lenhart, J. Quodbach & P. Kleinebudde
Fibrillated cellulose via high pressure homogenization: Analysis and application for orodispersible films.
AAPS PharmSciTech 21 (2020) 33. https://doi.org/10.1208/s12249-019-1593-7

H.L. Keizer & P. Kleinebudde
Elastic recovery in roll compaction simulation.
Int. J. Pharm. 573 (2020) 118810. https://doi.org/10.1016/j.ijpharm.2019.118810

Y. Roggo, V. Pauli, M. Jelsch, L. Pellegatti, F. Elbaz, S. Ensslin, P. Kleinebudde & M. Krumme
Continuous manufacturing process monitoring of pharmaceutical solid dosage form: a case study.
J. Pharm. Biomed. Anal. 179 (2020) 112971. https://doi.org/10.1016/j.jpba.2019.112971

V. Pauli, P. Kleinebudde & M. Krumme
Predictive model-based process start-up in pharmaceutical continuous granulation and drying.
Pharmaceutics 12 (2020) 67. https://doi.org/10.3390/pharmaceutics12010067

Y. Miyazaki, V. Lenhart & P. Kleinebudde
Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach.
Int. J. Pharm. 579 (2020) 119139. https://doi.org/10.1016/j.ijpharm.2020.119139

V. Lenhart, J. Quodbach & P. Kleinebudde
Mechanistic understanding regarding the functionality of microcrystalline cellulose and powdered cellulose as pelletization aids in wet extrusion/ spheronization.
Cellulose 27 (2020) 2189-2210. https://doi.org/10.1007/s10570-019-02895-y

S. Berkenkemper, A. Szepes & P. Kleinebudde
Functionality of disintegrants with different mechanisms after roll compaction.
Int. J. Pharm. 584 (2020) 119434. https://doi.org/10.1016/j.ijpharm.2020.119434

S. Pohl & P. Kleinebudde
Regime maps for granulation.
Int. J. Pharm. 587 (2020) 119660. https://doi.org/10.1016/j.ijpharm.2020.119660

J. Radtke & P. Kleinebudde
Real-time monitoring of multi-layered film coating processes using Raman spectroscopy.
Eur. J. Pharm. Biopharm. 153 (2020) 43-51. https://doi.org/10.1016/j.ejpb.2020.05.018

V. Pauli, P. Kleinebudde & M. Krumme
From powder to tablets: Investigation of residence time distributions in a continuous manufacturing process train as basis for continuous process verification.
Eur. J. Pharm. Biopharm. 153 (2020) 200-210. https://doi.org/10.1016/j.ejpb.2020.05.030

R.N. Elsergany, V. Lenhart & P. Kleinebudde
Influence of surface tension of wet massing liquid on the functionality of microcrystalline cellulose as pelletization aid.
Eur. J. Pharm. Biopharm. 153 (2020) 285-296. https://doi.org/10.1016/j.ejpb.2020.06.015 

J. Radtke & P. Kleinebudde
Raman-spectroscopy as a PAT-tool for film coating processes: In-line predictions using one PLS model for different cores.
Pharmaceutics 12 (2020) 796. http://dx.doi.org/10.3390/pharmaceutics12090796

V. Pauli, Y. Roggo, L. Pellegatti, N.Q.N. Trung, F. Elbaz, S. Ensslin, P. Kleinebudde & M. Krumme
Process analytical technology for continuous manufacturing tableting processing: A case study.
J. Pharm. Biomed. Anal. 162 (2019) 101-111. https://doi.org/10.1016/j.jpba.2018.09.016

R. Wiedey & P. Kleinebudde
Potentials and limitations of thermography as an in-line tool for determining ribbon solid fraction.
Powder Technol. 341 (2019) 2-10. https://doi.org/10.1016/j.powtec.2018.03.047

S. Grote, H. Osthues, F. Schaeffer & P. Kleinebudde
The influence of isomalt particle morphology on tabletability after roll compaction/ dry granulation.
Powder Technol. 341 (2019) 59-65. https://doi.org/10.1016/j.powtec.2018.01.077

H.L. Reimer & P. Kleinebudde
Hybrid modeling of roll compaction processes with the Styl’One Evolution.
Powder Technol. 341 (2019) 66-74. https://doi.org/10.1016/j.powtec.2018.02.052

P. Toson, D.G. Lopes, R. Paus, A. Kumar, J. Geens, S. Stibale, J. Quodbach, P. Kleinebudde, W.-K. Hsiao & J. Khinast
Model-based approach to the design of pharmaceutical roller-compaction processes.
Int. J. Pharm.: X 1 (2019) 100005. https://doi.org/10.1016/j.ijpx.2019.100005

J. Harting & P. Kleinebudde
Optimisation of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation.
Eur. J. Pharm. Biopharm. 137 (2019) 77-85. https://doi.org/10.1016/j.ejpb.2019.02.015

S. Grote & P. Kleinebudde
A comparative study about the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation.
Pharm. Dev. Technol. 24 (2019) 314-322. https://doi.org/10.1080/10837450.2018.1476977

V. Pauli, F. Elbaz, P. Kleinebudde & M. Krumme
Orthogonal redundant monitoring of a new continuous fluid-bed dryer for pharmaceutical processing by means of mass and energy balance calculations and spectroscopic techniques.
J. Pharm. Sci. 108 (2019) 2041-2055. https://doi.org/10.1016/j.xphs.2018.12.028

V. Pauli, Y. Roggo, P. Kleinebudde & M. Krumme
Real-time monitoring of particle size distribution in a continuous granulation and drying process by near infrared spectroscopy.
Eur. J. Pharm. Biopharm. 141 (2019) 90-99. https://doi.org/10.1016/j.ejpb.2019.05.007

A. Ito & P. Kleinebudde
Influence of granulation temperature on particle size distribution of granules in twin-screw granulation.
Pharm. Dev. Technol. 24 (2019) 874-882. https://doi.org/10.1080/10837450.2019.1615089

J. Radtke, R. Wiedey & P. Kleinebudde
Effect of coating time on inter- and intra-tablet coating uniformity.
Eur. J. Pharm. Sci. 137 (2019) 104970. https://doi.org/10.1016/j.ejps.2019.104970

A. Wilms, K. Knop & P. Kleinebudde
Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution.
Int. J. Pharm.: X 1 (2019) 100029. https://doi.org/10.1016/j.ijpx.2019.100029

P. Kleinebudde
Trends in continuous manufacturing of pharmaceutical drug products.
Pharm. Tech. Japan 35 (2019) 1175-1179.

R. Wiedey, R. Šibanc , A. Wilms & P. Kleinebudde
How relevant is ribbon homogeneity in roll compaction/ dry granulation and can it be influenced?
Eur. J. Pharm. Biopharm. 133 (2018) 232-239.

O.R. Arndt, R. Baggio, J. Harting, K. Adam, E. Franceschinis & P. Kleinebudde
Impact of different dry and wet granulation techniques on granule and tablet properties: A comparative study.
J. Pharm. Sci. 107 (2018) 3143-3152. Featured article December 2018.

S. Barimani & P. Kleinebudde
In-line Raman spectroscopy monitoring of tablet coating processes with colored coatings.
Talanta 178 (2018) 686-697.


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 (2018) 137-145.


A. Lazzari, P. Kleinebudde & K. Knop
Xanthan gum as rate-controlling polymer for the development of alcohol resistant matrix tablets and mini-tablets.
Int. J. Pharm. 536 (2018) 440-449.


J. Harting & P. Kleinebudde
Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation.
Eur. J. Pharm. Biopharm. 125 (2018) 169-181.


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


S. Grote & P. Kleinebudde
Roll compaction/ dry granulation of dibasic calcium phosphate anhydrous – Does the morphology of the raw material influence the tabletability of dry granules?
J. Pharm. Sci. 107 (2018) 1104-1111.


H. Mangal & P. Kleinebudde
Is the adjustment of the impeller speed a reliable attempt to influence granule size in continuous dry granulation?
Adv. Powder Technol. 29 (2018) 1339-1347.


S. Grote & P. Kleinebudde
Impact of functionalised particle structure on roll compaction/ dry granulation and tableting of calcium carbonate.
Int. J. Pharm. 544 (2018) 235-241.


K. Csordás, R. Wiedey & P. Kleinebudde
Impact of roll compaction design, process parameters and material deformation behaviour on ribbon relative density.
Drug Dev. Ind. Pharm. 44 (2018) 1295-1306.


R. Wiedey, R. Šibanc & P. Kleinebudde
Laser based thermo-conductometry as an approach to determine ribbon solid fraction off-line and in-line.
Int. J. Pharm. 547 (2018) 330-337.


A. Schmidt, H. de Waard, K.-P. Moll, M. Krumme & P. Kleinebudde
Continuous wet granulation with integrated in-barrel-drying.
Pharm. Res. 35 (2018) 167.

T. Wenzel, C. Stillhart, P. Kleinebudde & A. Szepes
Influence of drug load on dissolution behavior of tablets containing a poorly water-soluble drug: estimation of the percolation threshold.
Drug Dev. Ind. Pharm. 43 (2017) 1265-1275.


S. Barimani & P. Kleinebudde
Evaluation of in line Raman data for end-point determination of a coating process: Comparison of science based calibration, PLS-regression and univariate data analysis.
Eur. J. Pharm. Biopharm. 119 (2017) 28-35.


A. Perez Gago & P. Kleinebudde
MCC-mannitol mixtures after roll compaction/dry granulation: Percolation thresholds for ribbon microhardness and granule size distribution.
Pharm. Dev. Technol. 22 (2017) 764-774.


R. Wiedey & P. Kleinebudde
The density distribution in ribbons from roll compaction.
Chem. Ing. Tech. 89 (2017) 1017-1024.


R. Meier, K.-P. Moll, M. Krumme & P. Kleinebudde
Simplified, high drug-loaded formulations containing hydrochlorothiazide for twin-screw granulation.
Chem. Ing. Tech. 89 (2017) 1025-1033.


C. Stomberg & P. Kleinebudde
Development of a new dissolution test method for soft chewable dosage forms.
AAPS PharmSciTech 18 (2017) 2446-2453.


R. Meier, K.-P. Moll, M. Krumme & P. Kleinebudde
How deformation behaviour controls product performance after twin-screw granulation.
J. Pharm. Sci. 106 (2017) 291-301.


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


P. Kazemi, M.H. Khalid, A. Perez Gago, P. Kleinebudde, R. Jachowicz, J. Szlęk, A. Mendyk
Effect of roll compaction on granule size distribution of MCC-mannitol mixtures: computational intelligence modeling and parametric analysis.
Drug Des. Dev. Ther. 11 (2017) 241-251.


D. Hegyesi, M. Thommes, P. Kleinebudde, T. Sovány, P. Kása Jr., A. Kelemen, K. Pintye-Hódi & 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.


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


R. Meier, K.-P. Moll, M. Krumme & P. Kleinebudde
Impact of fill-level in twin-screw granulation on critical quality attributes of granules and tablets.
Eur. J. Pharm. Biopharm. 115 (2017) 102-112.


H. Mangal & P. Kleinebudde
Experimental determination of residence time distribution in continuous dry granulation.
Int. J. Pharm. 524 (2017) 91-100.


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


R. Meier, J. Harting, J. Happel & P. Kleinebudde
Implementation of microwave sensors in continuous powder feeding – a novel tool to bridge refill phases.
Pharm. Ind. 79 (2017) 576-582.

K. Pongsamart, P. Kleinebudde & S. Puttipipatkhachorn
Preparation of fenofibrate dry emulsion by using OSA starch as emulsifying agent and solid carrier.
Int. J. Pharm. 498 (2016) 347-354.


D. Medarevic, P. Kleinebudde, K. Bekcic, Z. Djuric & S. Ibric
Combined application of mixture experimental design and artificial neural networks in solid dispersion development.
Drug Dev. Ind. Pharm. 42 (2016) 389-402.


H. Mangal, M. Kirsolak & P. Kleinebudde
Roll compaction/ dry granulation: Suitability of different binders
Int. J. Pharm. 503 (2016) 213-219.


J. Kovacevic, S. Ibric, J. Djuris & P. Kleinebudde
Application of design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions.
Int. J. Pharm. 506 (2016) 312-319.


K. Tarp Jensen, L. Ingerslev Blaabjerg, E. Lenz, A. Bohr, H. Grohganz, P. Kleinebudde, T. Rades & K. Löbmann
Preparation and characterization of spray-dried co-amorphous drug-amino acid salts.
J. Pharm. Pharmacol. 68 (2016) 615-624.


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


L. Perez-Gandarillas, A. Perez-Gago, A. Mazor, P. Kleinebudde, O. Lecoq & A. Michrafy
Effect of roll-compaction and milling conditions on granules and tablet properties.
Eur. J. Pharm. Biopharm. 106 (2016) 38-49.


R. Meier, M. Thommes, N. Rasenack, K.-P. Moll, M. Krumme & P. Kleinebudde
Granule size distributions after twin-screw granulation - Do not forget the feeding systems.
Eur. J. Pharm. Biopharm. 106 (2016) 59-69.


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


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


A. Schmidt, H. de Waard, K.-P. Moll, M. Krumme & P. Kleinebudde
Quantitative assessment of mass flow boudaries in continuous twin-screw granulation.
Chimia 70 (2016) 604-609.


J. Quodbach & P. Kleinebudde
A critical review on tablet disintegration.
Pharm. Dev. Technol. 21 (2016) 763-774.


C.C. Sun & P. Kleinebudde
Mini review: Mechanisms to the loss of tabletability by dry granulation.
Eur. J. Pharm. Biopharm. 106 (2016) 9-14.

M.W. Tackenberg, R. Krauss, A. Marmann, M. Thommes, H.P. Schuchmann & P. Kleinebudde
Encapsulation of liquids using a counter rotating twin screw extruder.
Eur. J. Pharm. Biopharm. 89 (2015) 9-17.


G. Di Pretoro, L. Zema, A. Gazzaniga & P. Kleinebudde
Impact of needle-like crystals on wet and solid-lipid extrusion processes.
Powder Technol. 270 (2015) 476-483.


A. Dischinger, S. Page & P. Kleinebudde
Fast dissolving fillers in dry foam formulation.
Powder Technol. 270 (2015) 494-501.


M.W. Tackenberg, C. Geisthövel, A. Marmann, H.P. Schuchmann, P. Kleinebudde & M. Thommes
Mechanistic study of carvacrol processing and stabilization as glassy solid solution and microcapsule.
Int. J. Pharm. 487 (2015) 597-605.


J. Mosig & P. Kleinebudde
Critical evaluation of root causes of the reduced compactability after roll compaction/ dry granulation.
J. Pharm. Sci. 104 (2015) 1108-1118.


E. Lenz, A. Sprunk, P. Kleinebudde & S. Page
Impact of fillers on dissolution kinetic of fenofibrate dry foams.
Pharm. Dev. Technol. 20 (2015) 570-578.


J. Quodbach & P. Kleinebudde
Performance of tablet disintegrants: Impact of storage conditions and relative tablet density.
Pharm. Dev. Technol. 20 (2015) 762-768.


J. Ronowicz, M. Thommes, P. Kleinebudde & J. Krysinski
A data mining approach to optimize pellets manufacturing process based on a decision tree algorithm
Eur. J. Pharm. Sci. 73 (2015) 44-48.


C. Wörtz & P. Kleinebudde
Development of orodispersible polymer films with focus on the solid-state characterization of crystalline loperamide.
Eur. J. Pharm. Biopharm. 94 (2015) 52-63.


A. Mendyk, S. Güres, R. Jachowicz, J. Szlęk, S. Polak, B. Wiśniowska & P. Kleinebudde
From heuristic to mathematical modeling of drugs dissolution profiles: application of artificial neural networks and genetic programming.
Comp. Math. Meth. Med. 2015 (2015), Article ID 863874, 9 pages


M.W. Tackenberg, R. Krauss, H.P. Schuchmann & P. Kleinebudde
Encapsulation of orange terpenes investigating a plasticization extrusion process.
J. Microencaps. 32 (2015) 408-417.


C. Wörtz & P. Kleinebudde
Development of orodispersible polymer films containing poorly water soluble Active Pharmaceutical Ingredients with focus on different drug loadings and storage stability.
Int. J. Pharm. 493 (2015) 134-145.


M. Czajkowska, M. Sznitowska & P. Kleinebudde
Determination of coating thickness of minitablets and pellets by dynamic image analysis.
Int. J. Pharm. 495 (2015) 347-353.


E. Lenz, K. Tarp Jensen, L. Ingerslev Blaabjerg, K. Knop, H. Grohganz, K. Löbmann, T. Rades & P. Kleinebudde
Solid-state properties and dissolution behaviour of tablets containing co-amorphous indomethacine-arginine.
Eur. J. Pharm. Biopharm. 96 (2015) 44-52.


R. Meier, M. Thommes, N. Rasenack, M. Krumme, K.-P. Moll & P. Kleinebudde
Simplified formulations with high drug loads for continuous twin-screw granulation.
Int. J. Pharm. 496 (2015) 12-23.


G. Toschkoff, S. Just, K. Knop, P. Kleinebudde, A. Funke, A. Altmeyer, D. Djuric, G. Scharrer & J. Khinast
Modeling of an active tablet coating process.
J. Pharm. Sci. 104 (2015) 4082-4092.


M.W. Tackenberg & P. Kleinebudde
Encapsulation of liquids via extrusion – A review.
Curr. Pharm. Des. 21 (2015) 5815-5828.

J. Quodbach, A. Moussavi, R. Tammer, J. Frahm & P. Kleinebudde
Tablet disintegration studied by high-resolution real-time magnetic resonance imaging.
J. Pharm. Sci. 103 (2014) 249-255.


M.W. Tackenberg, M. Thommes, H.P. Schuchmann & P. Kleinebudde
Solid state of processed carbohydrate matrices from maltodextrin and sucrose.
J. Food Eng. 129 (2014) 30-37.


M.W. Tackenberg, M. Thommes, H.P. Schuchmann & P. Kleinebudde
Orange terpens, carvacrol and α-tocopherol encapsulated in maltodextrin and sucrose matrices via batch mixing.
J. Food Eng. 135 (2014) 44-52.


É. Bölcskei, G. Regdon jr., T. Sovány, D. Ghanam, K. Knop, P. Kleinebudde & K. Pintye-Hódi
Preparing of pellets by extrusion/spheronization using different types of equipment and process conditions.
Drug Dev. Ind. Pharm. 40 (2014) 762-764.


J. Mosig & P. Kleinebudde
Evaluation of lubrication methods: How to generate a comparable lubrication for dry granules and powder material for tableting processes.
Powder Technol. 266 (2014) 156-166.


K. Nikowitz, F. Folttmann, M. Wirges, K. Knop, G. Regdon jr. & P. Kleinebudde
Development of a Raman method to follow the evolution of coating thickness of pellets.
Drug Dev. Ind. Pharm. 40 (2014) 1005-1010.


A. Fussell, C.J. Strachan, P. Kleinebudde & H. Offerhaus
Coherent anti-Stokes Raman scattering (CARS) microscopy visualizes pharmaceutical tablets during dissolution.
J. Vis. Exp. Issue 89 (2014) URL: www.jove.com/video/51847 DOI: doi:10.3791/51847


J. Quodbach, A. Moussavi, R. Tammer, J. Frahm & P. Kleinebudde
Assessment of disintegrant efficacy with fractal dimensions from real-time MRI.
Int J. Pharm. 475 (2014) 605-612.


C. Krüger, M. Thommes & P. Kleinebudde
Influence of storage condition on properties of MCC II-based pellets with Theophylline-monohydrate.
Eur. J. Pharm. Biopharm. 88 (2014) 483-491.


D. Brock, J.A. Zeitler, A. Funke, K. Knop & P. Kleinebudde
Evaluation of critical process parameters for inter-tablet coating uniformity of active-coated GITS using terahertz pulsed imaging.
Eur. J. Pharm. Biopharm. 88 (2014) 434-442.


J.Quodbach & P. Kleinebudde
A new apparatus for real-time assessment of the particle size distribution of disintegrating tablets.
J. Pharm. Sci. 103 (2014) 3657-3665.


J. Quodbach & P. Kleinebudde
Systematic classification of tablet disintegrants by water uptake and force development kinetics.
J. Pharm. Pharmacol. 66 (2014) 1429-1438.


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

A. Fussell, E.T. Garbacik, C.J. Strachan, P. Kleinebudde & H. Offerhaus
In situ dissolution analysis using coherent anti-Stokes Raman scattering (CARS) and hyperspectral CARS microscopy.
Eur. J. Pharm. Biopharm. 85 (2013) 1141-1147.


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 (2013) 1-8.


Toschkoff, G., Just, S., Funke, A., Djuric, D., Knop, K., Kleinebudde, P., Scharrer, G., Khinast, J.G.
Spray models for discrete element simulations of particle coating processes
Chem. Eng. Sci. 101 (2013) 603-614.


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


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 (2013) 1122-1129.


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


Krueger, C., Thommes, M., Kleinebudde, P.
Influence of MCC II fraction and storage conditions on pellet properties
Eur. J. Pharm. Biopharm. 85 (2013) 1039-1045.


Sprunk, A., Page, S., Kleinebudde, P.
Influence of process parameters and equipment on dry foam formulation properties using indomethacin as model drug
Int. J. Pharm. 455 (2013) 189-196.


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 (2013) 1813-1824.


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. Analysis 78-79 (2013) 57-64.


Krueger, C., Thommes, M., Kleinebudde, P.
Spheronisation mechanism of MCC II-based pellets
Powder Technol. 238 (2013) 176-187.


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


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 (2013) 556-564.


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 (2013) 402-411.

J. Sakwanichol, S. Puttipipatkhachorn, G. Ingenerf & P. Kleinebudde
Roll compaction/ dry granulation: Possibility to use roll mill in dry granulation step.
Pharm. Dev. Technol. 17 (2012) 30-39.

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, A. Müllertz, V.-R. Kanikanti , H.-J. Hamann & P. Kleinebudde
Dissolution of solid lipid extrudates including biorelevant media.
Int. J. Pharm. 422 (2012) 116-124.

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


A. Kalivoda, M. Fischbach & P. Kleinebudde
Application of mixtures of polymeric carriers for dissolution enhancement of fenofibrate using hot-melt extrusion.
Int. J. Pharm. 429 (2012) 58-68.


É. Bölcskei, G. Regdon jr., T. Sovány, P. Kleinebudde & K. Pintye-Hódi
Optimization of preparation of matrix pellets containing Eudragit® NE 30D.
Chem. Eng. Res. Design 90 (2012) 651-657.


 A. Kalivoda, M. Fischbach, M. Maio & P. Kleinebudde
Preliminary studies to assess ultrasound-assisted compaction as a novel technique in solid dispersion preparation.
Pharm. Ind. 74 (2012) 652-662.


S. Güres, A. Mendyk, R. Jachowicz & P. Kleinebudde
Application of artificial neural networks (ANN) and genetic programming (GP) for prediction of drug release from solid lipid matrices.
Int. J. Pharm. 436 (2012) 877-879.


J. Quodbach, J. Mosig & P. Kleinebudde
Compaction behavior of isomalt after roll compaction.
Pharmaceutics 4 (2012) 494-500.


 A. Kalivoda, M. Fischbach & P. Kleinebudde
Application of mixtures of polymeric carriers for dissolution enhancement of oxeglitazar using hot-melt extrusion.
Int. J. Pharm. 439 (2012) 145-156.


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

T. Kuntz, M.A. Schubert & P. Kleinebudde
Increased compactability of acetames after roll compaction.
Eur. J. Pharm. Biopharm. 77 (2011) 164-169.


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.


J. Albers, K. Matthée, K. Knop & P. Kleinebudde
Prediction of solid dispersion formation to improve solubility of poorly soluble drugs.
J. Pharm. Sci. 100 (2011) 667-680.


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


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.


K. Wörtz, C. Tißen, P. Kleinebudde & J. Breitkreutz
A comparative study on two electronic tongues for pharmaceutical formulation development.
J. Pharm. Biomed. Anal. 55 (2011) 272-281.


D. Ghanam & P. Kleinebudde
Suitability of -carrageenan pellets for the formulation of multiparticulate tablets with modified release.
Int. J. Pharm. 409 (2011) 9-18.


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


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


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


M. Haaser, M. Windbergs, C.M. McGoverin, P. Kleinebudde, T. Rades, K.C. Gordon & C.J. Strachan
Analysis of matrix dosage forms during dissolution testing using Raman microscopy.
J. Pharm. Sci. 100 (2011) 4452-4459.


K. Wörtz, C. Tißen, P. Kleinebudde & J. Breitkreutz
Development of a taste masked generic ibuprofen suspension – Top down approach guided by electronic tongue measurements.
J. Pharm. Sci. 100 (2011).


D. Hasa, B. Perissutti, M. Grassi, M. Zacchigna, M. Pagotto, P. Kleinebudde & D. Voinovich
Melt extruded helical waxy matices as a new sustained drug delivery system.
Eur. J. Pharm. Biopharm. 79 (2011) 592-600.


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


D. Gallardo, B. Skalsky & P. Kleinebudde
Characterization of combinations between anionic-cationic poly(methyl methacrylate) copolymers.
Pharm. Ind. 73 (2011) 1875-1884.

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

K. Woertz, C. Tissen, P. Kleinebudde & J. Breitkreutz
Qualification of an electronic tongue according to ICH guideline Q2.
J. Pharm. Biomed. Anal. 51 (2010) 497-506.


M. Windbergs, M. Haaser, C. McGoverin, K. Gordon, P. Kleinebudde & C.J. Strachan
Investigating the structure and dissolution behaviour of solid lipid extrudates using Raman spectroscopy and mapping.
J. Pharm. Sci. 99 (2010) 1464-1475.


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


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


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


D. Ghanam, I. Hassan & P. Kleinebudde
Compression behaviour of kappa-carrageenan pellets.
Int. J. Pharm. 390 (2010) 117-127.


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.


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


C. Krüger, M. Thommes & P. Kleinebudde
Suitability of microcrystalline cellulose II as new pelletisation aid for wet extrusion-spheronisation in comparison to microcrystallline cellulose I.
J. Pharm. Innov. 5 (2010) 45-57.


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


D. Djuric & P. Kleinebudde
Continuous granulation with a twin-screw extruder: Impact of material throughput.
Pharm. Dev. Technol. 15 (2010) 518-525.


K. Wörtz, C. Tißen, P. Kleinebudde & J. Breitkreutz
Rational development of taste masked liquid formulations guided by an electronic tongue.
Int. J. Pharm. 400 (2010) 114-123.


Mendyk, P. Kleinebudde, M. Thommes, A. Yoo, J. Szleogonnek, & R. Jachowicz
Analysis of pellet properties with use of artificial neural networks.
Eur. J. Pharm. Sci. 41 (2010) 421-429.

A. Dukic-Ott, M. Thommes, J.-P. Remon, P. Kleinebudde & C. Vervaet
Production of pellets via extrusion/ spheronisation without the incorporation of microcrystalline cellulose: A critical review.
Eur. J. Pharm. Biopharm. 71 (2009) 38-42.

M. Windbergs, C.J. Strachan & P. Kleinebudde
Investigating the principles of recrystallzation from glyceride melts.
AAPS PharmSciTech. 10 (2009) 1224-1233.

M. Jurna, M. Windbergs, C.J. Strachan, L. Hartsuiker, C. Otto, P. Kleinebudde, J.L. Herek & H.L. Offerhaus
Development of a method using coherent anti-Stokes Raman Scattering microscopy to monitor drug dissolution in different oral pharmaceutical dosage forms.
J. Innovative Optical Health Science 2 (2009) 37-43.

M. Thommes, D.R. Ely & P. Kleinebudde
The water binding behavior of k-carrageenan determined by three different methods.
Pharm. Dev. Technol. 14 (2009) 249-258.

M. Windbergs, M. Jurna, H.L. Offerhaus, P. Kleinebudde & C.J. Strachan
Visualization of the physicochemical structure of oral solid dosage forms and changes upon dissolution using coherent anti-Stokes Raman Scattering microscopy.
Anal. Chem. 81 (2009) 2085-2091.

M. Windbergs, C.J. Strachan & P. Kleinebudde
Influence of structural variations on drug release from lipid/ polyethylene glycol matrices.
Eur. J. Pharm. Sci. 37 (2009) 555-562.

M. Windbergs, C.J. Strachan & P. Kleinebudde
Tailor-made dissolution profiles by extruded matrices based on lipid/ polyethylene glycol mixtures.
J. Contr. Rel. 137 (2009) 211-216.

M. Thommes, L. Baert, G. van´t Klooster, M. Geldof, L. Schueller, J. Rosier & P. Kleinebudde
Improved bioavailability of darunavir by use of κ-carrageenan as pelletisation aid.
Eur. J. Pharm. Biopharm. 72 (2009) 614-620.

H. Jaeda, K. Knop & P. Kleinebudde
Powder flow measurement – Comparison between two ring shear testers.
Pharm. Ind. 71 (2009) 1221-1228.

M. Windbergs, C.J. Strachan & P. Kleinebudde
Influence of the composition of gylcerides on the solid-state behaviour and the dissolution profiles of solid lipid extrudates.
Int. J. Pharm. 381 (2009) 184-191.

A. Yoo & P. Kleinebudde
Spheronisation of small extrudates containing k-carrageenan using two spheronizers.
J. Pharm. Sci. 98 (2009) 3776-3787.

M. Windbergs, C.J. Strachan & P. Kleinebudde
Understanding the solid-state behaviour of solid lipid extrudates and its influence on dissolution.
Eur. J. Pharm. Biopharm. 71 (2009) 80-87.

L. Ho, R. Müller, K.C. Gordon, P. Kleinebudde, M. Pepper, T. Rades, Y.C. Shen, P.F. Taday & J.A. Zeitler
Terahertz pulsed imaging as process analytical tool for sustained-release tablet film coating.
Eur. J. Pharm. Biopharm. 71 (2009) 117-123.

D. Djuric, B. Van Melkebeke, P. Kleinebudde, J.P. Remon & C. Vervaet
Comparison of two twin-screw extruders for continuous granulation.
Eur. J. Pharm. Biopharm. 71 (2009) 155-160.

C. Reitz & P. Kleinebudde
Spheronization of solid lipid extrudates.
Powder Technol. 189 (2009) 238-244.

J. Albers, R. Alles, K. Matthée, K. Knop, J. Schulze Nahrup & P. Kleinebudde
Mechanism of drug release from polymethacrylate-based extrudates and milled strands prepared by hot-melt extrusion.
Eur. J. Pharm. Biopharm. 71 (2009) 387-394.

M. Thommes & P. Kleinebudde
Comparison of different k-Carrageenans in pelletisation by extrusion/ spheronisation.
Pharm. Dev. Technol. 13 (2008) 27-35.

L. Ho, R. Müller, K.C. Gordon, P. Kleinebudde, M. Pepper, T. Rades, Y.C. Shen, P.F. Taday & J.A. Zeitler
Applications of terahertz pulsed imaging to sustained-release tablet film coating assessment and dissolution performance.
J. Contr. Rel. 127 (2008) 79-87.

É. Bölcskei, J. Bajdik, J. Müller, K. Knop, P. Kleinebudde & K. Pintye-Hódi
Pretreatment of pigments to prepare liquids for enteric coating.
Die Pharmazie 63 (2008) 514-515. doi: 10.1691/ph.2008.8074.

M.H. Herting & P. Kleinebudde
Studies on the reduction of tensile strength of tablets after roll compaction/ dry granulation.
Eur. J. Pharm. Biopharm. 70 (2008) 372-379. doi: 10.1016/j.ejpb.2008.04.003.

J. Bajdik, G. Baki, Z. Szent-Királlyi, K. Knop, P. Kleinebudde & K. Pintye-Hódi
Evaluation of the composition of the binder bridges in matrix granules prepared with a small-scale high-shear granulator.
J. Pharm. Biomed. Anal. 48 (2008) 694-701.

C. Reitz, C.J. Strachan & P. Kleinebudde
Solid lipid extrudates as sustained release matrices: The effect of surface structure on drug release properties.
Eur. J. Pharm. Sci. 35 (2008) 335-343.

Michalk, H.-J. Hamann, R. Kanikanti & P. Kleinebudde
Controlled release of active as a consequence of the die diameter in solid lipid extrusion.
J. Contr. Rel. 132 (2008) 35-41.

D. Djuric & P. Kleinebudde
Impact of screw elements in continuous granulation with a twin-screw extruder.
J. Pharm. Sci. 97 (2008) 4934-4942. doi: 10.1002/jps.21339.

D. Gallardo, B. Skalsky & P. Kleinebudde
Controlled release solid dosage forms using combinations of (meth)acrylate copolymers.
Pharm. Dev. Technol. 13 (2008) 413-423.

R. Müller & P. Kleinebudde
Prediction of tablet velocity in pan coaters for scale-up.
Powder Technol. 173 (2007) 51-58.

R. Müller & P. Kleinebudde
Comparison of a laboratory and a production coating spray gun with respect to scale-up.
AAPS PharmSciTech. 8 (2007) Article 3.

R. Müller & P. Kleinebudde
Abrasion of tablets in a laboratory and a production perforated pan coater.
Eur. J. Pharm. Biopharm. 67 (2007) 458-463.

N. Charoenthai, P. Kleinebudde & S. Puttipipatkhachorn
Use of chitosan-alginate as alternative pelletisation aid to microcrystalline cellulose in extrusion/ spheronisation.
J. Pharm. Sci. 96 (2007) 2469-2484.

N. Charoenthai, P. Kleinebudde & S. Puttipipatkhachorn
Influence of chitosan type on the production and the properties of extruded pellets with low amount of microcrystalline cellulose.
AAPS PharmSciTech 8 (2007) Article 64.

C. Reitz & P. Kleinebudde
Solid lipid extrusion of sustained release dosage forms.
Eur. J. Pharm. Biopharm. 67 (2007) 440-448.

C. Reitz & P. Kleinebudde
Influence of thermal and thermo-mechanical treatment: Comparison of two lipids with respect to their suitability for solid lipid extrusion.
J. Thermal Anal. Calorim. 89 (2007) 669-673.

M. Thommes, W. Blaschek & P. Kleinebudde
Effect of drying on extruded pellets based on k-Carrageenan.
Eur. J. Pharm. Sci. 31 (2007) 112-118.

M. Thommes & P. Kleinebudde
Properties of pellets manufactured by wet extrusion/ spheronisation process using κ-carrageenan: Effect of process parameters.
AAPS PharmSciTech 8 (2007) 4: article 95.

M.H. Herting & P. Kleinebudde
Roll compaction/dry granulation: Effect of raw material particle size on granule and tablet properties.
Int. J. Pharm. 338 (2007) 110-118.

M.H. Herting, K. Klose & P. Kleinebudde
Comparison of different binders for roll compaction/ dry granulation.
Pharm. Dev. Technol. 12 (2007) 525-532.

L. Ho, R. Müller, M. Römer, K.C. Gordon, J. Heinämäki, P. Kleinebudde, M. Pepper, T. Rades, Y.C. Shen, C.J. Strachan, P.F. Taday, J.A. Zeitler
Analysis of sustained-release tablet film coats using terahertz pulsed imaging.
J. Contr. Rel. 119 (2007) 253-261.

S. Page, K.-H. Baumann & P. Kleinebudde
Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater. Part I. Development of the model.
AAPS PharmSciTech. 7 (2006) Article 42.

S. Page, K.-H. Baumann & P. Kleinebudde
Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater. Part II. Application of the model.
AAPS PharmSciTech. 7 (2006) Article 43.

R. Müller & P. Kleinebudde
Influence of scale-up on the abrasion of tablets in a pan coater.
Eur. J. Pharm. Biopharm. 64 (2006) 388-392.

R. Müller & P. Kleinebudde
Comparison study of laboratory and production spray guns in film coating: Effect of pattern air and nozzle diameter.
Pharm. Dev. Technol. 11 (2006) 425-433.

J. Albers, K. Knop & P. Kleinebudde
Brand-to-brand and batch-to-batch uniformity of microcrystalline cellulose in direct tableting with a pneumohydraulic tablet press.
Pharm. Ind. 68 (2006) 1420-1428.

M. Thommes & P. Kleinebudde
Use of k-carrageenan as alternative pelletisation aid to microcrystalline cellulose in extrusion/spheronisation. I. Influence of type and fraction of filler.
Eur. J. Pharm. Biopharm. (2006) 59-67.

M. Thommes & P. Kleinebudde
Use of k-carrageenan as alternative pelletisation aid to microcrystalline cellulose in extrusion/spheronisation. II. Influence of drug and filler type.
Eur. J. Pharm. Biopharm. (2006) 68-75.

R. Müller & P. Kleinebudde
Scale-down experiments in a new type of pan coater.
Pharm. Ind. 67 (2005) 950-957.

F. Freitag, J. Runge & P. Kleinebudde
Co-processing of powdered cellulose and magnesium carbonate: Direct tableting vs. tableting after roll compaction/ dry granulation.
Pharm. Dev. Technol. 10 (2005) 353-362.

P.M. Fechner, S. Wartewig, A. Kiesow, A. Heilmann, P. Kleinebudde & R.H.H. Neubert
Interaction of water with different substituted cellulose ethers: A Raman spectroscopy and Environmental Scanning Electron Microscopy study.
J. Pharm. Pharmacol. 57 (2005) 689-698.

Tho, S.A. Sande & P. Kleinebudde
Cross-linking of amidated low-methoxylated pectin with calcium during extrusion/spheronisation: Effects on particle size and shape.
Chem. Eng. Sci. 60 (2005) 3899-3907.

Claviez, M. Bornhöft, C.-J. Partsch, U. Heimann, W. Marg, P. Kleinebudde & M. Suttorp
Hyponatriämie bei Säuglingen und Kleinkindern. Substitutionstherapie mit mikroverkapseltem, geschmacksneutralem Kochsalz.
Monatsschrift für Kinderheilkunde 135 (2005) 145-149.

M.Bornhöft, M. Thommes & P. Kleinebudde
Preliminary assessment of carrageenan as excipient for extrusion/spheronisation
Eur. J. Pharm. Biopharm. 59 (2005) 127-131.

F. Freitag, K. Reincke, J. Runge, W. Grellmann & P. Kleinebudde
How do roll compaction/ dry granulation affect the tableting behaviour of inorganic materials? Microhardness of ribbons and mercury porosimetry measurements of tablets.
Eur. J. Pharm. Sci. 22 (2004) 325-333.

R. Grulke, P. Kleinebudde & G. Shlieout
Mixture experiments on roll compaction. Part I and II.
Pharm. Ind. 66 (2004) 794-796 und 911-915.

P. Kleinebudde
Roll compaction/ dry granulation: Pharmaceutical applications.
Eur. J. Pharm. Biopharm. 58 (2004) 317-326.

S. Tobiska & P. Kleinebudde
Coating uniformity: Influence of atomizing air pressure.
Pharm. Dev. Technol. 8 (2003) 39-46.

S. Tobiska & P. Kleinebudde
Coating uniformity and coating efficiency in a Bohle-Lab-Coater using oval tablets.
Eur. J. Pharm. Biopharm. 56 (2003) 3-9.

F. Freitag & P. Kleinebudde
How do roll compaction/ dry granulation affect the tableting behaviour of anorganic materials? Comparison of four magnesium carbonates.
Eur. J. Pharm. Sci. 19 (2003) 281-289.

J. Breitkreutz, M. Bornhöft, F. Wöll & P. Kleinebudde
Pediatric drug formulations of sodium benzoate: I. Coated granules with a hydrophilic binder.
Eur. J. Pharm. Biopharm. 56 (2003) 247-253.

J. Breitkreutz, F. El-Saleh, C. Kiera, P. Kleinebudde & W. Widey
Pediatric drug formulations of sodium benzoate: II. Coated granules with a lipophilic binder.
Eur. J. Pharm. Biopharm. 56 (2003) 255-260.

Tho, S.A. Sande & P. Kleinebudde
Disintegrating pellets from a water-insoluble pectin derivative produced by extrusion/ spheronisation.
Eur. J. Pharm. Biopharm. 56 (2003) 371-380.

P.M. Fechner, S. Wartewig, M. Füting, A. Heilmann, R.H.H. Neubert & P. Kleinebudde
Comparison of microcrystalline cellulose and powdered cellulose before and after extrusion/ spheronization by FT-Raman spectroscopy and ESEM.
PharmSci 5 (2003) article 32 (http://www.aapspharmsci.org/).

F. Wöll & P. Kleinebudde
Charakterisierung der Porosität von Schülpen: Stanzmethode und NIRS-Methode.
Chem.-Ing. Tech. 75 (2003) 1756-1759.

F. Freitag & P. Kleinebudde
Walzenkompaktieren und Trockengranulieren pharmazeutischer Hilfsstoffe am Beispiel von Magnesiumcarbonat.
Chem.-Ing. Tech. 75 (2003) 1760-1763.

A. Sieg, K. Held, U. Redeker & P. Kleinebudde
Dissolution testing of reworked tablets.
Pharm. Tech. Eur. 14 (2002) Jan 20-25.

I. Tho, S.A. Sande & P. Kleinebudde
Pectinic acid, a novel excipient for production of pellets by extrusion/spheronisation: preliminary studies.
Eur. J. Pharm. Biopharm. 54 (2002) 95-99.

I. Tho, E. Anderssen, K. Dyrstad, P. Kleinebudde & S.A. Sande
Quantum chemical descriptors in the formulation of pectin pellets produced by extrusion/ spheronisation.
Eur. J. Pharm. Sci. 16 (2002) 143-149.

M. Husmann, S. Schenderlein, M. Lück, H. Lindner & P. Kleinebudde
Investigation of polymer erosion in microparticles produced by phase separation.
Int. J. Pharm. 242 (2002) 277-280.

G. Shlieout, R.L. Lammens, P. Kleinebudde & M. Bultmann
Dry granulation with a roller compactor. Part II: Evaluating the operation modes.
Pharm. Tech. Eur. 14 (2002) Sep 32-39.

J. Kristensen, P. Kleinebudde & T. Schæfer
Development of fast disintegrating pellets in a rotary processor.
Drug Dev. Ind. Pharm. 28 (2002) 1201-1212.

J. Breitkreutz, P. Kleinebudde & J. Boos
Kindgerechte Darreichungsformen – Arzneimitteltherapie für alle
Pharm. Ztg. 147 (2002) 3210-3218.

R. Thies & P. Kleinebudde
Melt pelletization of a hygroscopic drug in a high shear mixer. Part III: Effects of binder variation.
Chem. Pharm. Bull. 49 (2001) 140-146.

S. Tobiska & P. Kleinebudde
A simple method for evaluating the mixing efficiency of a new type of pan coater.
Int. J. Pharm. 224 (2001) 141-149.

I. Tho, P. Kleinebudde & S.A. Sande
Extrusion/spheronisation of pectin based formulations. I. Screening of important factors.
AAPS PharmSciTech 2 (4) (2001) article 26 (http://www.pharmscitech.com).

I. Tho, P. Kleinebudde & S.A. Sande
Extrusion/spheronisation of pectin based formulations. II. Effect of additive concentration in the granulation liquid.
AAPS PharmSciTech 2 (4) (2001) article 27 (http://www.pharmscitech.com).

N. Meyer, K. Nestler, L. Engisch, G. Marx, M. Füting, A. Kiesow, A. Heilmann, S. Wartewig & P. Kleinebudde
Raman spectroscopic surface characterization of cellulose derivatives.
Fresen. J. Anal. Chem. 370 (2001) 789-791.

R. Thies & P. Kleinebudde
Melt pelletisation of a hygroscopic drug in a high shear mixer. Part II: Mutual compensation of influence variables.
Eur. J. Pharm. Sci. 10 (2000) 103-110.


J. Kristensen, T. Schæfer & P. Kleinebudde
Direct pelletization in a rotary processor. I: Influence of process variables.
Pharm. Dev. Technol. 5 (2000) 247-256.


M. Jumaa, F. El Saleh, I. Hassan, B. W. Müller & P. Kleinebudde
Influence of cellulose type on the properties of extruded pellets.
Part I: Physicochemical characterization of the cellulose types after homogenization.
Colloid Polym. Sci. 278 (2000) 597-607.


P. Kleinebudde, M. Jumaa & F. El Saleh
Influence of degree of polymerization on behaviour of cellulose during homogenization and extrusion/ spheronization.
AAPS PharmSci 2 (2) (2000) article 21 (http://www.pharmsci.org/).


J. Kristensen, P. Kleinebudde & T. Schæfer
Direct pelletization in a rotary processor controlled by torque measurements.
II: Effects of changes in the content of microcrystalline cellulose.
AAPS PharmSci 2 (3) (2000) article 24 (http://www.pharmsci.org/).


F. El Saleh, M. Jumaa, I. Hassan & P. Kleinebudde
Influence of cellulose type on the properties of extruded pellets. Part II: Production and properties of pellets.
S.T.P. Pharma Sciences 10 (2000) 379-385.


G. Shlieout, R.L. Lammens & P. Kleinebudde
Dry granulation with a roller compactor. Part I: The functional units and operation modes.
Pharm. Tech. Eur. 12 (2000) Nov. 24-35.


T. Wagner, F. Balszuweit & P. Kleinebudde
Eine neue Methode zur Charakterisierung der spezifischen Oberfläche von Pellets mittels Flachbettscanner und Bildanalyse.
Pharm. Ind. 62 (2000) 985-991.

 

1999

C. Schmidt & P. Kleinebudde
Influence of the granulation step on pellets prepared by extrusion/ spheronization.
Chem. Pharm. Bull. 47 (1999) 405-412.


P. Kleinebudde, M. Schröder, P. Schultz, B. W. Müller, T. Waaler & L. Nymo
Importance of the fraction of microcrystalline cellulose and spheronization speed on the properties of extruded pellets made from binary mixtures.
Pharm. Dev. Technol. 4 (1999) 397-404.


M. Jumaa, P. Kleinebudde & B. W. Müller
Physicochemical properties and hemolytic effect of different lipid emulsion formulations using a mixture of emulsifiers.
Acta Pharm. Helv. 73 (1999) 293-301.


A. Claviez, R. Thies, P. Kleinebudde & M. Suttorp
Microencapsulated NaCl for oral salt-replacement therapy in infants.
J. Natl. Cancer I. 91 (1999) 1513-1514.


R. Thies & P. Kleinebudde
Melt pelletisation of a hygroscopic drug in a high shear mixer. Part I: Influence of process variables.
Int. J. Pharm. 188 (1999) 131-143.


 1998

C. Schmidt & P. Kleinebudde
Comparison between a twin-screw extruder and a rotary ring die press. Part II: Influence of process variables.
Eur. J. Pharm. Biopharm. 45 (1998) 173-179.


M. Jumaa, P. Kleinebudde & B. W. Müller
Mixture experiments with the oil phase of parenteral emulsions.
Eur. J. Pharm. Biopharm. 46 (1998) 161-167.


F. El Saleh & P. Kleinebudde
Mercury-free determination of apparent density and porosity of pellets by powder pycnometry.
Pharm. Tech. Europe 10 (1998) Nov. 18-26.


  1997

F. Ruchatz, P. Kleinebudde & B. W. Müller
Residual solvents in biodegradable microparticles. Influence of process parameters on the residual solvent in microparticles produced by the Aerosol Solvent Extraction System (ASES) process.
J. Pharm. Sci. 86 (1997) 101-105.


P. Schultz & P. Kleinebudde
A new multiparticulate delayed release system. Part I: Dissolution properties and release mechanism.
J. Contr. Rel. 47 (1997) 181-189.


P. Schultz, I. Tho & P. Kleinebudde
A new multiparticulate delayed release system. Part II: Coating formulation and properties of free films.
J. Contr. Rel. 47 (1997) 191-199.


P. Kleinebudde
The crystallite-gel-model for microcrystalline cellulose in wet-granulation, extrusion and spheronization.
Pharm. Res. 14 (1997) 804-809.


C. Schmidt, H. Lindner & P. Kleinebudde
Comparison between a twin-screw extruder and a rotary ring die press. Part I: Influence of formulation variables.
Eur. J. Pharm. Biopharm. 44 (1997) 169-176.


 1996

F. Ruchatz, P. Kleinebudde & B. W. Müller
Residual solvents in biodegradable microparticles: determination by a dynamic headspace gas chromatographic method.
Int. J. Pharm. 142 (1996) 67-73.


 1995

P. Schultz & P. Kleinebudde
Determination of pellet friability by use of an air stream apparatus.
Pharm. Ind. 57 (1995) 323-328.
Drugs made in Germany 39 (1996) 53-58.


P. Kleinebudde
Use of a power-consumption-controlled extruder in the development of pellet formulations.
J. Pharm. Sci. 84 (1995) 1259-1264.


M. Schröder & P. Kleinebudde
Development of disintegrating pellets obtained from extrusion / spheronization.
Pharmaceutical Science 1 (1995) 415-418.


M. Schröder & P. Kleinebudde
Structure of disintegrating pellets with regard to fractal geometry.
Pharm. Res. 12 (1995) 1694-1700.


M. Schröder & P. Kleinebudde
Influence of formulation parameters on dissolution of propyphenazone pellets.
Eur. J. Pharm. Biopharm. 41 (1995) 382-387.


 1994

H. Lindner & P. Kleinebudde
Use of powdered cellulose for the production of pellets by extrusion/ spheronization.
J. Pharm. Pharmacol. 46 (1994) 2-7.


D. Cordes, P. Kleinebudde & B. W. Müller
Bestimmung der Konsistenz halbfester Zubereitungen mit dem Texture Analyser.
Pharmazie 49 (1994) 180-182.


J. Bleich, P. Kleinebudde & B. W. Müller
Influence of gas density and pressure on microparticles produced with the ASES process.
Int. J. Pharm. 106 (1994) 77-84.


T. K. Bock, J.-S. Lucks, P. Kleinebudde, R. H. Müller & B. W. Müller
High pressure homogenization of parenteral fat emulsions - Influence of process parameters on emulsion quality.
Eur. J. Pharm. Biopharm. 40 (1994) 157-160.


P. Kleinebudde, A. J. Sølvberg & H. Lindner
The power-consumption-controlled extruder: a tool for pellet production.
J. Pharm. Pharmacol. 46 (1994) 542-546.


P. Kleinebudde
Shrinking and swelling properties of pellets containing microcrystalline cellulose and low substituted hydroxypropylcellulose. Part I: Shrinking properties.
Int. J. Pharm. 109 (1994) 209-219.


P. Kleinebudde
Shrinking and swelling properties of pellets containing microcrystalline cellulose and low substituted hydroxypropylcellulose. Part II: Swelling properties.
Int. J. Pharm. 109 (1994) 221-227.


 1993

P. Kleinebudde & H. Lindner
Experiments with an instrumented twin-screw extruder using a single step granulation/ extrusion process.
Int. J. Pharm. 94 (1993) 49-58.


H. Lindner & P. Kleinebudde
Anwendung der automatischen Bildanalyse zur Charakterisierung von Pellets.
Pharm. Ind. 55 (1993) 694-701.


P. Kleinebudde
Application of low substituted hydroxypropylcellulose (L-HPC) in the production of pellets using extrusion/ spheronization.
Int. J. Pharm. 96 (1993) 119-128.


vor 1992

B. W. Müller, P. Kleinebudde, T. Østberg & T. Waaler
Untersuchungen des Einflusses von Teilchengrößen und Additiva auf das Sedimentationsverhalten von Suspensionen mit Hilfe einer Sedimentationswaage.
Pharm. Ind. 52 (1990) 1267-1271.


B. W. Müller & P. Kleinebudde
Untersuchungen an sogenannten Mikroemulsionssystemen
1. Teil: Untersuchungen an arzneistofffreien Systemen.
Pharm. Ind. 50 (1988) 370-375.


B. W. Müller & P. Kleinebudde
Untersuchungen an sogenannten Mikroemulsionssystemen
2. Teil: Untersuchungen an arzneistoffhaltigen Systemen.
Pharm. Ind. 50 (1988) 1301-1306.