Amrit Paudel

2025

Implications of crystal disorder on the solid-state stability of olanzapine

Iyer, J., Barbosa, M., Pinto, J. F. & Paudel, A., Jan 2025, In: Journal of Pharmaceutical Sciences. 114, 1, p. 599-616 18 p.

Research output: Contribution to journal › Article › peer-review

In vitro dissolution and predictive release testing

Zupančič, O. & Paudel, A., 1 Jan 2025, Polymers for Oral Drug Delivery Technologies. Elsevier GmbH, p. 141-195 55 p.

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

Role of polymers in tableting

Zupančič, O., Martins Fraga, R. & Paudel, A., 2025, Polymers for Oral Drug Delivery Technologies. Parambath, A. (ed.). Elsevier Ltd., Vol. 1. p. 335-388 54 p.

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

2024

Accelerative Solid-State Oxidation Behaviour of Amorphous and Partially Crystalline Venetoclax

Afonso Urich, J. A., Marko, V., Boehm, K., Werner, B., Zangger, K., Saraf, I., Paudel, A. & Kushwah, V., Jun 2024, In: AAPS PharmSciTech. 25, 5, 114.

Research output: Contribution to journal › Article › peer-review

Comparing Low-Dose Carvedilol Continuous Manufacturing by Solid and Liquid Feeding in Self-Emulsifying Delivery Systems via Hot Melt EXtrusion (SEDEX)

Zupančič, O., Matić, J., Doğan, A., Gaggero, A., Khinast, J. & Paudel, A., 28 Sept 2024, In: Pharmaceuticals. 17, 10, 1290.

Research output: Contribution to journal › Article › peer-review

Open Access

Effect of processing and formulation factors on Catalase activity in tablets

Martins Fraga, R., Beretta, M., Pinto, J. F., Spörk, M., Zupančič, O., Fernandes Teixeira Pinto, J. F. & Paudel, A., 28 Aug 2024, (E-pub ahead of print) In: International Journal of Pharmaceutics. 664, 124626.

Research output: Contribution to journal › Article › peer-review

Influence of Crystal Disorder on the Forced Oxidative Degradation of Vortioxetine HBr

Modhave, D., Barrios, B., Iyer, J. & Paudel, A., Jan 2024, In: AAPS PharmSciTech. 25, 1, 13 p., 10.

Research output: Contribution to journal › Article › peer-review

Open Access

File

Influence of L-leucine content on the aerosolization stability of spray-dried protein dry powder inhalation (DPI)

Dieplinger, J., Isabel Afonso Urich, A., Mohsenzada, N., Pinto, J. T., Dekner, M. & Paudel, A., 5 Dec 2024, In: International Journal of Pharmaceutics. 666, 124822.

Research output: Contribution to journal › Article › peer-review

In-situ monitoring of in vitro drug release processes in tablets using optical coherence tomography

Wolfgang, M., Baniček, T., Paudel, A., Gruber-Woelfler, H., Spoerk, M., Kushwah, V. & Khinast, J. G., 1 Sept 2024, In: Journal of Pharmaceutical and Biomedical Analysis. 247, 116258.

Research output: Contribution to journal › Article › peer-review

Integration of mucus and its impact within in vitro setups for inhaled drugs and formulations: Identifying the limits of simple vs. complex methodologies when studying drug dissolution and permeability

Radivojev, S., Kargl, L., Pinto, J. T., Swedrowska, M., Malmlöf, M., Meindl, C., Forbes, B., Gerde, P., Paudel, A. & Fröhlich, E., 15 Aug 2024, In: International Journal of Pharmaceutics. 661, 124455.

Research output: Contribution to journal › Article › peer-review

Investigation of the Influence of Copovidone Properties and Hot-Melt Extrusion Process on Level of Impurities, In Vitro Release, and Stability of an Amorphous Solid Dispersion Product

Saraf, I., Jakasanovski, O., Stanić, T., Kralj, E., Petek, B., Williams, J. D., Dmytro, N., Georg, G., Bernd, W., Klaus, Z., Perhavec, P., German Ilić, I., Paudel, A. & Kushwah, V., 4 Nov 2024, In: Molecular Pharmaceutics. 21, 11, p. 5703-5715 13 p.

Research output: Contribution to journal › Article › peer-review

2023

Applying Material Science Principles to Chemical Stability: Modelling Solid State Autoxidation in Mifepristone Containing Different Degrees of Crystal Disorder

Iyer, J., Morgan, L. M., Harrison, P., Davis, A., Ray, A., Mitsche, S., Hofer, F., Saraf, I. & Paudel, A., Sept 2023, In: Journal of Pharmaceutical Sciences. 112, 9, p. 2463-2482 20 p.

Research output: Contribution to journal › Article › peer-review

Open Access

File

Assessment of Tribo-charging and Continuous Feeding Performance of Direct Compression Grades of Isomalt and Mannitol Powders

Beretta, M., Kruisz, J., Hörmann-Kincses, T. R., Magosi, V., Guo, M., Naderi, M., Heupl, S., Kastner, J., Spoerk, M. & Paudel, A., Apr 2023, In: AAPS PharmSciTech. 24, 4, 91.

Research output: Contribution to journal › Article › peer-review

Open Access

File

Data-Driven Prediction of the Formation of Co-Amorphous Systems

Fink, E., Brunsteiner, M., Mitsche, S., Schröttner, H., Paudel, A. & Zellnitz-Neugebauer, S., 2023, In: Pharmaceutics. 15, 2, 17 p., 347.

Research output: Contribution to journal › Article › peer-review

Open Access

Development of a Digital Interface for Personalized Dosing in Renal Impaired Patients: A Case-Study Using the ACE-Inhibitor Benazepril

Reinisch, V., Paudel, A. & Pinto, J. T., 2 May 2023, In: Studies in Health Technology and Informatics. 301, p. 133-139 7 p.

Research output: Contribution to journal › Article › peer-review

Open Access

Development of a Workflow to Engineer Tailored Microparticles Via Inkjet Printing

Winter, C., Zettl, M., Mantanus, J., Hadjittofis, E., Leitinger, G., Kolb, D., Hsiao, W. K., Spoerk, M., Paudel, A., Roblegg, E. & Pinto, J. T., 2023, In: Pharmaceutical Research. 40, 1, p. 281-294 14 p.

Research output: Contribution to journal › Article › peer-review

Finite-Temperature Mechanical Properties of Organic Molecular Crystals from Classical Molecular Simulation

Brunsteiner, M., Nilsson-Lil, S., Morgan, L. M., Davis, A. & Paudel, A., 5 Apr 2023, In: Crystal Growth and Design. 23, 4, p. 2155-2168 14 p.

Research output: Contribution to journal › Article › peer-review

Impact of Different Saccharides on the In-Process Stability of a Protein Drug During Evaporative Drying: From Sessile Droplet Drying to Lab-Scale Spray Drying

Dieplinger, J., Pinto, J. T., Dekner, M., Brachtl, G. & Paudel, A., 3 Apr 2023, In: Pharmaceutical Research. 40, 5, p. 1283-1298 16 p.

Research output: Contribution to journal › Article › peer-review

Open Access

File

Influence of PLGA End Groups on the Release Profile of Dexamethasone from Ocular Implants

Saraf, I., Kushwah, V., Alva, C., Koutsamanis, I., Rattenberger, J., Schroettner, H., Mayrhofer, C., Modhave, D., Braun, M., Werner, B., Zangger, K. & Paudel, A., 2023, In: Molecular Pharmaceutics. 20, 2, p. 1307-1322 16 p.

Research output: Contribution to journal › Article › peer-review

Investigation of the Impact of Saccharides on the Relative Activity of Trypsin and Catalase after Droplet and Spray Drying

Dieplinger, J., Moser, C., König, G., Pinto, J. T. & Paudel, A., Oct 2023, In: Pharmaceutics. 15, 10, 2504.

Research output: Contribution to journal › Article › peer-review

Open Access

Machine Learning–Enabled NIR Spectroscopy. Part 2: Workflow for Selecting a Subset of Samples from Publicly Accessible Data

Ali, H., Muthudoss, P., Ramalingam, M., Kanakaraj, L., Paudel, A. & Ramasamy, G., 10 Jan 2023, In: AAPS PharmSciTech. 24, 1, 16 p., 34.

Research output: Contribution to journal › Article › peer-review

Open Access

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Machine Learning-Enabled NIR Spectroscopy. Part 3: Hyperparameter by Design (HyD) Based ANN-MLP Optimization, Model Generalizability, and Model Transferability

Ali, H., Muthudoss, P., Chauhan, C., Kaliappan, I., Kumar, D., Paudel, A. & Ramasamy, G., Dec 2023, In: AAPS PharmSciTech. 24, 8, 254.

Research output: Contribution to journal › Article › peer-review

Open Access

Mechanoactivation as a Tool to Assess the Autoxidation Propensity of Amorphous Drugs

Iyer, J., Barbosa, M., Saraf, I., Pinto, J. F. & Paudel, A., 6 Feb 2023, In: Molecular Pharmaceutics. 20, 2, p. 1112-1128 17 p.

Research output: Contribution to journal › Article › peer-review

On the influence of raw material attributes on process behaviour and product quality in a continuous wet granulation tableting line.

Zupančič, O., Doğan, A., Martins Fraga, R., Demiri, V., Paudel, A., Khinast, J. G., Spörk, M. & Sacher, S., 1 Jun 2023, In: International Journal of Pharmaceutics. 642, 123097.

Research output: Contribution to journal › Article › peer-review

Pancreatic lipase digestion: The forgotten barrier in oral administration of lipid-based delivery systems?

Zupančič, O., Kushwah, V. & Paudel, A., Oct 2023, In: Journal of Controlled Release. 362, p. 381-395 15 p.

Research output: Contribution to journal › Review article › peer-review

Pharmaceutical hot melt extrusion process development using QbD and digital twins

Matić, J., Stanković-Brandl, M., Bauer, H., Lovey, J., Martel, S., Herkenne, C., Paudel, A. & Khinast, J., 25 Jan 2023, In: International Journal of Pharmaceutics. 631, 122469.

Research output: Contribution to journal › Article › peer-review

pH stimuli-responsive hydrogels from non-cellulosic biopolymers for drug delivery

Vegad, U., Patel, M., Khunt, D., Zupančič, O., Chauhan, S. & Paudel, A., Sept 2023, In: Frontiers in Bioengineering and Biotechnology. 11, 1270364.

Research output: Contribution to journal › Review article › peer-review

Open Access

File

Role of Crystal Disorder and Mechanoactivation in Solid-State Stability of Pharmaceuticals

Iyer, J., Brunsteiner, M., Modhave, D. & Paudel, A., Jun 2023, In: Journal of Pharmaceutical Sciences. 112, 6, p. 1539-1565 27 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

File

Screening Autoxidation Propensities of Drugs in the Solid-State Using PVP and in the Solution State Using N-Methyl Pyrrolidone

Iyer, J., Karn, A., Brunsteiner, M., Ray, A., Davis, A., Saraf, I. & Paudel, A., Mar 2023, In: Pharmaceutics. 15, 3, 848.

Research output: Contribution to journal › Article › peer-review

Open Access

Temperature cycling-induced formation of crystalline coatings

Zellnitz-Neugebauer, S., Lanzinger, M., Schröttner, H., Naderi, M., Guo, M., Paudel, A., Gruber-Wölfler, H. & Neugebauer, P., 2023, In: International Journal of Pharmaceutics. 632, 11 p., 122577.

Research output: Contribution to journal › Article › peer-review

Open Access

The Impact of the Water Evaporation Rate and Saccharide Excipients on the Oxidative Degradation of Polysorbates During Oven Drying and Spray Drying

Pinto, J. T., Rajkovaca, M. & Paudel, A., Jan 2023, In: Journal of Pharmaceutical Sciences. 112, 1, p. 36-39 4 p.

Research output: Contribution to journal › Article › peer-review

Theoretical and Experimental Investigation of Autoxidation Propensity of Selected Drugs in Solution State

Iyer, J., Brunsteiner, M., Ray, A., Davis, A., Saraf, I. & Paudel, A., 6 Mar 2023, In: Molecular Pharmaceutics. 20, 3, p. 1768-1778 11 p.

Research output: Contribution to journal › Article › peer-review

Trends in oral small-molecule drug discovery and product development based on product launches before and after the Rule of Five

Stegemann, S., Moreton, C., Svanbäck, S., Box, K., Motte, G. & Paudel, A., Feb 2023, In: Drug Discovery Today. 28, 2, 103344.

Research output: Contribution to journal › Review article › peer-review

Open Access

2022

Assessment of Diverse Solid-State Accelerated Autoxidation Methods for Droperidol

Iyer, J., Saraf, I., Ray, A., Brunsteiner, M. & Paudel, A., Jun 2022, In: Pharmaceutics. 14, 6, 1114.

Research output: Contribution to journal › Article › peer-review

Open Access

File

A Tribute to Professor Saranjit Singh - A Critical Thinker, Innovator, Mentor, and Educator

Ladumor, M. K., Paudel, A., Modhave, D., Sharma, S., Balhara, A., Singh, D. K., Ramalingam, M., Shah, R., Pavankumarraju, S., Kurmi, M., Mariappan, T. T., Bhutani, H. & Prasad, B., May 2022, In: Journal of Pharmaceutical Sciences. 111, 5, p. 1224-1231 8 p.

Research output: Contribution to journal › Comment/debate › peer-review

Continuous Processing of Micropellets via Hot-Melt Extrusion

Spörk, M., Koutsamanis, I., Kottlan, A., Makert, C., Piller, M., Rajkovaca, M., Paudel, A. & Khinast, J. G., Oct 2022, In: AAPS PharmSciTech. 23, 7, 264.

Research output: Contribution to journal › Article › peer-review

Elucidation of the effect of added fines on the performance of dry powder inhalation formulations

Stankovic-Brandl, M., Radivojev, S., Sailer, P., Penz, F. K. & Paudel, A., 15 Dec 2022, In: International Journal of Pharmaceutics. 629, 122359.

Research output: Contribution to journal › Article › peer-review

Focusing on powder processing in dry powder inhalation product development, manufacturing and performance

Stegemann, S., Faulhammer, E., Pinto, J. T. & Paudel, A., Feb 2022, In: International Journal of Pharmaceutics. 614, 121445.

Research output: Contribution to journal › Review article › peer-review

Forced Solid-State Oxidation Studies of Nifedipine-PVP Amorphous Solid Dispersion

Saraf, I., Roskar, R., Modhave, D., Brunsteiner, M., Karn, A., Neshchadin, D., Gescheidt, G. & Paudel, A., 7 Feb 2022, In: Molecular Pharmaceutics. 19, 2, p. 568-583 16 p.

Research output: Contribution to journal › Article › peer-review

Impact of Extractables/Leachables from Filter Materials on the Stability of Protein-Based Pharmaceutical Products

Kushwah, V., Münzer, J., Feenstra, V., Mohr, S. & Paudel, A., Oct 2022, In: AAPS PharmSciTech. 23, 7, 233.

Research output: Contribution to journal › Article › peer-review

Open Access

Insights into the Impact of Nanostructural Properties on Powder Tribocharging: The Case of Milled Salbutamol Sulfate

Beretta, M., Pinto, J. T., Laggner, P. & Paudel, A., 7 Feb 2022, In: Molecular Pharmaceutics. 19, 2, p. 547-557 11 p.

Research output: Contribution to journal › Article › peer-review

Lipid-based solubilization technology via hot melt extrusion: promises and challenges

Zupančič, O., Spoerk, M. & Paudel, A., 2022, In: Expert Opinion on Drug Delivery. 19, 9, p. 1013-1032 20 p.

Research output: Contribution to journal › Review article › peer-review

Machine Learning-Enabled NIR Spectroscopy in Assessing Powder Blend Uniformity: Clear-Up Disparities and Biases Induced by Physical Artefacts

Muthudoss, P., Tewari, I., Chi, R. L. R., Young, K. J., Ann, E. Y. C., Hui, D. N. S., Khai, O. Y., Allada, R., Rao, M., Shahane, S., Das, S., Babla, I., Mhetre, S. & Paudel, A., Oct 2022, In: AAPS PharmSciTech. 23, 7, 277.

Research output: Contribution to journal › Article › peer-review

Open Access

Phase Behavior of Drug-Lipid-Surfactant Ternary Systems toward Understanding the Annealing-Induced Change

Kushwah, V., Gomes Lopes, D., Saraf, I., Koutsamanis, I., Werner, B., Zangger, K., Roy, M. C., Bartlett, J. A., Frericks Schmidt, H., Shamblin, S. L., Laggner, P. & Paudel, A., 7 Feb 2022, In: Molecular Pharmaceutics. 19, 2, p. 532-546 15 p.

Research output: Contribution to journal › Article › peer-review

Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap

Stegemann, S., Sheehan, L., Rossi, A., Barrett, A., Paudel, A., Crean, A., Ruiz, F., Bresciani, M., Liu, F., Shariff, Z., Shine, M., Schmelzer, C. & Pense-Lheritier, A. M., Aug 2022, In: European Journal of Pharmaceutics and Biopharmaceutics . 177, p. 81-88 8 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

SEDEX—Self-Emulsifying Delivery Via Hot Melt Extrusion: A Continuous Pilot-Scale Feasibility Study

Zupančič, O., Doğan, A., Matić, J., Kushwah, V., Alva, C., Spoerk, M. & Paudel, A., Dec 2022, In: Pharmaceutics. 14, 12, 2617.

Research output: Contribution to journal › Article › peer-review

Open Access

The Influence of Relative Humidity and Storage Conditions on the Physico-chemical Properties of Inhalation Grade Fine Lactose

Stankovic-Brandl, M., Zellnitz, S., Wirnsberger, P., Kobler, M. & Paudel, A., Jan 2022, In: AAPS PharmSciTech. 23, 1, 1.

Research output: Contribution to journal › Article › peer-review

Topologically directed confocal Raman imaging (TD-CRI): Advanced Raman imaging towards compositional and micromeritic profiling of a commercial tablet components

Muthudoss, P., Kumar, S., Ann, E. Y. C., Young, K. J., Chi, R. L. R., Allada, R., Jayagopal, B., Dubala, A., Babla, I. B., Das, S., Mhetre, S., Saraf, I. & Paudel, A., 20 Feb 2022, In: Journal of Pharmaceutical and Biomedical Analysis. 210, 114581.

Research output: Contribution to journal › Article › peer-review

2021

Analytical and Computational Methods for the Determination of Drug-Polymer Solubility and Miscibility

Thakore, S. D., Akhtar, J., Jain, R., Paudel, A. & Bansal, A. K., 2 Aug 2021, In: Molecular Pharmaceutics. 18, 8, p. 2835-2866 32 p.

Research output: Contribution to journal › Review article › peer-review

Development and validation of a stability-indicating uplc method for the determination of hexoprenaline in injectable dosage form using aqbd principles

Urich, J. A. A., Marko, V., Boehm, K., García, R. A. L., Jeremic, D. & Paudel, A., 1 Nov 2021, In: Molecules. 26, 21, 6597.

Research output: Contribution to journal › Article › peer-review

Open Access

Amrit Paudel

Research output

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