91Ó°ÊÓ

Prof Schlindwein graduated as Chemical Engineer in 1984 from the Federal University of Rio de Janeiro, UFRJ, Brazil. She obtained her M.Sc. in Polymer Science and Technology from the Institute of Macromolecules of the UFRJ, Brazil in 1986, PhD in Chemistry from the Department of Chemistry of the University of Leicester, England, in 1990, and DSc in Chemistry from the UFRJ in 1992. 

She has over 25 years of experience in academia and is currently Professor of Pharmaceutics at the Leicester School of Pharmacy, De 91Ó°ÊÓ University (91Ó°ÊÓ). She has led the creation of the first MSc in Pharmaceutical Quality by Design (QbD) that has attracted national and international students since 2012. In the UK, education provision in the QbD area has been largely dominated by this programme. She has established a high-profile curriculum in this domain, through engagement with a number of multinational companies, including Astra Zeneca and GlaxoSmithKline, technology providers and the UK regulatory agency, MHRA. She has chaired several events and workshops to support and publicise the research and teaching excellence in pharmaceutical product development and manufacture. Her expertise is in the areas of polymer science and technology, advanced techniques for materials’ characterisation, pharmaceutical Quality by Design, and extrusion processes for early phase product development using in-line analytical tools

• Leicester Institute for Pharmaceutical Health and Social Care Innovations

 

Her current research focuses on material sciences, especially polymers used in pharmaceutical applications. She supervises PhD students on projects related to improving the formulation of poorly soluble drugs and conducting studies using various methods for amorphisation of crystalline drug actives like hot melt extrusion. She has extensive knowledge in Pharmaceutical Quality by Design practices applied to product development and manufacture.

• Quality by Design Principles and Tools

•  Pharmaceutical Materials Sciences

• Process Analytical Technology

• Hot Melt ExtrusionPharmaceutical Product Development and Manufacture

• PhD, MSc, ChemEng

•  BSc Pharmaceutical and Cosmetic Science,

•  Full time MSc Pharmaceutical Quality by Design,

•  Distance learning in MSc Quality by Design for the Pharmaceutical Industry

 

Member of the CMAC Advisory Board at University of Strathclyde

•  Member of the Academy of Pharmaceutical Sciences and Regulatory Focus Group

•  Member of the International Society of Pharmaceutical Engineering and Modelling Focus Group

 Contimuous manufacture of amorphous dispersions of porrly soluble drugs (2017 to date)

In-line process analytical technology for process monitoring (2028 to date)

Amorphous solid dispersion solubility predictions (2020 to date)

Tabletting School 2025 meeting at Leicester, 17-18th June 2025

A Hands-On Approach to Mastering Tablet Production

Bezerra, M.; Muirhead, G.; Berghaus, A.; Schlindwein, W., Enabling Rapid Product Development with in-line UV-Vis Spectroscopy as PAT tool for Hot Melt Extrusion: A case study, The Ninth pan-European Conference on PAT and QbD Sciences, EuFEPS, Manchester, May 2018

Almeida, J.; Bezerra, M.; Berghaus, A.; Markl, D.; Zeitler, A.; Muirhead, G., and Schlindwein, W., Building Predictive Models for in-line UV-Vis Spectroscopy to Monitor Continuous Pharmaceutical Hot Melt Extrusion Processes, 3rd International Symposium on Continuous Manufacturing Processes, London October 2018.

 Triboandas, H.; Schlindwein, W., Continuous manufacture and monitoring of itraconazole amorphous solid dispersions by hot melt extrusion using in-line UV-Vis spectroscopy, UkPharm Sci, APS meeting, Greenwich, 11-13 Sep 2019.

 Bezerra, M., Almeida, J., Triboandas, H., Berghaus, A., Parekh, R., Whitaker, D., Mack, J, and Schlindwein, W., HME process optimisation with in-line UV-Vis spectroscopy and machine learning algorithm, PBP world meeting, Austria, 23-26 March 2020.

Bezerra, M., Almeida, J., de Castro, M., Grootveld, M., and Schlindwein, W. Hot-Melt extrusion monitoring through In-line UV-Vis spectroscopy: challenging the framework using QbD, APS Annual Conference, Huddersfield, Sep 2024.

 de Castro, M, Smith, S., Khurana, J., Cordeiro, S. and Schlindwein, W., New Insights into Ibuprofen Polymorph Interconversion: Addressing Unresolved Dynamics, APS Annual Conference, Huddersfield, Sep 2024.

1. Almeida, J., Bezerra, M., Markl, D., Berghaus, A., Borman, P. and Schlindwein, W., Development and Validation of an in-line API Quantification Method using AQbD Principles based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process, Pharmaceutics, 12(2), 150 (2020) .
2. Triboandas, Hetvi; Pitt, Kendal; Bezerra, Mariana; Ach-Hubert, Delphine; Schlindwein, Walkiria, (2022), Itraconazole Amorphous Solid Dispersion Tablets: Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools, Pharmaceutics, 14(11) 2398,
3. Triboandas, H., Bezerra, M., Almeida, J., de Castro, M., Santos, B.A.M.C. and Schlindwein, W. (2024) Optimizing extrusion processes and understanding conformational changes in itraconazole amorphous solid dispersions using in-line UV–Vis spectroscopy and QbD principles. International Journal of Pharmaceutics: X, 8, pp. 100308.
4. Bezerra, M.; Almeida, J.; de Castro, M.; Grootveld, M.; Schlindwein,W. Enhancing Process Control and Quality in Amorphous Solid Dispersions Using In-Line UV–Vis Monitoring of L* as a Real-Time Response. Pharmaceutics (2025), 17, 151. .

 

The development of amorphous solid dispersions (ASDs) via hot melt extrusion (HME) has made significant progress and is increasingly recognized as a valuable technique inpharmaceutical formulation. ASDs improve the solubility and bioavailability ofpoorly water-soluble drugs by transforming them into an amorphous state, which is generallymore soluble than their crystalline counterparts. HME is especially useful inthis area because it efficiently disperses active pharmaceutical ingredients (APIs) withina polymer matrix through the application of heat and mechanical shear. Its versatility allows for continuous processing, the creation of various dosage forms (like films,tablets, and granules), solvent free process, and enhanced scalability. 

Over the past two decades, regulatory authorities have collaborated with industry toadvance changes in the quality paradigm, aiming to understand pharmaceutical processesand product quality more comprehensively. This new approach, often referred to as the’enhanced’ approach or pharmaceutical quality by design (QbD), encourages innovation across the pharmaceutical lifecycle.

The research carried out in the last 5 years show the potential of QbD approaches using continuous extrusion to advance the field of process analytical technology by offering a robust, real-time solution for ensuring product quality and optimizing manufacturing processes.

  Product Development – company RB (2022)

The project aimed to create solid dispersions in the form of powders and pellets using the hot melt extrusion method. It involved six different workstreams, each focused on a different active ingredient.

In-line PAT for cleaning validation – company Kindeva (2022/23)

The project aimed to investigate the feasibility of UV-Vis spectrophotometry in transmission configuration for the process control of pharmaceutical cleaning, batching and manufacturing.

Fast screening methods to develop amorphous drug products via hot melt extrusion – company RB (2021/22)

The project focused on developing methods for formulation optimisation and scall up manufacturing methods.

• Matheus de Castro – PhD student, 1^st supervisor (2024/27)
• Chuhong Cheng – PhD student, 2^nd supervisor (2024/27)

Industry funded project: Smart manufacturing platform for innovative oral delivery of amorphous drug substances (£120 k, PI – 2024/27)

This PhD project focuses on creating a new type of ibuprofen tablet that dissolves quickly in your mouth. The main goal is to explore how using a special form of ibuprofen (called "amorphous") can help solve problems with current medicines. This could lead to better manufacturing processes (like easier handling of the powder) and improved results for patients, such as better absorption of the drug and a better taste.

EPSRC grant: Mechanistic Multiscale Modelling of Drug Release from Immediate Release Tablets (£1.1 M, Co-I – 2024/27)

This is an EPSRC project lead by 91Ó°ÊÓ in collaboration with University of Surrey. The aim of the project is to develop first principles model to predict drug release profile from an IR tablet.

Innovate UK grant: A Regulatory Science Network for the Digital Transformation of Medicines Development and Manufacturing (£1 M CoI – 2024/25)

The proposed project aims to generate research and insights to help modernize the way medicines are developed and made in the pharmaceutical industry. It focuses on using data science, including artificial intelligence (AI) and predictive models, to improve the processes of creating and manufacturing medicines, especially in the health and life sciences fields. This project is in collaboration with University of Strathclyde, and CCDC Cambridge.

Novel Composition 2022 - International Publication number W O 2022/185073 Al

This invention is directed to a novel pharmaceutically active ingredient-containing composition. In particular, the present invention is directed to an NSAID-containing 5 composition in which the NSAID is in an amorphous form.