Webinar series: Advances In Amorphous Solid Dispersion Technologies

In this series of webinars we will discuss the latest developments in the fields of amorphous solid dispersion (ASD) focusing on Excipient Key Attributes linked to the most popular technologies: Hot Melt Extrusion (HME), Spray Drying and their Downstream Processing.

During these presentations Shin-Etsu, Leistritz, ProCepT, Alexanderwerk as well as invited speakers will give you more insights into ASD.

FIRST WEBINAR – Tuesday 29 June, 3pm CEST, 9am EST

SECOND WEBINAR – Wednesday 22 September, 3pm CEST, 9am EST

THIRD WEBINAR – Thursday 28 October, 3pm CEST, 9am EST

First Webinar: Hot Melt Extrusion (HME)

Hot Melt Extrusion is a well established technology used in ASDs. Besides the advantage of being a solvent free method some attributes of the API and polymer have to be considered like glass transition temperature and decomposition temperature.

Shin-Etsu, Leistritz, and Prof. Serajuddin from St. John‘s University will give you more insights into this technology.

The objective of this webinar is to address:

• How the extruder configuration can impact the ASD
• The advantages of HPMCAS in ASD
• How to optimize the extrusion process of HPMCAS

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First presentation: Hot melt extrusion for amorphous solid dispersion – Process Design and Applications

Speaker:
Kathrin Reusch, Leistritz GmbH

Presentation abstract:

The presentation will give a short background on solid dispersion by Hot Melt Extrusion showing specific process layouts of marketed extruded products.

Based on the case study: “Hot Melt Extrusion of Ritonavir/Lopinavir” process relevant parameters and their impact on the final product quality including scalability will be discussed.

Speaker biography:

Kathrin obtained her degree as Master of Science at the  University of Applied Science Fulda/Germany in 2014

The same year she joined Leistritz as a process engineer (Pharma) responsible for:

• Preparation, conduction and follow-up of extrusion trials – Definition of process layouts
• Process optimization, customer support & training
• Scale-Up experience
• Installation support (FAT, SAT)
• Organization of extrusion events (Pharma extrusion academy) and marketing tasks (website, publication, seminars)

In 2019 she took over the responsibility of product manager.

Second Presentation: Development of HPMCAS-based amorphous solid dispersions by melt extrusion

Speaker:
Abu Serajuddin, PhD, Professor of Industrial Pharmacy, College of Pharmacy and Health Sciences, St. John’s University, Queens, New York, USA

Presentation Abstract:

Despite the recent interest in the use of solvent-free hot-melt extrusion (HME) method for the development of HPMCAS-based ASDs, its application in the development of marketed products has rather been limited. Indeed, out of 7 ASDs containing HPMCAS that have been marketed in recent years, only one was manufactured by HME. HME is not generally used as it requires very high temperature to extrude HPMCAS (≥170°C), where the polymer and drug may degrade. The situation may change based on recent studies in our laboratory. We studied the effects of three solid surfactants (poloxamer 188, poloxamer 407 and TPGS) and a model drug (itraconazole) in reducing complex viscosity and thus processing temperature of HPMCAS-based ASDs.

Speaker biography:

Abu Serajuddin, PhD, is Professor of Industrial Pharmacy at St. John’s University, Queens, New York, USA.

Prior to joining academia in 2008, Dr. Serajuddin worked in the pharmaceutical industry for 32 years in scientific and managerial positions at Sanofi-Aventis, BMS, and Novartis. In his latest positions in the industry, he served as Executive Director and the US Head of Pharmaceutical R&D at Novartis Pharmaceutical Corp. He also headed Science and Technology (S&T) Forum at Novartis, responsible for fostering innovation in the company globally. He has published over 125 papers and book chapters, and he is a co-inventor in 13 patents. In recognition of his scientific and professional achievements, he was elected Fellow of American Pharmacists Association (APhA) and American Association of Pharmaceutical Scientists (AAPS).  AAPS also recognized him with three of its highest awards, namely, AAPS Research Achievement Award in Formulation Design and Development in 2010, AAPS Research Achievement Award in Manufacturing Science & Engineering in 2014, and the AAPS Lipid-based Drug Delivery Outstanding Research Award in 2015. Among many leadership positions in the AAPS, Dr. Serajuddin served as the chair of the Preformulation Focus Group (1994-96) and the Pharmaceutics and Drug Delivery Section (2001). He received the Ralph Shangraw Memorial Award in 2016, which is the highest scientific recognition given by the International Pharmaceutical Excipients Council (IPEC). For his academic and research excellence as a member of the faculty, St. John’s University bestowed him the University Medal for Outstanding Achievement in 2019.

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Selected Recent Publications on HME from Serajuddin Laboratory:

1. Kathawala, M. H., Solanki, N.G.,  Patel, N.G.,  Serajuddin, A. T. M. 2021. Effects of Surfactants on Itraconazole-HPMCAS Solid Dispersion Prepared by Hot Melt Extrusion, IV: Investigation of Polymer Grades and Extrudate Particle Size on Product Performance. Manuscript to be submitted to Journal of Pharmaceutical Sciences.
2. Patel, N.G. and Serajuddin, A.T., 2021. Development of FDM 3D-printed tablets with rapid drug release, high drug-polymer miscibility and reduced printing temperature by applying the acid-base supersolubilization (ABS) principle. International Journal of Pharmaceutics, 600, p.120524.
3. Siriwannakij, N., Heimbach, T., Serajuddin, A.T.M., 2021. Aqueous Dissolution and Dispersion Behavior of Polyvinylpyrrolidone Vinyl Acetate-based Amorphous Solid Dispersion of Ritonavir Prepared by Hot-Melt Extrusion with and without Added Surfactants. Journal of Pharmaceutical Sciences, 110(4), pp.1480-1494.
4. Batra, A., Desai, D. and Serajuddin, A.T., 2020. Conversion of α-lactose monohydrate to anhydrous form with superior tabletability by twin-screw extrusion at elevated temperature. International Journal of Pharmaceutics, 588, p.119790.
5. Can Wei, Nayan G. Solanki, Jaydip M. Vasoya, Ankita V. Shah, Abu T. M. Serajuddin. 2020. Development of 3D Printed Tablets by Fused Deposition Modeling Using Polyvinyl Alcohol as Polymeric Matrix for Rapid Drug Release. Journal of Pharmaceutical Sciences. 109(4), pp.1558-1572.
6. Solanki, N.G., Kathawala, M. and Serajuddin, A.T., 2019. Effects of Surfactants on Itraconazole-Hydroxypropyl Methylcellulose Acetate Succinate Solid Dispersion Prepared by Hot Melt Extrusion III: Tableting of Extrudates and Drug Release from Tablets. Journal of pharmaceutical sciences, 108(12), pp.3859-3869.
7. Solanki, N.G., Gumaste, S.G., Shah, A.V. and Serajuddin, A.T., 2019. Effects of Surfactants on Itraconazole-HPMCAS Solid Dispersion Prepared by Hot Melt Extrusion. II: Rheological Analysis and Extrudability Testing. Journal of Pharmaceutical Sciences. 108(9), pp. 3063-3073
8. Solanki, N.G., Lam, K., Tahsin, M., Gumaste, S.G., Shah, A.V. and Serajuddin, A.T., 2019. Effects of surfactants on itraconazole-HPMCAS solid dispersion prepared by hot-melt extrusion I: Miscibility and drug release. Journal of pharmaceutical sciences, 108(4), pp.1453-1465.
9. Vasoya, J.M., Desai, H.H., Gumaste, S.G., Tillotson, J., Kelemen, D., Dalrymple, D.M. and Serajuddin, A.T., 2019. Development of Solid Dispersion by Hot Melt Extrusion Using Mixtures of Polyoxylglycerides With Polymers as Carriers for Increasing Dissolution Rate of a Poorly Soluble Drug Model. Journal of pharmaceutical sciences, 108(2), pp.888-896.
10. Solanki, N.G., Tahsin, M., Shah, A.V. and Serajuddin, A.T., 2018. Formulation of 3D printed tablet for rapid drug release by fused deposition modeling: screening polymers for drug release, drug-polymer miscibility and printability. Journal of pharmaceutical sciences, 107(1), pp.390-401.
11. Solanki, N., Gupta, S.S. and Serajuddin, A.T., 2018. Rheological analysis of itraconazole-polymer mixtures to determine optimal melt extrusion temperature for development of amorphous solid dispersion. European Journal of Pharmaceutical Sciences, 111, pp.482-491.
12. Parikh, T. and Serajuddin, A.T., 2018. Development of fast-dissolving amorphous solid dispersion of itraconazole by melt extrusion of its mixture with weak organic carboxylic acid and polymer. Pharmaceutical research, 35, pp.1-10.
13. G. Gumaste, S. S. Gupta, A. T. M. Serajuddin. Investigation of Polymer-Surfactant and Polymer-Drug-Surfactant Miscibility for Solid Dispersion. AAPS Journal. 18(5), 1131–1143 (2016)
14. Parikh, H.K. Sandhu, T.T. Talele, A.T.M. Serajuddin. Development of Amorphous Solid Dispersions of Itraconazole Prepared by Solubilization in Concentrated Aqueous Solutions of Weak Organic Acids and Drying. Pharmaceutical Research, 33:1456–1471 (2016) \T. Parikh, S. S. Gupta, A. K. Meena, I. Vitez, N. Mahajan, A. T. M. Serajuddin. Application of film casting technique to investigate drug-polymer miscibility and physical stability of hot melt extrudates. Journal of Pharmaceutical Sciences, 104 (7), 2142-2152 (2015).
15. S. Gupta, A. Meena, T. Parikh, N Mahajan, I. Vitez, A. T. M. Serajuddin. Effect of Carbamazepine on the Viscoelastic Properties of Soluplus®. International Journal of Pharmaceutics, 478, 232-239 (2015).
16. Parikh, S. S. Gupta, A. Meena, A. T. M. Serajuddin. Investigation of thermal and viscoelastic properties of polymers relevant to hot melt extrusion, III: polymethacrylates and polymethacrylic acid based polymers. Journal of Excipients and Food Chemicals, 2014:5(1), 56-64.
17. Meena, T. Parikh, S. S. Gupta, A. T. M. Serajuddin. Investigation of thermal and viscoelastic properties of polymers relevant to hot melt extrusion, II: Cellulosic polymers. Journal of Excipients and Food Chemicals, 2014: 5(1), 46-55.
18. S. Gupta, A. Meena, T. Parikh, A. T. M. Serajuddin. Investigation of thermal and viscoelastic properties of polymers relevant to hot melt extrusion, I: Polyvinylpyrrolidone and related polymers. Journal of Excipients and Food Chemicals, 2014; 5(1), 32-45.