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Impact of Material Attributes & Process Parameters on Critical Quality Attributes of the Amorphous Solid Dispersion Products

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Impact of Material Attributes & Process Parameters on Critical Quality Attributes of the Amorphous Solid Dispersion Products Impact of material attributes & process parameters on critical quality attributes of the amorphous solid dispersion products obtained using hot melt extrusion Aniket Deepak Sabnis Submitted for the degree of Doctor of Philosophy Faculty of Life Sciences University of Bradford 2019 Impact of material attributes & process parameters on critical quality attributes of the amorphous solid dispersion products obtained using hot melt extrusion Aniket Deepak Sabnis Submitted for the degree of Doctor of Philosophy Faculty of Life Sciences University of Bradford 2019 Abstract Keywords: Hot melt extrusion, solid dispersion, crystallisation, Ibuprofen, Polyox, Soluplus®, AffinisolTMHPMC, controlled release. The feasibility of hot melt extrusion (HME) was explored for development of amorphous solid dispersion systems. Controlled release formulations were developed using a cellulose based derivative, AffinisolTMHPMC 100cP and 4M grades. BCS class II drugs ibuprofen and posaconazole were selected due to their difference in glass transition temperature and lipophilicity. This study focused on investigation of the impact the material attributes and process parameters on the critical quality attributes in preparation of amorphous solid dispersions using hot melt extrusion. The critical quality attributes were sub divided into three main attributes of material, process and product. Rheology of ibuprofen-Affinisol 100cP from melt phase to extrudate phase was tracked. A partial factorial design was carried out to investigate the critical parameters affecting HME. For optimisation of 40%IBU-Affinisol 100cP blends, a feed rate of 0.6kg/hr, screw speed of 500rpm and screw configuration with two mixing elements were found to be optimum for single phase extrudates. ATR-FTIR spectroscopy was found to be an indirect technique of choice in predicting the maximum ibuprofen drug load within extrudates. Prediction was based on the prepared extrudates without charging them to stability conditions. i An alternative strategy of incorporation of di-carboxylic acids to increase the dissolution of posaconazole-Affinisol 4M blends was investigated. Succinic acid and L- malic acid incorporation was found to increase the dissolution of posaconazole. Although, the extrudates crystallised out quicker than the naïve posaconazole-Affinisol 4M, but free posaconazole formed eutectic and co- crystal with succinic and L-malic acid within extrudates. This lead to an increase in dissolution of the extrudates compared to day 0. ii Declaration No portion of the work referred to in the thesis has been submitted in support of an application for another degree or qualification of this or any other university or other institute of learning i. The author of this thesis (including any appendices and/or schedules to this thesis) owns certain copyright or related rights in it (the “Copyright”) and s/he has given The University of Bradford certain rights to use such Copyright, including for administrative purposes. ii. Copies of this thesis, either in full or in extracts and whether in hard or electronic copy, may be made only in accordance with the Copyright, Designs and Patents Act 1988 (as amended) and regulations issued under it or, where appropriate, in accordance with licensing agreements which the University has from time to time. This page must form part of any such copies made. iii. The ownership of certain Copyright, patents, designs, trade marks and other intellectual property (the “Intellectual Property”) and any reproductions of copyright works in the thesis, for example graphs and tables (“Reproductions”), which may be described in this thesis, may not be owned by the author and may be owned by third parties. Such Intellectual Property and Reproductions cannot and must not be made available for use without the prior written permission of the owner(s) of the relevant Intellectual Property and/or Reproductions. iii iv. Further information on the conditions under which disclosure, publication and commercialisation of this thesis, the Copyright and an Intellectual Property University IP Policy see https://www.bradford.ac.uk/governance/ordinancesregulations/regulations/un iversity-regulations/regulation-14/), in any relevant Thesis restriction declarations deposited in the University Library, The University Library’s regulations (see https://www.bradford.ac.uk/library/about-us/regulations-and- policies/) and in the University’s policy on Presentation of Theses. iv Table of Contents Abstract ......................................................................................................... i Declaration .................................................................................................. iii Table of Contents ......................................................................................... v Abbreviations and symbols ...................................................................... xii List of Figures ............................................................................................ xv Chapter 1: Introduction ............................................................................. 25 1.1 Research objectives ........................................................................... 26 Ibuprofen ............................................................................................... 28 Posaconazole ........................................................................................ 30 AffinisolTMHPMC .................................................................................... 32 Dicarboxylic acids as co-formers ........................................................... 34 1.2 Thesis outline ..................................................................................... 38 Chapter 2: Literature review ...................................................................... 40 2.1 Introduction ......................................................................................... 40 2.1.1 Solid State chemistry .................................................................... 43 2.1.2 Classification of Solid forms ......................................................... 43 2.2 Cocrystals ........................................................................................... 45 2.3 Amorphous systems ........................................................................... 50 2.3.1 Limitations of amorphous form ..................................................... 52 2.3.2 Stabilisation of amorphous form ................................................... 53 2.4 Solid dispersion .................................................................................. 54 v 2.4.1 Factors affecting solubility of solid dispersions ............................. 56 2.4.2 Limitations of solid dispersions ..................................................... 59 2.5 Screening techniques for amorphisation ............................................. 59 2.5.1 Amorphisation- solution based techniques ................................... 61 2.5.1.1 Melting and quench cooling.................................................... 61 2.5.1.2 Spray drying ........................................................................... 63 2.5.1.3 Freeze drying ......................................................................... 65 2.5.1.4 Flash evaporation /Rotary evaporation .................................. 65 2.5.1.5 Supercritical fluid processing .................................................. 66 2.5.2 Amorphisation- Solid-state techniques ......................................... 66 2.5.2.1 Dehydration of crystalline hydrates ........................................ 66 2.5.2.2 Milling ..................................................................................... 67 2.5.2.3 Vacuum compression moulding ............................................. 69 2.6 Hot melt extrusion (HME) ................................................................... 71 2.6.1 Background and need in pharma ................................................. 72 2.6.2 Mechanism of Hot Melt Extrusion ................................................. 77 2.6.3 Selection of drug candidate .......................................................... 81 2.6.4 Polymer selection for HME ........................................................... 81 2.6.5 Pre-formulation and characterisation ............................................ 83 2.6.7 Process analytical technology (PAT) ............................................ 85 2.6.7 Advantages of HME...................................................................... 88 2.6.8 Challenges and Shortcomings ...................................................... 88 2.6.9 Summary ...................................................................................... 89 vi Chapter 3: Materials and Methods ............................................................ 90 3.1 Materials ............................................................................................. 90 3.2 Methods .............................................................................................. 90 3.2.1 Preformulation and characterisation of polymer, API and co-former properties .............................................................................................. 90 3.2.1.1 Thermo-analytical instruments ............................................... 90 3.2.1.1.1 Differential Scanning Calorimetry (DSC) .......................... 90 3.2.1.1.2 Thermo Gravimetric Analyser (TGA) ...............................
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