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Correlation of Physicochemical Properties of Model Drugs and Aerosol Deposition

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Correlation of Physicochemical Properties of Model Drugs and Aerosol Deposition CORRELATION OF PHYSICOCHEMICAL PROPERTIES OF MODEL DRUGS AND AEROSOL DEPOSITION w ANA CATARINA MATOS DE OLIVEIRA A thesis submitted for the degree of Doctor of Philosophy Department of Pharmaceutics The School of Pharmacy, University of London 29-39 Brunswick Square London WC IN 1 AX, UK MARCH 2009 ProQuest Number: 10104755 All rights reserved INFORMATION TO ALL USERS The quality of this reproduction is dependent upon the quality of the copy submitted. In the unlikely event that the author did not send a complete manuscript and there are missing pages, these will be noted. Also, if material had to be removed, a note will indicate the deletion. uest. ProQuest 10104755 Published by ProQuest LLC(2016). Copyright of the Dissertation is held by the Author. All rights reserved. This work is protected against unauthorized copying under Title 17, United States Code. Microform Edition © ProQuest LLC. ProQuest LLC 789 East Eisenhower Parkway P.O. Box 1346 Ann Arbor, Ml 48106-1346 Plagiarism Statement This thesis describes research conducted in the School of Pharmacy, University of London between 2004 and 2008 under the supervision of Prof. Graham Buckton and Dr. Simon Gaisford. I certify that the research described is original and that any parts of the work that have been conducted by collaboration are clearly indicated. I also certify that I have written all the text herein and have clearly indicated by suitable citation any part of this dissertation that has already appeared in publication. Signature Date Abstract Dry powder inhalers (DPIs) are recognized devices for the administration of medicines to the lungs. Nevertheless, in general the effectiveness of these devices is poor generating respiratory depositions lower than 20%. The major reason for this occurrence is possibly related to the inter particulate forces between the drug and carrier components of a DPI formulation. The surface energy of the involved particles in these systems may be critical since it is implicated on the detachment mechanism among drug and carrier particles upon aerosolization. The aim of this thesis is to test the hypothesis that the adhesion between fine particles and the carrier should correlate with the surface energy, if the morphology of all samples is identical. To investigate this it was necessary to test the in vitro deposition of spherical particles with different surface energies assessed by Inverse Gas Chromatography (IGC) using the same carrier lactose and inhaler (Aerolizer®). A range of polymers and drugs were used to create spherical model “drugs” by spray drying and their deposition patterns were then investigated on the Twin Stage Impinger (TSI). Subsequent to the establishment of settings in the SDMicro™ Spray Diyer four model drugs were selected and reproducibly produced throughout namely. Polyacrylic Acid (PAA), Salbutamol Sulphate (SS), Polyvinyl Alcohol (PVA) and Polyvinyl Pyrrolidone (PVP). The morphology of the spray dried particles examined by Scanning Electron Microscopy (SEM) was shown to be correlated with the process parameters, principally the molecular weight of the material, nature of the solvent and inlet and outlet temperature. In particular, low molecular weight materials were more easily and reproducibly spray dried. Following a succession of preliminary experiments a method was established, in order to correlate the surface energy and Fine Particle Fraction (FPF) of the model drugs SS, PAA and PVA. It was possible to distinguish variations in intra and inter batch for the surface energy occurred by physical aging from a variety of model drugs. Moreover, even though the dispersive surface energy for the model drugs selected was very similar between the ranges 30- 40 mJ/m^ a trend was achieved. In general, the FPF of the model drugs increased with decreasing surface energy and this may be related to a decrease on both the adhesion (drug- carrier/drug-device) and cohesion (drug-drug) of these particles hence presenting a superior in vitro deposition. However, no linear correlation between FPF and surface energy was reached with constant morphology suggesting that other factors apart from surface energy participate in the complex development of DPIs formulations. Acknowledgements I would like first to acknowledge my academic and industrial supervisors, Professor Graham Buckton, Dr. Simon Gaisford, Dr. Elizabeth Collins and Dr. Jeremy Clarke for their support and scientific guidance throughout my PhD. I would also like to express my gratitude to Pfizer for funding this project and for providing the opportunity to have my first insight of the pharmaceutical industry environment by being in contact with the best scientific experts. Special thanks go to Dave McCarthy for his helpful SEM work apart from his sympathy and kindness all the time. Thanks are also due to Dr. Hardyal Gill for his assistance with the IGC and to Keith Barnes for his wonderful help and support when things broke down especially during my first year... I would also like to acknowledge my friends in the lab for their continuous help and support in and outside SOP especially to Hisham, Liang, Cyrus, Peng, Claire, Mike, Fang, Mido, Amina, Viraj, Matt, Suchada and John who were essential to overcome all the worries particularly in the hard times. A special recognition goes to Laurent for his precious support and enthusiasm since the time I was an Erasmus student and in the beginning of my PhD. I would also like to thank all the friends I have made while I was living in University of London Halls with whom I shared my life and privacy. I would also like to thank my best friends back home for being always there... Joana, Catarina, Margarida and Silvia for their continued friendship and understanding since the first year of the University, always no matter how far you are. Muito Obrigada! The PhD was tough but absolutely memorable. In the past four years that I have lived in London I met some of the most wonderful people I have ever met with whom I lived amazing moments. To Olga, Paco and Alba I just need to say that I appreciate your friendship and support. Muchas Gracias! Finally, I would like to thank all my family for being the best family! I would never be able to fulfil this and other projects of my life without your love and support. I would like to take this opportunity to express my love to my parents and best friends Albertina and Antonio for being my inspiration in life and to whom this thesis is dedicated. Table of Contents Title 1 Plagiarism Statement 2 Abstract 3 Acknowledgements 4 Table of Contents 5 List o f Figures 11 List of Tables 17 List of Abbreviations 20 Chapter L Introduction 22 1. 1. Advantages of pulmonary delivery 23 1.2 . Anatomical and physiological features of the respiratory tract 24 1.3. Drug deposition in the respiratory tract 27 1.3.1. Inertial impaction 28 1.3.2. Gravitational sedimentation 28 1.3.3. Brownian diffusion 29 1.4. Particle forces in pharmaceutical powders 30 1.4.1. Van der Waals forces 30 1.4.2. Electrostatic forces 31 1.4.3. Capillary forces 31 1.5. Medical aerosol devices 32 1.5.1. Pressurized Metered Dose Inhalers (pMDIs) 32 1.5.2. Nebulizers 34 1.5.3. Dry Powder Inhalers (DPIs) 35 1.6. Spray drying process phases 38 1.6. 1. Atomization of feed into droplets 40 1.6.2 . Spray-gas contact 41 1.6.3. Evaporation of volatiles fromdroplets and particle 41 formation 1.6.4. Separation of particles from the drying gas 41 1.7. Surface energy and studies relating its impact on aerosol 42 deposition 1.8. Aims of the Thesis 48 Chapter 2. Materials and Methods ^9 2.1. Materials 50 2.1.1. Salbutamol Sulphate (SS) 51 2.1.2. Indometacin (IMC) 52 2.1.3. Triamterene (TAT) 52 2.1.4. Polymethaciy lates (Eudragit S-100 and Eudragit E-100) 53 2.1.5. Poloxamer 338 (Synperonic PE/F-108) 54 2.1.6. Polyacrylic Acid (PAA) 54 2.1.7. Polyvinyl Alcohol (PVA) 55 2.1.8. Polyvinyl Pyrrolidone (PVP) 56 2.2. Spray drying for the production of inhalable particles 57 2.3. Inverse Gas Chromatography (IGC) for the assessment of 59 surface energy 2.3.1. Introduction 59 2.3.2. Determination of the dispersive component of the surface 60 energy 2.3.3. Determination of the specific component of the surface 61 energy 2.3.4. Inverse gas chromatography apparatus 63 2.3.5. Inverse gas chromatography column preparation 65 2.4. Carrier particles: Lactose monohydrate (Respitose®) 66 2.5. Preparation of powder blends 67 2.6. Ultraviolet-Visible Spectroscopy (UV/VIS) for quantification 68 of the model drugs 2.6.1. Assessment of content uniformity 68 2.7. Inhalation device: the Aerolizer® 69 2.8. Twin Stage Impinger (TSI) for the in vitro assessment of the 70 deposition of model drugs 2.8.1. Twin stage impinger apparatus using Aerolizer® 71 2.9. Scanning Electron Microscopy (SEM) for the assessment of 73 particle morphology Chapter 3. The Impact o f Spray Drying Process Variables 74 on Particle Morphology 3.1. Introduction 75 3.2. Summary of the chapter 79 3.3. General method for preparation of feed solutions 80 3.4. Physicochemical properties of spray-dried model drugs 81 3.5. Spray drying of Salbutamol Sulphate (SS) 82 3.5.1. Methods 82 3.5.2. Results and discussion 83 3.6. Spray drying of Indometacin (IMC) 84 3.6.1 Method for Indometacin batches one and two 84 3.6.2. Results and discussion for Indometacin batches one and 85 two 3.6.3. Method for Indometacin batches three and four 87 3.6.4. Results and discussion for Indometacin batches three and 87 four 3.7.
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