Drug Delivery Innovations Driving Improved Patient Compliance Introduction This report gives in depth coverage of the factors

driving patient non compliance. The report then goes on to describe and analyse key technologies being developed to improve compliance in the oral and parenteral delivery spaces. Finally the report looks at new delivery devices being developed which will improve patient compliance. Features and benefits * Understand the causes of poor patient compliance and the technologies that are already in use to overcome these causes. * Assess key innovative modified release oral delivery technologies that are in development. * Assess key innovative modified release parenteral technologies that are in development. * Assess key innovative drug delivery devices that are in development and understand how they can improve patient compliance and for which indications. ighlights he importance of the oral route of administration from both a clinician and patient acceptance point of view means there has been a vast amount of development and research in drug delivery via this route. Noncompliance can be attributed to poor taste, difficulty in administration or swallowing, and the inconvenience of multiple doses per day. Of all the modifications to parenteral delivery systems, the transdermal administration route is attracting the most attention. Across all parenteral delivery forms, the continued increase in the number of experimental protein and peptide drug candidates means that there is a high level of unmet need for delivery systems for these types of drugs. Pharmaceutical devices will continue to drive patient compliance and acceptability as increased options make for a wider choice. The convergence of MEMS and nanotechnology with biological applications offers breakthrough in drug developments. Browse All Pharmaceuticals Market Research Reports Your key questions answered What new technologies are being developed to improve patient compliance? Which companies are the leaders in the development of new delivery technologies aimed at improving compliance?

 What technologies in development can be applied to the specific therapy areas that my company is involved in? How will new technologies drive improvements in patient compliance? What new devices are in development that we could license to deliver our pipeline products? Table of Contents About the author 2 Disclaimer 2 Executive summary 12 Patient compliance 12 Modified release oral delivery technologies 12 Modified release parenteral formulations 13 Devices 14 Chapter 1 Patient compliance 16 Summary 16 Introduction 17 Improving patient compliance: A focus on drug delivery 17 The route of administration 20 Enteral routes of administration 22 Oral formulations 22 Rectal formulations 23 Parenteral routes of administration 23 Injectable formulations 23 Inhaled formulations 24 Intranasal formulations 25 Transdermal and cutaneous formulations 25 Vaginal formulations 25 Future outlook on patient compliance 25 Chapter 2 Modified release oral delivery technologies 27 Summary 27 Introduction 28 Rapid release formulations 31 Delivery platforms for rapid-release oral formulations 33 Orally disintegrating tablets (ODTs) 33 Lyophilized tablets 34 Loosely-compressed tablets 34 Sugar-floss systems 36 Molded tablets 37 Oral thin film (OTF) technology 39 PharmFilm 39 RapidFilm 40 Fast Dissolving Oral Film 40 Orally Dissolving Film 40 Bi-Layer edible film 40 Versafilm 40

Quick-Dis 40 Flash-Dissolve Wafer 41 Dissolvable Films 41 Rapid-release oral transmucosal formulations 41 OraVescent 42 RapidMist 42 Mistocine 42 Sustained-release formulations 43 Controlled-release formulations 43 Delayed-release formulations 44 Pulsatile-release formulations 45 Delivery platforms for sustained- and controlled-release 47 Ion-exchange resin systems 48 Coating technologies 49 SODAS 50 SmartCoat 51 Diffucaps 51 LiquiXR 51 Polymer technology for diffusion or bioerodible delivery systems 52 MXDAS 53 Diffutab 53 TimerX 54 DiffCORE 54 Osmotic systems 55 OROS 56 L-OROS and OsmoCap-CAST 56 Micropump 57 Reservoir diffusion systems 57 Liposomal delivery systems 58 Encapsome 60 Multiphase systems 60 Duocap 60 Novacap 60 SmPill 61 Gastric retention systems 61 Acuform 61 Accordion Pill 61 ProRet and NectRet 62 Transmucosal systems 62 OT 63 BEMA 63 Proloc 63 Buccal patch 63 Future outlook for modified release oral formulations 63 Chapter 3 Modified release parenteral formulations 65 Summary 65 Introduction 66

Modified-release injectable formulations 66 Suspensions 67 Microparticulate sustained release systems 68 MICRODUR 69 SynBiosys 69 Medisorb 70 Medusa 70 Solid and multilayer microspheres 70 Liposomes and other vesicles 71 DepoFoam 72 Solid lipid nanoparticles 72 Biodegradable depot or implant formulations 72 DURIN Biodegradable Implants 73 Novadur 74 I-vation 74 Long-Acting Delivery (LAD) technology 74 In situ gel systems 74 SABER 76 Atrigel 77 ReGel 77 MedinGel 77 Non-biodegradable implants 77 Insertable implants 78 Modified-release inhaled formulations 78 Immediate release technologies 79 Advanced Inhalation Research (AIR) 79 Technospheres 80 Sustained release technologies 80 Technologies manipulating liquid aerosol particle size and porosity 80 Polymer technologies for sustained release 80 Microcrystallization 81 Liposomes 81 Modified release nasal delivery 81 Advances in transdermal and cutaneous delivery systems 83 Modification of the drug or drug delivery vehicle 84 Prodrugs and ion pairing 84 Supersaturation of drug solutions 84 Eutectic systems 85 Liposomes and other vesicles 85 Solid lipid nanoparticles 86 Lipid encapsulation 86 Modification of the stratum corneum 86 Hydration 87 Chemical disruption of lipid structures 87 Future outlook for modified release parenteral formulations 87 Chapter 4 Devices 89 Summary 89

Introduction 90 Oral devices 90 Oral micro-electro-mechanical systems (MEMS) 91 IntelliCap 91 ePille 92 MEMS based micromachine capsule 92 IntelliDrug dental implant 93 Magnetic delivery control 93 Injectable and implantable devices 94 Prefilled syringes (PFS) 94 Auto-injectors & pen injectors 95 Solid dose injection 97 Glide SDI 97 Portable infusion pumps 98 OmniPod 99 JewelPUMP 99 h-Patch 100 Other infusion pumps 101 Implantable infusion pumps 102 Implantable miniature infusion pumps 102 Implantable osmotic pumps 102 Needle-free injections 103 Zeneo 104 LectraJet 105 Mini-Ject 106 Biojector 2000 and ZetaJect 106 PenJet 107 DosePro 107 Other needle-free platforms 107 Inhalation devices 107 Nebulizers 108 Jet nebulizers 108 Ultrasonic wave nebulizers 109 Ultrasonic vibrating mesh nebulizers 109 Adaptive or responsive nebulizer technology 109 Metered dose inhalers (MDIs) 110 Respimat Soft Mist 112 Tempo inhaler 113 Dry powder inhalers (DPIs) 114 MicroDose DPI 116 Other novel inhalation devices 117 OnQ aerosol generator 117 Electronic cigarettes and nicotine vaporizers 118 Intranasal devices 118 Liquid spray, metered dose, and dry powder dispensers 118 Innovations in nasal delivery devices 119 OptiNose 119

DirectHaler Nasal 121 Controlled Particle Dispersion (CPD) 122 Transdermal devices 123 Transdermal patches 123 ChronoDose 124 Transdermal penetration enhancement devices 124 Iontophoresis 124 Microneedles 127 BD microneedle 127 Microstructured transdermal systems (MTS) 128 Microneedle enabling technology (mNET) 128 Microneedle pump 129 Bioerodible microneedles 130 Other microneedle platforms 130 Ultrasound (sonophoresis and phonophoresis) 131 SonoPrep 131 U-strip 131 Dermal ablation or poration 131 Laser ablation or poration 132 Thermal ablation 132 Radiofrequency thermal ablation 133 Mechanical ablation 134 Electroporation 135 Elgen DNA and Cellectra DNA 135 Future outlook for pharmaceutical devices 135 Appendix 137 Raisin system 137 ID-Cap 138 MagneTrace 139 Glossary 139 Bibliography 141 List of figures Figure Figure 21 Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure 1: The five dimensions of adherence 18 2: Toxic, therapeutic, and sub-therapeutic ranges of two hypothetical drugs 3: Injectable routes of administration 25 4: Standard burst release and sustained release delivery profiles 30 5: Rapid release delivery profile 33 6: Disintegration mechanism of superdisintegrant materials 36 7: Acupacs range of dissolvable films 42 8: Delayed release delivery profile 46 9: Pulsatile release delivery profile 48 10: SODAS microparticle 52 11: Matrix diffusion system 53 12: Bioerodible system 54

Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

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DiffCORE technology 55 Osmotic system 56 OsmoCap-CAST system 57 Reservoir diffusion system 59 Liposome 59 Accordion Pill 63 MICRODUR microparticles 70 Medusa nanogel depot system 71 Solid microspheres 72 DURIN biodegradable implants 74 I-vation bioerodible implant 75 SABER in situ gel system 77 Atrigel in situ gel system 78 IntelliCap device 92 ePille device 93 Intellidrug dental implant 94 Oval Medicals range of auto-injector devices 97 Glide SDI device 99 OmniPod insulin management system 100 JewelPUMP device 101 h-Patch device 102 DUROS osmotic pump implant 104 Zeneo range of needle-free injection devices 105 Lectrjet range of needle-free injection devices 106 Mini-Ject auto-injection device 107 Components of a pressurized metered dose inhaler 111 Cross-section of the Respimat SoftMist metered dose inhaler 114 Dreamboat range of dry powder inhalers 117 MicroDose dry powder inhaler 118 Optinose breath activated dry powder nasal device 121 DirectHaler Nasal dry powder nasal device 122 ViaNase electronic atomizer device 123 SmartRelief iontophoresis patch device 126 ActivaPatch iontophoresis patch device 127 BD Soluvia microneedle prefilled injection device 128 Solid and hollow microstructured transdermal system 129 Microneedle pump device 130 Bioerodible microneedle device 131 ViaDor radiofrequency dermal ablation technology 135 Prelude SkinPrep mechanical dermal ablation device 136 Raisin system 139

List of Table Table 1: Onset of action times based on route of administration 23 Table 2: Comparison of orally disintegrating tablet formulations 39

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