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.

Highlights

The 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.

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?
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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

Table of figures
Figure 1: The five dimensions of adherence 18
Figure 2: Toxic, therapeutic, and sub-therapeutic ranges of two hypothetical drugs 21
Figure 3: Injectable routes of administration 25
Figure 4: Standard burst release and sustained release delivery profiles 30
Figure 5: Rapid release delivery profile 33
Figure 6: Disintegration mechanism of superdisintegrant materials 36
Figure 7: Acupac’s range of dissolvable films 42
Figure 8: Delayed release delivery profile 46
Figure 9: Pulsatile release delivery profile 48
Figure 10: SODAS microparticle 52
Figure 11: Matrix diffusion system 53
Figure 12: Bioerodible system 54
Figure 13: DiffCORE technology 55
Figure 14: Osmotic system 56
Figure 15: OsmoCap-CAST system 57
Figure 16: Reservoir diffusion system 59
Figure 17: Liposome 59
Figure 18: Accordion Pill 63
Figure 19: MICRODUR microparticles 70
Figure 20: Medusa nanogel depot system 71
Figure 21: Solid microspheres 72
Figure 22: DURIN biodegradable implants 74
Figure 23: I-vation bioerodible implant 75
Figure 24: SABER in situ gel system 77
Figure 25: Atrigel in situ gel system 78
Figure 26: IntelliCap device 92
Figure 27: ePille device 93
Figure 28: Intellidrug dental implant 94
Figure 29: Oval Medical’s range of auto-injector devices 97
Figure 30: Glide SDI device 99
Figure 31: OmniPod insulin management system 100
Figure 32: JewelPUMP device 101
Figure 33: h-Patch device 102
Figure 34: DUROS osmotic pump implant 104
Figure 35: Zeneo range of needle-free injection devices 105
Figure 36: Lectrjet range of needle-free injection devices 106
Figure 37: Mini-Ject auto-injection device 107
Figure 38: Components of a pressurized metered dose inhaler 111
Figure 39: Cross-section of the Respimat SoftMist metered dose inhaler 114
Figure 40: Dreamboat range of dry powder inhalers 117
Figure 41: MicroDose dry powder inhaler 118
Figure 42: Optinose breath activated dry powder nasal device 121
Figure 43: DirectHaler Nasal dry powder nasal device 122
Figure 44: ViaNase electronic atomizer device 123
Figure 45: SmartRelief iontophoresis patch device 126
Figure 46: ActivaPatch iontophoresis patch device 127
Figure 47: BD Soluvia microneedle prefilled injection device 128
Figure 48: Solid and hollow microstructured transdermal system 129
Figure 49: Microneedle pump device 130
Figure 50: Bioerodible microneedle device 131
Figure 52: ViaDor radiofrequency dermal ablation technology 135
Figure 53: Prelude SkinPrep mechanical dermal ablation device 136
Figure 54: Raisin system 139


Table of tables
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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