Drug delivery innovations driving improved patient complianceDocument Transcript
Drug Delivery Innovations Driving Improved Patient ComplianceIntroductionThis report gives in depth coverage of the factors driving patient non compliance.The report then goes on to describe and analyse key technologies being developedto improve compliance in the oral and parenteral delivery spaces. Finally the reportlooks at new delivery devices being developed which will improve patientcompliance.Features and benefits• * Understand the causes of poor patient compliance and the technologies that arealready in use to overcome these causes.• * Assess key innovative modified release oral delivery technologies that are indevelopment.• * Assess key innovative modified release parenteral technologies that are indevelopment.• * Assess key innovative drug delivery devices that are in development andunderstand how they can improve patient compliance and for which indications.ighlightshe importance of the oral route of administration from both a clinician and patientacceptance point of view means there has been a vast amount of development andresearch in drug delivery via this route. Noncompliance can be attributed to poortaste, difficulty in administration or swallowing, and the inconvenience of multipledoses per day.Of all the modifications to parenteral delivery systems, the transdermaladministration route is attracting the most attention. Across all parenteral deliveryforms, the continued increase in the number of experimental protein and peptidedrug candidates means that there is a high level of unmet need for deliverysystems for these types of drugs.Pharmaceutical devices will continue to drive patient compliance and acceptabilityas increased options make for a wider choice. The convergence of MEMS andnanotechnology with biological applications offers breakthrough in drugdevelopments.Browse All Pharmaceuticals Market Research ReportsYour key questions answered• What new technologies are being developed to improve patient compliance?• Which companies are the leaders in the development of new delivery technologiesaimed at improving compliance?
• What technologies in development can be applied to the specific therapy areasthat 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 pipelineproducts?Table of ContentsAbout the author 2Disclaimer 2Executive summary 12Patient compliance 12Modified release oral delivery technologies 12Modified release parenteral formulations 13Devices 14Chapter 1 Patient compliance 16Summary 16Introduction 17Improving patient compliance: A focus on drug delivery 17The route of administration 20Enteral routes of administration 22Oral formulations 22Rectal formulations 23Parenteral routes of administration 23Injectable formulations 23Inhaled formulations 24Intranasal formulations 25Transdermal and cutaneous formulations 25Vaginal formulations 25Future outlook on patient compliance 25Chapter 2 Modified release oral delivery technologies 27Summary 27Introduction 28Rapid release formulations 31Delivery platforms for rapid-release oral formulations 33Orally disintegrating tablets (ODTs) 33Lyophilized tablets 34Loosely-compressed tablets 34Sugar-floss systems 36Molded tablets 37Oral thin film (OTF) technology 39PharmFilm 39RapidFilm 40Fast Dissolving Oral Film 40Orally Dissolving Film 40Bi-Layer edible film 40Versafilm 40
Quick-Dis 40Flash-Dissolve Wafer 41Dissolvable Films 41Rapid-release oral transmucosal formulations 41OraVescent 42RapidMist 42Mistocine 42Sustained-release formulations 43Controlled-release formulations 43Delayed-release formulations 44Pulsatile-release formulations 45Delivery platforms for sustained- and controlled-release 47Ion-exchange resin systems 48Coating technologies 49SODAS 50SmartCoat 51Diffucaps 51LiquiXR 51Polymer technology for diffusion or bioerodible delivery systems 52MXDAS 53Diffutab 53TimerX 54DiffCORE 54Osmotic systems 55OROS 56L-OROS and OsmoCap-CAST 56Micropump 57Reservoir diffusion systems 57Liposomal delivery systems 58Encapsome 60Multiphase systems 60Duocap 60Novacap 60SmPill 61Gastric retention systems 61Acuform 61Accordion Pill 61ProRet and NectRet 62Transmucosal systems 62OT 63BEMA 63Proloc 63Buccal patch 63Future outlook for modified release oral formulations 63Chapter 3 Modified release parenteral formulations 65Summary 65Introduction 66
Modified-release injectable formulations 66Suspensions 67Microparticulate sustained release systems 68MICRODUR 69SynBiosys 69Medisorb 70Medusa 70Solid and multilayer microspheres 70Liposomes and other vesicles 71DepoFoam 72Solid lipid nanoparticles 72Biodegradable depot or implant formulations 72DURIN Biodegradable Implants 73Novadur 74I-vation 74Long-Acting Delivery (LAD) technology 74In situ gel systems 74SABER 76Atrigel 77ReGel 77MedinGel 77Non-biodegradable implants 77Insertable implants 78Modified-release inhaled formulations 78Immediate release technologies 79Advanced Inhalation Research (AIR) 79Technospheres 80Sustained release technologies 80Technologies manipulating liquid aerosol particle size and porosity 80Polymer technologies for sustained release 80Microcrystallization 81Liposomes 81Modified release nasal delivery 81Advances in transdermal and cutaneous delivery systems 83Modification of the drug or drug delivery vehicle 84Prodrugs and ion pairing 84Supersaturation of drug solutions 84Eutectic systems 85Liposomes and other vesicles 85Solid lipid nanoparticles 86Lipid encapsulation 86Modification of the stratum corneum 86Hydration 87Chemical disruption of lipid structures 87Future outlook for modified release parenteral formulations 87Chapter 4 Devices 89Summary 89
DirectHaler Nasal 121Controlled Particle Dispersion (CPD) 122Transdermal devices 123Transdermal patches 123ChronoDose 124Transdermal penetration enhancement devices 124Iontophoresis 124Microneedles 127BD microneedle 127Microstructured transdermal systems (MTS) 128Microneedle enabling technology (mNET) 128Microneedle pump 129Bioerodible microneedles 130Other microneedle platforms 130Ultrasound (sonophoresis and phonophoresis) 131SonoPrep 131U-strip 131Dermal ablation or poration 131Laser ablation or poration 132Thermal ablation 132Radiofrequency thermal ablation 133Mechanical ablation 134Electroporation 135Elgen DNA and Cellectra DNA 135Future outlook for pharmaceutical devices 135Appendix 137Raisin system 137ID-Cap 138MagneTrace 139Glossary 139Bibliography 141List of figuresFigure 1: The five dimensions of adherence 18Figure 2: Toxic, therapeutic, and sub-therapeutic ranges of two hypothetical drugs21Figure 3: Injectable routes of administration 25Figure 4: Standard burst release and sustained release delivery profiles 30Figure 5: Rapid release delivery profile 33Figure 6: Disintegration mechanism of superdisintegrant materials 36Figure 7: Acupac’s range of dissolvable films 42Figure 8: Delayed release delivery profile 46Figure 9: Pulsatile release delivery profile 48Figure 10: SODAS microparticle 52Figure 11: Matrix diffusion system 53Figure 12: Bioerodible system 54
Figure 13: DiffCORE technology 55Figure 14: Osmotic system 56Figure 15: OsmoCap-CAST system 57Figure 16: Reservoir diffusion system 59Figure 17: Liposome 59Figure 18: Accordion Pill 63Figure 19: MICRODUR microparticles 70Figure 20: Medusa nanogel depot system 71Figure 21: Solid microspheres 72Figure 22: DURIN biodegradable implants 74Figure 23: I-vation bioerodible implant 75Figure 24: SABER in situ gel system 77Figure 25: Atrigel in situ gel system 78Figure 26: IntelliCap device 92Figure 27: ePille device 93Figure 28: Intellidrug dental implant 94Figure 29: Oval Medical’s range of auto-injector devices 97Figure 30: Glide SDI device 99Figure 31: OmniPod insulin management system 100Figure 32: JewelPUMP device 101Figure 33: h-Patch device 102Figure 34: DUROS osmotic pump implant 104Figure 35: Zeneo range of needle-free injection devices 105Figure 36: Lectrjet range of needle-free injection devices 106Figure 37: Mini-Ject auto-injection device 107Figure 38: Components of a pressurized metered dose inhaler 111Figure 39: Cross-section of the Respimat SoftMist metered dose inhaler 114Figure 40: Dreamboat range of dry powder inhalers 117Figure 41: MicroDose dry powder inhaler 118Figure 42: Optinose breath activated dry powder nasal device 121Figure 43: DirectHaler Nasal dry powder nasal device 122Figure 44: ViaNase electronic atomizer device 123Figure 45: SmartRelief iontophoresis patch device 126Figure 46: ActivaPatch iontophoresis patch device 127Figure 47: BD Soluvia microneedle prefilled injection device 128Figure 48: Solid and hollow microstructured transdermal system 129Figure 49: Microneedle pump device 130Figure 50: Bioerodible microneedle device 131Figure 52: ViaDor radiofrequency dermal ablation technology 135Figure 53: Prelude SkinPrep mechanical dermal ablation device 136Figure 54: Raisin system 139List of TableTable 1: Onset of action times based on route of administration 23Table 2: Comparison of orally disintegrating tablet formulations 39
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