RESUMO
Subcutaneous (SC) drug delivery can be a safe, effective alternative to the traditional intravenous route of administration, potentially offering notable advantages for both patients and healthcare providers. The SC Drug Development & Delivery Consortium convened in 2018 to raise awareness of industry challenges to advance the development of patient-centric SC drug delivery strategies. The SC Consortium identified better understanding of patient preferences and perspectives as necessary to optimize SC product design attributes and help guide design decisions during SC product development. This manuscript provides a comprehensive overview of patient-centric factors for consideration in the SC drug delivery design and development process with the aim of establishing a foundation of existing knowledge for patient experiences related to SC drug delivery. This overview is informed by the outcomes of a multi-step survey of Consortium members and key pharmaceutical stakeholders. Framed in the context of the patient's treatment journey, the survey findings offer future perspectives to fill data gaps to advance patient-centric SC drug delivery.
Assuntos
Sistemas de Liberação de Medicamentos , Indústria Farmacêutica , Humanos , Injeções Subcutâneas , Preferência do Paciente , Desenho de Fármacos , Adesão à MedicaçãoRESUMO
Many biologics are now self-administered by patients at home. A variety of self-injection devices are available, including vials and syringes, prefilled syringes, and spring-driven prefilled pens or auto-injectors. Each has advantages and drawbacks, and different devices suit different patients. For example, some patients have difficulty achieving consistent and successful self-injection due to poor manual dexterity, or experience anxiety at the prospect of self-injection or injection-site pain. These factors can reduce patients' medication adherence and overall experience. Furthermore, while self-injection brings patients many benefits, the proliferation of single-use injection devices has implications for environmental sustainability, including the reliance on single-use plastics, repeated freighting requirements, and need for incineration as hazardous waste. Recently developed, innovative electromechanical auto-injector devices offer technological enhancements over existing devices to overcome some of these issues. Features include customisable injection speeds or durations, consistent rate of injection, electronic injection logs and reminders, and step-by-step, real-time instructions. Indeed, a growing body of evidence points to higher adherence rates among patients using electromechanical devices compared with other devices. Further, with time, the reusability of electromechanical devices may prove to lighten the environmental impact compared with disposable devices, especially as research continues to optimise their sustainability, driven by increased consumer demands for environmental responsibility. This narrative review discusses the differences between prefilled syringes, spring-driven prefilled pens, and electromechanical devices. It also explores how these features may help reduce injection-associated pain and anxiety, improve patient experience, connectivity and adherence, and drive sustainability of biologic drugs in future.
Biologics are a type of medicine becoming widespread in the treatment of many diverse diseases. Biologics are injected under the skin and can sometimes be injected by patients themselves at home. Many injection devices are available to help patients with this self-injection, and fall into three broad categories: prefilled syringes, prefilled pens, and electromechanical devices. Each has its own advantages and disadvantages, and different devices suit different patients. For example, some patients have difficulty achieving consistent and successful self-injection because of limited hand movement or become anxious at the prospect of self-injection or injection-site pain. These factors can reduce patients' ability and willingness to take medication as prescribed and may worsen their overall experience. Further, many disposable devices involve single-use plastics and may pose an environmental toll. Reusable electromechanical devices are the newest of the available devices and offer enhanced features over some earlier devices. These include customisable injection speeds or durations, consistent rates of injection, electronic injection logs, reminders, and real-time instructions. Evidence suggests that patients using electromechanical devices may have higher rates of adherence (i.e. more patients take their medication as prescribed) than those using other devices. Additionally, with time and further research, the reusability of electromechanical devices may prove to lighten the environmental impact compared with disposable devices. Here we discuss the differences between prefilled pens, prefilled syringes, and electromechanical devices, and explore the features that may help reduce injection-associated pain and anxiety, improve patient experience, connectivity, and adherence, and drive greater sustainability.
Assuntos
Produtos Biológicos , Humanos , Adesão à Medicação , Injeções , Seringas , DorRESUMO
PURPOSE: Elevated intraocular pressure (IOP) is a major risk factor for glaucoma. One consequence of raised IOP is that ocular tissues are subjected to increased hydrostatic pressure (HP). The effect of raised HP on stress pathway signaling and retinal ganglion cell (RGC) survival in the human retina was investigated. METHODS: A chamber was designed to expose cells to increased HP (constant and fluctuating). Accurate pressure control (10-100 mmHg) was achieved using mass flow controllers. Human organotypic retinal cultures (HORCs) from donor eyes (<24 h post mortem) were cultured in serum-free DMEM/HamF12. Increased HP was compared to simulated ischemia (oxygen glucose deprivation, OGD). Cell death and apoptosis were measured by LDH and TUNEL assays, RGC marker expression by qRT-PCR (THY-1) and RGC number by immunohistochemistry (NeuN). Activated p38 and JNK were detected by Western blot. RESULTS: Exposure of HORCs to constant (60 mmHg) or fluctuating (10-100 mmHg; 1 cycle/min) pressure for 24 or 48 h caused no loss of structural integrity, LDH release, decrease in RGC marker expression (THY-1) or loss of RGCs compared with controls. In addition, there was no increase in TUNEL-positive NeuN-labelled cells at either time-point indicating no increase in apoptosis of RGCs. OGD increased apoptosis, reduced RGC marker expression and RGC number and caused elevated LDH release at 24 h. p38 and JNK phosphorylation remained unchanged in HORCs exposed to fluctuating pressure (10-100 mmHg; 1 cycle/min) for 15, 30, 60 and 90 min durations, whereas OGD (3 h) increased activation of p38 and JNK, remaining elevated for 90 min post-OGD. CONCLUSIONS: Directly applied HP had no detectable impact on RGC survival and stress-signalling in HORCs. Simulated ischemia, however, activated stress pathways and caused RGC death. These results show that direct HP does not cause degeneration of RGCs in the ex vivo human retina.