A disposable injection pen is a pen-type syringe that is prefilled with medicine, also known as a prefilled injection pen. According to the latest interpretation of disposable medical devices by the International Medical Device Industry Association, "medical device products that are only used on one patient (including multiple uses) and discarded after use are disposable medical devices", that is, disposable injection pens It is a disposable medical device product. Currently, such products on the market are mostly used in the field of chronic diseases such as diabetes, and mainly include insulin, peptide drugs and various high value-added biological agents.
Disposable pre-filled injection pens do not require patients to switch drugs between bottles and syringes when injecting themselves. The desired dose can be set directly through the dose setting component and injected. The desired dose can be a fixed dose or a syringe. It is a variable dose that can get patients out of danger faster than traditional disposable syringes and powder injection drugs. Disposable injection pens have outstanding advantages in terms of convenience, safety, and drug utilization during drug injection. They can help ordinary patients master the operation steps faster and further improve the self-management of patients in the field of chronic diseases.
Development history of disposable injection pens
Prefilled syringes Portable injection devices Disposable injection pens
The disposable injection pen is a re-innovation product that is developed, evolved and integrated from the traditional syringe through the prefilled syringe and the convenient pen-type syringe. Its structural design combines the advantages of the two injection products and is a new innovation in the history of injection pen development. milestone.
During World War II, prefilled syringes first appeared in order to meet the needs of field hospitals for on-site sterile medical care. In the early 1950s, BD provided glass prefilled syringes for the polio vaccine project. Compared with the injection method of traditional syringes, prefilled syringes can not only reduce the overfilling of drugs and save 10% to 20% of raw materials, but also make the operation faster and easier during the process of dispensing and absorbing medicinal liquids, so in The field of medical devices is developing rapidly and is widely used in the injection of drugs such as insulin and human growth hormone.
In the mid-1980s, Novo developed a new injection device, the injection pen. Compared with traditional injection methods, the injection pen has many advantages and the market has developed rapidly. In the late 1980s, Novo comprehensively considered the advantages of injection pen products and prefilled syringes as well as market demand, innovated on the injection pen prototype, and developed a new generation of injection device "disposable injection pen".
In recent years, due to the increase in the types of chronic diseases, the exponential growth in the number of patients, the continuous development of medical technology and markets, the increase in the number of biotechnology therapies and drug candidates administered through the injection route, pharmaceutical preparations in the form of prefilled packaging have become increasingly important in the medical device industry. It has almost become a product that injection suppliers must provide. Large pharmaceutical companies such as Novo, BD, Pfizer, and Eli Lilly are all involved in promoting the development of injection devices. Each company's own insulin, growth hormone, GLP-1 and other commonly used chronic disease drugs generally use prefilled syringes and disposable Injection pens and other packaging forms to meet different customer needs. Currently, disposable injection pens and prefilled syringes on the market have their own advantages in market application and development due to differences in the specificity of filled drugs, use environments and product prices, and cannot yet replace each other.
Disposable injection pen product introduction
Injection pens can be divided into reusable injection pens and disposable injection pens. Disposable injection pens can be further subdivided into disposable dose-adjustable injection pens (the latest registered disposable injection pen by Chengji Pharmaceutical), disposable fixed injection pens. Dosing pen.
Among the above two categories of products, according to the different customized requirements of specific filling drugs, after adding new technologies and functions, disposable multi-dose injection pens (Novo's Victoza, Flexpen), disposable dual-chamber premixed pens are derived Injection pens (AstraZeneca Bydureon, BYDUREON® BCise™ injection pen) disposable fully automatic injection pens (EPIPEN, JEXT emergency pen) products, etc.
The operation of a disposable injection pen is the same as that of a reusable injection pen with a replaceable vial. The difference is that the disposable injection pen has fewer parts, a relatively simple dose setting mechanism, the drug storage part and the injection mechanism are integrated and non-detachable, and the pen is filled Medication cannot be reset after use. Disposable injection pens not only improve the convenience of operation, but also reduce the risks and losses of drugs during transportation and storage. They are currently mostly used in long-acting drugs or other high value-added biological agents for patients with chronic diseases.
The structure of the disposable multi-dose injection pen is designed based on the need to inject different fixed doses of drugs within a certain period. For example, ① the dose of Novolin can be adjusted as needed; ② In order to adapt to the different injection doses of patients at different stages, the scale The barrel is divided into 4 scales Victoza et al.
Disposable fixed-dose injection pens vary greatly in design and principle based on specific drug characteristics, usage and dosage. There are currently two structures that are more common: one is to use a spring to drive the locking component to achieve quantitative dosing. For example, ① Eli Lilly’s Forteo injection pen for teriparatide, ② AstraZeneca’s long-acting sustained-release injection suspension exenatide uses a dual-chamber cartridge premixed injection pen Bydureon; the other is a trigger-type automatic Drug delivery device. For example: first aid pen Epipen, Jext, Anapen, etc.
Sustainable development of injection pens
Since the 1980s, the global disposable medical device industry has been booming. Injection pens have achieved the perfect combination of drugs and devices. At present, the penetration rate in the field of chronic diseases in European and American countries has reached 70%-80%. It is the annual sales volume of medical device products. One of the major single varieties with sales exceeding US$1 billion. Throughout its development history, since Novo launched the first-generation pen injector, the technology and market in this field have been dominated by foreign companies, and most of them are committed to customized applications, stylized appearance design and the development of innovative auxiliary products. widgets to help patients with usage management, etc.
Amazon founder Bezos said: We often focus on ‘What changes will happen in the next 10 years? ’ but rarely think about, ‘What’s going to be constant in the next 10 years? ’ In fact, the second question is more important than the first question, because what remains unchanged is the essence, and strategy needs to be based on things that do not change.
The essence of patient self-management is that patients want treatment at lower prices, simpler operations, and safer drug delivery methods.
The market and development of injection pens are based on user needs.
If relevant domestic enterprises in this field want to develop stably and gain a certain market, they need to enrich their product categories while meeting the needs of the market and users, and have independent innovation capabilities when imitation products mature. In the future, autonomous injection equipment will develop to adapt to a wider range of drugs and meet the treatment needs of patients with various conditions, leading to a revolution that will completely change the packaging form and delivery methods of injections.
