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As advancements in pharmaceutical technology increase in the use of automated injection systems for health care treatment, traditional glass vials, syringes and cartridges must withstand higher automated delivery forces and pressures. The fragile nature and dimensional variability in wall thickness of glass components may lead to breakage, which presents challenges to automatic administration systems.
Auto-injector spring forces, frictional forces and the dimensional consistency of the syringes, cartridges and/or vials are important factors with regard to the functional performance of automated injection systems. Many pharmaceutical companies are faced with overcoming the inconsistencies and fragile aspects of glass containers and are considering the use of the more robust polymer vials, syringes and cartridges to contain and deliver drug products in automated systems.
Discussions (see the links below) are occurring regarding the performance and use of polymer cartridges, syringes and vials when compared to glass containment systems. Studies have been presented on topics such as:
-comparison of dimensional variations
-syringe flange strength
-syringe piston movement
-syringe piston release and travel forces
A recent study by West has shown that the Daikyo Crystal Zenith® 1mL long insert molded syringe (made from a cyclic olefin polymer) demonstrated a significant increase in flange strength and maintained low dimensional variability as compared to a glass 1 mL long staked needle syringe.
For more information read West’s recent technical poster, which was presented at the PDA meeting in Orlando, FL, Apr. 2013.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
<p><em>Harold Murray, Project Engineer, and Robert Froio, Intern, West Pharmaceutical Services, Inc.</em></p><p>Flange strength and dimensional variability are critical attributes when designing or selecting an auto-injector device to use in conjunction with a 1mL long syringe. Studies were performed to compare these attributes using Daikyo Crystal Zenith® (CZ) 1mL long syringes and glass 1mL long syringes.</p>
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
In an effort to treat more complex diseases, the injectables market has seen high-value molecules dominate clinical pipelines. As modern molecules continue to gain market share, it is becoming the norm for drug manufacturers to plan containment system compatibility earlier in their drug development process due to the sensitivities of their complex molecules. With packaging systems becoming an integral part of the drug development and research process, a challenge drug manufacturers face is the plentitude of choice.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
In a previous <a href="/zh-cn/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
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