With the growing percentage of APIs sensitive to oxygen, LOG offers a wide range of oxygen barrier packaging solutions specifically designed for oxygen-sensitive pharma formulations. Within this article, LOG presents insights about OTR testing and its oxygen barrier bottle portfolio.
Many of today’s pharmaceutical formulations, to some degree, are sensitive to oxidation. Besides a loss of efficacy and reduction in shelf life, exposure to oxygen can result in product discoloration, toxicity, or other pharmacological properties associated with negative side effects. See how LOG’s oxygen barrier packaging solutions can support you in the development of a safe and stable product that guarantees its utmost efficiency.
Oxygen Transmission Rate
- Definition: Oxygen transmission rate (OTR) is the rate at which oxygen molecules traverse through a solid material over a given time period.
- Permeability: All polymers are permeable to gases and vapors to different extents, and oxygen is no different.
- Rate in Packaging: In terms of packaging, OTR is the rate at which oxygen molecules will permeate through the package wall
- Measurements: OTR is measured in cc/bottle per day
When a plastic bottle consists of a very low oxygen permeation rate it is considered an oxygen barrier bottle. The lower the oxygen permeation rate, the higher the barrier property of the bottle. Key factors with which the OTR of a bottle can be influenced are the characteristics of the raw material, the know-how of using inner barrier layers, and environmental conditions such as temperature and relative humidity.
Do you have issues stabilizing your oxygen-sensitive formulation? Watch the following real-world case study in which LOG helped its customer to solve peaks of unknown impurity and stabilize their oxygen-sensitive formulation using the right type of passive and active oxygen protection:
Testing Container Closure Systems for OTR
LOG performs OTR testing of its barrier packages to enable our customers to predict and calculate the amount of oxygen that will permeate into the packaging in a given time. For this, LOG is following industry standards which provide guidelines on how to perform OTR testing for several applications, including plastic films, sheets, laminates, and rigid plastic packaging.
The stages for testing packaging for OTR include:
- The package is placed in predetermined environmental conditions.
- The package is purged with pure nitrogen (N2) gas. The N2 forces the existing gas contents (including oxygen) in the package through an outlet tube to a coulometric sensor, which reads the Oxygen content.
- The test output is presented as the volume of oxygen permeated per day per package.
LOG’s Barrier Packaging Solutions
LOG’s OxyBlock® and MultiBlock® barrier packaging solutions provide remarkable barrier protection for oxygen-sensitive formulations and are commercially used by leading pharmaceutical manufacturers worldwide.
- The OxyBlock® bottle provides protection to formulations sensitive to oxygen permeation.
- According to laboratory testing, the OxyBlock® barrier bottle performs up to 100x better as an oxygen barrier compared to a standard HDPE bottle.
- The MultiBlock® bottle provides protection for formulations that are sensitive both to oxygen and moisture permeation.
- Superior performance tests have shown that the 60ml MultiBlock® bottle has up to 12x better moisture barrier performance and 100x better oxygen barrier performance compared to standard HDPE bottles.
LOG’s barrier bottles are used and endorsed by global pharmaceutical companies and are commercially used in the market for the last 10 years. With LOG’s professional expertise in active and passive barrier packaging, our team of experts would be more than happy to speak with you further and provide you with samples of our innovative barrier packaging solutions for your oxygen-sensitive formulations.
Feel free to contact us for any questions regarding the OTR, including the laboratory test results for our barrier products, which can be provided upon your request. If you produce oxygen-sensitive pharmaceutical formulations, you can be confident in LOG’s knowledge and product portfolio offering you outstanding oxygen barrier packaging solutions for your drug formulation!
For the last 50 years, LOG has been serving as a leader in the global pharmaceutical packaging industry, delivering innovative, highly engineered, active, and passive packaging solutions from its manufacturing sites in Israel and Hungary.
LOG adheres to the strictest quality manufacturing standards and is fully committed to compliance with GMP standards for primary packaging. The quality management systems (QMS) of both manufacturing sites are ISO 9001 and ISO 15378 certified.
Tags: Active Barrier, Active Packaging, ASTM F-1307, Barrier Packaging, HDPE, OTR, Oxygen Transmission Rate, Passive Barrier, Pharma Packaging, Pharmaceutical, Polymer, PP, VWTR