In recent years there has been an increase in the demand for various healthcare products and medicinal formulations owing to a more health-conscious global populace. Big and small players in the pharmaceutical industry have been rapidly innovating to provide safe medications and products designed to satisfy this global demand. One challenge that the industry has had to contend with is the exposure of many drug formulations or medical devices to oxygen while in storage or transit.
Oxygen exposure may drastically reduce the shelf-life and efficacy of healthcare products. It may even result in the production of noxious by-products that impact patient safety. While many intrinsic and extrinsic approaches have been designed to provide a consistently low-oxygen packaging environment, not all are practical nor effective. From our experience, oxygen absorbers present the easiest and most cost-effective solution to this problem and in this blog post, we give the lowdown on Cilicant’s excellent oxygen absorbers for healthcare products.
Oxidative degradation in pharmaceutical packaging
Most packaging solutions for modern pharmaceutical products are made from several types of plastics and polymers. With low production costs and general ease of transportation, polymer-based packaging solutions have become the default choice for many drugs and medical products. Despite their great qualities, polymer-based packaging solutions need active regulation of oxygen levels to minimize the potential for oxidative degradation of packaged products.
The extent of oxidative degradation of packaged pharmaceuticals will depend on the presence of or absence of oxygen in the headspace and the ingress of atmospheric oxygen into the packaging environment. The ingress of oxygen is measured by a parameter better known as the oxygen transmission rate (OTR). Left uncontrolled, available oxygen in the packaging environment will affect pharmaceuticals and medical products in several ways that will not only lower product quality and efficacy, but also expose patients to the risk of taking in toxic by-products.
Mechanisms of oxidative degradation
Several mechanisms are responsible for driving the oxidative degradation of packaged pharmaceutical products. These mechanisms may reduce the shelf-life of the packaged product, lower its efficacy, or produce harmful chemicals that may negatively impact the health of patients. For the sake of brevity, we have summarized some key mechanisms of oxidative degradation below:
- Oxidizing agents – Impurities (e.g., peroxides) and other oxidants in drug excipients can cause oxidative instability in packaged pharmaceuticals and medical devices. These impurities may be produced as a by-product of the manufacturing process, or because of polymer degradation.
- Autoxidation – Complex autoxidation reactions may produce free radicals that can reduce the efficacy of drug formulations. These free radicals may participate in complex chain reactions that target the active pharmaceutical ingredient or its excipients, destabilizing the drug formulation.
- Catalysis – When metal catalysts are present in the packaging environment, they can reduce molecular oxygen into free radicals. These kinetically active free-radical species (e.g., superoxides and hydroxyls) lower drug potency and create potentially dangerous adducts.
- Electron transfer – Oxidative degradation may also be driven by direct or catalysed electron transfer from the active pharmaceutical ingredient. Mobile oxidizing species resulting from electron transfer processes are important mechanisms for the loss of efficacy in drug formulations, as well as the creation of unsafe by-products.
Controlling oxygen permeation with Cilicant oxygen absorbers
From its earliest days, Cilicant has invested a lot of resources into the research and development of the best oxygen absorbers for pharmaceutical products. Cilicant oxygen absorber sachets for pharmaceuticals are the direct result of this effort and they are designed to perform exceptionally well in a diverse range of products and packaging options. Effective in controlling both ambient and permeating oxygen, Cilicant oxygen absorber sachets stand up to stringent lab testing and provide class-leading performance.
Cilicant oxygen absorber sachets are fast-acting, reducing the risk of oxidative degradation by lowering available oxygen to as little as 0.01% in a comparatively short time. This is much more effective than modified atmosphere packaging that only achieves residual oxygen levels ranging from 0.3-3%. Cilicant oxygen absorbers may also be faster than alternative approaches such as the use of chemical additives. The graph below compares the effectiveness of Cilicant oxygen absorbers in lowering oxygen levels against the use of a chemical additive over a short period of time.
What can oxygen absorbers be used in?
Oxygen absorbers may be used in stabilizing a variety of medicaments against oxidation. A good example of this is the protection of the drug atorvastatin from oxidative degradation. Atorvastatin is a leading pharmaceutical product used in lowering LDL cholesterol levels in the blood, while concomitantly increasing the levels of HDL cholesterol. The solid dosage form of atorvastatin is highly susceptible to oxidative degradation and requires packaging in an oxygen-free environment. Cilicant oxygen absorbers remove oxygen from the headspace of the packaging container and actively counteract oxygen ingress, maintaining the active pharmaceutical ingredient in a high level of purity.
Amlodipine, a calcium channel blocker, is another example of a drug that would benefit from the use of oxygen absorbers in the packaging environment. Used to prevent or lower the frequency of angina, amlodipine is one of the most popular antihypertensive drug prescriptions. When tested under laboratory conditions, studies have shown that amlodipine is highly degraded in oxidative conditions. When added to the amlodipine packaging container, oxygen absorber sachets provide a simple, cost-effective solution for extending the shelf life of amlodipine tablets while lowering the risk of exposing patients to potentially harmful degradation products.
In addition to their high levels of efficacy in preventing the oxidative degradation of solid dosage forms, oxygen absorbers may also be used to protect newer medical devices from exposure to oxygen-induced degradation. A good example of this is the medical device known as a ‘treated stent’ that is used in managing certain cardiovascular conditions. These devices are often coated with a pharmaceutical substance that, while unstable to atmospheric oxygen, reduces the chances of the patient’s body reacting against the treatment. By creating an oxygen-free packaging atmosphere, oxygen absorbers extend the shelf-life and effectiveness of these vital medical devices, affording patients a better quality of life.
Cilicant: The premier brand of oxygen absorbers
Cilicant oxygen absorbers are increasingly becoming the first choice for many healthcare manufacturers and distributors across the globe. Manufactured in a facility that is certified to stringent international quality standards (cGMP ISO 15378:2017), Cilicant oxygen absorbers provide dependable quality that our pharmaceutical partners can rely on. Cilicant oxygen absorber sachets are compliant with USFDA, RoHS, Kosher, Halal, and other regulatory requirements.
All Cilicant oxygen absorber sachets are supplied in GRAS (Generally regarded as safe) packaging materials designed to prevent direct contact with the pharmaceutical formulation. Used in airtight or hermetically sealed containers, Cilicant oxygen absorbers provide industry-leading protection of drugs against oxidative degradation. Cilicant oxygen absorbers may also be used with high-quality packaging films with a low OTR to significantly extend the shelf-life of these packaging forms.
Contact our technical representative to know more about Cilicant oxygen absorbers. – Contact Team CILICANT
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