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Whether oral solid dosage pharmaceuticals, drug delivery systems or diagnostic and medical devices, many healthcare products are susceptible to degradation and stability issues.
Colorcon is a leading specialist in controlled atmosphere packaging with indepth knowledge of moisture, oxygen and odor management inside healthcare packaging. Contact us for more details on which solution is the most suitable for your specific needs.
Tablets are the most widely used form of oral dosage in the world, and their stability is important. Susceptible to damage and degradation from moisture, oxygen, they can also present challenges with unpleasant odors. To maintain potency, stability, and shelf life, Colorcon offers a variety of moisture and oxygen absorbing products tailored for specific needs.
Tablets are usually produced by compressing active pharmaceutical ingredients (APIs) together with excipients. Tablets are typically packaged in blister or sealed into a bottle for distribution. Throughout their journey, their potency, safety, and shelf-life must be preserved, with the biggest risk being moisture degradation.
Environmental moisture can permeate plastic films and bottles, and affect the tablets inside. While most APIs can handle some moisture exposure, over time, more and more moisture vapor enters the bottle. Degradation by moisture ingress reduces the efficacy of the drug and can produce toxic by-products. If uncoated, the tablets may start to crumble, swell, and/or change color as the water is absorbed and reacts with the tablet ingredients. To prevent degradation desiccants are used to adsorb the moisture and protect the tablets.
Colorcon’s moisture control products are specially designed to have a higher affinity for water than the pharmaceuticals they are designed to protect. Silica gel and molecular sieve each provide unique properties that allow Colorcon to tailor our moisture absorbing products to fit industry’s specific needs. When placed inside a container, these desiccant packets, desiccant canisters, and other formats quickly catch moisture from the air and are designed work over the shelf-life of the product to maintain a safe environment in the bottle, providing peace of mind that the pharmaceutical tablets will be ready to do their job when needed.
Our desiccant canisters and desiccant capsules offer excellent advantages with a rigid body designed for high-speed production processes. For customers seeking a more flexible product, Colorcon’s line of non-woven desiccant packets and sachets provide high-quality moisture protection in a broad range of shapes and sizes. Or, if preferred, desiccant washers and inserts are also available to meet specific needs.
While most APIs are susceptible to moisture degradation, some specialized pharmaceuticals are also highly sensitive to oxygen. Oxygen is the second most common gas in our atmosphere. Without it, life as we know it would not exist. However, oxygen is also highly reactive with some substances, including molecules found in many pharmaceutical tablets. Oxidation can cause tablets to change in color as the oxygen reacts with the API molecules. As the reactions continue, the drug becomes less effective and can produce toxic by-products, similar to the way moisture can. To protect tablets from oxidation, Colorcon provides oxygen scavenger materials and oxygen barrier bottles.
PharmaKeep® oxygen scavengers use a specially designed polymer to remove oxygen from the bottle headspace, protecting the tablets from oxidation. Traditional oxygen scavengers require a certain level of moisture in order to pull oxygen out of the air before it can react with the tablet. Our system is unique as it functions even when the relative humidity inside the bottle is 0%.
While moisture control and oxygen protection products aim to protect the tablet from degradation and ultimately the end user from toxic side effects products, odor control products are designed to mask unpleasant smells. Many APIs today are complex molecules designed to treat a huge array of diseases. When tablets are uncoated any odors from the active ingredients are easily detected and smelt by the consumer. Fishy or sulfur odors can upset even the sturdiest of stomachs.
Coloron’s odor control packets, canisters, and capsules use activated carbon to remove these odors. The activated carbon acts as an air filter, adsorbing and trapping the odorous molecules in its structure, in much the same way desiccants adsorb and trap moisture. When pharmaceuticals require both moisture protection and odor control, Colorcon’s line of 2 in 1 products combine silica gel and activated carbon into one unit, protecting the tablets from degradation and the user from unwanted odors.
As mentioned, moisture is one of the biggest challenges for tablet or capsule stability. A desiccant container is often the standard solution for the problem, but there are also more tailored and innovative approaches.
Desiccant packets are the most popular form we produce. The packets (or sachets) come in a range of shapes and sizes and can be made to fit any container. Colorcon offers desiccant packets from sizes starting at 0.25 g up to 10 g, with desiccant fills including silica gel and molecular sieve. Odor control packets use activated carbon, while the 2 in 1 packets use a combination of activated carbon and silica gel. They are available as pre-cut or reel-wound Continu-Strip® with or without a hole punch.
Desiccant canisters offer an excellent alternative for high-volume production. Canisters are injection molded from high density polyethylene (HDPE) to create a rigid body capable of being used in high-speed insertion equipment. The system has been upgraded recently, introducing the laser-marked canister to the current labeled and printed lines. The laser-marked canister uses laser light to mark the canister, providing the customer with a product free of inks, adhesives, varnishes, and paper labels.
Desiccant capsules contain excellent humidity sensitive ingredients. Relying on different substances – from silica gel to molecular sieve, as well as more specialized solutions such as PharmaKeep and EQius – they are a type of desiccant container that can be customized to help create a safe and sterile environment. Three types of the capsule are available – cylindrical (which are dropped into pharmaceutical packaging), snapped (commonly integrated into closures), and flat capsules (ideal for fish-bone blister packaging).
Desiccant washers and inserts, snuggly fitted into the closure and can be integrated into the system without any risk of dislocation. A wide range of sizes and a tightness guarantee make them extremely versatile.
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