Reliable protection against moisture
What is the purpose of a moisture-protective film coating?
Insulating the tablet core with a suitable film coating plays an important role in achieving an adequate moisture barrier. It improves the stability of the tablet and provides protection to prevent degradation of the active ingredients and extend shelf life. Tablet cores with highly hygroscopic active ingredients, such as extracts, or solid dosage forms marketed in countries with high humidity must be effectively protected from moisture. Strong antioxidants such as vitamin C should also be protected from moisture, as they react easily with oxygen. Moisture accelerates this oxidation process, causing the vitamin C to degrade and lose its effectiveness.
What problems can be caused by moisture in/on tablets?
Moisture can cause a variety of problems with tablets and other solid dosage forms. These problems affect both the physical properties of the tablets and their chemical stability and can ultimately affect the efficacy, safety and shelf life of the product. Here are some known problems that can be caused by moisture:
Chemical decomposition (degradation)
- Hydrolysis: Many active pharmaceutical ingredients are susceptible to hydrolysis, a chemical reaction with water that can lead to the decomposition of the active ingredient. This can reduce the effectiveness of the drug or even produce toxic degradation products.
- Oxidation: Moisture can promote the oxidation of active ingredients (e.g. vitamin C), especially if oxygen is present in the environment. Oxidation can significantly impair the stability and efficacy of active ingredients.
Physical changes
- Sticking together: Moisture can cause tablets to stick together during storage or processing. This can lead to surface defects where layers of the tablet peel off or the tablet loses its shape.
- Softening and deformation: Tablets can absorb moisture and become soft or lose their shape, making handling, packaging and storage more difficult.
- Breakage or abrasion: Moisture can reduce the mechanical strength of tablets, causing them to break or crumble during transportation or handling.
Changes in the release properties
- Change in the dissolution profile: Moisture can alter the release of the active substance from the tablet. Moisture-induced changes in the tablet matrix may result in faster or slower release, which may impair the intended therapeutic effect.
- Gelation or clumping: Moisture can cause the polymer layer of enteric-coated or sustained-release tablets to dissolve irregularly, which can lead to undesirable release effects.
Aesthetic and sensory problems
- Discoloration: Moisture may cause discoloration of the tablets, which may indicate chemical degradation or physical changes. This may affect patient confidence in the product.
- Odor and taste changes: Moisture can cause odors or changes in taste, especially in tablets with hygroscopic ingredients or those containing flavors.
Surface changes: The surface of the tablet may become rough or sticky due to moisture, making handling and ingestion by the patient more difficult.
Packaging problems
- Packaging degradation: Moisture can also affect the packaging, especially in the case of blister packs or other airtight packaging. This can lead to a reduced protective function of the packaging and an increased risk of moisture damage.
- Lack of tightness: If moisture penetrates the packaging, this can impair the effectiveness of the entire packaging solution, resulting in a shortened shelf life of the product.
Hygroscopicity and change in mass
- Weight gain: Some tablets can absorb moisture from the environment, leading to weight gain and a change in dosage. This is particularly problematic with hygroscopic substances, which have a strong tendency to absorb water from the environment.
- Changes in concentration: The absorption of moisture can also lead to a dilution or change in the concentration of the active ingredients within the tablet.
Why is a moisture-protective film coating important?
Maintaining stability and effectiveness
- Pharmaceutical industry: Many active pharmaceutical ingredients are sensitive to moisture. This sensitivity can lead to degradation of the active ingredient, changes in release properties or aggregation. An effective moisture barrier increases the stability of the active ingredient and ensures that the drug remains safe and effective throughout its shelf life.
- Nutritional supplements (nutraceuticals): Nutritional supplements such as vitamins, minerals and herbal extracts are often hygroscopic, which means they can attract moisture from the environment. A protective film prevents these ingredients from deteriorating or losing their effectiveness.
Extension of shelf life
- The protection against moisture extends the shelf life of the products, which not only ensures the quality and safety of the products, but also offers economic benefits, as fewer products have to be disposed of due to loss of quality.
Improved storage and transportation conditions
- Products that are protected against moisture can be safely handled under a wider range of storage and transportation conditions without compromising their quality. This is particularly important for global trade, where products are often exposed to different climatic conditions.
Optimization of production processes
- Pharmaceutical and nutraceutical industries: A moisture-protective film coating ensures consistent product quality and can help prevent problems such as tablets sticking or breaking during production or packaging.
Aesthetic and functional advantages
As well as protecting against moisture, the film coating improves the appearance of the tablet by creating a smooth, glossy surface that increases end-user acceptance. In addition, a protective coating can also help to mask the taste or odor of active ingredients.
Link to: Film Coating
The advantages of moisture-protective coating at a glance:
- Protection against moisture and preservation of product stability
- Extended shelf life of the products
- Improved storage and transportation conditions
- High adaptability to different products and industries
Overview of ready-to-use film coating systems with moisture protection properties:
We develop customized solutions that meet the specific requirements and challenges of the respective products. For reformulations and new developments. Get in touch with us.
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