Hydroxypropyl methyl cellulose (HPMC; CAS No. -65-3) is an odorless and tasteless, white to slightly off-white, fibrous or granular, free-flowing powder that is a synthetic modification of the natural polymer, cellulose. It is used in the food industry as a multipurpose food ingredient. HPMC is approved by FDA as both a direct and an indirect food additive, and is approved for use as a food additive by the EU. The JECFA has evaluated the food uses of HPMC and established an acceptable daily intake (ADI) of 'not specified' for such uses. Based on the no-observed-adverse-effect level (NOAEL) of mg/kg body weight/day from a 90-day feeding study in rats, a tolerable intake for ingestion of HPMC by humans of 5 mg/kg body weight/day is posited and, as such, is more than 100-fold greater than the estimated current consumption of 0.047 mg/kg body weight/day.
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In the world of nutritional supplements and pharmaceuticals, innovation plays a crucial role in developing safe and effective products that meet the needs of a broad audience. One of the notable innovations in these industries has been the use of Hydroxypropyl Methylcellulose (HPMC). This versatile substance was a game-changer not only because of its functional benefits, but also because it offers a plant-based alternative that fits various lifestyles, including those of vegetarians and vegans.
In this blog we will delve deeper into what exactly HPMC is, why it is increasingly used instead of traditional binding agents such as gelatin, and how it contributes to the safety and quality of nutritional supplements. We will also discuss HPMC's approval and safety profile, supported by regulatory authorities and scientific studies, to highlight why consumers can confidently choose products containing this substance.
Hydroxypropyl methylcellulose, often abbreviated to HPMC or also called hypromellose, is a chemical compound widely used as an aid in pharmaceutical and food products. HPMC is a type of cellulose ether, a derivative of natural cellulose, which is extracted from plant sources such as wood pulp or cotton fibers. This compound is specifically valued for its ability to serve as a thickener, stabilizer, emulsifier and film former. It has many functions.
Chemical composition and origin
Hydroxypropyl methylcellulose (HPMC) is produced by treating natural cellulose with methyl chloride and propylene oxide. Cellulose, the basis of HPMC, is an organic compound found in the cell walls of plants, giving HPMC its plant origin. During the production process, hydroxypropyl and methyl groups are added to the cellulose chain. This chemical process improves the solubility of HPMC in cold water and increases its gelation temperature, making it particularly useful in applications requiring thermal stability.
Comparison with other thickeners
Compared to other thickeners such as gelatin, which is of animal origin, HPMC offers a crucial advantage: it is 100% vegetable. This not only makes HPMC suitable for vegetarians and vegans, but also offers significant advantages in terms of stability and shelf life. HPMC is less susceptible to microbial degradation than gelatin, which is especially important for nutritional supplements and medications that require storage in various climates and conditions. In addition, HPMC is resistant to pH fluctuations. While gelatin can break down or lose its effectiveness at different pH levels, HPMC maintains its stability over a wide pH range, making it an excellent choice for formulations that require consistent performance regardless of the acidic or basic conditions in which they are used .
The safety profile of Hydroxypropyl Methylcellulose (HPMC) has been thoroughly reviewed and approved by several regulatory authorities worldwide, including the European Food Safety Authority (EFSA) and the US Food and Drug Administration (FDA). These approvals underline the safe use of HPMC in both food products and medicines and number E464 is permitted as an additive of food and medicines.
Regulatory Approvals
HPMC is recognized as a safe food additive and pharmaceutical excipient. In the European Union, HPMC is included in the list of permitted substances that can be added to foods and medicines. The EFSA has evaluated HPMC and concluded that it does not pose a significant risk to public health when used according to approved guidelines and therefore number E464 is authorized for use in food.
Support from scientific studies
A series of scientific studies have extensively investigated the safety of HPMC. These studies have shown that HPMC is safe for consumption and has no toxic effects when ingested within stated limits. The studies focus on several aspects, including the degradation of HPMC in the human body and the absence of allergic reactions, which contributes to its profile as a non-irritating and non-sensitizing substance.
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HPMC is especially valued for its role as a capsule shell. Traditional gelatin capsules are made from animal by-products, making them unsuitable for vegetarians and vegans. HPMC capsules, on the other hand, are completely plant-based and offer an excellent alternative that suits a wide range of dietary preferences.
Choosing HPMC over other binders offers important advantages for specific consumer groups:
In this blog, we took an in-depth look at Hydroxypropyl Methylcellulose (HPMC), a plant-based compound that revolutionized the nutritional supplement and pharmaceutical industries. We found that HPMC not only provides functional benefits as a thickener and stabilizer, but is also a safe and inclusive alternative to gelatin, making it suitable for a wide audience, including vegetarians and vegans.
The approval from regulatory authorities such as EFSA and the FDA emphasizes the safety of HPMC, supported by extensive scientific studies. Furthermore, the moisture-resistant properties and thermal stability of HPMC in capsule and tablet forms are undeniable, contributing to the quality and sustainability of nutritional supplements.
At Golden Naturals, we understand the importance of transparency and the need for consumers to make informed choices about the products they use. That is why we clearly state on our labels when capsules are made from HPMC. This is declared on the label under the ingredient declaration as a thickener (cellulose as capsule shell). This openness ensures that you, our valued customer, know exactly what you are taking and are assured of a product that is not only effective, but also meets your dietary needs and ethical considerations
As a consumer, it is important to choose products that are not only safe and effective, but that also fit your ethical beliefs and health needs. Products with HPMC guarantee that you are taking supplements that:
We encourage you to look at the ingredient list on your next supplement purchase and choose products with HPMC. By doing this, you not only support sustainable production practices, but you also take care of your health in a safe and responsible way.
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