The dosage form of pharmaceuticals, OTC medicinal substances, nutrition supplements and nutraceuticals is quite relevant for consumers. Swallowing troubles due to dry mucous membranes in mouth and oesophagus, stomach acidity, sensitivity against the product consistency (e.g. allergic reactions to fine powders, gels, oily liquids, dry granules), nausea due to smell or taste (e.g. intolerance to bitter or acidulous notes, artificical sweetness or synthetic flavours) are factors that may hinder the ingestion of products and, hence, their absorption by the human organism. This shows the importance of the conditioning forms for the a.m. products, a factor which has largely evolved in recent times in order to alleviate the ingestion of such products by any individual consumer.
At the same time, the increasing consumers’ awareness of nutritional and dietary issues as well as the prominent trend for health-promoting and vitality-enhancing substances have led to a multiplication of offered products and the related necessity to make dosage forms adequate for everyone’s physiology. Most consumers aim at a healthy and stable body-and-mind balance or an increased vitality and stamina. This modern lifestyle motto includes a conscious nutrition, sport practice and a cautious care for one’s health, which may comprise the intake of nutraceuticals as a daily diet complementation. Here we speak of coated compound tablets, coated granules and pellets, softgels and hard capsules that are the usual dosage forms found in the market segment of nutraceuticals, diet supplements, pharmaceuticals and OTC medicinal products. On that account Norevo has developed the aqueous shellac solution NORELAC B20 that facilitates the oral ingestion and the absorption of active substances out of the afore-mentioned products by the human organism.
NORELAC B20 is a clear aqueous solution (abt.25% dry matter) of selected, dewaxed and physically decoloured shellacs. This highly stable solution is low viscous and not sticky and, as such, is applicable without anti-sticking agents. Its pH-value lies between 7.0 and 7.6, its odour is slightly sweetish. NORELAC B20 is ready to use and can be applied either directly or diluted in demineralised water. According to one’s needs it is possible to influence its properties by means of formulations including natural or synthetic polymers.
Shellac is a permitted food additive (E 904) in Europe, corresponding to the European Directive (EU) Nr.231/2012 ff. and to the European Pharmacopeia (Ph.Eur). In the USA ist corresponds to the norms of the USP/NF (United States Pharmacopeia). NORELAC B20 is kosher certified.
Properties & Applications
The key properties of the aqueous shellac solution NORELAC B20 in the production of nutraceuticals, diet supplements, pharmaceuticals and OTC medicines are as follows:
- Film-building solution, barrier against moisture, light protection (UV-resistant)
- Enteric coating, resistant against gastric juices
- Taste or odour masking coating
- Microencapsulation of solid and liquid substances
- Sealing surface coating to facilitate the swallowing of big tablets, pills, softgels or hard capsules
Films based on NORELAC B20 are water resistant and practically impermeable to vapour and oxygen, they prevent a decoloration caused by humidity or a bleaching effect due to UV influence; this improves the storage life of softgel capsules. NORELAC B20 acts as an enteric barrier coating against gastric juices (possibly in combination with a water soluble polymer); it hereby protects the ingested products against the stomach acidity (pH values between 1 in the empty stomach and 4 in the filled organ) and enables a targeted delivery of active principles, i.e. the absorption of diet supplements or medicinal substances by the intestine with its high pH levels between 6.8 and 8.
As for its gustatory and olfactory improvement functionality to obtain a noticeable masking effect on off-tastes or off-smells, NORELAC B20 can be combined with a water soluble polymer such as HPMC and a plasticiser.
For microencapsulation purposes, the aqueous shellac solution NORELAC B20 can be applied in various encapsulation processes such as:
- Spraycoating in fluid bed coaters and coating pans
- Extrusion and/or Co-Extrusion
- Powder, granules, pellets, microcapsules – e.g. for prebiotics or probiotics, Omega-3 products, vitamins, minerals, colour pigments, garlic capsules and further functional plant extracts – are enrobed by spraycoating in order to create a barrier against humidity, oxygen and ultraviolet rays as well as for masking possible off-taste and off-smell notes and to protect the afore-mentioned substances from gastric acidity.
- Microencapsulation process by spraydrying: here the liquids (e.g. solutions, suspensions, emulsions) are atomised together with NORELAC B20 through two-substance nozzles. The contact of the droplets with the hot air and the correlated quick evaporation produce dry, encapsulated particles that become a fine powder. This process is adequate for the encapsulation of flavours, vitamins, probiotic bacteria etc. The choice of the right equipment along with the definition of the suitable parameters are essential in order not to damage the active substances as well as to avoid a polymerisation of the shellac film. The use of NORELAC B20 in this type of process is new and provides the manufacturers of the a.m. products with both a protective and polishing solution on water basis.
- Microencapsulation through extrusion is commonly used for the production of foodstuffs and nutraceuticals. In the case of NORELAC B20, the core ingredients and the aqueous solution are mixed together or emulsified, which provides small droplets that are subsequently dried or crosslinked. This enables a gentle encapsulation process of heat-sensitive and acid-reactive core ingredients such as active substances, microorganisms, flavours, vitamin preparations, colour pigments, minerals. Through co-extrusion it is possible to encapsulate liquids, for example Omega-3 oils while protecting them from acidic gastric juices. The microencapsulation of core ingredients and active principles in the field of functional foodstuffs, diet supplements and nutraceuticals leads to improved sensory properties, an efficient protection against gastric acidity as well as a controlled delivery of active substances in the guts and, hence, a better absorption of those substances by the human body. At the same time, this process gives a higher quality stability to the finished products throughout a longer shelf life.
Nutraceuticals, diet supplements and cosmeceuticals – A growing market segment based on nutritional and health challenges for the future generations
In the last decades a common discussion topic was how to eat properly in order to keep healthy. Nowadays the nutrition topic has shifted to a wider, deeper and yet more specific level of nutritional considerations regarding the targeted functionality of nutraceuticals, diet supplements – and, to a certain extent, cosmeceuticals as well – on the human metabolism. The market offers a wide range of functional brand, generic and OTC products that are obtainable at the pharmacist’s or the chemist’s as well as in drugstores, supermarkets, convenience stores and food shops. On the one side there is the longer life expectancy of consumers on all continents, on the other side new markets are arising with a growing consumption potential along the product chain: foodstuffs ® dietary supplements ® nutraceuticals ® medicinal substances / pharmaceuticals.
With regard to the afore-mentioned market segment, the leading consumer binary block USA + Europe has seen new countries cropping up on all continents and joining the user groups with a rising demand for health-enhancing products: Japan and Israel (small countries with a strong health-oriented mentality), India, Brazil, China and the Asian-Pacific region are active parts of the global nutrition and health-promoting trends and, as such, have become new target markets for the manufacturers of these products.
Comparing the basic nutrition needs with the growing diversification of individual feel-good expectations and the collective wellness & fitness trends, it appears that nutraceuticals and diet supplements play an important role for worldwide health-conscious consumer groups. As to medicinal substances, health-enhancing products, pharmaceuticals and cosmeceuticals, the endless diversity of products and available dosage forms reflect the factual consumption of these products on a worldwide scale.
Consuser-friendly dosage form
The properties of NORELAC B20 as described above are applicable across a wide range of industrial applications. Its film-building and barrier-forming properties are advantageous in the production of softgels and hard capsules, tablets, granules and pellets. The microencapsulation of solid constituents and liquid substances is optimally performed by its encapsulating ability. Moreover, NORELAC B20 fulfils the shellac-typical functionality of a surface polishing and sealing agent that provides both a smooth surface and a protective polishing layer. This improves the finished product quality in its dosage form, general sensory profile and shelf life stability. This, above all, makes the finished products easy to swallow, then to ingest without degradation by gastric acidity so that a delayed release and targeted delivery of the active substances is achieved in the intestine for an optimum absorption through the human organism.