[:en]There are four main areas that define whether a cough and cold botanical extract is successful. In this white paper we explore these areas and look into the most successful cough and cold extracts used in Pharma. We review both natural and synthetic extracts and the broad differences between them.[:eu]There are four main areas that define whether a cough and cold botanical extract is successful. These are efficacy, commercial viability, flavour and of course, safety.

Whilst a natural extract has its own set of properties and not all synthetic products are created equal, there are some broad differences between natural and synthetic that we will touch on whilst exploring each area.

Efficacy
Efficacy depends on what you are trying to achieve. In general cough and cold products are either expectorants, antitussives or decongestants / anti-inflammatories.

Expectorants seek to remove mucus from the lungs and airways. They primarily do this by increasing the amount of water in the mucus, thus thinning it and allowing you to more easily cough it out. As a result, expectorants often actually increase the amount that you cough. Therefore, many expectorants also lubricate the airways and may act as a relaxant to make each cough more productive and less of an irritant.

Antitussives, on the other hand, aim to reduce coughing. In general, when someone has a mucusy cough, the secretion of this mucus and other obstructive material through coughing is to be encouraged. However, it may be that a cough is particularly dry and disrupts sleep or makes the patient so uncomfortable that they need respite. In these cases, an antitussive product may be desirable. It should be noted that most antitussives work by sending signals to the brain in order to suppress the instinct to cough, and this can produce side effects such as drowsiness.

Decongestants work by shrinking blood vessels in affected areas and decongestion medication tends to contain anti-inflammatory agents. In the case of a cold, by reducing inflammation in the nose, more space is given for air to flow through and for mucus to drain. This should result in increased comfort levels and are used particularly for blocked noses.

As can be seen, each of these groups looks to achieve subtly different goals, and this study will examine natural extracts that are suited to each purpose.

Commercial Viability
There is clearly proven demand for cough and cold medication, with powerful incumbent brands such as Covonia, Brochostop, Buttercup and Echinaforce widely available. It is noteworthy that 8% of all products that have been granted a Traditional Herbal Registration (THR) by the MHRA specifically target cough and cold indications (In House Research). However, how a product is packaged, marketed and distributed can still have a significant impact on sales. Using natural extracts is a differentiator that marketing teams can use to their benefit.

Marketresearchfuture.com have indicated that “the market for herbal medicine is expected to reach $ 111 billion by the end of 2023, this market is projected to growing at a CAGR of ~ 7.2 % during 2017-2023.”

They have identified that “Some of the major drivers for the global herbal medicine market are rising elderly population, growing consumer awareness regarding the use of herbal medicines with slight or no side effects, and the release of Current Good Manufacturing Practices (CGMP) for dietary supplements by the FDA” as well as acknowledging that rising costs of synthetic medication have also played their part in a substitution effect towards naturally based remedies.

This demand shift echoes a wider and long-lasting trend towards natural products in related categories such as nutrition, as consumers continue to move away from synthetic and towards natural. This preference has long existed in certain regions, especially within Asia, but is now also becoming prevalent in the West.

This movement is generally positive for all cough and cold botanical extracts, increasing their chances of success. However, it should also be noted that as with “superfoods” in the nutrition category, there are also certain botanical extracts that have a higher profile and this may also have an impact on commercial viability. For example, the anti-inflammatory properties of ginger are fairly well known which may make the marketing of products containing ginger extract easier than a lesser known ingredient.

Flavour
There are botanical extracts that can be used as flavouring agents as well as, or in combination with, active ingredients. A good example of this is wild cherry and liquorice which are proven popular flavours.

Flavour is a double edged sword, especially in relation to children. It is important that the taste of medication is palatable, however there is always the concern that if it is too appealing then children may seek it out even when not actually sick!

Indeed, flavours that children like tend to be different from successful adult flavours. On the whole, children prefer sweeter flavours that mimic the taste of candy, such as blackcurrant whereas citrus based flavours such as lemon or orange are more popular with adults.

SAFETY
Whilst medication is a heavily regulated area, it is still important for consumers to be aware of the potential side effects of certain ingredients. In general, botanical extracts are less likely to cause harmful side effects than synthetically produced medication, however any sensitivities or allergies need to be taken into account regardless.

Moreover, due care should be taken when giving cough and cold medicine to children, with most of these medications unsuitable for pregnant women or children under one, even if made from natural sources.

Other things that consumers may look for are the presence of Non-Steroid Anti-Inflammatories. These are unadvisable for patients with high blood pressure and other conditions. This has led to demand for natural alternatives such as medication that contains gingerols.

For producers of medicinal products it is key to have Drug Master Files outlining Active Pharmaceutical Ingredients. Manufacturers of botanical extracts, such as Quest have an ongoing Drug Master File development programme with dossiers being compiled for many of the herbal substances and herbal preparations listed described below.

Best Selling Cough and Cold Botanicals
In this section, we examine Quest’s best-selling botanicals, grouped by their primary objective. In most cases, manufacturers of cough and cold syrups combine more than one of these in order to create a multipurpose medicine:

Expectorants

Cocillana – Cocillana, also known as Guapi bark refers to the genus Guarea. It is an evergreen tree that is a member of the Meliaceae family and is native to the eastern Andes in South America. The bark is traditionally used as an expectorant. It is known to contains resins, tannins and coumarins.

Ipecacuanha – The root of Cephaelis ipecacuanha has a long traditional use as an expectorant. Cephaelis ipecacuancha, a member of the Rubiaceae is native to Brazil and the root is known to contain the alkaloids emetine and cephaeiline as well as tannins.

Liquorice – A well-known flavour, liquorice root (Glycyrrhiza glabra) has expectorant and anti-tussive properties. The plant has a widespread distribution but is chiefly found in the Mediterranean and Asia. The compound responsible for the sweet taste is glycyrrhizic acid. Glycyrrhizic acid is classified as a saponin. Saponins are known to possess anti-tussive effects. It also has anti-inflammatory and antioxidant properties. Other compounds present in the root are essential oils and flavonoids.

Senega – Senega refers to plants from the Polygala genus and are members of the Polygalaceae. The herbal drug is chiefly P. senega which is native to North America and P. tenuifolia which is found in the Far East. It is commonly known by the name snake root, rattlesnake root, amongst others. The root is used medicinally due to its anti-tussive properties which are believed to be associated with the saponin content. Saponins are triterpenoids that form a soap action when mixed with water. Moreover, it has anti-inflammatory properties, helping with swelling of the throat, nose and chest.

Squill – Squill refers to the genus Drimia and is a member of the lilly family. Drimia species have a widespread distribution but two species are mainly used in herbal medicine. Drimia maritima or Mediterranean Squill is native to the Mediterranean, particularly southern Italy whilst Drimia indica or Indian Squill is native to India. Both contain cardiac glycosides such as bufadienolides and It is the bulb of squill that is used to medicinally. When used in moderate doses Squill is an effective expectorant (and emetic in larger quantities), however patients with certain heart, stomach or bowel conditions and pregnant or breast-feeding women should not take squill as the cardiac glycosides may be toxic when taken at higher doses.

Thyme – A common garden herb, Thymus vulgaris is a member of the Labiatae and is often used for cooking. Thyme is characterized by essential oils with thymol being a main constituent. Thyme has a long history of being used in liquid form to thin mucus and relieve congestion. In fact, it has anti-viral, anti-fungal, anti-bacterial properties and can act as an antitussive in the case of dry coughs.

Wild Cherry Syrup – Wild Cherry Syrup is a preparation containing an extract from the inner bark of the wild cherry tree, Prunus serotina. The plant is mainly found in Canada and the United States and is a member of the Rosaceae family. It contains volatile compounds known ans cyanogenic glycosides as well as phenolics and sugar. Like thyme, wild cherry bark also has an antitussive effect when dealing with dry coughs. In addition to this Wild Cherry is a mild sedative and has a pleasant taste, enabling it to be used as a natural flavouring agent.

Antitussives, Anti-inflammatories and Anti-bacterial agents

Marshmallow Root – Also known as Althaea officinalis, the Marshmallow plant is a member of the Malvaceae and is found in Europe, North America and western parts of Asia. As well as being an antitussive, it is also an anti-inflammatory, helping to soothe the throat. The root is known to contain up to 35% mucilage consisting of polysaccharides and is also known to contain flavonoids.

Ginger – Primarily used for its anti-inflammatory and purported anti-bacterial properties, ginger root (Zingiber officinalis) is a member of the Zingiberaceae which has antitussive properties. The plant is distributed across Asia, tropical Africa and the West Indies. It is often combined with honey to balance out its sharp taste and produce a pleasant and effective remedy. Compounds characteristic of ginger root are essential oils and complex molecules known as gingerols and shoagals.

Euphorbia – Euphorbia hirta is a member of the Euphorbiaceae family and is commonly known as Asthma-weed. It has a widespread distribution. The herb is used medicinally for its pectoral and anti-asthmatic properties. The herb also possesses antibacterial activity. It is known to contain flavonoids and its choline and shikimic acid content may contribute to its medicinal activity.

Why Quest?
As with any medicinal ingredient, preparing botanical extracts requires precision and attention to detail. Quest has Good Manufacturing Practice (GMP) accredited production facilities, an experienced quality assurance team and has been entrusted to supply the largest cough and cold brands in the UK and Asia.

To learn more, you can contact us on +44 198 125 1713 or through our contact form[:]