Saliva (Medical Device)
Indication
Artificial Saliva is used for a fast and long-lasting relief for dry mouth, Xerostomia*.
Product range
Artificial Saliva Orthana is available as API, powder for tableting, or as an OEM product under your brand name in:
• Saliva spray in 50 ml bottles and 500 ml refill bottles; both sizes are available with or without Flavour.
• Saliva gel in a 50 ml bottle with a pump (requested by many patients for night use, as well as by many hospitals. This is one of our major market segments).
• Saliva lozenges, 30 lozenges in a pack.
• Saliva pastilles (product development stage)
Documents available
Medical Device class 1 Registration, Free Sales Certificate, CoC, Stability Test Data, MoA, Flow Chart, MSDS, Technical Data Sheet.
How it works
The active ingredient mucin sticks to the mouth cavity and the teeth providing long- lasting caring wetting and comfort. Simultaneously, mucin protects human surfaces against bacteria and fungus, and counteracts the formation of ulcers.
It is important that a saliva substitute replicate human saliva as closely as possible. The solution remains neutral, since the acidity in the mouth is undesirable, as this can lead to the increased soreness and further increases tooth damage risk.
For more information on examples of the OEM products please visit: http://www.aspharma.co.uk/
*Dry mouth also called Xerostomia is a condition of not having enough saliva, or spit, to keep the mouth
wet.
*Dry mouth may occur naturally with ageing or as a recognized side-effect of many prescribed drugs, smoking and drinking alcohol. Some serious cases are caused by certain cancer treatments, systemic diseases as Sjogren’s syndrome, Rheumatoid Arthritis, Parkinson’s disease, and Alzheimer’s disease, damage to the gland’s nerve system, Diabetes, HIV/AIDS, and
Anaemia.
*Artificial Saliva is gluten free, has no reported side effects
and suitable for children and pregnant women.
Artificial Saliva Ingredients
|
Ingredient
|
Purpose
|
|---|---|
|
Mucin (from porcine gastric linings)
|
Lubrication and protection of the oral mucous membrane
|
|
Methyl-4-hydroxybenzoate
|
Component of preservation system. The preservation properties of the product meet the requirements of oral preparations conforming to Ph. Eur. The preservative functions
|
|
Benzalconium chloride
|
Component of preservation system. The preservation properties of the product meet the requirements of oral preparations cf. to Ph. Eur. The preservative functions
|
|
EDTA disodium salt x H2O (E386)
|
Component of preservation system
|
|
H2O2
|
Component preservation system. The component functions as a bactericide.
|
|
Xylitol
|
Sweetener and growth inhibitor towards Streptococcus mutants since xylitol cannot be metabolised by this microorganism, which is present in high amount in subjects suffering from Xerostomia. Furthermore, xylitol has a positive
|
|
Peppermint oil
|
Component of flavour system
|
|
Spearmint oil
|
Component of flavour system
|
|
Mineral salts
|
Mimic of physiological property
|
Dry mouth should not be ignored. Some of the most important consequences of the hyposalivation (too small quantities of saliva secretion) are: increased infections of the salivary glands and the mucosa in the mouth, bleeding gums, burning sensation of the mucosa and tongue, difficulty in speaking and swallowing, mouth sores and ulcers, bad breath, cracked lips, tooth decay, taste disturbance, sleep disturbance.