SILFAR^® S 184

1. Pharmaceutical use

SILFAR^® S 184 complies with the requirements set down in the monographs "Simeticone (EP)" and "Simethicone (USP)". SILFAR^® S 184 is produced under cGMP and is suitable for use as an active pharmaceutical ingredient (API) e.g. in antiflatulence and antacid preparations.

It works by acting as an antifoam agent to prevent or relieve flatulence in the alimentary canal and by forming a protective lining on e.g. the gastric mucous membrane.

It is often combined with fermentation preparations. When administered to patients, preparations containing the antifoam SILFAR® S 184 eliminate any flatulence that might hinder X-ray, ultrasonic or gastroscopic examinations. SILFAR^® S 184 may be used to make tablets and coated tablets.

SILFAR^® S 184 is also antifoam in fermentation and downstream processes, such as active-ingredient extraction and solvent recovery, especially when USP/EP compliant products are mandatory. SILFAR^® S 184 is readily sterilized by heat.

2. Use in Food Processing

SILFAR^® S 184 is a silicone compound based on E 900 and E 551 and may be used in Europe only as a processing aid for food. Therefore, it has to be ensured by the producer of the foodstuff that only technically unavoidable traces of the product remain in the final food.

In the food industry, SILFAR^® S 184 is primarily used when foaming lipophilic systems are present (i.e. for foam control in foodstuffs containing vegetable oils, fats).

Furthermore, SILFAR^® S 184 is a base material for the production of food-compatible antifoam agents.

3. Contact with Food

SILFAR^® S 184 complies with the Recommendations of the BfR concerning the manufacture of essential commodities that have contact with food "XV. Silicones".

SILFAR^® S 184 is suitable for use under the following section(s) of Title 21 of the Code of Federal Regulations

§175.105 ADHESIVES

§175.300 RESINOUS AND POLYMERIC COATINGS

§176.170 COMPONENTS OF PAPER AND PAPERBOARD IN CONTACT WITH AQUEOUS AND FATTY FOODS

§176.180 COMPONENTS OF PAPER AND PAPERBOARD IN CONTACT WITH DRY FOOD

§176.200 DEFOAMING AGENTS USED IN COATINGS

§176.210 DEFOAMING AGENTS USED IN THE MANUFACTURE OF PAPER AND PAPERBOARD

Regulatory sanctioning of the ingredients in a product does not imply that the finished product manufactured from those ingredients is considered safe by regulatory bodies. Responsibility for compliance with specific limits e.g. on migration/extraction resides with the manufacturer of the finished product.

Further details and information on potential restrictions please see the datasheet on Regulatory Product Information.

4. Use in Agrochemical Formulations

SILFAR^® S 184 and it components meet the criteria for an exemption from the requirements of a tolerance when used as an additive in pesticide formulations to be applied to growing crops or raw agricultural commodities after harvest as specified in 40 CFR 180.950 and 180.960.

National regulations applicable in the countries concerned must be observed.