triButyrate® is produced adhering to the strictest pharmaceutical production criteria for Active Pharmaceutical Ingredients (API), as well as for applicable finished dosage form. The production of triButyrate® is a 12-step synthesis. To satisfy current specifications and purity levels of the finished API. Very strict and narrow production controls and extremely high purity levels of raw materials are required in order to obtain the ultra-pure product necessary for all known indications and applications.
triButyrate® has a Drug Master File, (DMF # 9716) filed with the Food and Drug Administration, (FDA) for the production of the Active Pharmaceutical Ingredient. triButyrate® powder is produced under the strictest pharmaceutical standards - in an ISO 9002 certified plant. In cases where triButyrate® tablets are used for Clinical Studies and other similar purposes, these are produced on a "tolling" arrangement for the various institutions, who supply their triButyrate® powder to an accredited and an approved good manufacturing practices GMP) pharmaceutical plant, with the know-how and rights to produce the 1 gram enteric-coated tablets. This ensures maximum safety and purity. Each tablet batch is analyzed according to Good Laboratory Practices (GLP) regulations, with records and samples being stored for long-term stability testing, etc. Currently long-term stability data for 48 months is available. The powder is suitable for capsules, also suppositories, and suspensions as well as for making intravenous solutions. However, to ensure sterility and a pyrogen-free solution, the final solution must be sterilized after the solution has been packaged in its final dosage form.
The triButyrate® bulk substance has extremely favorable tablet making properties,and only small amounts of excipients have to be added, to make tablets of perfect quality, size and with optimal properties. The triButyrate® 1 gram tablets are lightly coated, to cover the slight characteristic odor and taste, and also to ensure that the tablets dissolve in the intestines, rather than in the stomach, for maximum bio-availability and minimum gastric distress. This is important considering the large quantities (often 20 grams daily) that are recommended as a result of clinical work and experience for each application/ indication.
triButyrate® powder and tablets are stored under optimal conditions at several warehouse locations strategically placed worldwide. Although the shelf life of the powder is in excess of five years, the shelf life for the tablets has, for regulatory reasons, been set to be three years. triButyrate® 1 gram enteric coated content tablets come packed in vacuum plastic pouches (99.5% vacuum) of 600 tablets, being the most common market dosage for early and safe distribution and administration, or in 7,200 tablet bulk packages.
As new and better technology and/or analysis methods become available, these are incorporated in our production process, in order to assure maximum efficacy and safety at all times and to constantly improve the quality of triButyrate® in powder and tablet form.
All rights to the product and trademark triButyrate® are owned by
Fyrlklövern Scandinavia AB.