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Biosint S.p.A. and L-carnitine production. (Advertisement).

Biosint S.p.A., Sermoneta, (Rome), Italy is an affiliate of SigmaTau S.p.A., the second largest Italian pharmaceutical company, with affiliates worldwide. Sigma-tau, a leading investor in pharmaceutical R&D, is undisputed as the worldwide leader in carnitine and metabolic research and additionally ranks among the top 25 niche companies in the world in patent activity. More than 20 percent of Sigma-tau's revenues, a rate that exceeds the industry average, are devoted to clinical research, including dialysis and inborn metabolic diseases. Sigma-Tau is also focused on the development and production of orphan drugs for small numbers of patients whose pharmaceutical needs might not otherwise be met. One of them is an FDA-approved levocarnitine injection drug for the prevention and treatment of carnitine deficiency in chronic uremia patients affected by end stage renal disease.

The R & D professionals at Sigma-tau, Biosint (and Sigma-tau HealthScience S.p.A., Pomezia-Rome, Italy as exclusive distributor of Biosint food grade products worldwide), have developed a number of 1-carnitine molecules and product forms that simultaneously possess superior handling characteristics and the highest available content of active 1-carnitine principle available in the world. One such product is CarniShield' B94, a remarkable form of l-carnitine that is free flowing, ready to blend or tablet, and yet delivers 94% pure 1-carnitine. Other offerings, such as 1-carnitine fumarate DuraCarn[TM], a quickly growing alternative to 1-carnitine tartrate because of its optimized handling characteristics and partide dynamics, and recently acetyl-1-carnitine galactarate, have received considerable attention in the literature and/or press.

L-carnitine as manufactured by Biosint SpA is certified USP, FCC, meets AfFCO (animal feed codex) and GRAS, and is approved for pharmaceutical uses by over thirty-one health ministries worldwide. Biosint 1-carnitine is produced via a purely synthetic, pharmaceutical batch process that consistently yields a pure, white, pharmaceutical grade particle. There is no sugar, starch, plant, animal fats or proteins whatsoever used in this process. The product is certified BSE safe, GMO free and kosher. Biosint 1-carnitine base (inner salt) is derived synthetically from (gamma-trimethyl-beta-acetylbutyrobetaine).

There are, in the marketplace, other sources of L-Carnitine that are produced via the biofermentation of genetically modified organisms (GMO). STHS does not use any organisms or biofermentation, due to its exclusive pharmaceutical batch process.

Once considered as an alternative to the pharmaceutical batch process because of its inherent cost savings, the preparation of 1-caritine by the microbiological (biofermentation) route, is susceptible to batch variation of the type unacceptable to Biosint's pharmaceutical requirements, and was therefore ruled out by Biosint long ago. Such processes are characterized in that bioreactor microorganism or its mutant is cultivated with crotonobetaine and / or gamma-butyrobetaine in the presence of a growth substrate, after which the culture liquid is guided out-side the bioreactor in a cycle in which a significant biomass is removed to waste treatment. Biofermentation of mutant bacteria to produce 1-carnitine, while considerably cheaper, may bring about unnecessary risk in biomass removal and treatment as well as a socially questionable burden on our planet.

Carnitine exists in two isomeric forms: 1-caritine and d-carnitine. The latter has no physiological role other than acting as a competitive inhibitor of 1-carnitine, the only isomer biologically active and with a fundamental role in the utilization of lipid substrates by the cellular mitochondria. There are in the marketplace other sources of d- or dl-carnitine of highly improbable efficacy and, in the case of d-carnitine, not allowed for food or feed use. Biosint and Sigma-tau do not now nor have they ever been a supplier of any forms of carnitine other than the pure 1-carnitine form. L, dl- and 1-isomers can be distinguished optically by using refractometric techniques that determine the specific rotation and therefore the optical purity of the isomer. Biosint 1-caritine meets or exceeds all USP as well as all other existing codex requirements for optical purity and of course other codex parameters. The ratio of allowable d- and I Isomer is strictly governed within the USP and other codices and is represent ed by specific rotation values and acceptable limits within the monograph(s), as well as an indexed refractometric technique, that is, not to exceed d-carni tine by more than the allowable 0.5% permitted in all codices. Biosint products always fall well within the normal range for this as well as all codex parameters.

Certain 1-carnitine suppliers have been known to seemingly confuse the whole issue of optical purity. One example of such confusion is to claim a 0% d-carnitine level in their product, yet provide specification sheets and certificates of assay stating only that their product meets the 0.5% codex specification. Another example is to imply that theirs is the only 1-carnitine form. This is misleading and confusing to customers who eventually leam the reality from the true nature of the specifications. Those readers who would like a free copy of the refractometric procedure used by USP (Sigma-Tau authored the monograph for USP) for the determination of optical purity (specific rotation) may obtain one by contacting the author at the address below.

About the author:

Ken Hassen is vice president and general manager of Sigma-tau HealthScience Inc., the U.S. division of Sigma-tau HealthScience S.p.A., Pomezia, (Rome) Italy, suppliers of L-Carnitine products to the worldwide nutritional supplement industries. Mr. Hassen has held clinical lab management and senior business management positions in the area of food, pharmaceutical, animal fred, nutritional and beverage ingredients at Exxon Corp., Gist-B rocades, Con Agra and El. DuPont. He is a biochemist and a Ph.D candidate in International Business. He can be reached at Sigma-tan HealthScience Inc., South Frederick Avenue, Suite 103, Gaithersburg, Maryland, 20877, U.S.A.
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Author:Hassen, Ken
Publication:Nutraceuticals World
Article Type:Advertisement
Geographic Code:4EUIT
Date:May 1, 2003
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