CalciTech creates high purity calcium for pharma industry
purity calcium carbonate is targeting the pharmaceutical industry
concerned by growing regulatory pressure on heavy metal
contamination.
CalciTech says its synthetic calcium carbonate product, initially aimed at the paper industry, could also offer major advantages for pharmaceutical manufacturing,
Its process is similar to the one used by producers of precipitated calcium carbonate, starting with the same raw material - limestone. But after burning the material it succeeds in putting the calcium into a solution using a promoter that boosts the mineral's solubility.
When the calcium is separated out, it leaves behind more of the impurities than the calcium formed through suspension by current methods.
"They can get some of the impurities out but not to the same extent as us," said Marc Lakmaaker, head of communications at the firm.
While the company has not tested the product, called CalciSPTM, in food, its directors believe that many drug makers will be interested in its low heavy metal content.
The company said the product would be ideal as the primary calcium source in osteoporosis drugs as well as in mineral additives.
In addition, it could also be used as a buffering and dissolution aid in soluble tablets with potential as a bulking agent in tabletting
"In our discussions with producers, it has become apparent that regulations have had a strong impact on demand for super pure products," noted Jean-Claude Masson, CalciTech's marketing manager for non-paper products.
He cited California's Proposition 65, which requires the Governor to publish a list of chemicals known to the state to cause cancer or reproductive toxicity. This has been a major driving force for purity improvement within the industry.
An analysis at the Analytical Laboratory of the Geneva Institute of Technology found that CalciTech's calcium carbonate had significantly lower levels of mercury, lead and arsenic than a market-leading precipitated calcium carbonate and a ground calcium carbonate.
Lead levels were at 26 parts per billion in the new calcium, compared with 88 ppb in the GCC product and 40 ppb in the PCC product. Mercury was at 0.0002 ppm, well below the requirements of the US Pharmacopeia 25 (USP25).
Lakmaaker told sister site, NutraIngredients.com that CalciSPTM also has good processing properties and could save industry money by protecting equipment.
"We can manipulate the crystal size and shape so that they are smooth and have little abrasiveness. This means less wear and tear on machinery."
The technology can also modify particle distribution, an advantage for food and tablet formulators.
"One type is rice-shaped and very smooth, compared with the brittle, sharp edges of ground calcium carbonate. It is also very uniform," said Lakmaaker.
CalciTech is not yet producing the product, supplying bulk samples from a small-scale production plant in Germany. Nor has it decided on product pricing although Lakmaaker said it will be similar to rival products.
However the firm's know-how comes from several years of previous experience of the calcium carbonate industry, and management includes the former research director for Specialty Minerals, a major calcium carbonate producer.
