New excipient drives industry search for alternatives
Cargill-Cerestar's plans to unveil a new excipient at CPhI which is
developed on the back of a directly compressible excipient platform
allowing tablets to be produced using lower compression forces.
In-PharmaTechnologist took time out with the company's business manager of Pharma and Cosmetics, James Taylor, to talk about the new product and other industry wide issues.
Cargill-Cerestar Food & Pharma Specialties, have placed a special focus on C*PharmMannidex DC at this year's CPhI event taking place in Madrid. This mannitol excipient enables customers to formulate tablets with higher doses of active ingredients.
This is useful where customers are increasing their use of starch-based excipients that are not animal derived.
Taylor told InPharmaTechnologist: "C*PharmMannidex DC exhibits low hygroscopicity. The low water attracting properties means it retains a resistance to moisture exposure ensuring the tablet and it's constituent materials remain unaffected."
The reduced calorie product is a non-cariogenic excipient, which is suitable for producing tablets with direct compression. The excipient exhibits good compressibility at all compression forces.
Taylor commented that a tablet produced with lower compression forces would result in lower machinery ware cutting long-term costs on machinery life span. In addition, the fewer processing steps involved in producing the excipient also adds to less machinery wear and tear.
C*PharmMannidex DC is suitable for the production of tablets via direct compression. It meets all requirements of Ph. Eur., USP / NF and JP, when tested accordingly.
The drive towards alternatives to animal-based products also works to the product's advantage. It has generally been accepted that starch-based excipients such as C*PharmMannidex DC are more cheaper than similar cellulose-based products and more importantly animal-based ones.
However, Taylor was adamant that the industry drive towards the search of alternatives would only occur if it were economically feasible.
"Manufacturers and producers would still use the same machines to produce excipients. Alternatives would need to be directly replaceable without the extra cost in replacing machinery," he said.
Taylor commented on the advent of the Good Manufacturing Practice (GMP) guidelines. These regulations under law require that manufacturers, processors, and packagers of drugs, medical devices take proactive steps to ensure that their products are safe, pure, and effective.
GMP certification reflects consistent quality standards in production, technology and quality control. GMP standards have long existed for pharmaceuticals but were only introduced last year for active agents. Outside of the European Union, these GMP regulations are known as the ICH Q7A standards, recognized by Europe, Japan and the US.
"The advent of GMP has once again raised the standards in which we are finding smaller companies struggling to meet the demand and expectation," he said.
The pharmaceutical industry has become a leading beacon for GMP. From experience it is known that standards from pharma are often taken on by the supplements industry a few years later.
