NPcaps makes its European debut
entry as Capsugel used the CpHi show to launch the latest addition
to its range of two-piece capsules. The product claims to offer
customers better control with no slow down of drug release.
Capsugel's Non-animal Polymer Capsules (NPcaps) are made of pullulan, a water-soluble polysaccharide that is produced from corn syrup by a fermentation process. They contain no genetically modified raw materials.
An advantage of pullulan is that it is very stable and well-characterised raw material, matching performance characteristics of gelatin. In vitro studies with paracetomol show that pullulan matches the dissolution profile of gelatin across the entire pH range.
Gamma scintigraphy testing of subjects in the fasted state has demonstrated that initial disintegration is rapid (an average of nine minutes post-dose).
Speaking at the Conference on Pharmaceutical Ingredients (CPhI) meeting in Brussels, Belgium, last week, a spokeswoman for Capsugel told InPharmaTechnologist.com: "The launch of the new NPcaps was primarily a health-related move. With recent food alerts involving gelatin-based products, an alternative was our response to customer calls. We looked at alternatives such as our Vcaps range but found that they were not suited to pharma."
The design of the NPcaps ensures that cross-linking does not occur. This is the process in which the fill material (i.e. drug) reacts with the amino acids in which gelatin is composed of.
"The NPcaps are suitable for all types of applications. From powder fills and semi solids to liquid fills. Essentially the NPcaps can meet any specific requirement for a specific drug," the spokeswoman added.
The development of capsules today is likely to be the result of as much R&D as the drugs it encapsulates. In developing a drug delivery method, capsules have been and continue to be popular with manufacturers. They are ideal for controlled-release formulation, which helps to improve a dosage regime.
Capsules can also reduce stability problems with sensitive drugs and combination products. They can also be used to provide an improved formulation for a less-than-optimal existing drug.
They have a primary advantages over tablets, requiring fewer excipients than tablets do, avoiding the need for bulking substances.
The spokeswoman said: "We expect initial costs to be high. However, we feel that customers will be prepared to pay for this. We're confident that once this product has become established. The price will go down. We expect it to eventually become the same as gelatin costwise."
Having received the patent for the product and now awaiting legislation, Capsugel are expecting to launch the product in January 2005. The product is already commercialised in Japan having been approved by the authorities.
Capsugel's range of capsules is designed for use in the pharmaceutical and dietary supplements industry. In 2003 it sold more than 135 billion capsules worldwide - 45 per cent in the US, 40 per cent in Europe, and the remaining 15 per cent in Asia.
The spokeswoman added: "Regarding the future, we are mainly concentrating on the NPcaps for the pharma market. That is our priority."
"The potential of this market is huge with the capacity to grow even bigger. At the moment tablets are competitively stronger than capsules. Although capsules occupy a tiny share of the market, there is space to grow."
