Lactose product from DMV
Netherlands, Pharmatose DCL14, has properties that give it
performance advantages over rival excipients used as
filler/binders, according to the company.
Lactose is an established excipient with properties that make it ideal as a tablet filler or binder. Pharmatose DCL14 is a directly compressible product made up of a mixture of fine crystals of lactose monohydrate and amorphous lactose, and this is the key to its performance, according to Gerad Bolhuis, an associate professor in the department of pharmaceutical technology and biopharmacy in the University of Groningen in the Netherlands.
Prof Bolhuis noted that tablet manufacturers are looking for a number of key characteristics in compressible filler/binders, including high compactibility to keep the tablet intact after leaving the machine.
Flow properties must also be good to allow uniform die filling and to minimise variations in tablet weight, a critical factor when one considers that tabletting machines can typically be compressing 8,000 to 10,000 tablets per minute. And the excipient must offer compatibility with a range of drugs, good mixing properties, a high drug uptake capacity and the stability to allow a long shelf life.
DMV claims that DCL14 offers better compaction properties than any other spray-dried lactose product. Its uniform particle size, and the fact that each particle is spherical, also gives it a high degree of flowability, it added.
But are there areas where DCL14 cannot be used? Prof Bolhuis pointed out that there are occasions when a reaction could occur between the lactose and an active drug, for example if the latter contained a primary amine group, but said this was only a theoretical possibility.
Importantly, said Prof Bolhuis, DCL14 has advantages over some expensive, rival filler/binders, such as microcrystalline cellulose. The latter has excellent binding properties but flowability is rather poor and it can only be used with other filler/binders. DCL14 can be used on its own, he noted.
Other alternatives to DCL14 include co-processed products such as MMC with lactose and sugar alcohols, but these are generally much more expensive than DCL14, said Prof Bolhuis.
