At Recipharm our team regularly works with modified release concepts. This allows us to advise you on the technology most suited to your active ingredient and your needs.
There are a number of well-established MR (modified release) technologies that allow for greater control over the rate and/or the site of release of drugs, allowing pharmaceutical companies to achieve specific clinical objectives that cannot be attained with conventional dosage forms.
Improved efficacy and performance, reduced adverse events and increased convenience and patient compliance are all benefits that can be achieved by MR.
MR dosage forms can be divided into monolithic and multiple unit formulations. Monolithic formulations (usually tablets) are often simple to manufacture as they may be produced by conventional tableting processes.
Multiple unit preparations, such as pellets, require a more complex manufacturing process, but offer less variable gastrointestinal (GI) transit. This makes it easier to combine components with different drugs or varying release profiles.
At Recipharm, we are experienced at developing both types of formulations, meaning we can adapt to the nature of your drug candidate.
From our state-of-the-art development facilities, we offer comprehensive development services for coated pellets.
Coated pellets are extremely useful for a number of purposes. By applying a polymeric coating to sub-millimeter spherical particles, the drug release can be controlled. By varying the composition and thickness of the coating, a range of different release profiles can be achieved.
Our equipment allows us to work with batch sizes from 400 g to 150 kg with absolute control over all relevant process parameters. This allows us to go from lab-scale to full commercial scale on the same site, eliminating the risk of variations in release rate during scale-up.
We can also work with coating solutions based on water as well as organic solvents. Analytical chemical development is available at the same site.
Modified release tablets
Recipharm has experience in developing MR (modified release) tablets with a robust release rate from small-scale all the way into commercial production.
Tablets can often be a cost-efficient way to achieve a modified release MR product. In particular, hydrophilic matrix tablets are frequently used in order to achieve a near constant release rate.
In a hydrophilic matrix tablet the drug is dispersed in a polymer. When the tablet is immersed in water, the polymer will swell and start to form a gel layer that will control the release rate. This can be adjusted by varying the composition as well as tablet size and shape.