Regulatory filing strategy for generic mesalazine modified release formulations

Gastrointestinal release behaviour of modified-release drug products: dynamic dissolution testing of mesalazine formulations.

The aminosalicylate mesalazine (mesalamine) forms the mainstay of treatment in ulcerative colitis (UC), a disease for which many commercial modified-release products have been developed with the aim of providing targeted gastrointestinal release. The release profiles of five of these commercial formulations were evaluated in bicarbonate buffer using a novel dissolution model that mimics the dyn...

In-vitro dissolution testing of 5-aminosalicylic acid release from pH dependent mesalazine formulations.

Figure 2 Experiment B: dissolution of Salofalk 1.5 g granules (batch no. 10F18833L) and Mezavant 1200 mg (batch no VB032) at sequential pH 1.0, 6.0, and 6.8 (n=6). We have read with interest the abstract presented at the last ECCO Congress by Tenjarla & Abinusawa1. While we agree with the authors' final statement that ‘consideration of the potential release profiles [of 5-ASA] may be a useful t...

Neurotransmission: Spontaneous and Evoked Release Filing for Divorce

Neurotransmitter release can be evoked by action potentials or occur spontaneously, but the relationship between those modes has been unclear. The direct visualization of release events has now shown that individual synapses display preferences for evoked versus spontaneous transmission that are determined by the release machinery at active zones.

Controlled Release Gel Formulations

Simple gel formulations may be applied to enhance the systemic and local exposure of potential compounds. The aim of this thesis is the development and characterization of controlled release formulations based on thermoreversible poloxamer gels, which are suitable for novel drug delivery applications. In particular co-solvents (DMSO, ethanol), mucoadhesive polymers (chitosan, alginate) and salt...

Polysaccharide-Based Nanoparticles for Controlled Release Formulations