Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride.

This work describes the potential applicability of the BCS-based Biowaiver to oral solid dosage forms containing Levamisole hydrochloride, an anthelmintic drug on the WHO List of Essential Medicines. Solubility and permeability data of levamisole hydrochloride were searched in the literature and/or measured experimentally. Levamisole hydrochloride is a highly soluble drug, but there is no clear evidence of high permeability in humans, indicating that it should provisionally be assigned to BCS class III.

Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 - 18 years).

Objectives: To develop an oral solid dosage form of levamisole suitable for the paediatric population in terms of dose accuracy, palatability, stability and ease of administration.

Methods: Small undividable tablets (Ø5 - 8 mm) in four different strengths were manufactured to allow for flexible and accurate dosing. In vitro dissolution testing was used to determine drug release in different media.

[Orphan drugs: availability, reliability and reimbursement].

Orphan drugs are drugs used in the treatment of life-threatening or chronic diseases that affect fewer than 1 out of 2000 persons in the European Union. Since the implementation of the European Regulation on Orphan Medicinal Products in 2000, 61 orphan drugs have been brought to market. One-third of these were granted their marketing authorisations based on non-comparative clinical research.

Treatment outcome of intravenous artesunate in patients with severe malaria in the Netherlands and Belgium.

Background: Intravenous (IV) artesunate is the treatment of choice for severe malaria. In Europe, however, no GMP-manufactured product is available and treatment data in European travellers are scarce. Fortunately, artesunate became available in the Netherlands and Belgium through a named patient programme.