Using Modified QbD to Develop a Novel Pediatric Formulation of Ezogabine
March 3rd 2021The epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
ECHA’s Microplastics Use Restriction—Impact on Pharmaceuticals
January 3rd 2021To restrict the use of intentionally added microplastics, the European Chemicals Agency has proposed a restriction dossier that describes various measures aimed at minimizing the use of microplastics in various industrial segments, including pharmaceuticals. In this paper, the authors discuss these restrictions.
Development of a Validated Method of Testing for NDMA in Ranitidine
October 3rd 2020This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
Assessment of Nanosuspension Formulation for Intranasal Administration
Research suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
Approaches to Reduced Sampling and Testing for Starting Materials
December 2nd 2019This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.
Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis
May 2nd 2019In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.
Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3
May 2nd 2018The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
Evaluating the Impact of Sterilization on Gel Formulations
Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.