SAPhS PharmaLunch Basel, January 26, 2018 Klaus Rose, M.D., M.S., klausrose Consulting, Pediatric Drug Development & More - Chronological age, physiology, and why children are not "therapeutic orphans" - Medical sense in FDA/EMA-demanded pediatric studies? - Largest systematic abuse of patients in clinical research in history? - Challenges for clinical community, media, lawyers, Ethics Committees/IRBs - Ways forward More Information & Registration
Hot-melt extrusion (HME) technology has been used for manufacturing extended-release abuse-deterrent formulations (ADFs) of opioid-type analgesics with improved tamper-resistant properties. Our objective was to describe application of this technology to immediate-release (IR) ADFs.
Polyethylene glycol (PEG) is a chemically inert, amphiphilic polymer used as an excipient in many pharmaceuticals for decades, and as a conjugate with biologicals (ie, PEGylation) since 1990. To date, the US FDA has approved 14 PEGylated therapies with diverse indications.
This study focuses on understanding the physicochemical principles for the preparation of high drug-loaded microgranules with a desired size distribution and mechanical properties. Mesalamine was selected as a model drug, and microgranulation was performed using an extruder and a conical screen mill.
The vulnerability of controlled release formulations when co-ingested with alcohol represents a current major concern of regulatory agencies. Dose dumping might occur when drugs and/or excipients exhibit higher solubility in ethanolic solutions compared to water.
IPEC-Americas and IPEC Europe have jointly published a guide for excipient makers and users on co-processed excipients. This guide offers best practice and voluntary guidance on the development, manufacture and use of co-processed excipients and provides support to both manufacturers and users of co-processed excipients.
Development of sustained release formulations of Metformin hydrochloride (Met) having low bioavailability and short half-life is one of the frontier areas of research towards achieving novel drug delivery systems.
The aim of the present investigation was to understand the swelling behaviour of HPMC and PEO-based matrices and to evaluate the impact of porosity on the swelling kinetics. It was noticed that the HPMC has higher swelling rates but both undergo diffusion oriented swelling mechanism.
This study aimed to compare the dissolution and the intestinal absorption of tacrolimus in self-microemulsifying drug delivery system (SMEDDS) and solid dispersion (SD). Poloxamer 188 SD was prepared by the combination of the solvent evaporation method and the freeze drying method. Hydroxypropyl methylcellulose (HPMC) SD was prepared by the solvent evaporation method combined with the vacuum drying method.
Nowadays most of the drug substances are coming into the innovation pipeline with poor water solubility. Here, the influence of excipients will play a significant role to improve the dissolution of poorly aqueous soluble compounds. The drug substance needs to be dissolved in gastric fluids to get the better absorption and bioavailability of an orally administered drug. Dissolution is the rate-controlling stage for drugs which controls the rate and degree of absorption.