08. July 2018
Magnesium stearate (MgSt) is the most commonly used excipient for oral solid dosage forms, yet there is significant commercial physicochemical variability that can lead to variable performance of critical product attributes. Differential scanning calorimetry (DSC) is often used as a quality control tool to characterize MgSt, but little data is available regarding the physicochemical relevance for the DSC thermograms. The main aim of this study was to decipher MgSt’s complex thermotropic...
20. August 2016
Abstract Active pharmaceutical ingredients (APIs) with strongly pH-dependent aqueous solubility can face the problem of precipitating from solution when the pH changes from acidic in the stomach to neutral in the intestine. The present work investigates the effect of two polymeric excipients – polyvinylpyrrolidone (PVP) and Soluplus – on the ability to either prevent precipitation, or to control the size distribution of precipitated particles when precipitation cannot be prevented. Two...
20. June 2016
Abstract Since the discovery about 30 years ago (2-hydroxypropyl) beta-cyclodextrin, a highly soluble derivative of beta-cyclodextrin, has become an approved excipient of drug formulations included both in the United States and European Pharmacopoeias. It is recommended to use as solubilizer and stabilizer for oral and parenteral formulations. Recently, its pharmacological activity has been recognized in various diseases. The increasing applications require a closer look to the...
29. February 2016
The study investigated the use of monoacyl phosphatidylcholine (MAPC) in self-nanoemulsifying drug delivery system (SNEDDS). A D-optimal design was used to generate two sets of formulations containing long-chain (LC) or medium-chain (MC) glycerides, caprylocaproyl macrogol-8 glycerides (Labrasol), Lipoid S LPC 80 (LPC) (80% MAPC) and ethanol. The formulations were characterized using dynamic light scattering, microscopy, in vitro lipolysis and viscometric measurements. All LC formulations...