02. May 2018
One of the most common classes of excipients used in protein formulations are buffers. The aim of this work is to investigate the effect of buffers on protein stabilization given by sugars during freeze drying. Methods Molecular Dynamics simulations of human growth hormone (hGH) in the presence of sucrose and trehalose were performed, and the impact of phosphate and citrate buffers on their protective action was analyzed. Results We found that buffers broke the hydrogen bonding network formed...
19. October 2017
Die Europäische Arzneimittelagentur (EMA) und die Europäische Kommission haben die Liste von Hilfsstoffen überarbeitet, die vorgibt, welche Stoffe die Pharmaunternehmen unter welchen Bedingungen auf der Verpackung und in der Packungsbeilage deklarieren müssen. Unter anderem gehören neuerdings auch 26 potentiell allergene Duftstoffe dazu.
20. February 2017
Abstract Barrier coatings are frequently employed on solid oral dosage forms under the assumption that they prevent moisture sorption into tablet cores thereby averting premature degradation of moisture-sensitive active ingredients. However, the efficacy of moisture barrier coatings remains unproven and they may actually accelerate degradation. This study aimed to investigate the barrier performance of four coating systems following application onto a low hygroscopic tablet formulation...
13. June 2016
In this work calcium stearate (CaSt) multi-particulates loaded with codeine phosphate (COP) were developed in an attempt to provide extended release (ER) combined with alcohol dose dumping (ADD) resistance. The pellets were prepared via wet/extrusion spheronization and ER characteristics were obtained after fluid bed drying at 30 °C. Pore blockers (i.e., xanthan, guar gum and TiO2) were integrated to control the uptake of ethanolic media, the CaSt swelling and consequently, the COP release....
21. April 2016
Reduction of intestinal load of phosphorus is important for the prevention and treatment of chronic kidney disease (CKD)-mineral and bone disorder (MBD). However, this strategy is limited by patients’ poor adherence to dietary prescription and by the existence of hidden sources of phosphorus. In addition to food containing phosphate-based additives, it was recently claimed that medications may contribute to increase the load of phosphate (P), mainly present as an excipient. To identify...
18. March 2016
Abstract: The objective of this study was to design and evaluate Sitagliptin Phosphate immediate release (IR) 50 mg tablet using Response Surface Methodology for the managemant of Type-II diabetes mellitus. Response surface methodology (RSM) computations for this optimization study were performed employing Minitab 16. Different formulations of immediate release were prepared by applying 2 factor 2 level Central Composite Design (CCD) using Minitab 16 which gave 13 formulation for each layer....
17. February 2016
Context: Most of the active pharmaceutical ingredients (APIs) suffer from a drawback of poor aqeous solubility. In addition to the same, some APIs show poor tabletting behavior creating problems in formulation development. Crystal engineering can be an efficient tool in rectification of such problems associated with the APIs. Thus present work deals with crystallization of ibuprofen (a model drug) onto the surface of dicalcium phosphate (DCP) particles using different techniques. Objective: The...
14. November 2015
Barrier coatings are frequently employed on solid oral dosage forms under the assumption that they prevent moisture sorption into tablet cores thereby averting premature degradation of moisture-sensitive active ingredients. However, the efficacy of moisture barrier coatings remains unproven and they may actually accelerate degradation. This study aimed to investigate the barrier performance of four coating systems following application onto a low hygroscopic tablet formulation containing...