14. March 2017

Abstract Using pharmaceutical salts in solid dosage forms can raise stability concerns, especially salt dissociation which can adversely affect the product performance. Therefore, a thorough understanding of the salt instability encountered in solid state formulations is imperative to ensure the product quality. The present article uses the fundamental theory of acid base, ionic equilibrium, relationship of pH and solubility as a starting point to illustrate and interpret the salt formation and...

28. January 2017

Abstract The objective of this work was to access thymol-excipient compatibility using an alternative protocol of mixture design subsidizing the development of nanostructures lipid carriers containing this drug. Simultaneous DTA-TG analyses associated with infrared spectroscopy were performed according to simplex centroid mixture designs with three components. Two designs were used: the design A containing stearic acid (SA), soybean lecithin (LC), and sodium taurodeoxycholate (TAU) and the...

13. December 2016

Abstract Previously, granulated lactose carriers were shown to improve uniformity and aerosolization of a low-dose model drug. In the present study, the blending uniformity and aerosol dispersion performance were assessed for 2 model drugs salbutamol sulfate (SS) and rifampicin (RIF), blended at high loadings (10% or 30% drug) with granulated lactose carriers. The model drug powders differed in particle size distribution, morphology, density, and surface energies. Content uniformity of RIF...

21. March 2016

Influence of some commercially available types of microcrystalline cellulose (MCC) on the stability of certain active pharmaceutical ingredients (APIs), when in contact, has been investigated. Two structurally similar APIs, perindopril erbumine (PER) and enalapril maleate (EM), both well-known angiotensin-converting enzyme inhibitors were used. The main properties of an MCC that could determine the stability for each API were measured and correlated to the stability of these two APIs in binary...

02. March 2016

Aim: To evaluate possible interaction between apple cider vinegar (ACV) which is the most frequent used active ingredient of diet pills with 20 different excipients. Materials and Methods: The pure drug ACV and drug-excipient powder mixtures which were stored under the condition of 40°C and 75% relative humidity for a period of 21-day and interaction were seen by using modern instrumental technique high-performance liquid chromatography, Fourier transmission infrared and differential scanning...

09. February 2016

Excipients are more complex than well-characterized active pharmaceutical ingredients (“APIs”). Often, it is the multi-component nature of the excipient that drives many of the interactions with APIs. Even for the most commonly used excipients, it is necessary to understand the context of their manufacture in order to identify potential API interactions with trace components. This workshop will illustrate the contrasting nature of excipients, and help identify reaction mechanisms. This...

01. February 2016

Poor water solubility of many drugs has emerged as one of the major challenges in the pharmaceutical world. Polymer-based amorphous solid dispersions have been considered as the major advancement in overcoming limited aqueous solubility and oral absorption issues. The principle drawback of this approach is that they can lack necessary stability and revert to the crystalline form on storage. Significant upfront development is, therefore, required to generate stable amorphous formulations. A...

12. December 2015

29. July 2015

By: Ming Huang, Research Investigator IIRobert Wethman, Senior Research ScientistJohn Wasylyk, Principal ScientistBristol-Myers Squibb More

02. March 2015

Mol. Pharmaceutics, 2015, 12 (3), pp 857–866 DOI: 10.1021/mp500692a Publication Date (Web): January 13, 2015 Copyright © 2015 American Chemical Society *E-mail: lubach.joseph@gene.com This study investigated the presence of specific drug–excipient interactions in amorphous solid dispersions of lapatinib (LB) and four commonly used pharmaceutical polymers, including Soluplus, polyvinylpyrrolidone vinyl acetate (PVPVA), hydroxypropylmethylcellulose acetate succinate (HPMCAS), and...