22. October 2017

Direct analysis of excipients without protein removal prior to hydrophilic interaction liquid chromatography (HILIC) HPLC analysis.

08. March 2017

Abstract Associative interactions between folic acid and proteins are well known. This work leverages these interactions to engineer folic acid nanoparticles for controlled release of insulin during diabetes therapy. The insulin-loaded folic acid nanoformulation is synthesized during this study and more than 70% protein loading with less than 10% insulin loss have been maintained during the synthesis process. The folic acid nanoparticles of 50–150 nm size are further characterized in the...

01. March 2017

Abstract The purpose of the present study was to develop a near-infrared spectroscopy (NIRS) method to quickly, accurately, and precisely evaluate and control the coating process of the low dose drug, glimepiride on tablet. For this purpose, a calibration set for the drug was quantified using a partial least-squares regression method with a high-performance liquid chromatography (HPLC) as the reference method. The correlation coefficient (R2) between the NIRS method and the HPLC method in the...

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...

22. March 2016

The International Conference on Harmonization Q8 (R2) includes a requirement that “Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of the drug product,” that is, the need to assess the robustness of a formulation. In this article, a quality-by-design–based definition of a “robust formulation” for a biopharmaceutical product is proposed and illustrated with a case study....

29. January 2016

The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The...

12. December 2015