Effect of coating excipients on chemical stability of active coated tablets.

The objective of this study was to understand the impact of coating excipients on the chemical stability of active pan coated peliglitazar, which was prone to acid as well as base-catalyzed degradation. Four different coating formulations containing either polyvinyl alcohol (PVA) or hydroxypropyl methylcellulose (HPMC) as a coating polymer and triacetin (glycerol triacetate) or polyethylene glycol (PEG) as a plasticizer/detackifier were used for coating of peliglitazar in a perforated pan coater. Tablets of one-milligram strength were manufactured by suspending the drug in the coating suspension and spray coating onto inert core tablets.

Buffer exchange path influences the stability and viscosity upon storage of a high concentration protein.

High concentration protein solutions are generally produced by spin column concentration (SCC) during early development and by tangential flow filtration (TFF) during later stages, when greater quantities of protein become available. This is based on the assumption that the protein generated by the SCC process would be fairly similar to the TFF process material. In this study, we report the case of high concentration solutions of an Fc fusion protein produced by the two processes using the same upstream drug substance (DS) with very different storage stability.

Investigation into stability of poly(vinyl alcohol)-based Opadry® II films.

Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry® II 85F was used as the model PVA-based coating formulation.

Identification and control of a degradation product in Avapro film-coated tablet: low dose formulation.

A degradation product was formed during the long-term stability studies (LTSS) of the low dose formulation of Avapro film-coated tablet. The degradant was identified as the hydroxymethyl derivative (formaldehyde adduct) of the drug substance, irbesartan, based upon analysis with LC/MS, LC/MS/MS, and chromatographic comparison to the synthetic hydroxymethyl degradation product. Laboratory studies demonstrated that the interaction of individual excipients with the drug substance at elevated temperature and polyethylene glycol (PEG) used in the coating material, Opadry II White, leads to the generation of this formaldehyde adduct.