Comparison of Excipients in Approved Parenteral Products and Their Maximum Daily Exposure Values.

The following article analyses the excipients used in the parenteral formulations registered by the U.S. Food and Drug Administration (FDA) in the years 2011 and 2021.

Hydroxypropyl methylcellulose mediated precipitation inhibition of sirolimus: from a screening campaign to a proof-of-concept human study.

The aim of this study was to develop a sirolimus (BCS class II drug substance) solid oral dosage form containing a precipitation inhibitor, which would result in an improved sirolimus absorption in humans compared to the formulation containing nanosized sirolimus without a precipitation inhibitor, i.e., Rapamune.

Reduced intravenous toxicity of amiodarone nanosuspension in mice and rats.

The toxicity of amiodarone Lek formulation (test formulation) was investigated after a single intravenous (i.v.) administration to mice and rats.

Use of factorial design for evaluation of factors affecting the chemical stability of sirolimus (rapamycin) in solid dosage form.

Effects of four process and formulation parameters (spraying rate of ethanol solution, drying and tablet hardness and hydroxypropyl methyl cellulose (HPMC) content) were evaluated in terms of initial quality of tablets using factorial design approach. For determination of stability of final drug product, the tablets were exposed to stress testing conditions and the three most significant factors were investigated (spraying rate of ethanol solution, drying and HPMC content). Considering the chemical stability of Sirolimus, the following responses were found to be most important: total sum of degradation products, levels of impurity I and assay of isomer C.