Formulation aspects of intravenous nanosuspensions.

Intravenous (IV) route is preferred for rapid onset of action, avoiding first pass metabolism and achieving site specific delivery. Development of IV formulations for poorly water soluble drugs poses significant challenges. Formulation approaches like salt formation, co-solvents, surfactants and inclusion complexation using cyclodextrins are used for solubilisation.

Effect of primary drying temperature on process efficiency and product performance of lyophilized Ertapenam sodium.

The present work aimed to investigate the impact of primary drying temperature on lyophilization process efficiency and product performance of lyophilized Ertapenam sodium (EPM). Phase behavior of EPM formulation (200 mg/mL) using differential scanning calorimetry (DSC) and freeze drying microscopy (FDM) showed Tg' at -28.3 °C (onset) and Tc at -25.

Crystallization of Cyclophosphamide Monohydrate During Lyophilization.

The purpose of this study was to investigate the phase behavior of cyclophosphamide (CPA) during various stages of lyophilization, with special emphasis on obtaining crystalline CPA monohydrate (CPA-MH) in the lyophilized product. Subambient differential scanning calorimetry and low-temperature X-ray diffractometry (LTXRD) were used to study the phase behavior of CPA solution (3.7% w/v).

Challenges in Translational Development of Pharmaceutical Cocrystals.

The last 2 decades have witnessed increased research in the area of cocrystals resulting in deeper scientific understanding, increase in intellectual property landscape, and evolution in the regulatory environment. Pharmaceutical cocrystals have received significant attention as a new solid form on account of their ability to modulate poor physicochemical properties of drug molecules. However, pharmaceutical development of cocrystals could be challenging, thus limiting their translation into viable drug products.