Trehalose

Abstract For monoclonal antibody drug products as for other biologics, while the innovator drug products first becomes commercially available, they are often followed by one or more biosimilar products. These biosimilars often differ from the innovator product, as well as from each other, in…
Read More...

Abstract Lipid nanoparticles (LNPs) have demonstrated their therapeutic potential as safe and effective drug delivery systems for nucleic acids during the COVID-19 pandemic. However, one of the main challenges during technical CMC (Chemistry, Manufacturing, and Controls) development is their…
Read More...

Abstract Background: Dry powders offer the potential to increase stability and reduce cold-chain requirements associated with the distribution of vaccines and other thermally sensitive products. The Alberta Idealized Nasal Inlet (AINI) is a representative geometry for in vitro characterization of…
Read More...

The FDA approved 50 novel drugs in 2024, marking another milestone year in pharmaceutical innovation. While various summaries have highlighted these approvals, the composition and presentation of these new drug products — encompassing APIs and excipients — are often less explored. To address…
Read More...

As a follow up on the article 𝐖𝐡𝐢𝐜𝐡 𝐝𝐫𝐮𝐠𝐬 𝐰𝐢𝐥𝐥 𝐥𝐨𝐬𝐞 𝐩𝐚𝐭𝐞𝐧𝐭𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐦𝐢𝐧𝐠 𝐲𝐞𝐚𝐫𝐬? by Joanna Sadowska, PhD, EMBA in which includes over 30 products going off-patent from 2025 to 2037 we pulled together the dosage form and composition of these products. Please note that the composition may vary in…
Read More...

Abstract Background: Spray drying, whilst a popularly employed technique for powder formulations, has limited applications for large-scale proliposome manufacture. Objectives: Thus, the aim of this study was to investigate spray drying parameters, such as inlet temperature (80, 120, 160, and 200…
Read More...

Abstract Delivering live bacterial therapeutics to the colon orally is challenging due to the harsh gastrointestinal (GI) conditions and/or the manufacturing processes involved in the production of dry formulations, which can drastically decrease cell viability. In previous work, we evaluated the…
Read More...

Abstract Previously, a nasal powder formulation of the influenza vaccine was proposed to ensure its stability over fifteen months at room temperature and to have sufficient moisture-resistant characteristics to enable handling without special humidity control. In this study, a carrier-based…
Read More...

Abstract Solid-state protein formulations are known to exhibit enhanced storage stability compared to their liquid dosage form counterparts. pH is one of the factors affecting the stability of protein formulations. The pH of protein formulations in the solution could be influenced by the buffer…
Read More...

Abstract Pharmaceutical peptides are susceptible to aggregation in solution, making stabilization by addition of suitable excipients essential. To investigate this stabilization, lengthy and cost-intensive experiments are often necessary. In this work, a differential scanning calorimetry (DSC)…
Read More...