Protein-based pharmaceuticals such as monoclonal antibodies are the fastest growing class of therapeutic agent. As with all protein therapeutics, antibody aggregation must be avoided during production, storage and use. With recent advances…

Article By Dr. Catherine Sheehan - Senior Director of Science – Excipients at the United States Pharmacopeial Convention With significant innovations in pharmaceuticals, including biologic drugs and treatments for rare diseases, the need…

Co-processed Excipients: Drug approval process | Compendial vs. Novel Excipients Common Technical Documentation Format – CTD Throughout a drug approval process a team of drug regulatory experts needs to compile mandatory documentation,…

The application of hot melt coating (HMC) as an economic and solvent-free technology is restricted in pharmaceutical development, due to the instable solid-state of HMC excipients resulting in drug release instability. We have previously…

Biopharmaceuticals are one of the fastest growing areas within the pharmaceutical industry. As protein drugs require parenteral administration, they are commonly formulated as aqueous solutions. However, this is not always feasible due to…

Tablets are the most frequently employed dosage form. Their advantage lies in their availability, easy administration, good stability, and low price. The easiest technology to produce tablets is direct compression, even though the use of…

A drug-dev.com article by Dr. William Small and Arsalan Khan It wouldn’t come as a surprise to anyone that active pharmaceutical ingredients (APIs) come in a wide variety. Small molecule, large molecule, peptide, monoclonal antibody,…

The current research work was aimed with an objective of formulation development of fast dissolving tablet of montelukast by using co-processed excipient and to evaluate the effect of co-processed excipient over physical mixture of same…

The development of orodispersible tablets (ODTs) for poorly soluble and poorly flowable drugs via direct compression is still a challenge. This work aimed to develop ODTs of poorly soluble drugs by combining cyclodextrins that form…

The purpose of this research was to produce co-processed excipients using mannitol as base material with some of the most used binders: potato, maize pre-gelatinized starch, and K-25, K-29/32, K-90 povidone. Mannitol, one commercial…