If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drug products, developers may have to go back and change their API production processes. In the worst cases, Phase 1 and Phase 2 trials may have to be redone. And due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
To demonstrate the process by which a placebo formulation was designed for an oral solid dose product that would be dispensed to the patient as a fast-dissolve tablet. The tablet is added to water and the resulting solution is dosed as a antibiotic mouthwash. Placebo matching was required not only for the tablet but also for the solution which the patient took.
Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.
In this installation, materials are received in 50-pound bags and semi-bulk bags and are security screened for foreign objects while being conveyed to a weigh hopper, where they are automatically hatched in predetermined weights and discharged into process drums.
Medical prescription drug errors by doctors, pharmacists and patients account for 1.5 million incidences of sickness, injuries or deaths in the U.S. each year. By Jay Anbil and Steve Yoder
From a recent survey conducted within the pharmaceutical industry, by Colorcon, it was confirmed that oral solid dosage forms are a preferred choice for formulation of pediatric medicines.
Spurred by pharmaceutical industry demand for continuous ultra-low-rate powder feeders where accuracy is measured in milligrams, today’s microfeeding technology adds new possibilities for improved efficiency and automation available to all.