Use of recombinant proteins as therapeutics has become an attractive strategy for altering the biology of disease progression and offers significant commercial opportunities. However, bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.
People expect options in most areas of their lives, so why should their medication be any different?
Swallowing tablets or capsules is difficult for many, and size is just one of the problems.
A significant share of current drug development pipelines include active pharmaceutical ingredients (APIs) that fall into BCS (biopharmaceutical classification system) 2 and 4 spaces. These compounds are typically characterized by their lowaqueous solubility and thus poor bioavailability, requiring advanced formulation approaches. Various approaches have been developed to enable these types of compounds, including particle size reduction (eg, micronization), chemical modification (eg, salt forms and pro-drugs), complexing agents, solubilized liquid forms (eg, SEDDS), and solid amorphous dispersions.
The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.
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.
To improve the suspendibility of a water- insoluble active pharmaceutical ingredient (API) in a sorbitol- based reconstitutable powder for oral suspension formulation using two novel excipients Sentry™Polyox™WSR N80, NF (polyethylene oxide) and Avicel CL-611® NF (microcrystalline cellulose/carboxymethylcellulose sodium).
To observe, using carbon-13 nuclear magnetic resonance (13C-NMR), the effect of dilute acid and pepsin on gelatin crosslinks, induced by addition of 13C-enriched formaldehyde (13CH2O) to an aqueous gelatin solution.
Many factors found in the laboratory can influence the behavior of a balance. Learn how to anticipate and regulate them to achieve the ideal settings for your balance and the most reliable weighing results. By Michelle Sheridan, Sales Specialist, Premium Weighing Sartorius Corporation
Syloid® XDP silicas are mesoporous, amorphous, silica gel excipients with a unique morphology that create an excellent solid porous carrier for pharmaceutical formulations. The combined adsorption capacity, porosity, particle size, and density provides a tool to create formulations which can expedite manufacturing and improve efficacy of the final dosage form.