This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.
“Why do you need this laboratory information management system (LIMS)?” “We have an enterprise resource planning (ERP) system, why do we need to purchase yet another software product?” “How will the system you’re recommending improve lab operations?”
A centrifuge is an integral component of a laboratory that is critical to the success of an analysis. They come in a variety of sizes, from mini-centrifuges that hold only a few small tubes and spin a few thousand RPM to high capacity centrifuges that hold up to 6 liters of samples to ultracentrifuges that spin upwards of 100,000 RPM. Multiple options in size as well as other areas can make choosing the right centrifuge for your application an overwhelming task.
At Metrics Contract Services, Dr. Michael DeHart manages all aspects of personnel and operations relating to formulating and manufacturing a client’s pharmaceutical materials for Phase I, II and III clinical trials. In this article, Dr. DeHart discusses how scientific advances are addressing challenges posed by the poor solubility or stability of drug candidates.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.
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.