Drug delivery as solid dosage forms is complex with a number of factors that can noticeably influence their therapeutic benefit. The drug must be stabilized in the tablet and at the same time be available for absorption in a short time after dosing . The formulation and design of soluble oral tablets needs several factors to be considered.
R&D spending in the pharmaceutical industry through 2015 was valued at around $58bn as organisations vied to gain a competitive advantage by bringing new drugs to market as quickly as possible. Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality. The pharma industry is increasingly embracing the principles of Quality by Design (QbD) to improve efficiency and ensure good quality and reduced variability throughout the drug production process.
At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.
Cost reduction initiatives in R&D organizations frequently focus on the potential benefits of process improvements such as enhanced monitoring and improved QC of raw materials but often overlook the impact of better data management. Those that do typically focus on achieving efficiency gains by transitioning from paper to electronic systems but while such a transition has been demonstrated to save time3, efficiency gains are only beneficial if any time saved is used productively.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process. 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.
Moisturising creams serve to keep the skin feeling smooth, soft, and looking radiant and healthy by retaining moisture or water in the outer most skin layer. Different moisturising creams will be defined by their viscosity or thickness. Formulating moisturising creams therefore largely depends upon the required end product consistency, influencing the choice of material to use.
Anton Paar's Generation M density meters and Abbemat refractometers deliver accurate and repeatable measurement results while providing system security for 21 CFR Part 11 compliance.
One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.
Properties such as flow function, arching dimension and bulk density ensure proper flow to the tablet die or capsule, no jams in the process occur and proper compaction force to produce the tablet is defined.
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.