Iontophoresis is established as a method of enhancing transdermal delivery of drugs. However, its application to enhance the delivery of highly lipophilic compounds is limited due to lack of any charge and poor water solubility of molecules. Propofol a lipophilic sedative was complexed with Captisol (SBECD).
This paper is a comparative analysis between application of the FDA Process Validation Guidance (2011) to new products and legacy products. While the three stages of process validation (design, qualification, and continued monitoring) provide a clear framework for the development, scale-up, qualification, and manufacturing of new commercial products, the application of these process validation principles to legacy products is only briefly mentioned in the FDA guidance.
Pharmaceutical and nutraceutical drugs often consist of two main components: active pharmaceutical ingredients (API’s) and excipients.
To properly and accurately calibrate and adjust relative humidity instruments is no simple task.
Air particle counting instruments used for biopharmaceutical environmental monitoring have essentially remained unchanged for many decades. However, every year millions of dollars and countless labor hours are spent on the manually intensive activities associated with paper-based methods.
This article will discuss some of the trends in automated solid dose inspection, the benefits of a low-cost, portable and product-flexible platform, what to look for when evaluating an advanced solution, and describe the available new technology.
The manufacturing of immunotherapy drugs is very complex and requires very sophisticated production of control. Dendritic cells (DC) population is a key functional constituent of cell based immunotherapy drugs. The correct cell count and adequate viability of DC is an important quality control criteria for the release of final product.
Fermenters for Research & Development have to meet very high standards in regard to flexibility, so that they can be easily adapted to the requirements of a wide variety of microorganisms and process conditions. For that purpose, modular fermentation systems were developed, consisting of single modules like drive, fermentation vessel, analytical instrumentation, stirrer, foam separator, ventilation and so on.
Solid-dose tablet and capsule manufacturing is a mainstay of the pharmaceutical industry, as it results in a consistent, effective, and economical platform for drug delivery. Not only are tablets and capsules convenient and easy for consumers to handle, they are also very stable and have a high throughput, offering benefits to both consumers and pharmaceutical companies alike.
Information about the health of a control system, the I/O systems, field devices and final control elements can be critical for plant operation and uptime. Timely diagnostic information can mean the difference between a quick repair and hours or days of unplanned downtime.
Approximately 25% of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years. While such highly potent compounds can have significant benefits in the treatment of certain medical conditions, they present substantial challenges to the pharmaceutical industry.
A one-stop-shop fluid management component supplier assures quality, streamlines processes, and limits costs. To be certain you receive the preeminent and safest single-use component, take time to evaluate your fluid-management supplier or a supplier under consideration by asking the 6 important questions we pose in this whitepaper.
For drying processes conducted under vacuum, precise control over process conditions is often critical. Accurately controlling the vacuum can help to significantly decrease total process time and improve process yields.
Of the wide range of vacuum pump technologies used in the pharmaceutical and chemical process industries, many incorporate wetted materials that prove problematic because of poor corrosion resistance.
Over the past 25 years considerable efforts have been made to develop a low cost, environmentally friendly, moisture specific method of material analysis. Leading these endeavors is Arizona Instrument LLC, who has successfully designed the Computrac® Vapor Pro® series of moisture analyzers.
The Computrac® Vapor Pro® Rx is an excellent alternative to Karl Fischer titration offering equivalent results, easier usage, and faster test times than the Karl Fischer when testing lyophilization closures. The instrument is highly durable, and since it uses no solvents or reagents, it is a greener alternative to Karl Fischer analysis.