Articles in this Issue

• Transferring Raman Spectral Libraries and Chemometric-based Methods Between Different Instruments...

  Jason D. Rodriguez, Ph.D., Connie M. Gryniewicz-Ruzicka, Ph.D., John Kauffman, Ph.D., Sergey Arzhantsev, Ph.D., Allison L. Saettele, Katherine A. Berry, Benjamin J. Westenberger, Dr. Lucinda F. Buhse, Ph.D.
  Portable Raman instruments have become important tools in the screening of raw materials and finished products . An ongoing challenge that the Raman community faces is the issue of distributing spectral libraries and chemometric-based methods across different instruments .

• Stage Appropriate Dissolution Methods in Formulation Development

  Michael Hawley, Ph.D.
  The dissolution method is a critical part of oral drug product development. It provides the most intimate link between material properties, formulation design, process influence and the ultimate performance in the patient. The information that the team needs from the dissolution method changes as a project advances in time. At all stages of development, a properly designed dissolution method allows the drug product development team to understand and assess the risks that exist in their drug product, to develop a robust formulation and process that minimizes these risks and to identify important changes in the drug product during its manufacture.

• Determining Bulk Powder Particle Size through Texture Analysis

  Ryan Gosselin, Ph.D., Marc-Olivier Lacombe, Nicolas Abatzoglou, Ph.D.
  Particle size analysis is routinely employed for material quantification in a growing number of fields (e.g. pharmaceutical, food, metallurgy). The term “particle size” is not an unambiguous one. Problems can arise if the particles have a very large aspect ratio, such as fibers or needles, leading to disagreements between different particle size analyzers [1]. For this reason, we consider that the definition of size is directly dependent upon the methodology employed to quantify it.

• Formulation Considerations and Applications of Solid Lipid Nanoparticles

  Anne Grana, Aimee Limpach, Ph.D., Harsh Chauhan, Ph.D
  Nanoparticles are submicron-sized colloidal particles. These colloidal systems are dispersions of one phase within another and can vary in size from 1nm to 1µm. They are widely used throughout scientific research in numerous applications in electronic, optical, biomedical and pharmaceutical fields. In the pharmaceutical field, nanoparticles are widely used as drug delivery systems. As a drug delivery system, nanoparticles can be prepared using different biodegradable materials such as natural or synthetic polymers, metals or lipids

• An Overview of Supercritical Fluid Chromatography Mass Spectrometry (SFC-MS) in the Pharmaceutical...

  Laila Kott
  Before SFC was coupled to mass spectrometers, systems used both UV and flame ionization detectors (FID). This may not seem intuitive, however, when one considers that supercritical fluid chromatography (SFC) is essentially a hybrid of gas chromatography and liquid chromatography (supercritical CO2 is composed of gaseous carbon dioxide molecules pressed as closely together as they can be, without forming a liquid), then the use of both these detectors makes sense.

• Container Closure Integrity Testing Method Development and Validation for Prefilled Syringes

  Lei Li
  Utilization of prefilled syringes as a preferred container closure system for biologics has been increasing [1]. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity [2, 3]. In 2008, FDA further promoted container and closure system integrity (CCI) testing as a component of the stability protocol for sterile products [4].

• Single-Use Roundtable

  Mark Trotter, Dr. Peter Kraemer, Dhaval Tapiawala, Ken Clapp, Joshua Hays
  The major motivators for implementing SUS are manufacturing cost reductions, increased production effi ciency, and lowering overall risk factors. These motivators are important for process development and manufacturing engineers and scientists to employ when designing new or upgrading legacy systems.

• USP Develops New Standards Related to Sterilization and Bioburden Control – An Update on USP’s...

  Don Singer
  In his preview of the upcoming USP workshop, R. Tirumalai described the importance of microbial contamination control and issues related to sterilization being major considerations for any manufacturer: “manufacturing processes must minimize potential risk to the patient and the product” [1]. This is the underlying concept for the U.S. Pharmacopeial Convention (USP) workshop entitled, “Microbiological Control of Compendial Articles,” which will take place at USP’s headquarters in Rockville, MD on March 18–19, 2013. The workshop will highlight current and proposed USP public standards focusing on topics relevant to microbiological contamination and bioburden control.

• An Interview With Dr. Firouz Asgarzadeh, Evonik Corporation

  Evonik has been manufacturing the EUDRAGIT® line of polymers for over 50 years for the traditional use in the preparation of functional coatings. Beyond that, over the past decade, EUDRAGIT® polymers have been used increasingly in the formulation development of poorly soluble drugs in combination with Hot Melt Extrusion and Spray Drying techniques.