Howard Stevens, Fiona MacDougal
Controlled onset oral drug delivery can be simply described as drug release following a pre-determined time delay; the challenge for the formulation scientist is achieving this reliably in vivo. Some of the key life cycle management targets for this technology include engineering drug delivery to meet the challenge of nocturnal and pre-wakeup drug delivery for diseases such as rheumatoid arthritis and cardiovascular conditions, which typically exhibit a circadian morning exacerbation of symptoms [1,2], facilitating daytime repeat dosages and providing pharmacological opportunities for one or more different drugs to be delivered at different times or rates from a single dosage unit.
Dissolution testing is a labor intensive test from setup and initiation, sampling through analysis, and reporting. Each step in the process has its unique challenges; manual sampling requires a significant
amount of human involvement while semi- and fully automated sampling involve mechanical systems that move samples outside of the dissolution vessel. With mechanical systems there are pumps, valves, and tubing that can fail or become clogged due to particulates, resulting in missed samples and possibly a failed test.
H. Michael Wolff
Rationale for giving a drug transdermally has to be driven by an unmet medical need that can be met by this route, thus adding value to a drug therapy. For example, stable plasma level time profiles over extended time periods may reduce not only the dosing frequency, but possibly also side effects of the medication and daily doses that have to be
administered by other routes.
Lipid Based Drug Delivery (LBDD) is a multi-disciplinary approach, a congregation of organic chemistry, physics, bio pharmaceutics, and
formulation technologies surrounding the function of fatty acids, fatty acid esters, and their assemblies—with the aim of improving drug
release and absorption.
Urvi Gala, Harsh Chauhan, Ph.D
Bitter taste perception is supposed to have evolved as a mechanism that averts possible toxins ingestion. But many compounds such as flavanoids and isoflavones which have a bitter taste are known to elicit beneficial response [1]. Approaches such as phylogenetic-like tree construction, quantitative nuclear magnetic resonance, and ligand
identification have been used to recognize the bitter loci in molecules [2-4]. However, structural modification of these loci can alter their pharmacological response. Thus, the most suitable alternative is to mask the taste of these bitter loci.
Sure, we offer the Mini Spray Dryer B-290 and the Nano Spray Dryer B-90 that are used to spray dry both aqueous and organic solvent based formulations. The achievable powder particle size
range is from 300 nm to 60 microns depending on your choice of nozzle and the solids loading of your formulation. We now offer an ultrasonic nozzle to create particles closer to what can be
accomplished on the industrial scale.
Over the recent years the share of BCS class II (low solubility, high permeability) drug candidates in the pipelines of innovator companies has grown to about 70% of the overall candidate portfolio. For many of these candidates their low solubility in the GI
tract directly translates into poor bioavailability. Hence, one of the most important areas for oral drug delivery has been overcoming the solubility-driven bioavailability challenges of these compounds.
Specific technologies developed to address this issue have helped to enable several important novel medicines and also to improve upon existing ones via lifecycle management efforts. Among the
technologies developed to date, four stand out due to the fact that applying them, highly relevant Medicines have been introduced into the market and are available to the patient today. These four
technologies are: self-emulsifying drug delivery systems, nanocrystal formulations, solid dispersions made by hot melt extrusion, and spray dried solid dispersions.
Shaukat Ali, Karl Kolter
Orally disintegrating tablets (ODT) or sublingual technologies have drawn attention in the industry as a promising approach to deliver drugs in life cycle management to a wide range of the patient population [1-6]. Those technologies are also aimed at patients incapable of swallowing pills, especially in pediatric and geriatric populations [7]. The criteria for rapid dissolution and onset of active ingredients in an ODT dosage depends on the performances of individual excipients which must qualify 3 unique criteria: (i) hydrophilic in nature, (ii) dissolves quickly with good mouth feel, and (iii) is highly compressible. Identifying such excipients and/or technologies to meet these criteria could be challenging, especially to overcome the drug’s loading and stability.
There has been continuous development in high efficiency, energy selective detectors over the past decade. These new detectors have been combined with improved optics and miniature sources, which has enabled dramatic improvements in the quality of data, spatial resolution, portability of equipment, and significant reduction in data collection times.
Sofie Goetschalckx, Virginie Fabre, Marijke Wynants, Landry Bertaux, Mark Plavsic, Otmane Boussif, Lada Laenen
Viral contaminations of biopharmaceutical manufacturing cell culture facilities are a significant threat to product manufacture and supply and one for which having a risk mitigation strategy is highly desirable. Although they are rare, they still occur sporadically, and they have a potential to incur serious consequences such as plant shutdown,
manufacturing interruption, cost associated with investigation and remediation, business impact, drug supply interruption, regulatory impact, and patient safety, to mention a few. Introduction of adventitious agents can occur at any step in a complex manufacturing process of biologics when cells are exposed to raw materials, and in many cases they may only be detected after amplification by growth
in the cell substrate or in production bioreactors.
Counterfeit pharmaceuticals are a global problem and include not only products containing potentially harmful substances, but also products that contain no or diluted amounts of active pharmaceutical ingredients (API). Because of this growing problem, the need for fast and easy screening techniques in the field has become increasingly urgent. Handheld Raman spectroscopy provides regulatory enforcement agencies the ability to examine the chemical composition of authentic products on the spot, resulting in rapid
identification of counterfeits and immediate removal from the supply chain.
The first commercial Raman handhelds were developed and sold as early as 2002. These initial opportunities were fueled from the Homeland Security, Hazmat, and Defense markets for unknown material identification, and to a lesser extent, academic and government labs for niche applications.
Tim Sandle, PhD
Culture media is of fundamental importance for most microbiological tests: to obtain pure cultures, to grow and count microbial cells, and to cultivate and select microorganisms. Without high-quality media,
the possibility of achieving accurate, reproducible, and repeatable microbiological test results is reduced [1]. A microbiological culture medium is a substance that encourages the growth, support, and
survival of microorganisms. Culture media contains nutrients, growth promoting factors, energy sources, buffer salts, minerals, metals, and gelling agents (for solid media) [2].
This summer and fall, Eurofins Lancaster Laboratories will expand its current cell banking capabilities by doubling the number of cell
banking clean-room suites from two to four, by adding long-term cell banking storage for both production and non-production cell banks, by increasing the maximum bank size from 400 to >1000 vials, and by offering insect cell bank production and testing services.
David Elder, Ph.D.
An evaluation of an analytical method’s specificity should be performed as part of the validation process in accordance with ICH Q2 [1] and the approach used is dependent on the intended objective of the analytical procedure. In reality, certain methods may either be not specific (or not specific enough) for their intended objectives. In these cases, orthogonal
approaches using two or more complementary analytical methodologies would be necessary to achieve the appropriate discriminatory power.
For example, titrimetric and UV potency assays for API are non-specific and cannot detect the presence of related substances,
John Coates
In recent years there has been an emphasis on changing the way we view instrumentation and a desire to make instruments smaller and lower in cost [1-3]. This trend was motivated by the rapid growth in
telecommunication technology in the late1990s. During the past two to three years, a new set of miniaturized (small scale) instrument platforms
and products have been produced, including Raman, Infrared (IR and NIR), UV/Vis, and non-optical technologies like Mass Spectrometry and NMR. However, this article focuses on new technologies applied to the near infrared (NIR).
Bill Hartzel, Hope Mueller
Recalls and warning letters are littering the news and don’t help those pharma and biopharm companies engaged in producing sterile dose forms. The issues that lead to unacceptable products may have a
direct impact on product availability, and even patient safety, if they go undetected. Many of the negative headlines arise from problems that occurred in the aseptic parenteral filling process, and frequently
they involve microbial contamination or contamination by foreign particulates.