The blood–brain barrier (BBB) forms an interface between the circulating blood and the brain, and functions as a tremendously effective barrier for the delivery of potential neurotherapeutics into the brain parenchyma. Conversely, the BBB possesses various carrier-mediated transport systems for the uptake of small molecules, such as essential nutrients and vitamins. These transporters have become an attractive target for drug/prodrug design in an attempt to ferry drug molecules across the BBB. Central nervous system (CNS) drug delivery is often limited by poor brain penetration of the potential drug candidate. As a result of its unique barrier properties, the BBB poses a huge challenge for the delivery of potential neurotherapeutics into the brain parenchyma.1 It is estimated that only 2% of small-molecule drugs and ,0.1% of novel protein and peptide pharmaceuticals developed for CNS diseases reach therapeutic concentrations in the brain.2,3 Many of the pharmacologically active drugs tend to fail..
When Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
Henrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.
Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen.
...an uninformed decision based on commercial requirements alone may, ultimately, have disastrous consequences on the efficacy of the target recombinants.
During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.
The use of PVA copolymer-based film can solve the problems associated with lack of film adhesion... to tablets containing large amounts of waxy excipient or a lubricant.
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
This article examines the different types of dessicants avaliable to the pharmaceutical industry. It provides information on choosing the right type, and how and when it should be used.
As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them?
The use of PVA copolymer-based film can solve the problems associated with lack of film adhesion... to tablets containing large amounts of waxy excipient or a lubricant.
The EU has changed history and set the pace for future productrelated legislation with its Registration, Evaluation and Authorization of Chemicals (REACH) Regulation no. 1907/2006, which came into effect in June 2007.
Cycle design and robustness testing using advanced process analytical technology.
Spraying techniques can be used to produce powder form formulations. The concept works by the adsorption/absorption of a liquid SELF onto a neutral carrier…
A sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.
The adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.
There are two ways in which 'difficult' samples are usually categorized: either by the problems posed by the physical nature of the post-vivo sample matrix containing the chemical entity to be analysed, or...
The use of PVA copolymer-based film can solve the problems associated with lack of film adhesion... to tablets containing large amounts of waxy excipient or a lubricant.
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
The importance of liposomes as an effective drug delivery system is well accepted in the pharmaceutical industry, but their handling remains a challenge.
Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
The blood–brain barrier (BBB) forms an interface between the circulating blood and the brain, and functions as a tremendously effective barrier for the delivery of potential neurotherapeutics into the brain parenchyma. Conversely, the BBB possesses various carrier-mediated transport systems for the uptake of small molecules, such as essential nutrients and vitamins. These transporters have become an attractive target for drug/prodrug design in an attempt to ferry drug molecules across the BBB. Central nervous system (CNS) drug delivery is often limited by poor brain penetration of the potential drug candidate. As a result of its unique barrier properties, the BBB poses a huge challenge for the delivery of potential neurotherapeutics into the brain parenchyma.1 It is estimated that only 2% of small-molecule drugs and ,0.1% of novel protein and peptide pharmaceuticals developed for CNS diseases reach therapeutic concentrations in the brain.2,3 Many of the pharmacologically active drugs tend to fail..
Research shows that both drug prescription and alcohol consumption increase within the elderly population. It is, therefore, necessary to fully understand the impact of alcohol consumption on solid oral dosage forms, especially extended release formulations.
Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.
In the wake of economic growth, healthcare reforms, and large-scale industry investment, Turkish pharmaceutical companies are charting their own destiny.
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.
Understanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product.
This article looks at how to adopt a systematic and prospective approach in the API development process to achieve documented, controlled synthetic processes...