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...
The authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.
Cycle design and robustness testing using advanced process analytical technology.
By optimizing formulation and process varibles, pellets can be prepared that can release a poorly soluble drug for 12-24 h following zero-order kinetics.
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
Based on formulation simplicity and blinding capability, hard gelatin capsules are preferrable compared with other oral solid dosage forms, including tablets, in the early clinical phases of drug development.
Industry needs a standard to connect systems and equipment sooner rather than later.
It's time to maintain a thorough traceable excipient trail.
India's pharmaceutical industry, which is one of the country's major economic sectors, is poised to make signficant gains on the global market.
An LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
An LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
Orally disintegrating tablets offer numerous advantages compared with traditional tablets and capsules, and can be an effective solution for developing line extensions of currently marketed therapies.
Hot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.
USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
...some companies complained that what they received was not joint advice or combined advice but parallel advice, without coherence...
During the past years, there has been increasing demand for fast dissolving disintegrating tablets (FDDTs), such as orally disintegrating tablets (ODTs) and sublinguals.