2007

Sep 2007

Jan 2008

2007

2006

Mar 08

Fall 2006

In the inaugural edition of Milestones, read about the changing dynamic of the drug development industry, service offerings at various Aptuit facilities around the world, Aptuit's recent acquisition of EaglePicher Pharmaceutical's API business, and much more.

Aptuit Milestones

Summer 2007

In this second edition of Milestones read about the shifting arena of drug development, the critical role of consulting, getting the right form first time and much much more.

02.24.2003

G. Patrick Stahly, Vice President, Scientific Operations, is featured in Chemical & Engineering News discussing polymorphism and crystallization. Pat discusses the significance of polymorph screening in the evaluation and selection of a solid form.

Chemical & Engineering News

April 2004

This issue of Crystal Growth & Design features isolation and characterization of polymorphs using capillary crystallization and thermal microscopy techniques

2004 VOL.4,NO.3

03.17.2006

This issue of Crystal Growth & Design summarize the discovery of a New Polymorph of Dehydroepiandrosterone (Prasterone) and Solution of Its Crystal Structure from X-ray Powder Diffraction Data using a combination of proprietary SSCI software and the Cambridge Crystallographic Data Centre’s program DASH.

Crystal Growth and Design Vol6 No4 March 2006

2007

An understanding of solid-State chemistry,including polymorphism,can reduce the time to filing an investigative new drug(IND)application. Obtaining a stable formulation for IND studies is crucial and must be the focus of much of the early solid-state chemistry research.

Fall 2006

Aptuit Chief Operating Officer and Scottish native, Frank Wright, takes a closer look at how Aptuit’s presence in Scotland is helping the company engineer a better drug development process. Provided by the Capital Group UK http://www.capitalgroupuk.com/.

2000

Safety Pharmacology Studies for Human Pharmaceuticals

2005

The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization by Human Pharmaceuticals

09/2006

09/2006

09/2006

09/2006

09/2006

2007

The propensity for segregation in powder blends in precision filling technologies is not well understood. Concerns exist that the filling processwill promote segregation through a vibratory action. This initial work sets out to monitor blend segregation, and weight uniformity variation, on capsule blends filled using the Xcelodose 600* system as a function of particle size and diluent choice. Additionally, this is compared with the effects of handfilling in early clinical supplies manufacture. Finally, homogeneity will be considered as a function of filling time.

2007

The delivery of poorly water-soluble drugs has been the subject of much research, as approximately 40% of new chemical entities are hydrophobic innature. One area in which published literature is lacking is the field of non-aqueous emulsions and some researchers have used polyethylene glycol (PEG) as a continuous phase for such emulsions (1-6). The nature of this emulsion will allow capsule filling at a later stage.In this study, an attempt has been made to develop non-aqueous emulsions of the type oil-in-PEG suitable for drug loading.

2007

For most investigators at early stage development, a principle criterion for a dose formulation is to achieve sufficient solubility in the dose vehicle to obtain the target dose concentration. Dose vehicles themselves are alsogenerally as simple as possible.

2006

Our scientists are developing new methods in which to conduct Ethoxyresorufin O-dealkylase (EROD) assays that save time and produce more accurate results.

2007

In vitro drug inhibition data are used in guiding the design of clinical drug interaction studiesor, when no effect is observed in vitro, to claim that no interaction will occur in vivo.Therefore, it is advisable that the in vitro experiments are performed with confidence in themethod used and data obtained. Here we present the validation of phenacetin O -deethylase (CYP1A2) using an HPLC method with tandem mass spectrometric detection.

08.22.2006

With biotech and pharma companies increasingly turning to third parties to manage their clinical supply activities, it is critical for these companies to control and track activities in their information systems. This white paper explores the various integration methods available.

08.21.2006

Although clinical supply management is often considered a back-office business unit for a sponsor, it is critical to the drug development process. This white paper examines the importance of and strategic advantage of end-to-end IT to manage and control these core activities between contractors and vendors.

08.22.2006

The process of introducing an IT product or application into an organization working in a regulated environment involves a series of complex business processes. This white paper examines the importance of and steps to successful validation in a client’s regulatory environment.