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Investigation into the Activity of Zoledronic Acid and Nimesulide in a Model of Bone Cancer Pain

Cancer patients commonly have associated metastatic bone cancer pain. Metastases in the bone can cause severe changes; interruption of bone resorption and osteoclast production, leading to weakening, fracture and bone pain. Opiates that are commonly used in the treatment of cancer pain have various unwanted side effects, making this area of analgesia research of high interest to the pharmaceutical industry, with bisphosphonates (through an inhibition of osteoclast activity and anti-tumour mechanisms) and COX-2 inhibitors (through anti-inflammatory and anti-tumour activity) emerging as two of the potential challengers.

Screening and Animal Bioavailability Studies on Itraconazole Amorphous Dispersions

Purpose:Identify amorphous dispersions of itraconazoleto increase bioavailability. Methods:An amorphous dispersion screen was performed using six polymers, two concentrations, and two preparations (flash evaporation, freeze drying). Materials were characterized using XRPD,DSC, TGA, and moisture sorption, and abbreviated physical stability

Loss of Torsade de Pointes in a Rabbit Model - The impact of α - Chloralose Formulation

The model of Torsades de Pointes (TdP) in anaesthetised rabbits, as described by Carlsson, is used to determine the impact of a prolonged QT interval vs the risk of TdP. The anaesthetic of choice for this model is α-chloralose; however,a change in commercial availability of α-chloralose to one with higher levels of the ß-anomer produced solubility issues. A review of the literature highlighted that hydroxypropyl-ß-cyclodextrin could be used as a vehicle to produce a 50 mg/mLα-chloralose solution which was stable at room temperature.

Use of the anaesthetised guinea pig model in PK/PD modelling for cardiovascular safety; Thioridazine case study

The anaesthetised guinea pig is widely used as a model for screening cardiovascular safety, however, little has been published over it’s sensitivity for use as an early model for safety. Hence it was our aim to use the phenothiazine antipsychotic, thioridazine, in this model to assess the potential for use inPK/PD modelling cardiovascular end points(QTcB interval).

Evaluation of nine reference compounds in a Zebrafish model of cardiac function

The zebrafish has been suggested as a cost effective, early stage, medium throughput, vertebrate test system that would enable in vivo assays to be conducted earlier with lower costs than those for established in vivo assays

Man Vs. Machine - which is better for QT Interval analysis?

The QT interval from an electrocardiogram (ECG) recording is representative of the ventricular repolarisation time with prolongation of this interval being associated with an increased risk of polymorphic ventricular arrhythmias.Therefore the accurate measurement of QT interval in pre-clinical cardiovascular safety testing is clearly important in the reliable detection of QT prolonging agents and the assessment of the associated risk. While automated ECG interval analysis is cost effective it is often inaccurate as aresult of both inter- and intra animal variability in ECG waveform morphology. Although manual analysis of the ECG intervals is perceived to produce the most reliable results, the benefit may be outweighed by the increased time and cost involved.

Evaluation of the T-Cell dependent antibody response (TDAR) to Tetanus Toxoid (TT)

In this study we firstly set out to establish an immunization protocol that would result in a robust antibody response to TT in the cynomolgus monkey. Concurrently, we developed an ELISA method to determine serum levels of anti-TT specific IgG antibodies. Upon establishment of a successful immunization and detection method, we looked to determine the effects of a known immunosuppressant (Methotrexate) on the secondary T cell dependent antibody response (TDAR) to TT.

Evaluation of Semi-Automated Powder in Bottle Filler

The Powder in Bottle (PIB) dosage form is frequently used in Phase I clinical studies. Often the PIB dosage form is continued going into preliminary Phase IIaclinical studies. The quantities required for the Phase IIastudies are larger and the manual fill of bottles is both time consuming and labor intensive when providing large quantities. A system capable of filling both accurately and rapidly would significantly improve efficiency and reduce cost in the pharmaceutical development process.

$Characterization of API: PolymerMixtures using X-ray Powder Diffraction$

Characterization of API: PolymerMixtures using X-ray Powder Diffraction

Thermal methods are commonly used to determine miscibility of dispersion systems based on the appearance of one or two glass transition (Tg) temperatures, however limitations exist. The purpose of this project was to investigate using x-ray powder diffraction (XRPD) data and computational methods to analyze active pharmaceutical ingredient (API):polymermixtures in order to determine miscibility of these systems.

Non Aqueous Emulsions For Oral Drug Delivery

The delivery of poorly water-soluble drugs has been the subject of much research,as approximately 40% of new chemical entities are hydrophobic in nature. 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.

Tomtec Sorbent Screening

Optimization of the solid phase extraction (SPE) process can be time consuming because of the sequential testing of different sorbent chemistries, and the further optimization of the condition, equilibration, wash and elution steps. In order to speed up and rationalize method development, a sorbent screening experiment was designed and automated on a Tomtec Quadra 96.

Symbiosis sorbent screening

Solid Phase Extraction (SPE) may provide cleaner extracts from biological samples by the selective removal of matrix interferents which may cause ionization suppression or enhancement over methods which employ the use of protein precipitation or liquid-liquid extractions.

An Assessment of the Suitability of the Xcelodose600 in the Filling of Blended Products

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.

Extraction of basic compounds

This poster describes a case study, involving one analyte (X) and its two metabolites (Y and Z), which were developed for use in treatment of Parkinson’s disease, whereby several aspects of the method transfer required alteration to achieve compatibility with the new site whilst meeting regulatory validation requirements.

Comparison of Aquity and Agilent 1200RR

Over the last 5 years significant advances have been made in HPLC. However, the majority of these have focused around a bewildering array of new stationary phases to improve peak shape, reduce tailing, alter selectivity, etc. Recently, a new breakthrough in chromatography has allowed the user to further investigate the potential of the Van Deemter Plot (Figure 1) through the use of smaller sub 2 micron particle size material.

Cytochrome P450 Inhibition Screening: Validation of an HPLC-MS/MSmethod for CYP1A2, 2C9, 2C19and 3AInhibition

Drug-drug interaction is an important issue during the discovery and development phase of a new drug. The effect of a newdrug on specific probes for various enzymes of cytochrome P450 are routinely examined using in vitro approaches. The invitro data can then be used in guiding the design of potential clinical interaction studies. Therefore the in vitro experimentsmust be performed with absolute confidence in the method used to obtain the data

Validation of a Chronic Portal Vein Cannulation Model in the Rat

The objective of this study was to develop and validate a method of chronic cannulation of the portal vein in rats with exteriorization of the cannula via a tail cuff.

Oral bioavailability in early development

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.

Validation of an LC-MS/MS method for the In Vitroinhibitory effects of Phenacetin

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.

Validation of Mechanism Based Inhibition - Our Experience

Initially, preliminary experiments were conducted to optimize the experimental design required to estimate the kinetic parameters in which incubations were performed with/without NADPH regenerating system and different concentrations of the MBIs at a fixed pre-incubation time. Comparisons were made between enzyme activities with/without NADPH-regenerating system.

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