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Abstracts from the ukpharmsci conference, 13 september 2010
 Cvek B, Dvorak Z, “Can the old drug, disulfi ram, have a bright new
future as a novel proteasome inhibitor?” Drug Discovery Today
DMSO is a solvent frequently used for preparing disulfi ram
solution. The particle size of in situ formed disulfi ram Cu(II)
 Walker MB, Edwards K, Farmer PJ, “Disulfi ram, metal, and mela-
complex in DMSO might infl uence the growth of the cancer
noma” J Chem Edu
2009; 86(10): 1224–1226
 Ökçelìk B, Atay O, “Quantitative determination of disulfi ram-con-
taining pharmaceuticals by IR spectroscopy and high pressure liquid chromatography methods” FABAD J Pharm Sci
2003; 28: 193–200
 Sharma VK, Aulakh JS, Malik AK, “Fourth derivative spectrophoto-
metric determination of fungicide thiram tetramethyldithiocarbamate in commercial sample and wheat grains using copper (II) sulphate”
 Sauna ZE, Shukla S, Ambudkar SV, “Disulfi ram, an old drug with
new potential therapeutic uses for human cancers and fungal infec-tions” Molecular BioSystems
2005; 1: 127–134
The infl uence of API isolation and drying methods post crystallisation on API
properties and performance during drug product processing
A. Balasundaram, M. Boukerche, C. Davies, N. Dawson, and P.L. Goggin
Pfi zer Global Research & Development, UK
E-mail: neil.dawson@pfi zer.com, arulsuthan.balasundaram@pfi zer.com, moussa.boukerche@pfi zer.com
INTRODUCTION AND OBJECTIVES
API physical propertie
Wet granulation processes can increase the processability Test
(e.g. fl ow) of active pharmaceutical ingredients (API) which
have physical and mechanical properties that mean they
cannot be successfully processed into drug product by other
manufacturing methods. In addition, APIs that are wet granu-
lated often have cohesive properties and hence can adhere to
manufacturing equipment and restrict fl ow.
The purpose of this study is to understand how the drying
of the API from the crystalliser impacts the physical proper-ties of the API and subsequent downstream drug product 3) Drug product:
High shear wet granulation experiments
performance following wet granulation. A series of drying
were conducted in the Fukae Powtec high speed mixer
conditions were investigated to produce variation of API
(250 g batch size) using standardised conditions.
The following quality attributes of the drug product were
MATERIALS AND METHODS
Total of 8 API lots were dried using either tray or agitated
Compact radial tensile strength (RTS) at 0.85 solid fraction
1) Crystallisation and Isolation:
The crystallisation process
was developed using parallel conditions in 50 ml-scale Compact dissolution
crystalliser (MultiMax). Optimised conditions were then
scaled up in a 1 L scale crystalliser (LabMax) to assess
the robustness of the crystallisation process. Thereafter RESULTS AND DISCUSSION
multiple batches were processed at 1 kg scale in a 20 L fi xed rig. These batches were dried using various operat-
During the drying process, agglomerates are formed. Increased
ing conditions in an AFD to deliver different API particle
drying time increased the degree of agglomeration and den-
properties. The resultant API was used to investigate the
sifi cation of the API. Tray dried batches typically had minimal
robustness of the wet granulation process.
agglomeration, a relatively low particle size (D[v,0.9]) and
2) API physical properties:
The following particle and bulk
low bulk density compared to batches which were agitated
powder properties were determined (Table 1).
fi lter dried. Fewer agglomerates of API led to poor blend fl ow
and wet granulation processability issues. Controlling the CONCLUSION
agglomeration state through the AFD conditions resulted in improved API bulk powder densifi cation, defi ned by the API
Control of agitator fi lter dryer conditions were identifi ed as a
particle size distribution and bulk density. These were identi-
key step in the drying process of the API improving the proc-
fi ed as important quality attributes of the API from a wet essability of a wet granulated drug product.
granulation processing perspective. The drying process did not have any impact on compact RTS, hardness, disintegra-tion and dissolution. The compacts achieved a high RTS and
this in turn formed tablets with high crushing strength.  G. Nichols et al
“A review of the terms agglomerate and aggregate
Targetted compact disintegration time of less than 15 minutes
with a recommendation for nomenclature used in powder and particle
were met and the dissolution profi les showed 75% release at
characterisation” Int. J. Pharm.
The Synthesis of New Microgel Particles Based On 2-Hydroxyethyl(meth)acrylates
1School of Pharmacy, University of Reading, Whiteknights, Reading, RG6 6AD, UK.
Abstract – Microgel particles based on 2-hydroxyethylacr-
ylate (HEA) and 2-hydroxyethylmethacrylate (HEMA)
were synthesised by surfactant-free emulsion copolymeri-
sation. The particles were characterised by dynamic light
scattering and electron microscopy and it is anticipated
that they could have applications in ocular therapeutics.
Random copolymers consisting of varying ratios of 2-hydroxy-ethylmethacrylate (HEMA) and 2-hydroxyethylacrylate (HEA) have previously been synthesised . These polymers have demonstrated promising thermal and biological proper-ties, with polymers with a HEMA content of 0–100% being found to be non-irritating with respect to mucosal tissues, and the temperature response being dependent on the HEMA/HEA concentration. In this research, cross-linked microgel particles have been synthesised as a possible injectable deliv-ery vehicle, a novel application for these copolymers.
Typical SEM image of HEMA microgel particles cross-linked
MATERIALS AND METHODS
The method of synthesis used was surfactant-free emulsion
polymerisation (SFEP) . In this method the monomer(s) RESULTS AND DISCUSSION
and cross-linker, in this case ethylene glycol dimethacrylate (EGDMA), are added to water at a low weight fraction of Dynamic light scattering was used to measure the mean around 1%. The mixture is heated and continuously stirred.
hydrodynamic diameter of the microgel particles. Variations
Following the addition of a suitable initiator, such as ammo-
in the HEMA/HEA ratio in the reaction mixture were found
nium persulphate, a cloudy dispersion of microgel particles to result in signifi cantly different reaction yields and particle is obtained. Unreacted monomer was removed from the par-
sizes, with all samples having a signifi cant degree of polydis-
ticle dispersion by dialysis. Particles were synthesised with persity (see Fig. 1). The largest particle sizes, around 1 μm, nominal relative HEMA/HEA ratios of 0–100 mol% and were observed at the highest HEMA contents, 90–100%, sug-nominal cross-linker contents of 2 and 5 mol%.
gesting that HEMA is incorporated preferentially into the
ANNEXE 1 : Règlement intérieur des Comités Techniques FEADER 2007-2013 I- FONCTIONNEMENT DES COMITES TECHNIQUES I.1. Objet Toutes les demandes de subventions relevant des dispositifs précisés dans la liste de la partie II sont soumises à l’avis du Comité Technique (CT) ad hoc dont le rôle est de donner un avis technique, économique et éventuellement d’opport
You Should Continue Breastfeeding -1 (Drugs and Breastfeeding) Introduction Over the years, far too many women have been wrongly told they had to stop breastfeeding. The decision about continuing breastfeeding when the mother takes a drug, for example, is far more involved than whether the baby will get any in the milk. It also involves taking into consideration the risks of not bre