Nutritional Techniques and Formulations II
was used. 15 patients were cured, 115 received HEN at
March 1st and 62 died (including 43 with cancer). In
4 patients HEN was stopped. Time of treatment ranged
from 1 to 51 months. Complications free HEN course
was observed in 141 patients, in 30 HEN complications
and in 12 pneumonia has occurred. 38 patients required
66 rehospitalisations. 85% survived over 3 months. Main
indications in children was dysphagia in 62 patients,
malnutrition in 25 and GI tract stenosis in 6. HEN was
provided through PEG in 65, through PEG/PEJ in 10
and through nasogastric tube in 8 children. Surgical
gastrostomy was created in 8 and jejunostomy in 1 child.
3 children were cured, 84 received HEN at March 1st,
5 died and in 3 was discontinued. In 29 complications
were not observed, in 13 access related complications
were found and in 11 pneumonia. 24 children required 62
rehospitalisations. 99% survived >3 months.
Conclusion: Although results were good, HEN availability
across country was low due to small center number and
NHS limitations. Low number of children received HEN
due to cancer is surprising.
Disclosure of Interest: M. Pertkiewicz NPS Consultant
P237
STANDARDIZATION OF ATP-BIOLUMINISCENCE METHOD
FOR MICROBIOLOGICAL CONTROL OF LAMINAR FLOW
CABINS AND COMPARISON WITH CONVENTIONAL
PLAQUE CONTROLS
M.E. Ferreyra1 , M.C. Ocaña1 , L.S. Sanabria1 . 1 Nutritional
Support Unit, Edgardo Rebagliati Hospital, Lima, Peru
Rationale: It is essential to preserve aseptic technique
for Parenteral Nutrition preparation under laminar flow
hood. It has been the usual method to perform colony
counts using plaque controls culturing samples from
surfaces prone to contamination. Results from plaque
method take 24 to 48 hours for results and do not
detect organic material independent from microbial
contamination. Adenosine Triphosphate-Bioluminiscence
detect most organic material and results are available
in minutes.
At our Unit we studied both methods comparatively.
Methods: Samples for both techniques were taken in
three areas:
1. Pre-cabin,
2. Cabin and
3. Post-cabin.
Measurements were performed using: Luminometer HY-
LITE 2(® Merck), Thioglycolate liquid medium and di-
gested casein-soy.
Relative frequency tables, central tendency and disper-
sion parameters were used.
Results: 384 samples were taken for ATP-Bioluminiscence
Method: Negative results for the 3 areas were: (1) 95.4%,
(2) 93.1% and (3) 87.2%.
240 samples were taken for Conventional Plaque Controls:
Negative results for the 3 areas were: (1) 89%, (2) 98.5%
and (3) 97.5%
Conclusion:
1. Standardization of ATP-bioluminiscence method is
safe, effective and fast to detect contamination of
areas related to laminar flow cabins,
125
2. The ATP-bioluminiscence method may detect organic
residues that Conventional Plaque Controls cannot
detect,
3. A negative Conventional Plaque Control may not be a
guaranty for an aseptic area.
References
[1] Merck KGaA, 64271. Manual de instrucciones HY-LiTE 2.
Germany. 06/2005
[2] The Merck Index: an encyclopedia of chemicals, 2001.
Disclosure of Interest: None declared.
P238
MODEL TO MEASURE PHENYTOIN DISSOLUTION
INTERACTION WITH ENTERAL NUTRITION
M.G. Klang1 . 1 Research Pharmacy, Mem. Sloan-Kettering
Cancer, New York, United States
Rationale: Seventeen case reports have documented
as much as 90% loss of active Phenytoin when given
with enteral nutrition solutions. This study attempts to
determine the extent of phenytoin dissolution from two
types of formulations when combined with either enteral
nutrition formula (ENF) or Calcium Caseinate (CC).
This study used both diluted and undiluted phenytoin
suspension and compared phenytoin tablets crushed and
mixed with water to the same concentrations.
Methods: This study used a two-stage dialysis first
exposure to Simulated Gastric Fluid (SGF pH 1.2) and later
to Simulated Intestinal Fluid (SIF pH 6.8). The phenytoin
dose (25, 12.5 and 6.25 mg/ml) was combined with 5 ml
of one of the following: water, ENF or 3.7% CC inside a
sealed dialysis packet. Samples were removed from the
dialysis baths after 2 and 3 hours in SGF and after 24 hours
in SIF.
HPLC analysis was done using an Agilent 1100, @ 1 ml/hr,
SB-CN Zorbax 4.6X150 5 mm at 50ºC. Mobile phase consist
of ACN: Methanol: Acetic Acid: Triethylamine: water
(150:125:1.0:0.6:725).
Results: All mixtures increased in amount dissolved
over time except the undiluted phenytoin suspension
when combined with ENF or CC. The tablet formulation
showed similar final dissolution for all concentrations and
combinations as did the suspension formulation when
mixed with only water. There was a drop in solubility
for the suspension/nutrition combination after the packet
was moved into SIF dialysate. This phenomenon did not
occur for the other combinations.
Table: Difference in phenytoin solubility when combined with
enteral nutrition
Water ENF Calcium Caseinate
3.7%
Suspension
25 mg/mL 2.63 0.04 0.35
12.5 mg/mL 2.10 0.98 0.76
Tablet
25 mg/mL 3.54 2.86 2.76
12.5 mg/mL 1.87 2.49 1.30
Conclusion: The concentrated phenytoin suspension is
very viscous, which inhibits the free diffusion of solids