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Creating a dessert-like formulation as drug delivery carrier for patients with
swallowing difficulties
L. Miller, V.F. Patel
Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, AL10 9AB, UK.
INTRODUCTION
Dysphagia is a growing health problem associated with
several disease states prevalent in today’s ageing population.
A complex condition, its pathophysiology differs depending
on several factors creating variance in patient requirements.
Currently there are limited formulations designed for oral
medication delivery for dysphasic patients [1]. Alternative
formulations are not suited to all types of dysphagia and are
not available for most drugs. Underdeveloped ability to
swallow solid dosage forms in children leads to a similar
shortage of appropriate formulations. Scarcity of suitable
formulations results in adaptions of existing formulations,
leading to unpredictable medication delivery, affecting the
patient clinically and the prescriber legally. The aim of the
study is to develop a dessert-like formulation using selection
of available excipients which could hold drugs in the gel
matrix, be visually attractive and convenient to use.
helped to reduce the lag time for dispersion but also produce
lump free dispersion. Reduction in lag time was further
improved on mixing effervescent agents with excipient
mixture before processing through spray drying. Also
resultant gel was relatively more firmed which could be due
to change in micro-environmental pH occurs in presence of
citric acid and sodium bicarbonate and led to increase gel
strength of Carbopol present in excipient mixture.
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Viscosity (Pa.S) Log Scale
Abstract–Current project present a feasibility study to create
dessert-like formulation which could be used as drug
delivery carrier in patient with swallowing difficulties.
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Shear rate (S-1) Log Scale
MATERIALS AND METHODS
RESULTS AND DISCUSSION
The ultimate aim of the project is to create a dry mix of
excipients which can turn into a dessert on addition to
purified water (10 mL) under normal stirring at room
temperature within 10 minutes. In addition, the target
dessert-like formulation should produce scoop-able
consistency to enable it to be eaten by user without much
struggle and therefore all the initial observation and
screening tests were designed accordingly.
Screening revealed that most of the excipients tested did not
rapidly disperse throughout the aqueous medium which
could be due to their highly hydrophilic nature and/or not
having warmed dispersion medium to accelerate dissolution.
Combination of Carbopol 974, Xanthan Gum and Ac-Di-sol
in a ratio of 1:2:4 produce an appealing gel with suitable
consistency. Spray drying of optimized mixture not only
Fig 1: Rheological comparison of developed prototype
formulation (Blue diamond) against marketed product Thick
and Easy (Green triangle, 2 Scoop equivalent).
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Set custard
chocolate mousse
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jelly
hot custard
Viscosity (Pa.s) Log Scale
Numerous hydrophilic excipients were tried alone and in
combination with each other to assess their ability to
dissolve and form a gel in purified water at room
temperature as a first step to screen for further optimization.
Excipients were added slowly into a glass vial containing
purified water (10 mL) with and without stirring and the
visually observed for their gel forming tendency. To reduce
dispersion time and also to ensure even dispersion of these
hydrophilic excipients trials were also performed to spray
dry excipients together, compression of mixtures into a
tablet and the addition of effervescent agents to the excipient
mixture. Rheology was performed on several of the
optimized excipient combinations and compared against
marketed products using TA AR1500EX Rheometer.
Continuous ramp followed by steady state flow test was
performed to derive texture profiles at room temperature.
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Petit Filous yogurt
1 Scoop equivilant mix
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1.5 scoop equivilant mix
2 Scoop equivilant mix
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2 scoop thick and easy
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Sheer rate (S-1) Log Scale
Fig 2: Rheological profile of marketed products in comparison to
different consistencies of developed prototype formulation.
CONCLUSION
This study demonstrated the development of a novel
formulation concept which has potential to deliver the
medication in patients suffering from swallowing difficulty.
However, this was a feasibility study and further
optimization is required to realise its full potential.
REFERENCES
[1] J. Kelly. G. D`Cruz, D. Wright, “A qualitative study of the problems
surrounding medicine administration to patients with dysphagia”
Dysphagia, 24 (2009) 49-56.