international journal of advances in pharmaceutical research

Phani Ratna Prasanth.G, et al. / International Journal of Advances in Pharmaceutical Research
dosing is thus necessary to maintain stable plasma
concentration.
MATERIALS AND METHODS
Materials
Dexlansoprazole, a gift sample from labs of Alkem,
sugar spheres, PVP K 30, HPMC E5, dibasic sodium
phosphate, Light magnesium carbonate, sodium
lauryl sulphate, Mannitol, Eudragit L 100 55, HPMC
P 55 PEG 4000, Triethyl citrate, diethyl phthalate,
cetyl alcohol, talc, titanium dioxide, iso propyl
alcohol were obtained as a gift sample from Alkem
research center.
Methods
Preparation of Dexlansoprazole 30 mg Delayed
release Pellets
6, 7, 8, 9
Drug loading
Weigh all the ingredients as per the given formula in
table 1 and prepare the drug solution. Take 500 ml of
purified water in beaker and kept for stirring under
mechanical stirrer. Specified quantities of PVP K30,
HPMC E5, dibasic sodium phosphate, Magnesium
carbonate and SLS were added slowly and stir it for
a uniform suspension. Then drug was added in the
above solution and stirring was continued for 30
mins to form a vortex of the solution. Now pass the
dispersion using Nylon cloth of mesh no 200. The
solution is now ready for drug loading. Finally the
drug is loaded using the dispersion over sugar
spheres in the chamber of FBP.
Barrier coating: (Sub coating) 5
Sub coating was done to protect and also for
increasing the stability of a drug. Mechanical
strength of pellets is also increased. In order to
prevent interaction with functional groups contained
in the enteric film coat, it is one of the advantages to
combine enteric coatings with sealing coats made up
of cellulose derivatives.
500gm water is taken in a beaker and kept it for
stirring, specified quantities of PVP K30, HPMC E5,
dibasic sodium phosphate, magnesium carbonate and
mixed well for 30 min. Add slowly mannitol to the
coating solution under stirring for 15 min. After
formation of a suspension the solution is ready for
sub coating and the drug loaded pellets were coated
by using Fluidized bed coater.
Enteric Coating 10
Step I: 300ml of IPA and 900 ml of acetone were
taken in a beaker and kept for stirring under a
mechanical stirrer.
Step II: All the ingredients should be weighed
accurately and should be passed through 200# for
proper formation of dispersion.
Step III: In another portion of solution add talc and
titanium dioxide and stir it.
Step IV: Now step II form was added slowly to step I
and stirring was done for 20 min until it forms a
uniform mixture. Add plasticizer to the above
dispersion.
Step V: Add dispersion step IV to step III under
continuous stirring to form a homogenized mixture.
Now filter through a nylon cloth. Now the filtered
solution is ready for enteric coating and check the
pH of the solution.
Step VI: enteric coating using the dispersion of step
V over the barrier coated pellets with the help of
fluidized bed coater. Wurster insert and a bottom
spray gun. Spread of the solution was carried out at
at atomization pressure of 2 kg/cm 2 , an inlet
temperature of 35 o C, spray rate of 6 ml/min and a
fan speed of 7 to 9. Up on completion of spraying,
the various loading on sugar spheres were further
dried at 60 o C inlet temperature for 5 min and the in
process parameters were given in table 1. The final
end product was then sieved on top of a 20-mesh
screen to eliminate fines.
Evaluation of Pellets 1,12
Evaluation of pellets must be done to obtain product
performances. Evaluation at different stages during
manufacturing process were as follows
Acid resistance: amount of drug resisted after 2 hr
in acid was 99.75%.
Pellets size analysis: Formulated Dexlansoprazole
delayed release pellets size change during different
stages such as drug loading, Barrier coating and
enteric coating of pellets were shown in table no 3
Particle size distribution: This was done for proper
coating. Particle size was determined by using SEM.
Samples of F9 formulation were mounted on metal
tubes and SEM photograph was taken as shown in
figure 5.
Determination of drug contents: Enteric coated
pellets of Dexlansoprazole 30 mg were transferred to
100 ml vol. flask, added 70 ml of methanol and
sonicate for 15 min with intermittent shaking and
dilute to volume with methanol. Filter through 0.45µ
filter and further dilute 5 ml of this solution to 100
ml with mobile phase. Results were tabulated in
table 4.
Invitro dissolution studies: An invitro dissolution
study for the finished product formulation was
carried out using dissolution USP method I (basket)
for Dexlansoprazole delayed release pellets. The
dissolution medium consisted of 900 ml of pH 1.2
buffer maintained at a temp of 37+0.5 o C and was
run for 2 hr initially and release should not be more
than 10%. Transfer the weighed pellets equivalent to
30 mg of Dexlansoprazole in to each of six jars.
After 2 hrs the previous acid medium was replaced
with 900 ml of pH 6.8 buffer and release study was
done.
IJAPR / May. 2012/ Vol. 3 / Issue. 5 / 907 - 913 908