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Phani Ratna Prasanth.G, et al. / International Journal <strong>of</strong> Advances <strong>in</strong> Pharmaceutical Research<br />
IJAPR<br />
Available Onl<strong>in</strong>e through<br />
www.ijapronl<strong>in</strong>e.org<br />
Research Paper<br />
ISSN: 2230 – 7583<br />
DESIGN, CHARACTERIZATION and EVALUATION OF DEXLANSOPRAZOLE<br />
ENTERIC COATED PELLETS<br />
Phani Ratna Prasanth.G* 1 , P.Pavan Kumar 2 , K.Santhi 1 , C.I.Sajeeth 1<br />
*1 Grace College <strong>of</strong> Pharmacy, Kodunthirapully, Palakkad, Kerala, India<br />
2 Natco Pharma limited, Hyderabad, Andhra Pradesh<br />
Received on 25 – 01 - 2012 Revised on 23 – 03- 2012 Accepted on 27– 04 – 2012<br />
ABSTRACT<br />
The first and ma<strong>in</strong> aim <strong>of</strong> the present <strong>in</strong>vestigation was to prepare delayed release i.e., enteric coated pellets <strong>of</strong><br />
Dexlansoprazole by us<strong>in</strong>g hydroxypropyl methyl cellulose based sub coat<strong>in</strong>g and methacrylic acid copolymer<br />
based enteric coat<strong>in</strong>g. By us<strong>in</strong>g various concentrations <strong>of</strong> polymers, it was found to play a great role <strong>in</strong> delay<strong>in</strong>g<br />
the release from the enteric coated pellets. The different batches <strong>of</strong> pellets were prepared by drug suspension<br />
layer<strong>in</strong>g and were developed us<strong>in</strong>g fluid bed layer<strong>in</strong>g and coat<strong>in</strong>g techniques. Ten formulations hav<strong>in</strong>g alkaliz<strong>in</strong>g<br />
agents, solubiliz<strong>in</strong>g agents, polymers at different concentration levels were prepared <strong>in</strong> sub coat<strong>in</strong>g as well as<br />
enteric coat<strong>in</strong>g were prepared. The formulated enteric coated pellets were evaluated for drug content, size analysis,<br />
particle size analysis and <strong>in</strong>vitro dissolution study <strong>in</strong> pH 1.2 buffer for 2 hours followed by test<strong>in</strong>g <strong>in</strong> pH 6.8 buffer.<br />
Among all the formulations, capsules <strong>of</strong> F9 batch showed superior properties along with excellent drug release<br />
(94%) when compared to other formulations. This concluded that FBP technique is a best useful method for<br />
prepar<strong>in</strong>g the enteric coated pellets. DSC study also revealed that there was no chemical <strong>in</strong>teraction between the<br />
drug and pellets. It was shown better stability that storage conditions were excellent. It can be the good way to<br />
improve the bioavailability <strong>of</strong> Dexlansoprazole.<br />
Key words: Dexlansoprazole, sub coat<strong>in</strong>g, Enteric coat<strong>in</strong>g, and Fluid bed layer<strong>in</strong>g<br />
INTRODUCTION<br />
Dur<strong>in</strong>g the past few decades various types <strong>of</strong> oral<br />
delayed release formulations have been developed to<br />
improve the cl<strong>in</strong>ical efficacy <strong>of</strong> drug hav<strong>in</strong>g short<br />
half life as well as to improve patient compliance.<br />
Proton Pump Inhibitors (PPIs) are used <strong>in</strong> the<br />
treatment <strong>of</strong> acid-related gastro-duodenal disorders<br />
by reduc<strong>in</strong>g gastric acid secretion. PPIs are<br />
substituted benzimidazoles and all share a similiiar<br />
core structure and mode <strong>of</strong> action but differ <strong>in</strong><br />
substituent groups.<br />
Correspond<strong>in</strong>g Author,<br />
Phani Ratna Prasanth G,<br />
Email: prasanth_599@yahoo.com<br />
Contact: +91-7736147009<br />
The stability <strong>of</strong> PPIs <strong>in</strong> aqueous media is a function<br />
<strong>of</strong> pH with an <strong>in</strong>creased rate <strong>of</strong> degradation as the<br />
pH decreases. Degradation leads to discoloration <strong>of</strong><br />
pellets, film layer or dissolution medium. Exposure<br />
<strong>of</strong> Dexlansoprazole to the acid content <strong>of</strong> stomach<br />
would lead to significant degradation <strong>of</strong> the drug and<br />
hence reduced bioavailability 2 .<br />
Delayed release dosage form is best formulations<br />
which are used for drugs that are destroyed <strong>in</strong> the<br />
gastric fluids, or cause gastric irritation or are<br />
absorbed preferably <strong>in</strong> the <strong>in</strong>test<strong>in</strong>e. Such<br />
preparations conta<strong>in</strong><strong>in</strong>g an alkal<strong>in</strong>e core material<br />
compris<strong>in</strong>g the active substance, a separat<strong>in</strong>g layer<br />
and enteric coat<strong>in</strong>g layer 3, 4 .<br />
In the present study an effort has been made to delay<br />
the release <strong>of</strong> drug form the prepared drug loaded<br />
pellets by us<strong>in</strong>g enteric polymers such as HPMC<br />
Powder 55 S and Eudragit Liquid 100 55. The drug<br />
hav<strong>in</strong>g relatively short half life (1 hour) and frequent<br />
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dos<strong>in</strong>g is thus necessary to ma<strong>in</strong>ta<strong>in</strong> stable plasma<br />
concentration.<br />
MATERIALS AND METHODS<br />
Materials<br />
Dexlansoprazole, a gift sample from labs <strong>of</strong> Alkem,<br />
sugar spheres, PVP K 30, HPMC E5, dibasic sodium<br />
phosphate, Light magnesium carbonate, sodium<br />
lauryl sulphate, Mannitol, Eudragit L 100 55, HPMC<br />
P 55 PEG 4000, Triethyl citrate, diethyl phthalate,<br />
cetyl alcohol, talc, titanium dioxide, iso propyl<br />
alcohol were obta<strong>in</strong>ed as a gift sample from Alkem<br />
<strong>research</strong> center.<br />
Methods<br />
Preparation <strong>of</strong> Dexlansoprazole 30 mg Delayed<br />
release Pellets<br />
6, 7, 8, 9<br />
Drug load<strong>in</strong>g<br />
Weigh all the <strong>in</strong>gredients as per the given formula <strong>in</strong><br />
table 1 and prepare the drug solution. Take 500 ml <strong>of</strong><br />
purified water <strong>in</strong> beaker and kept for stirr<strong>in</strong>g under<br />
mechanical stirrer. Specified quantities <strong>of</strong> PVP K30,<br />
HPMC E5, dibasic sodium phosphate, Magnesium<br />
carbonate and SLS were added slowly and stir it for<br />
a uniform suspension. Then drug was added <strong>in</strong> the<br />
above solution and stirr<strong>in</strong>g was cont<strong>in</strong>ued for 30<br />
m<strong>in</strong>s to form a vortex <strong>of</strong> the solution. Now pass the<br />
dispersion us<strong>in</strong>g Nylon cloth <strong>of</strong> mesh no 200. The<br />
solution is now ready for drug load<strong>in</strong>g. F<strong>in</strong>ally the<br />
drug is loaded us<strong>in</strong>g the dispersion over sugar<br />
spheres <strong>in</strong> the chamber <strong>of</strong> FBP.<br />
Barrier coat<strong>in</strong>g: (Sub coat<strong>in</strong>g) 5<br />
Sub coat<strong>in</strong>g was done to protect and also for<br />
<strong>in</strong>creas<strong>in</strong>g the stability <strong>of</strong> a drug. Mechanical<br />
strength <strong>of</strong> pellets is also <strong>in</strong>creased. In order to<br />
prevent <strong>in</strong>teraction with functional groups conta<strong>in</strong>ed<br />
<strong>in</strong> the enteric film coat, it is one <strong>of</strong> the advantages to<br />
comb<strong>in</strong>e enteric coat<strong>in</strong>gs with seal<strong>in</strong>g coats made up<br />
<strong>of</strong> cellulose derivatives.<br />
500gm water is taken <strong>in</strong> a beaker and kept it for<br />
stirr<strong>in</strong>g, specified quantities <strong>of</strong> PVP K30, HPMC E5,<br />
dibasic sodium phosphate, magnesium carbonate and<br />
mixed well for 30 m<strong>in</strong>. Add slowly mannitol to the<br />
coat<strong>in</strong>g solution under stirr<strong>in</strong>g for 15 m<strong>in</strong>. After<br />
formation <strong>of</strong> a suspension the solution is ready for<br />
sub coat<strong>in</strong>g and the drug loaded pellets were coated<br />
by us<strong>in</strong>g Fluidized bed coater.<br />
Enteric Coat<strong>in</strong>g 10<br />
Step I: 300ml <strong>of</strong> IPA and 900 ml <strong>of</strong> acetone were<br />
taken <strong>in</strong> a beaker and kept for stirr<strong>in</strong>g under a<br />
mechanical stirrer.<br />
Step II: All the <strong>in</strong>gredients should be weighed<br />
accurately and should be passed through 200# for<br />
proper formation <strong>of</strong> dispersion.<br />
Step III: In another portion <strong>of</strong> solution add talc and<br />
titanium dioxide and stir it.<br />
Step IV: Now step II form was added slowly to step I<br />
and stirr<strong>in</strong>g was done for 20 m<strong>in</strong> until it forms a<br />
uniform mixture. Add plasticizer to the above<br />
dispersion.<br />
Step V: Add dispersion step IV to step III under<br />
cont<strong>in</strong>uous stirr<strong>in</strong>g to form a homogenized mixture.<br />
Now filter through a nylon cloth. Now the filtered<br />
solution is ready for enteric coat<strong>in</strong>g and check the<br />
pH <strong>of</strong> the solution.<br />
Step VI: enteric coat<strong>in</strong>g us<strong>in</strong>g the dispersion <strong>of</strong> step<br />
V over the barrier coated pellets with the help <strong>of</strong><br />
fluidized bed coater. Wurster <strong>in</strong>sert and a bottom<br />
spray gun. Spread <strong>of</strong> the solution was carried out at<br />
at atomization pressure <strong>of</strong> 2 kg/cm 2 , an <strong>in</strong>let<br />
temperature <strong>of</strong> 35 o C, spray rate <strong>of</strong> 6 ml/m<strong>in</strong> and a<br />
fan speed <strong>of</strong> 7 to 9. Up on completion <strong>of</strong> spray<strong>in</strong>g,<br />
the various load<strong>in</strong>g on sugar spheres were further<br />
dried at 60 o C <strong>in</strong>let temperature for 5 m<strong>in</strong> and the <strong>in</strong><br />
process parameters were given <strong>in</strong> table 1. The f<strong>in</strong>al<br />
end product was then sieved on top <strong>of</strong> a 20-mesh<br />
screen to elim<strong>in</strong>ate f<strong>in</strong>es.<br />
Evaluation <strong>of</strong> Pellets 1,12<br />
Evaluation <strong>of</strong> pellets must be done to obta<strong>in</strong> product<br />
performances. Evaluation at different stages dur<strong>in</strong>g<br />
manufactur<strong>in</strong>g process were as follows<br />
Acid resistance: amount <strong>of</strong> drug resisted after 2 hr<br />
<strong>in</strong> acid was 99.75%.<br />
Pellets size analysis: Formulated Dexlansoprazole<br />
delayed release pellets size change dur<strong>in</strong>g different<br />
stages such as drug load<strong>in</strong>g, Barrier coat<strong>in</strong>g and<br />
enteric coat<strong>in</strong>g <strong>of</strong> pellets were shown <strong>in</strong> table no 3<br />
Particle size distribution: This was done for proper<br />
coat<strong>in</strong>g. Particle size was determ<strong>in</strong>ed by us<strong>in</strong>g SEM.<br />
Samples <strong>of</strong> F9 formulation were mounted on metal<br />
tubes and SEM photograph was taken as shown <strong>in</strong><br />
figure 5.<br />
Determ<strong>in</strong>ation <strong>of</strong> drug contents: Enteric coated<br />
pellets <strong>of</strong> Dexlansoprazole 30 mg were transferred to<br />
100 ml vol. flask, added 70 ml <strong>of</strong> methanol and<br />
sonicate for 15 m<strong>in</strong> with <strong>in</strong>termittent shak<strong>in</strong>g and<br />
dilute to volume with methanol. Filter through 0.45µ<br />
filter and further dilute 5 ml <strong>of</strong> this solution to 100<br />
ml with mobile phase. Results were tabulated <strong>in</strong><br />
table 4.<br />
Invitro dissolution studies: An <strong>in</strong>vitro dissolution<br />
study for the f<strong>in</strong>ished product formulation was<br />
carried out us<strong>in</strong>g dissolution USP method I (basket)<br />
for Dexlansoprazole delayed release pellets. The<br />
dissolution medium consisted <strong>of</strong> 900 ml <strong>of</strong> pH 1.2<br />
buffer ma<strong>in</strong>ta<strong>in</strong>ed at a temp <strong>of</strong> 37+0.5 o C and was<br />
run for 2 hr <strong>in</strong>itially and release should not be more<br />
than 10%. Transfer the weighed pellets equivalent to<br />
30 mg <strong>of</strong> Dexlansoprazole <strong>in</strong> to each <strong>of</strong> six jars.<br />
After 2 hrs the previous acid medium was replaced<br />
with 900 ml <strong>of</strong> pH 6.8 buffer and release study was<br />
done.<br />
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Calculations: % <strong>of</strong> Dexlansoprazole<br />
A T W Std 5 900 P<br />
Dissolved = -----×-------×------×------×------×100<br />
A s 100 50 LC 100<br />
Where,<br />
A T : average <strong>of</strong> the area counts <strong>of</strong> the<br />
Dexlansoprazole peak obta<strong>in</strong>ed from the<br />
chromatograms <strong>of</strong> Test preparation<br />
A s: average <strong>of</strong> the area counts <strong>of</strong> the Dexlansoprazole<br />
peak obta<strong>in</strong>ed from the chromatograms <strong>of</strong> the<br />
standard preparation<br />
W std : Weight <strong>of</strong> Dexlansoprazole work<strong>in</strong>g standard<br />
<strong>in</strong> mg<br />
P: potency <strong>of</strong> Dexlansoprazole work<strong>in</strong>g standard (%<br />
on as is basis as dexlansoprazole)<br />
LC: label claim <strong>of</strong> Dexlansoprazole mg per capsule.<br />
Volume with drawal: 5 ml and replaced at same<br />
temp<br />
Dilution Factor: 100<br />
Bath volume: 900 ml<br />
After specified <strong>in</strong>terval withdraw sample from a<br />
zone midway between the surface <strong>of</strong> the medium and<br />
top <strong>of</strong> the rotat<strong>in</strong>g blade and not less than 1 cm from<br />
the vessel wall and filter through 0.45 micron<br />
membrane filter.<br />
Differential Scann<strong>in</strong>g calorimetry studies: 11<br />
DSC scan <strong>of</strong> about 5 mg us<strong>in</strong>g an automatic thermal<br />
analyzer system performed accurately weighed <strong>of</strong><br />
Dexlansoprazol, API and polymers Eudragit and<br />
HPMC <strong>of</strong> 1:1 <strong>in</strong> ratio respectively. Figure no 2, 3, 4<br />
shows the DSC thermographs <strong>of</strong> pure drug <strong>of</strong><br />
Dexlansoprazole and polymers. Thermographs<br />
obta<strong>in</strong>ed by DSC studies revealed that the melt<strong>in</strong>g<br />
po<strong>in</strong>t <strong>of</strong> pure drug is 145 O C and that the polymer<br />
and pure drug shows sharp endothermic peak at<br />
142.3 O C. Eudragit shows sharp endothermic peak at<br />
138 o C. From this it may be concluded that the drug<br />
is <strong>in</strong> the formulation without <strong>in</strong>teract<strong>in</strong>g with the<br />
polymer and excipients.<br />
Stability studies:<br />
The stability studies <strong>of</strong> the optimized capsule<br />
formulation F9 were carried out accord<strong>in</strong>g to ICH<br />
guide l<strong>in</strong>es at 40+2 o C/75+5 % RH for two months by<br />
stor<strong>in</strong>g the sample <strong>in</strong> stability chamber (thermo lab).<br />
Samples were collected at 15 days <strong>in</strong>terval.<br />
RESULTS & DISCUSSION<br />
In the present study delayed drug delivery <strong>of</strong><br />
Dexlansoprazole were successfully developed by<br />
enteric polymers which <strong>of</strong>fer a suitable and practical<br />
approach <strong>in</strong> serv<strong>in</strong>g desired dissolution<br />
characteristics with <strong>in</strong>creased bioavailability. The<br />
enteric coated pellets size was found to be <strong>in</strong>creased<br />
dur<strong>in</strong>g drug load<strong>in</strong>g, barrier coat<strong>in</strong>g and enteric<br />
coat<strong>in</strong>g <strong>of</strong> pellets as shown <strong>in</strong> table 3. Among all the<br />
formulations F9 shows <strong>in</strong>vitro dissolution pr<strong>of</strong>ile<br />
with<strong>in</strong> acceptable <strong>of</strong>ficial limit. Particle size<br />
distribution was also determ<strong>in</strong>ed for proper coat<strong>in</strong>g<br />
and the micrograph <strong>of</strong> formulation F9 was shown <strong>in</strong><br />
figure 5. DSC studies with other excipients revealed<br />
that there was no <strong>in</strong>teraction and also selected<br />
formulation was stable after stability studies.<br />
DISCUSSION<br />
In coat<strong>in</strong>g process the enteric coat<strong>in</strong>g was done with<br />
the percentage build up <strong>of</strong> 25-28% with 8% sub<br />
coat<strong>in</strong>g. Acid resistance test failed up to 26% but at<br />
28% build up acid resistance test passed. But for<br />
safer side we coated up to 30% with 8% sub coat<strong>in</strong>g.<br />
Based on the results Formulation F9 was found to be<br />
satisfactory as it has excellent release properties<br />
where it has shown an excellent stability. There was<br />
no significant change <strong>in</strong> <strong>in</strong>vitro release pr<strong>of</strong>ile. It<br />
shows that the formulation F9 was stable. Also from<br />
the stability studies it was confirmed that it was<br />
stable under the desired conditions which was shown<br />
<strong>in</strong> fig 6<br />
CONCLUSION<br />
The aim <strong>of</strong> the present study was to formulate and<br />
evaluate delayed release pellets <strong>of</strong> Dexlansoprazole<br />
by enteric coat<strong>in</strong>g. It is an acid liable drug so it is<br />
degraded at acidic pH <strong>of</strong> stomach. So an attempt was<br />
made to stabilize the drug and by us<strong>in</strong>g alkal<strong>in</strong>e<br />
agent magnesium carbonate. F<strong>in</strong>ally enteric coat<strong>in</strong>g<br />
was given to bypass the stomach. The enteric coat<strong>in</strong>g<br />
was carried out by us<strong>in</strong>g enteric polymer HPMC P<br />
55 S. the core pellets were prepared us<strong>in</strong>g suspension<br />
layer<strong>in</strong>g technique <strong>in</strong> fluid bed process. Sub coat<strong>in</strong>g<br />
was given to core pellets to avoid direct contact <strong>of</strong><br />
drug with enteric coat<strong>in</strong>g materials. An average<br />
weight build up <strong>of</strong> 8% w/w was given to core pellets.<br />
Enteric coat<strong>in</strong>g was given to sub coated pellets at an<br />
average weight build up <strong>of</strong> 30% w/w <strong>of</strong> sub coated<br />
pellets and the acid resistance pr<strong>of</strong>ile is seen.<br />
Stability studies were also conducted for 2 months<br />
and it was concluded that the drug release from F9<br />
formulation was best suitable formulation.<br />
ACKNOWLEDGEMENTS<br />
The authors wish to thanks the pr<strong>in</strong>cipal Dr.<br />
Y.Haribabu; I place on record my gratitude to<br />
Dr.K.Santhi, Dr. C.I.Sajeeth and management <strong>of</strong><br />
Gracecollege <strong>of</strong> pharmacy, Kerala for cont<strong>in</strong>uous<br />
support, encouragement and excellent facilities. Very<br />
special thanks to management <strong>of</strong> Alkem Research<br />
centre group for gift samples <strong>of</strong> drug and provid<strong>in</strong>g<br />
excellent <strong>research</strong> facilities.<br />
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Formula<br />
<strong>in</strong> mg<br />
Drug<br />
load<strong>in</strong>g<br />
Barrier<br />
coat<strong>in</strong>g<br />
Enteric<br />
Coat<strong>in</strong>g<br />
TABLE & FIGURES<br />
Table 1: Design <strong>of</strong> formulation <strong>of</strong> Dexlansoprazole delayed release pellets<br />
Ingredient F1 F2 F3 F4 F5 F6 F7 F8 F9 F10<br />
Sugar spheres 171 171 171 171 171 171 171 171 171 171<br />
Dexlansoprazole 30 30 30 30 30 30 30 30 30 30<br />
PVP K30 2.8 5.6 5.6 - - 5.6 - 5.6 5.6 5.6<br />
HPMC E-5 - - - 5.6 5.6 - 5.6 - - -<br />
Dibasic sodium 3.5 3.5 3.5 - - - - - - -<br />
Phosphate<br />
Magnesium - - - 3.5 3.5 3.5 3.5 3.5 3.5 3.5<br />
Carnonate<br />
SLS 0.59 0.59 0.59 0.59 0.59 0.94 0.94 0.94 0.94 0.94<br />
PVP K30 10.5 10.5 10.5 - - 10.5 - 10.5 10.5 10.5<br />
HPMC E-5 - - - 10.5 10.5 - 10.5 - - -<br />
Dibasic sodium 3.5 3.5 7 - - - - - - -<br />
phosphate<br />
Magnesium - - - 7 7 7 7 7 7 7<br />
carbonate<br />
Mannitol 76.40 73.60 70.10 70.10 70.10 69.75 62.75 76.75 69.75 62.75<br />
Eudragit L 100 42 42 42 42 35 - - - - -<br />
55<br />
HPMC P 55 S - - - - - 35 40 38 42 49<br />
Titanium dioxide 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4<br />
Triethyl citrate 1.05 1.05 1.05 1.05 1.05 1.05 - - 1.05 1.05<br />
Talc 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8<br />
Inlet temperature<br />
Outlet temperature<br />
Table 2: In process parameters <strong>of</strong> coat<strong>in</strong>g<br />
Parameters<br />
Condition<br />
Atomization air pressure<br />
Pan RPM<br />
Spray rate<br />
55 o C to 60 o C<br />
45 o C to 50 o C<br />
1-2kg/Sq.cm<br />
8-10 RPM<br />
70-140 g/m<strong>in</strong><br />
Table 3: Sieve analysis <strong>of</strong> pellets <strong>in</strong> different stages<br />
Pellets <strong>in</strong> different stages<br />
Size <strong>of</strong> pellets (µm)<br />
Core pellets 600-710<br />
Drug loaded pellets 710-810<br />
Barrier coated pellets 810-830<br />
Enteric coated pellets 830-850<br />
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Table 4: Determ<strong>in</strong>ation <strong>of</strong> drug contents<br />
Batch no<br />
Drug contents<br />
F3 87.34+0.48<br />
F4 88.11+0.016<br />
F5 95.10+0.25<br />
F6 98.20+0.056<br />
F7 98.90+0.012<br />
F8 99.8+0.31<br />
F9 99.75+0.18<br />
F10 94.6+0.09<br />
Where n=3<br />
Fig 1: Invitro comparative dissolution pr<strong>of</strong>ile <strong>of</strong> pellets <strong>in</strong> pH 6.8 buffer<br />
Fig 2: DSC <strong>of</strong> pure drug Dexlansoprazole<br />
Fig 3: DSC <strong>of</strong> Dug + HPMC (1:1 ratio)<br />
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Fig 4:DSC <strong>of</strong> Drug + Eudragit L 100 S (1:1)<br />
Fig 5: SEM photograph <strong>of</strong> formulation F9<br />
Fig 6: Stability study at 40 ± 2 C and 75 ± 5 % RH Dexlansoprazole pellets.<br />
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pharmacy, Page no 180-184<br />
2.Ijeoma F. Uchegbu and Andreas. G. Schatzle<strong>in</strong>.<br />
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