international journal of advances in pharmaceutical research
international journal of advances in pharmaceutical research international journal of advances in pharmaceutical research
Phani Ratna Prasanth.G, et al. / International Journal of Advances in Pharmaceutical Research Formula in mg Drug loading Barrier coating Enteric Coating TABLE & FIGURES Table 1: Design of formulation of Dexlansoprazole delayed release pellets Ingredient F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 Sugar spheres 171 171 171 171 171 171 171 171 171 171 Dexlansoprazole 30 30 30 30 30 30 30 30 30 30 PVP K30 2.8 5.6 5.6 - - 5.6 - 5.6 5.6 5.6 HPMC E-5 - - - 5.6 5.6 - 5.6 - - - Dibasic sodium 3.5 3.5 3.5 - - - - - - - Phosphate Magnesium - - - 3.5 3.5 3.5 3.5 3.5 3.5 3.5 Carnonate SLS 0.59 0.59 0.59 0.59 0.59 0.94 0.94 0.94 0.94 0.94 PVP K30 10.5 10.5 10.5 - - 10.5 - 10.5 10.5 10.5 HPMC E-5 - - - 10.5 10.5 - 10.5 - - - Dibasic sodium 3.5 3.5 7 - - - - - - - phosphate Magnesium - - - 7 7 7 7 7 7 7 carbonate Mannitol 76.40 73.60 70.10 70.10 70.10 69.75 62.75 76.75 69.75 62.75 Eudragit L 100 42 42 42 42 35 - - - - - 55 HPMC P 55 S - - - - - 35 40 38 42 49 Titanium dioxide 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 Triethyl citrate 1.05 1.05 1.05 1.05 1.05 1.05 - - 1.05 1.05 Talc 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 2.8 Inlet temperature Outlet temperature Table 2: In process parameters of coating Parameters Condition Atomization air pressure Pan RPM Spray rate 55 o C to 60 o C 45 o C to 50 o C 1-2kg/Sq.cm 8-10 RPM 70-140 g/min Table 3: Sieve analysis of pellets in different stages Pellets in different stages Size of pellets (µm) Core pellets 600-710 Drug loaded pellets 710-810 Barrier coated pellets 810-830 Enteric coated pellets 830-850 IJAPR / May. 2012/ Vol. 3 / Issue. 5 / 907 - 913 910
Phani Ratna Prasanth.G, et al. / International Journal of Advances in Pharmaceutical Research Table 4: Determination of drug contents Batch no Drug contents F3 87.34+0.48 F4 88.11+0.016 F5 95.10+0.25 F6 98.20+0.056 F7 98.90+0.012 F8 99.8+0.31 F9 99.75+0.18 F10 94.6+0.09 Where n=3 Fig 1: Invitro comparative dissolution profile of pellets in pH 6.8 buffer Fig 2: DSC of pure drug Dexlansoprazole Fig 3: DSC of Dug + HPMC (1:1 ratio) IJAPR / May. 2012/ Vol. 3 / Issue. 5 / 907 - 913 911
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Phani Ratna Prasanth.G, et al. / International Journal <strong>of</strong> Advances <strong>in</strong> Pharmaceutical Research<br />
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 />
IJAPR / May. 2012/ Vol. 3 / Issue. 5 / 907 - 913 910
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