ABSTRACT:
Pantoprazole sodium is an antiulcer drug. This compound inhibits gastric acid formation and thereby it is very efficient for the treatment of gastric and duodenum ulcers. But pantoprazole sodium is acid labile drug that will degrade in acidic environment of stomach resulting in therapeutic inefficacy. Hence it is necessary to bypass the acidic pH of the stomach which can be achieved by formulating delayed release dosage forms (single unit or multiple units) by using different enteric polymers
The present study was an attempt to formulate and evaluate enteric coated tablets for pantoprazole sodium sesquihydrate. Different core tablets were prepared using different superdisintegrants (Sodium starch glycolate, croscarmellose sodium,
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Finally, magnesium stearate (passed through a 60-mesh/250 micron screen) was introduced to the powder mixture. The final mixture was shaken manually for 5-10 min in a plastic bag. This powder was passed through the hopper of 16 station rotary tabletting machine and punched into tablets using 8mm s/c. the process is similar for all core formulations, which are prepared by direct compression technique.
FORMULATION OF ENTERIC COATED TABLETS OF PANTOPRAZOLE SODIUM
Formulation design:
Pantoprazole enteric coated tablets were prepared using different polymers like HPMC 5cps (sub coat) AQOAT, CAP and KOLLICOAT MAE 30DP.
Different formulations of pantoprazole sodium enteric coated tablets were prepared using the polymers in different ratios keeping core tablet (C3) constant. They are assigned with formulation codes.
GENERAL FORMULATION
A formula is set using following ingredients:
Coating polymer - HPMC 5cps, CAP, AQOAT, KOLLICOAT MAE30DP
Solvent - Isopropyl alcohol, Dichloromethane, Water
Plasticizer - Triethyl
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Figure 15: FTIR spectra of pantoprazole sodium+kollicoat MAE 30DP
Drug-excipient compatability studies: FTIR
In the FTIR spectra of pure drug and different polymers it is observed that the peaks of major functional groups which are present in spectrum of pure drug are observed in combination of drug and polymers. There was no appearance or disappearance of any characteristics peak in the FTIR spectrum of Optimized formulation. This shows that there is no chemical interaction between the drug and the polymers used .The presence of peaks at the expected range confirms that the materials taken for the study are genuine and there were no possible interactions occurred.
7.1.2 PREFORMULATION CHARACTERISTICS
Table 23: Preformulation of powder blend of pantoprazole sodium core tablet
Formulation code Angle of repose Bulk density
(gm/cm2) Tapped density (gm/cm2) Hausners ratio %compressibility C1 25.7±0.03 0.34±0.02 0.42±0.03 1.24 19.04±0.01 C2 26.8±0.01 0.36±0.02 0.45±0.05 1.26