CHAPTER 7 SUMMARY AND CONCLUSION

VII. SUMMARY AND CONCLUSION

Sitagliptin Phosphate Monohydrate is a dipeptidyl peptidase (DPP4) inhibitor anti diabetic

for the treatment of type II diabetes. DPP4 inhibitors are a class of compound that work
affecting the action of natural hormone in the body called incretins. It decreases the blood
sugar level by increasing consumption of sugar by the body, mainly increasing insulin
production in the pancreas, and by reducing production of sugar by the liver.

There is need to develop mouth dissolving tablet required initially for naive patients for
immediate therapeutic response of sitagliptin phosphate monohydrate.

Objective of the present study was to formulate and evaluate mouth dissolving tablet of
sitagliptin phosphate monohydrate using natural disintegrant.

Initially UV-spectrophotometric analysis was done at λmax of 267nm for Sitagliptin

phosphate monohydrate in 0.1N HCl.

After literature review studies, Hibiscus rosa-sinesis and Plantago ovata Forskl (Husk)
powder were selected as natural disintigrant for mouth dissolving tablet as these are
extracted from natural source.

The materials were characterized and were found to comply with the standards. The

material used and method as well as results obtained and discussion have been presented.

in chapter 5 and 6 respectively

From the investigations following conclusions were drawn:

1. FTIR data confirmed that the drug and excipients used for MDT formulation were
compatible with each other.
2. The invitro disintegration time increased with the increase in amount of natural
disintegrant. Increase in small amount of natural disintegrant that is 2% to 8% is enough
to influence the disintegration performance in the MDT.

3. The 32 full factorial design studies for Sitagliptin MDT suggested that the
independent variable (Hibiscus rosa-sinesis Mucilage and P. ovata Forskl Powder )
shows effect on the dependent variables (responses) such as drug release time and
invitro disintegration time. An increase in the amount of natural disintegrant

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TABLET USING NATURAL DISINTEGRANT”
CHAPTER 7 SUMMARY AND CONCLUSION

decreased the time required for wetting of the MDT.

4. An increase in natural disintegrant amount, it positively affects the in vitro dissolution

of sitagliptin phosphate monohydrate from MDT. F9 MDT showed in vitro cumulative
dissolution of 97.3% in 20 minutes and disintegrated within 29.98 sec, thus it was
selected as the best formulation. The drug release kinetics for F9 is first order with high
k value of 7.404 indicating burst release.

5. The 32 full factorial design studies for sitagliptin phosphate monohydrate MDT the
independent variable (H. rosa-sinesis Mucilage and Plantago ovata Forskl Powder)
had influence on dependent variables such drug release and invitro disintegration
time.

Finally it is concluded that;

The F9 formulation containing 50mg of drug, 16 mg of natural disintegrant showed

minimum disintigration time (29.98 sec) and maximum % drug release (97.3% in
20min) and thus may be considered as potential MDT for delivery of sitagliptin
phosphate monohydrate for naive and continued treatment of diabetic mellitus.

“FORMULATION AND EVALUATION OF SITAGLIPTIN MOUTH DISSOLVING

74
TABLET USING NATURAL DISINTEGRANT”