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single unit dosage form comprising both Ibuprofen and Famotidine can be advantageous.
But this combination is associated with the formulation challenges to prepare the stable
formulation of Ibuprofen and Famotidine as they both are chemically incompatible. This
formulation challenges have been overcome by preparing a multi-layered tablet. Multi-
layered Tablet formulation was extensively evaluated for all the in-process tests,
dissolution, disintegration into two halves, etc. Optimized formulation was kept on
accelerated stability study and results were found satisfactory.

Another strategy for development of Platform technology was designed as immediate
release Ibuprofen layer and sustained floating layer of Famotidine. The rationale for the
drug combination has already been explained in the above section. Famotidine is well
absorbed in stomach and upper GIT. Moreover, colonic metabolism of Famotidine is
partly responsible for the poor bioavailability of Famotidine from the colon. Floating drug
delivery systems are less bulky than gastric fluids and hence remain buoyant in the
stomach without affecting the gastric emptying rate for a prolonged period. While the
system is floating on the gastric contents, the drug is released slowly at the desired rate
from the system. This results in an increased gastric retention time and control of the
fluctuation in plasma drug concentration. Floating Famotidine layer was prepared using
effervescent approach using Sodium bicarbonate as a gas generating agent,
Hypromellose as a release rate controlling polymer and Wet Granulation Method has
been employed. Hence, sustained release floating layer improves the pharmacokinetics of
Famotidine. Multi-layered Tablet formulation was extensively evaluated for all the in-
process tests, dissolution, floating lag time, Disintegration into two halves, etc. Optimized
formulation was kept on accelerated stability study and results were found satisfactory.

Another strategy for development of Platform technology was designed as an extended-
release Metformin HCl layer and an immediate layer of Vildagliptin. There are many
rationales for Metformin and Vildagliptin fixed dose combination. Metformin is a
Biguanide anti-hyperglycemic agent used in the treatment of non-insulin dependent
diabetes mellitus (NIDDM) and Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor
class of drugs. Both have a synergistic effect where one increases the secretion of insulin
and other makes a better use of insulin in body. Co-therapy of this drug combination
improves and control the glycemic level in the blood. But this combination is not widely
used as patient compliance is more problematic with a regimen that requires
administration of two separate dosage forms. In such cases, a single unit dosage form
comprising both Ibuprofen and Famotidine be advantageous. But this combination is
associated with the formulation challenges to prepare the stable formulation of Ibuprofen
and Famotidine as they both are chemically incompatible. This formulation challenges
have been overcome by preparing a multi-layered tablet. Multi-layered Tablet formulation

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