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Ph.D.
(Pharmacy)
DESIGN AND DEVELOPMENT OF
MULTILAYERED TABLETS AS PLATFORM TECHNOLOGY FOR
FIXED-DOSE COMBINATION THERAPY
Ph.D. Scholar : Jain Abhishek Kailash
Research Supervisor : Dr. Geeta K. Patel

Regi. No.: 16146021006
Abstract :
The aim was to prepare a stable fixed dose combination unit dosage form of
Incompatible drugs.
Chemical incompatibility between drug-drug and drug-excipient is the most observed
challenge during formulation of FDC’s.To avoid such problems, layered tablets are
prepared as a novel drug delivery system. Multilayered tablet is a very effective
technology for sequential release of two or more drugs in combination, separates two
incompatible drug or excipients and provides multi drug release profile of tablet.

In current research work, two incompatible drugs were selected, and the techniques used
to design both the drugs in a single unit dosage form is the layered tablet. Layered tables
were prepared by incorporating the middle inactive separating layer in between the two
active layers. The final Tri-layered tablet prepared was evaluated for all in-process
parameters and charged for accelerated stability studies.

The model drug selected for developing the platform technology of tri-layered tablet were
1) Ibuprofen and Famotidine Immediate release tablet, 2) Ibuprofen (Immediate Release)
and Famotidine Sustained release floating tablets and 3) Metformin HCl Sustained
release and Vildagliptin HCl immediate release tablet. All the three formulations were
prepared as a tri-layered tablet with different release criteria. Tri-layered tablets of all the
formulation were kept on accelerated stability study for 6 months.
To develop a platform technology of Tri-layered Tablets, the first strategy used was to
design an immediate release layer for Ibuprofen and Famotidine as a model drug. There
are many rationales for Ibuprofen and Famotidine fixed dose combination. Ibuprofen is
NSAIDs and widely indicated for a wide range of arthritis and non-arthritic condition.
Chronic therapy of NSAIDs is linked with major side effects like gastritis, dyspepsia,
gastric and duodenal ulceration. Gastric and duodenal ulceration is a consequence of
impaired mucosal integrity. This risk can be reduced by co-therapy with Famotidine.
Famotidine is a histamine type-II (H2) receptor antagonist helps to reduce acid secretion
in the stomach. This FDC is reported to decrease incidence of gastrointestinal ulcers. But
such therapies are not widely used as patient compliance is more problematic with a
regimen that requires administration of two separate dosage forms. In such cases, a
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