Bilayer tablet is suitable for sequential release of two drugs in combination and also for controlled release tablet in which one layer is for immediate release as initial dose and the second layer is for controlled release or maintenance dose. Bilayer tablet is an improved beneficial technology to overcome the shortcoming of the monolayer tablet. This technology avoids frequent administration of dosage form. Now a days such technology is used for co-administration of two drugs like anti-diabetic, anti-hypertensive, anti-inflammatory to the patients. Conventional solid oral dosage forms are a traditional approach, but bilayer tablet is a novel approach that requires new machinery for manufacturing. The technique is cost effective, safe and reproducible.
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Dhruti Avlani - Bilayer Tablet
1. Presented By: DHRUTI AVLANI
Roll No.: 27720316018
Reg No.: 162772310024
M.Pharm, 1st
Year, 1st
Semester
NSHM Knowledge Campus, Kolkata –
Group of Institutions
GUIDE: Dr.Sutapa Biswas Majee
2. Novel drug delivery system suitable for sequential release of two
drugs in combination
Separate two incompatible substances (heterogeneous)
Sustained release (homogeneous) tablet in which one layer is immediate
release (IR) as initial dose and the second layer is controlled release (CR)
as maintenance dose [1]
.
Granulation 1
Homogeneous Type: Same
drug with different release
pattern
Bilayer
Tablet
Press
COMPRESSION
Granulation 2
Heterogeneous Type: Different
drugs with same or different
release pattern
Drug 1 (IR)
Drug 1 (CR)
Drug 1
Drug 2
3.
4. Compaction
Sieving
Granulates of
API 1/2
Preblending
Blending (API 1)
Lubrication
Blend Layer 1
Compression
layer 1
Dry
granulationBlendingTabletting
Preblending
Lubrication
Blend Layer 2
Compression layer
2 on layer 1
HETEROGENEOUS BILAYER TABLET
BILAYER TABLET
Simple Compaction and
Ejection
Blending (API 2)
API 1/2
Multiple Compaction and
Ejection
A1 B1 C1 D1 E1
A B C D E
5. 1.DUREDAS™ TECHNOLOGY (1 Immediate
Release & 1 Controlled Release Layer)
Controlled
release
hydrophilic
swellable matrix
The
controlled
release layer
remain intact
Hydrophilic
polymer start
to swell up by
taking water
from GI fluid
After swelling up,
drug release
occurs in a
controlled release
manner
Immediate
release
layer
Release of the
drug from the
immediate layer
by diffusion
Controlled
release
matrix
DUREDAS™
TECHNOLOGY
(2 Controlled
Release Layers)
[2]
Solvent Influx
Hydrophilic
Polymer
Mixture of
Hydrophilic &
Hydrophobic
Polymer
Hydrophilic
polymer start to
swell up by taking
water from GI fluid
Rate of
swelling is
different for
two layers
Drug release occurs at a
slower rate from the
swollen polymer mixture
Drug
Molecule
6. 2. OROS® PUSH-
PULL TECHNOLOGY
3. DUROS
TECHNOLOGY
4. PRODAS
TECHNOLOGY [2]
Drug
Layer 1
Drug
Layer 2
Delivery Orifice
Push Layer
Drug
Layer
7. DRUG MAIN EXCIPIENT PRESENT IN
EACH LAYER
REMARKS
IMMEDIATE
RELEASE
LAYER
CONTROLLED
RELEASE
LAYER
Indomethacin
(Floating tablet)
Ac-di-sol
(Super
disintegrant)
HPMC K-4M
(Rate controlling
Polymer)
Releases the drug from fast
release layer within 2 hours
and followed by controlled
release for 24 hours. Reduce
dose frequency and improve
patient compliance.
Zolpidem
tartarate (Matrix
tablet)
Ac-di-sol
(Super
disintegrant)
HPMC K-100M
(Rate controlling
Polymer)
Optimised formulation
released more than 50% of
drug within the first 30
minutes and remaining drug
released could be extended
upto 6 hours.
9. Bilayer tablet is suitable for sequential release of two drugs in
combination and also for controlled release tablet in which one layer
is for immediate release as initial dose and the second layer is for
controlled release or maintenance dose.
Bilayer tablet is an improved beneficial technology to overcome
the shortcoming of the monolayer tablet. This technology avoids
frequent administration of dosage form. Now a days such
technology is used for co-administration of two drugs like anti-
diabetic, anti-hypertensive, anti-inflammatory to the patients.
Conventional solid oral dosage forms are a traditional approach,
but bilayer tablet is a novel approach that requires new machinery
for manufacturing. The technique is cost effective, safe and
reproducible.
10. 1. Reddy P, Rao D, Kumar R. 2013. Bilayer technology- an emerging
trend: A review. International Journal of Research and
Development in Pharmacy and Life Sciences; 2: 405.
2. Balaji G, Ghana P, Karudampala S, Venkatesh B. 2013. Bilayer
tablet: A review. International Journal of Research and Reviews
in Pharmacy and Applied Sciences; 3: 488-506.
3. Nilawar P, Wankhade VP, Badnag DB. 2013. An emerging trend on
bilayer tablet. International Journal of Pharmacy and
Pharmaceutical Science Research; 3: 15-21.