Presented By: DHRUTI AVLANI

Roll No.: 27720316018Reg No.: 162772310024M.Pharm, 1st Year, 1st SemesterNSHM Knowledge Campus, Kolkata – Group of Institutions

GUIDE: Dr.Sutapa Biswas Majee

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 TabletPress

COMPRESSION

Granulation 2

Heterogeneous Type: Different drugs with same or different

release pattern

Drug 1 (IR)

Drug 1 (CR)

Drug 1

Drug 2

Compaction

Sieving

Granulates of API 1/2

Preblending

Blending (API 1)

Lubrication

Blend Layer 1

Compression layer 1

Dry

gr

anul

ati

onBl

endi

ng

Tabl

etti

ng

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

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

2. OROS® PUSH-PULL

TECHNOLOGY

3. DUROS TECHNOLOGY

4. PRODAS TECHNOLOGY [2]

Drug Layer

1Drug Layer

2

Delivery Orifice

Push Layer

Drug Laye

r

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.

TRADE NAME CHEMICAL NAME MANUFACTURERALPRAX PLUS® Sertaline, Alprazolam Torrent

Pharmaceuticals Ltd.Newcold Plus® Levocetrizine HCl,

Phenylpropanolol-amine, Paracetamol

Piramal Healthcare Ltd.

DIUCONTIN-K® 20/250

Furosemide, Potassium chloride

T.C. Healthcare Ltd.

PIOKIND®-M15 Pioglitazone, Metformin HCl

Psychotropis India Ltd.

Revelol®-Am25/5 Metoprolol succinate, Amlodipine besylate

Ipca Laboratories Ltd.

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.

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.