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1
Dr. Vithalrao Vikhe Patil Foundation’s College of Pharmacy, Vilad Ghat, Ahmednagar,
(MS), India, 414111.
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Department of Pharmaceutics Dr. Vithalrao Vikhe Patil Foundation’s College of Pharmacy,
Vilad Ghat, Ahmednagar, (MS), India, 414111.
ABSTRACT
Article Received on
12 May 2018, For patent extension, few pharmaceutical companies are currently
Revised on 03 June 2018, developing the bi-layer tablets, addition in therapeutic efficacy etc. Bi-
Accepted on 24 June 2018,
DOI: 10.20959/wjpr201813-12785 layer tablet is a novel era for the unbeaten development of controlled
release formulation along by various features to provide a method of
successful drug delivery system and for separation of two incompatible
*Corresponding Author
Abhishek R. Bura substances two drugs are used in combination for sequential release
Dr. Vithalrao Vikhe Patil and as initial dose sustained release tablet in which one layer is
Foundation’s College of immediate release and the second layer is maintenance dose. Bi-layer
Pharmacy, Vilad Ghat,
tablets can be major option to avoid chemical incompatibilities among
Ahmednagar, (MS), India,
414111.
APIs by physical separation and to allow the development of dissimilar
drug release profiles. The present article provides a review of the oral
drug delivery system, types of the tablets, Bilayer tablet developing, various type of tablet
presses use, quality and the GMP requirements for high production output and current
developments in the field of Bilayer technology and production of superiority bi-layer tablets
need to be carried out on the reason built tablet presses, such as layer parting, lacking in
hardness, incorrect individual layer weight control, cross-contamination among the layers and
reduced the yield.
INTRODUCTION
Oral intake has long been the most suitable and commonly employed route of the drug
delivery due to its simplicity of the administration. The conventional dosage form produces
the extensive variation in the drug concentration in the bloodstream and tissues with the
resulting unwanted toxicity and the poor efficiency. The aim in the designing sustained or the
controlled delivery systems are to reduce the frequency of the dosing or to raise efficacy of
the drug by the localization at the site of action, reducing the dose required. The main
purpose of sustained release drug delivery is to make sure the safety and to improve the
effectiveness of the drugs as well as patient compliance[7] now a day’s various developed &
developing countries are a move towards combination therapy for the treatment of various
diseases & disorders requiring long-term therapy. There are some key advantages of bi-layer
tablets which are compared to conservative bi- tablets. for instance, by physical division, such
tablets are typically used to avoid chemical incompatibilities of formulation components.[9]
However, these drug delivery procedure is mechanically complicated to design/manufacture
and the harder to predict their long-term mechanical properties due to poor mechanical and
compression character of the component materials in the compacted next layers.
6) Chewable tablets.
DISADVANTAGES
1) Irritant effects on the gastrointestinal mucosa by some solids.
2) A possibility of bioavailability problems resulting from slow disintegration and
dissolution.
3) Some drugs resist compression into tablets.
4) Difficulty in swallowing in some patients; pediatrics and geriatrics.
BILAYER TABLETS
A multi-layered tablet is a tablet that has more than one separately compressed powder layers
within its final single body e.g. a bi-layered tablet consists of the two sequentially
compressed layers that form a single final coherent tablet body at the end of the compression
method. Multi-layered tablets are favored due to their controlled release profiles of the active
ingredients.[4] The intention of any drug delivery system is to supply a therapeutic amount of
the drug to the appropriate site of the body to achieve rapid and or uphold the required drug
concentration. Combination therapy is more helpful as compared to mono-therapy because in
this we can reduce the dose-dependent on its side effects. Low dose combination of two
dissimilar drugs reduces the side effect of a single drug in high dose.[5]
2. Inlay tablets
By the coating, it’s a category of a layered tablet in which instead of the core tablets being
completely surrounded. Peak surface is completely covered. While preparation, the only
bottom of the die cavity is filled with the coating material and core is placed upon it. The
coating material is displaced to form the sides by applying compression force and compact
the entire tablet Under GMP conditions.[20]
sided press with the displacement measurement is the preferred presses for bi-layer tablet
manufacture.[15]
2. L-OROS TM Technology
This system is mostly used for the solubility problem, where a lipid soft gel product
containing the drug in a dissolved state initially prepared and then coated with the barrier
membrane then osmotic push layer and then with semi-permeable membrane drilled with exit
orifice for the drug release.
3. DUROS Technology
The system consists of an outer cylindrical titanium alloy reservoir. It protects the drug
molecules from enzymes. These give a small drug dispensing system in the continues and
consistent which release little quantity of concentrated form.
4. Duras Technology
The dual release drug absorption system utilizes in the bi-layer tableting technology. This is
specifically developed to give two dissimilar release rates or dual release of drug from a
single dosage form. The tablets are prepared as an immediate release layer and controlled
release layer within the single tablet.
5. Geminex Technology
It is dual drug delivery technology, which can deliver the one or more drugs at particular
times. This technology controls the release rate of the two drugs by maximizing their
individual therapeutic effect and minimizes the side-effects. The benefits of this technique are
that two dissimilar actives can be delivered at the different rates in the single tablet.
6. PRODAS
These are system is based on encapsulation of controlled release mini tablets in the size
ranging from the 1.3 to 4.5 mm diameter. This technology is a mixture of multiparticulate and
hydrophilic matrix technology thus shows benefits of both. These combinations may include
instant release, late release and or controlled release mini tablets.
CONCLUSION
Bilayer tablets present a good opportunity for manufacturers to split themselves from their
competitors. The bi-layer tablet excellence and GMP requirements vary broadly range. Lack
of accuracy at low compression forces required to safe interlayer bonding.
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