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Bilayer tablets are new novel of tablets for the successful development of controlled release formulation along with many features to provide a way of successful drug delivery system. Bilayer tablets have been developed to achieve modified release of drug. Bilayer tablets are suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. So use of bilayer tablets is a very different aspect for anti-hypertensive, diabetic, anti-inflammatory and analgesic drugs where combination therapy is often used. Bilayer tablet is improved beneficial technology to overcome the shortcoming of the single layered tablet. In the case of bilayer tablets drug release can be rendered almost unidirectional if the drug can be incorporated in the upper non adhesive layer its delivery occurs into the whole oral cavity. To reduce capital investment, quite often existing but modified tablet presses are used to develop and produce such tablets. The present article explains why the production and development of quality bi-layer tablets needs to be carried out on purpose-built tablet presses to overcome common bi-layer problems, such as hardness, insufficient, layer-separation, inaccurate individual layer weight control, reduced yield, cross-contamination between the layers, etc. Using a modified tablet press may therefore not be your best approach to producing a quality bi-layer tablet under GMP-conditions.
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Scope and Importance:
Bilayer tablets offer an excellent opportunity for manufacturers to separate themselves from their competitors, improve their products’ efficacy, and protect against impersonator products. Bi-layer tablet quality and GMP requirements can vary widely. This explains why many different types of presses are being used to produce bi-layer tablets, ranging from simple single-sided presses to highly sophisticated machines. When a quality bi-layer tablet needs to be produced in conjunction with accurate weight control of both layers, compression force-controlled presses are clearly limited because of their insufficient sensitivity and hence lack of accuracy at low compression forces required to secure interlayer bonding.
Bilayer tablets are prepared with one layer of drug for immediate release with the second layer designed to release drug later, either as a second dose or in an extended release forms. The bilayer tablets with two incompatible drugs can also be prepared by compressing separate layers of each drug so as to minimize area of contact between two layers. An additional intermediate layer of inert material may also be included. To produce adequate tablet formulation, certain requirements such as sufficient mechanical strength and desired drug release profile must be met. At times, this may be difficult task for formulator to achieve these conditions especially in bilayer tablet formulation where double compression technique is involved, because of poor flow and compatibility characteristic of the drug which will result in capping and/or lamination. The compaction of a material involves both the compressibility and consolidation.
According to IMS Health Consulting, an international research company, in 2012 the size of the global pharmaceutical market reached $940 billion. In monetary terms it grew by 6%. In the future the sector is expected to grow at no less than 3% to 4% a year and if this happens the global pharmaceutical market is expected to reach $1.1 trillion by 2015 and will reach $1.2 trillion in 2016 and up to $1.5 trillion by 2020. The global demographic, epidemiological and economic changes are transforming the pharmaceutical market. The world population is growing rapidly and is projected to raise from 7 billion in 2011 to 7.7 billion in 2020 and 9.6 billion in 2050, hence an increase in the demand for pharmaceuticals.
International symposium and workshops
1. 5th PCNE Working Symposium 2016, Hillerød, Denmark, 19-20 February 2016.
2. 8th Pharma Sciences symposium, Osaka, Japan, 21-22 January 2016.
3. ISOPP 2016, Santiago, Chile, April 17-20, 2016.
Relevant Society and Associations
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This page was last updated on January 23, 2020