The Challenges of Producing Bilayer Tablet: A Review
Abstract
Bilayer tablets are the advanced form of conventional immediate release tablet system, which consist of either two similar or different drugs combined in a single dose for effective treatment of the disease improving patient compliance. However, the multilayer tablet technology is demanding It also necessitates meticulous selection of excipients and manufacturing conditions for each technological stage. The aim of this review is to provide an outline of state of art of bilayer tablet technology and emphasise the difficulties experienced during Bilayer tablet manufacturing along with itsĀ intend solutions for these challenges.
Keyword: Bilayer tablet, Conventional release, Challenges encountered, Compliance.
Keywords:
Bilayer tablet, Conventional release, Challenges encounteredDOI
https://doi.org/10.22270/jddt.v11i4-S.4922References
Abdul S, Poddar S. A flexible technology for modified release of drugs: multi layered tablets. Journal of Control Release. 2004; 97(3):393-405. https://doi.org/10.1016/S0168-3659(04)00186-5
Yadav G, Bansal M, Thakur N, Khare P. Multilayer tablets and their drug release kinetics for oral controlled drug delivery system, Middle-East Journal of Scientific Research.2013; 16(6):782-795.
Reddy P, Rao D, Kumar R. Bi-layer technology-an emerging trend: a review. International Journal of research and development in Pharmacy and Life Sciences. 2013; 2(3):404-411.
Rayaprolu M, Junju M K, Voleti V K, Sai P B, Pavani M. A new venture in drug delivery: Bilayer tablets review. International journal of research in pharmaceutical and nano sciences.2013; 2(3):305-316.
Patel M, Ganesh N, Tamizh M. Challenges in the formulation of bi-layered tablets: a review, International Journal of pharmaceutical research and development.2011; 2(10):30-42.
Martindale. The Extra Pharmacopoeia, The Pharmaceutical Press, London, 31st edition, 1996, 936-937.
Abebe A, Akseli I, Sprockel O, Kottala N, Cuitino AM. Review of bilayer tablet technology. International Journal of Pharmaceutics.2014; 461(1-2):549-58. https://doi.org/10.1016/j.ijpharm.2013.12.028
Busignies V, Mazel V, Diarra H, Tchoreloff P. Role of the elasticity of pharmaceutical materials on the interfacial mechanical strength of bilayer tablets. International Journal of Pharmaceutics. 2013; 457(1):260-67. https://doi.org/10.1016/j.ijpharm.2013.09.009
Kottala N, Abebe A, Sprockel O, Bergum J, Nikfar F, Cuitino A M. Evaluation of the performance characteristics of bilayer tablets: Part I. Impact of material properties and process parameters on the strength of bilayer tablets. American association of pharmaceutical scientists, Pharmaceutical Science and Technology. 2012; 13(4):1236-42. https://doi.org/10.1208/s12249-012-9845-9
Kottala N, Abebe A, Sprockel O, Akseli I, Nikfar F, Cuitino A. Influence of compaction properties and interfacial topography on the performance of bilayer tablets. International Journal of Pharmaceutics. 2012; 436(1-2):171-8. https://doi.org/10.1016/j.ijpharm.2012.05.026
Wu C.Y, Seville J.P. A comparative study of compaction properties of binary and bilayer tablets. Powder Technology. 2009; 189:285-94. https://doi.org/10.1016/j.powtec.2008.04.026
Balamuralidhara V, Kumar P T, Srujana N, Venkatesh M, Gupta N V, Krishna K. PH sensitive drug delivery systems: a review, American Journal of drug discovery and development.2011; 1(1):25. https://doi.org/10.3923/ajdd.2011.24.48
Wu C Y, Seville J P, A comparative study of compaction properties of binary and bilayer tablets, Powder Technology. 2009; 89(2): 285-294. https://doi.org/10.1016/j.powtec.2008.04.026
Abebe A, Akseli I, Sprockel O, Kottala N, Cuitino A M. Review of bilayer tablet technology. International Journal of Pharmaceutics. 2014; 461(1-2):549-58. https://doi.org/10.1016/j.ijpharm.2013.12.028
Li S P, Karth M G, Feld K M, Dipalo L C, Pendaharkar C M, Williams R O. Evaluation of bilayer tablet machines - a case study. Drug Development and Industrial Pharmacy. 1995; 21:571-90. https://doi.org/10.3109/03639049509048124
Inman S, Briscoe B, Pitt K .Topographic characterization of cellulose bilayered tablets interfaces, Chemical engineering research and design. 2007; 85 (7): 1005-1012. https://doi.org/10.1205/cherd06188
Podczeck F, Muti E.The tensile strength of bilayered tablets made from different grades of microcrystalline cellulose, European Journal of Pharmaceutical Science. 2010; 4 (3):483-488. https://doi.org/10.1016/j.ejps.2010.08.002
Yang L, Venkatesh G, Fassihi R. Compaction simulator study of a novel triple-layer tablet matrix for industrial tableting. International Journal of Pharmaceutics. 1997; 152:45-52. https://doi.org/10.1016/S0378-5173(97)04911-9
Desai D, Wang J, Wen H, Li X, Timmins P. Formulation design, challenges, and development considerations for fixed dose combination (FDC) of oral solid dosage forms. Pharmaceutical development and technology. 2013; 18(6):1265-76. https://doi.org/10.3109/10837450.2012.660699
Dietrich P, Bauer-Brandl A, Schubert R, Influence of tableting forces and lubricant concentration on the adhesion strength in complex layer tablets, Drug development and Industrial Pharmacy.2000; 26 (7):745-754. https://doi.org/10.1081/DDC-100101293
Tye C K, Sun C C, Amidon G E. Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablet tensile strength, and tablet solid fraction, Journal of Pharmaceutical Sciences.2005; 94 (3):465-472. https://doi.org/10.1002/jps.20262
Qiu Y, Chidambaram N, Flood K. Design and evaluation of layered diffusional matrices for zero-order sustained-release. Journal of control release. 1998; 51(2-3):123-30. https://doi.org/10.1016/S0168-3659(97)00119-3
Maroni A, Zema L, Carea M, Sangalli M.E. Oral pulsatile drug delivery systems. Expert opinion of drug delivery. 2005; 2(5):855-71. https://doi.org/10.1517/17425247.2.5.855
Kottala N, Abebe A, Sprockel O. Characterization of interfacial strength of layered powder-compacted solids. Powder Technology.2013; 239:300-307. https://doi.org/10.1016/j.powtec.2012.12.028
Jones R.M, 1999. Mechanism of Composite Materials, 2nd ed. Taylor & Francis, Philadelphia.1999: 245- 246.
Sonar G S, Jain D, More D, Preparation and in vitro evaluation of bilayer and floating-bioadhesive tablets of rosiglitazone maleate, Asian Journal of Pharmaceutical Sciences.2007; 2(4):161-169.
Admassu A, Ilgaz A , Omar S , Niranjan K, Alberto M. Review of bilayer tablet technology, International Journal of Pharmaceutics. 2014; 461: 549-558. https://doi.org/10.1016/j.ijpharm.2013.12.028
Muzzio F J, Lerapetritou M, Portillo P., Llusa M, Levin M. A forward-looking approach to process scale up for solid dose manufacturing, Pharmaceutical Dosage Forms: Tablets. 2008; 3(1):1283-1316.
Ankit S, Shashi M K. Bilayer tablet; a promising approach for delivery of dual drugs, International Journal of Physical and Social Science. 2014; 4(9):87-101.
Karehill P, Glazer M, Nystrom C. Studies on direct compression of tablets. The importance of surface roughness for the compactability of some directly compressible materials with different bonding and volume reduction properties, International Journal of Pharmaceutics.1990; 64 (1):35-43. https://doi.org/10.1016/0378-5173(90)90176-5
Vogeleer J, Smet D. Bilayer tablets - why special technology is required. Pharmaceutical processing. 2002; 1:30-36.
Vishwakarma A G, Mogal R T, Pawar A Y. Bilayer Tablet - A New Ways in Oral Drug Delivery System. International Journal of Pharmaceutical Technology and Research, 2014; 6(5):1416-1428
Published
Abstract Display: 1479
PDF Downloads: 1095
PDF Downloads: 1581 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).

.