AN OVERVIEW ON BILAYERED TABLET TECHNOLOGY
Abstract
Bilayer tablet is new novel of tablet for the successful development of controlled release formulation along with many  features to provide a way of successful drugdelivery system. Bi-layer tablet is suitable for sequential release of two drugs incombination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediaterelease as initial dose and second layer is maintenance dose. So use ofbi-layer tablets is a very differentaspectfor anti-hypertensive, diabetic, anti-inflammatory and analgesic drugs where combination therapy is often used.  Bi-layer tablets have been developed to achieve modified release of drug. Bilayer tabletis improved beneficial technology to overcome the shortcoming of the single layered tablet. In the case of bilayered 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.
Â
Keywords:Approaches, Bilayer tablets, OROS push pull technology, DUROS technology,immediate release, GMP requirements for bilayer tablet.
References
Banker S, Gilbert J, and Rhodes T. ChristopherModern Pharmaceutics, Marcel Dekkerâ€, Inc., New York, p.575.
Chun YW and Jonathan PK, A Comparative Study of Compaction of Binary and Bilayer Tablets, Powder Technology†Science Direct, 189, 2009, 285-294.
Aggarwal Swati, Syan N, and Mathur P, Bilayer Tablet Technology- Opening New Ways in Drug Delivery Systems: An Overviewâ€, International Journal of research In Pharmaceutical and Biomedical Sciences, 4 (1), 2013, 8-16.
MalathiParnapalli, and Arshad BK, Recent Approaches in Bilayered Technology: Reviewâ€, International Journal of Pharmaceutical Sciences and Research, 3(12), 2012, 4681- 4688.
Soma C, Reddy Suryaprakash C, Tabasum SG,and Varma V, An Overview on Bilayer Tabletsâ€, International Journal of Pharmacy & Technology, 4 (2), 2012, 2143-2156.
Dandare MS, Sarage RD, andBhaskara S, Bilayer Tablet: A Novel Approach For Immediate Release of Telmisartan and Hydrochlorothiazide Combinationâ€, 4(1), 2012, 3970-3983.
Martindale, the Extra Pharmacopoeia, 31stEd. The Pharmaceutical Press, London; 1996.p.936–937.
Shiyani B et al. Formulation and evaluation of bilayer tablet of Metoclopramide hydrochloride and Ibuprofen.â€AAPS Pharm Sci Tech 2008; 9(3):818-27.
Pranjal Kumar Singh et al, and Sanjoo Kumar et al, Bilayer and Floating Bioadhesive Tablets: Innovative approach to Gastroretentionâ€, Journal of Drug Delivery & Therapeutics; 2011, 1(1): 32-35
Deshpande R, Govda DV, Bilayer Tablets an Emerging Trends: A Reviewâ€, International Journal of Pharmaceutical Sciences and Research, 2(10), 2011, 2534-2544.
Kale SS, Saste VS, Ughade PL, Baviskar DT; Bilayer Tabletâ€; International Journal of Pharmaceutical Sciences Review and Research; 2011; 9(1) : 25-30.
Shiyani B, Gattani S and Surana S, Formulation and evaluation of bilayer tablet of Metoclopramide hydrochloride and Ibuprofenâ€. AAPS Pharm Sci Tech. 2008;9(3):818-27.
Kulkarni A et al, Development and evaluation of bilayer floating tablets of atenolol and lovastatin for biphasic release profileâ€. AAPS Pharm Sci Tech. 2008;9(3):818-27.
Panchelhitenashok and Tiwariajaykumar, A Novel approach of bilayer tablet technology-A reviewâ€, IRJP, 3(5), 2012.
Nirmal J et al, Saisivam S et al, Peddanna C et al, Muralidharan S et al, and Nagarajan M et al, Bilayer tablets of atorvastatin calcium and nicotinic acid: formulation and evaluationâ€. Chem.Pharm.Bull.2008;56: 1455–1458,26-102-1PB.
Muzzio FJ, Lerapetritou M, Portillo P, Llusa M, Levin M, Morris KR, Soh LPJ, McCann RJ and Alexander A. A forward-looking approach to process scale-up for solid dose manufacturing.†In: Augsburger, L.L., Hoag, S.W. (Eds.), Pharmaceutical Dosage Forms: Tablets: Manufacture and Process Control. 2008 ;( 3).
Dey S, SanhatiSinha Roy, AmitavaGhosh, and BhaskarMazumder; Bilayer Tablet Technologyâ€: A Suitable Approach for Bimodal Release and Co-administration of Drug(s) Through Oral Route: 1-35
Panchal HA, andTiwari AK; A Novel Approach of Bilayer Tablet Technology: A Review; International Research Journal of Pharmacy; 2012, 3 (5) : 44-49
Pujara ND, Gokani RK, andPaun JP; Bilayer tablet- an emerging trendâ€; Interrnational journal of pharmaceutical research and development; 2012; 4(4) : 103-104
Divya A, Kavitha K, Kumar MR, DakshayaniS,andJagadees Singh SD;Bilayer Tablet Technology: An Overviewâ€, Journal of Applied Pharmaceutical Science, 01 (08), 2011, 43-47.
Varaiya C. Bi-layer neutraceutical tablets: Rewardsand challengesâ€. In: Keefer R, Calvin J, Kirsch D, Bubb G, Bowman L, Matthews S. Multi-layer tabletting Q & A. CSC Publishing.
Jan Vogeleeret al; Bi-layer tablets - why special technology is required The Courtoy-R292F tablet press, designed for quality bi-layer tablets NiroPharma Systems.
Abshagen U et al and Spo ¨rl-Radun S et al, First data on the effects and pharmacokinetics of isosorbide-5-mononitrate in normal manâ€, Eur. J.Clin.Pharmacol.;1981; 19p.423–429.
Hutt V et al, Bonn R et al, Fritschi E et al and Jaeger H et al, Evaluation of the pharmacokinetics and absolutebioavailability of three isosorbide- 5- mononitratepreparation in healthy volunteersâ€, Arzneim.-Forsch./Drug Res.;1995, p.142–145.
Patel Mehul,Ganeshet al andNanjanSockanet al, Challenges in the Formulation of Bilayered Tablets: A Reviewâ€, International Journal of Pharma Research and Development,2010, ISSN 0974 – 9446.
Rudnic EM et al and Kottkeet al MK Tablet dosage form. In Banker GS, Rhodes CT, editors. Modern Pharmaceutics. 3rd ed., vol 72. New York: Marcel Dekker Inc. p 369.
Breech AJ et al, Lucisano L J et al and Franz RM et al Investigation into substrate cracking of a film coatedbilayered tabletâ€. J. Pharm.Pharmacol. 1998;40:282-283.
M.A. Kalamet al, M. Humayunet al, N. Parvezet al, S.Yadavet al, A.Garget al, S.Aminet al ,Y. Sultana etal and A. Ali.,Continentalet al J. Pharmaceutical Sciences;2007,1: 30 – 35
Li S.P. et al, Karth M.G. et al, Feld K.M. et al, Pendharkar C.M. et al and Willams R.O. et al, Evaluation of Bilayer tablet machinesâ€. A Case study. Drug Dev. Ind. Pharm. 1995; 21(5): 571 590.
Debnath M, Bilayer Tableting Technology: An Overviewâ€, Journal of pharmacy Research, 5(1), 2012, 310-314
Science a n d Technologies [ online]. [cited 2012 Available from URL: http://www.durect.com
Naisarg d. Pujararonak k. Gokani and Jalpa s. paun.Bilayer tablet –An emerging trend ijprd, 2011; vol-4(04): june-2012 (102 - 111).
http://www.port/ technology.com
Shirwalkar A A, Kumar SM and Jacob S,Recent developments in floating drug delivery systems for gastric retention of drugs, an overviewâ€. Indian drugs. 2006; 43(9): 697-704.
Inman SJ, Briscoe BJ, Pitt KG and Shiu C, The Non-Uniformity of Microcrystalline Cellulose Bilayer Tablets, Powder Technologyâ€, Science Direct, 188, 2009, 183-294.
Singh Manoj K, Prajapati SK, Mahor A, Rajput N and Singh R, Formulation and In-vitro Evaluation of Microcrystalline Chitosan Based BuccoadhesiveBilayered Tablets of Repaglinideâ€, International Journal of Pharmaceutical and Biological Archives, 2 (4), 2011, 1282-1290.
Panchal HA and Tiwari AK, A Novel Approach of Bilayer Tablet Technology: A Reviewâ€, International Research Journal of Pharmacy, 3 (5), 2012, 44-49.
Reddy S, Panakanti PK, Kandaghatla R and Yamsani MR, Formulation and Release characteristic of a Bilayer matrix Tablet Containing Glimepiride Immediate Release Component and Metformin Hydrochloride As sustained Release Componentâ€, International Journal of Pharmaceutical Science and Nanotechnology, 3(1), 2010, 851-859.
The United States Pharmacopoeia, United states Pharmacopoeialconventionâ€, Inc., Rockville, MD, 2000:1944.
Singh B. N., Kim and K.H., Floating drug delivery systems an approach to oral controlled drug delivery via gastric retentionâ€, J Control Rel 63, 2000, p.235-59.