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Patel pharmacy college Saffrony institute of technology Linch , mehsana . 2011-2011 1Introduction: Introduction Bilayer tableting 2 + Bilayer tablets can be a primary option to avoid chemical incompatibilities between API by physical separation, and to enable the development of different drug release profiles (immediate release with extended release) 1 .Advantages: Advantages Release of both drugs starts immediately Combination of incompatible drugs 2 Physical/chemical incompatibility can be prevented by physical separation of two drugs. Combination of different release profiles Immediate release and sustained release profile can be achieved in single tablet by forming IR layer and SR layer. Reduced Pill Burden By reducing individual dose of two drug due to their additive effect . Example: Salbutamol + Theophylline 3Advantages: Advantages 4 Reduce the side effects Reduced by using one drug of the combination for this purpose 2 . Amiloride may prevent hypokalemia caused by hydrochlorthiazide 19, 20 Elegance to the productAdvantages: Advantages 5 Hypertension Heart Disease Diabetes Hyperlipidemia Obesity Co-morbid Conditions 2 Co-morbid Conditions means pertaining to a disease or other pathological process that occurs simultaneously with another 18 . Treat different ailments in the same patient (co-morbidity), at the same time and with one pill Example: Combination of β - blocker and ACE inhibitor or Diuretics is beneficial to treat Hypertention and Heart failure. Only Allows for synergistic combinationIdeal candidate of bilayer tablets: Ideal candidate of bilayer tablets Drug produces additive/synergistic effect Anti- asthmatic: Salbutamol + Theophylline Drugs having opposite side effects, may reduce the side effect Omeprazole + NSAIDS Hydroclorothiazide + Amiloride Incompatible drugs Low biological half life (ideal for modified release bilayer) Unstable at intenstinal pH ( ideal for bilayer floating) High first pass metabolism with low biological half life (ideal for buccoadhesive bilayer) 6DIFFERENT TYPES: DIFFERENT TYPES Bilayer modified release tablet Example: Aceclofenac 9 : NSAIDS, COX-2 inhibitor; t/2 = 3-4 hrs Metoclopramide HCL + Ibuprofen 13, 14 : Metoclopramide HCL is anti emetic; Given as immediate release dose and Ibuprofen is NSAID; given as SR dose, due to its low t/2 (2 hrs). This is widely used combination in treatment of migraine. It improve the absorbance of Ibuprofen, whose absorption is less due to gastric stasis 10 especially in migraine. 7DIFFERENT TYPES: DIFFERENT TYPES Bilayer floating tablet Example: Rosiglitazone maleate 6,7,8 Oral anti-diabetic; t/2 = 3-4 hrs; its solubility is decreased by increasing pH . Metoprolol Tartrate 3,4,5 Β 1 -selective adrenergic blocker; t/2 = 3-4 hrs; it degraded in colon Captopril 11,12 ACE inhibitor; 37.5 – 75 mg dose is required in three times; most stable at 1.2 pH. 8DIFFERENT TYPES: DIFFERENT TYPES Bilayer bucoadhesive tablet Example: Propranolol HCL Non-selective β -adrenergic blocker; t/2 = 3-5 hrs; high first pass metabolism. Drug in buccoadhesive layer, Backing layer is consist of Ethyl Cellulose. 9Practical problems in developing Bilayer tablets: Practical problems in developing Bilayer tablets What are Fixed Dose Combinations??? 15, 16, 17 10 Maintenance Dose (A) = ( K E × Minimum Effective Concentration ×Vd)/1000 (mg/hr) Where, K E = elimination rate constant Vd = volume of distribution A = 0.693 × b ×h / t ½ Where, b = Immediate release dose h = time for release t ½ = biological half lifePractical problems in developing Bilayer tablets: Practical problems in developing Bilayer tablets Layer-separation Order of layer sequence Layer weight ratio Elastic mismatch of the adjacent Layers Cross contamination between layers. 11REFERENCE: REFERENCE Patel Mehul, et al; Challenges in the formulation of bilayered tablets: a review. IJPRD; Vol. 2; 2010, 30-42. Pharmaceutical Development with Focus on Paediatric formulations. WHO/FIP TRAINING WORKSHOP ; 28 April 2008 – 2 May 2008. Hoffman BB. Catecholamines, sympathomimetics drugs, and adrenergic receptor antagonists. In: Hardman JG, Limbird LE, eds. Goodman and Gilman ’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001:255Y256. Kendall MJ, Maxwell SR, Sandberg A, Westergren G. Controlled release metoprolol. Clinical pharmacokinetic and therapeutic implications. Clin Pharmacokinet. 1991;21:319Y330. Hwang SJ, Park H, Park K. Gastric retentive drug-delivery systems. Crit Rev Ther Drug Carrier Syst. 1998;15:243Y284. 12REFERENCE: REFERENCE J. E. F. Reynolds. Martindale-the extra Pharmacopoeia. Director of the Council of Royal Pharmaceutical Society of Great Britain, 2005, 34: 345. G. K. McEvoy. AHFS Drug Information. Authority of the board of the American Society of the Health-System Pharmacists, 2004, 3055-3058. M. C. Chapel Sky, K. Thompson-culkin, A. K. Miller, et al. Pharmacokinetics of rosiglitazone in patients with varying degrees of renal insuffi ciency. J. Clin. Pharmacol., 2003, 43: 252-259. British Pharmacopoeia 2005 v1983ol-1. P.No:40 & http/www .medindia .net/doctors/drug-information/aceclofenac htm. http://en.wikipedia.org/wiki/Gastric_stasis 13REFERENCE: REFERENCE C. Dollery , Therapeutics Drugs, Churchill Livingstone, New York 1999, pp. c38–c43. N. H. Anaizi and C. Swenson, Instability of captopril solution, Am. J. Hosp. Pharm. 50 (1993) 486–488. B. G. Wells, J. T. DiPiro, T. L. Schwinghammer, and C. W. Hamilton. Pharmacotherapy Handbook, McGraw-Hill, New York, 2006, pp. 535–547. Bhavesh Shiyani , Surendra Gattani and Sanjay Surana . Formulation and Evaluation of Bi-layer Tablet of Metoclopramide Hydrochloride and Ibuprofen, AAPS PharmSciTech , Vol. 9, No. 3, September 2008, 818-827. Deelip Derle , Omkar Joshi, Ashish Pawar , Jatin Patel, Amol Jagadale ; formulation and evaluation of buccoadhesive bi-layer tablet of propranolol hydrochloride. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 1, Issue 1, July-Sep. 2009; 206-212. 14REFERENCE: REFERENCE Gosh R., Modern concept in pharmacology and therapeutics, 24 th edition, Hilton and Co., p 761. Chong H. Choe , Selim S. Bouhaouala , Itzhak Brook, Thomas B. Elliott, Gregory B. Knudson. In Vitro development of resistance to Ofloxacin and doxycycline in Bacillus anthracis sterne , Antimicrobial agents and chemotherapy. June 2000; 44(6): 1766. Cedillo-Ramírez E, Villafuerte -Robles L, Hernandez- leon A Effect of added Pharmatose DCL11 on the sustained-release of metronidazole from Methocel K4M and Carbopol 971P NF floating matrices, Dev Ind Pharm 2001; 31(4): 200-208. http://medical-dictionary.thefreedictionary.com/comorbid http://congestive-heart-failure.emedtv.com/amiloride/side-effects-of-amiloride.html http://blood-pressure.emedtv.com/hydrochlorothiazide/side-effects-of-hydrochlorothiazide.html 15Slide 16: THANK YOU 16 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.