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PHARM SEM- 2 To Department of pharmaceutics I.B.S.S.college of pharmacy Malkapur 2011-2011 2 Formulation and Evaluation of Bi-layer tablet Content : Introduction Advantage Limitation Diff.types of Bilayer tablet Reason of selecting the bilayer Practical Problem at the time of formulation Quality and GMP Objective Plan of work Reference Content 3 Slide 4: 4 Introduction : Bilayer tableting 5 Introduction + 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 : Release of both drugs starts immediately Combination of incompatible drugs2 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 6 Advantages Advantages : 7 Advantages Reduce the side effects Reduced by using one drug of the combination for this purpose2. Amiloride may prevent hypokalemia caused by hydrochlorthiazide19, 20 Elegance to the product Advantages : 8 Advantages Co-morbid Conditions means pertaining to a disease or other pathological process that occurs simultaneously with another18. 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 combination Slide 9: 9 Limitations of Bilayer tablet : Capping Hardness problem Layer Separation Slide 10: 10 Steps of compression of bi-layer tablet : 1. Filling of first layer. 2. Compression of first layer. 3. Ejection of upper punch. 4. Filling of second layer. 5. Compression of both layer together. 6. Ejection of bi-layer tablet Slide 11: 11 Bilayer tablet approach : Two drugs in same tablet with different layers. One is immediate release and other is sustained release layer. Tablet having sustained release layer and floating layer. 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) 12 Ideal candidate of bilayer tablets DIFFERENT TYPES : Bilayer modified release tablet Example: Aceclofenac9 : NSAIDS, COX-2 inhibitor; t/2 = 3-4 hrs Metoclopramide HCL + Ibuprofen13, 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 stasis10 especially in migraine. 13 DIFFERENT TYPES DIFFERENT TYPES : Bilayer floating tablet Example: Rosiglitazone maleate6,7,8 Oral anti-diabetic; t/2 = 3-4 hrs; its solubility is decreased by increasing pH. Metoprolol Tartrate3,4,5 Β1-selective adrenergic blocker; t/2 = 3-4 hrs; it degraded in colon Captopril11,12 ACE inhibitor; 37.5 – 75 mg dose is required in three times; most stable at 1.2 pH. 14 DIFFERENT 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. 15 DIFFERENT TYPES Slide 16: 16 Reasons for selecting bilayer tablet by pharmaceutical companies Several pharmaceutical Companies are currently developing multiple layered tablets containing two or more active pharmaceutical materials (or combination therapy) for variety of reasons including: To get synergistic effects To inhibit drug interaction Drug incompatibility Patent extension Slide 17: 17 Therapeutic justification To reduce capital investment To get sustained release tablets preparation in combination, in which generally one layer is in immediate release form and second layer may be extended release form. 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. 18 Practical problems in developing Bilayer tablets Slide 19: 19 Bi-layer tablets : Quality and GMP-requirements Preventing capping and separation of the two individual layers that Constitute the bi-layer tablet Providing sufficient tablet hardness, High yield Preventing cross-contamination between the two layers Producing a clear visual separation between the two layers Accurate and individual weight control of the two layers AIM : To formulate and evaluate the bilayer tablet To improve the patient compliance towards the therapy. To minimize the pill burden of the patient AIM 20 Objective of present study : The main objective of present work is to formulate safe, convenience Dosage form which prevent interfere in release profile of both drug with each other. It is great advantageous to both patient and clinician that medication to be formulated so that it may be administered as a single tablet in once a day. Improve the patient compliance towards the therapy Formulation and evaluation of bilayer floating tablets by using optimized immediate and floating sustained release layer. Objective of present study 21 Plan of work : 1. Literature Survey for Review and Research Articles. 2. Experimental Work A.Preformulation Studies i.Organoleptic characteristics ii.Bulk density iii.Tapped density iv.Carr’s Index (Compressibility Index) and Hausner’s Ratio v.Drug Excipients compatibility study B. Formulation and development of Bilayer Tablet C. Formula Optimization for bilayer Tablets Plan of work 22 Slide 23: 23 D. Evaluation of Developed Bilayer Tablet i. Assay ii. Thickness iii. Hardness iv. Friability v. Dissolution profiles vi. Stability of drug Tablets. 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. 24 REFERENCE 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 25 REFERENCE 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. 26 REFERENCE Slide 27: 27 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.