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Published on March 13, 2014

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PowerPoint Presentation: R & D “EFFECT OF CONCENTRATION OF MAGNESIUM STEARATE AND VENDORS ON FORMULATION OF TABLET FLECAINIDE ACETATE 100 mg Ph.Eur ” PRESENTED BY: PRASANDEEP BISWAL M.PHARM-2 nd Year PHARMACEUTICS REGD.NO-1161651012 Under the Joint Guidance Of Dr.Snigdha Pattnaik Mr. Ashok b Cheware Associate Professor General Manager Dept.of Pharmaceutics (R&D) SCHOOL OF PHARMACEUTICAL SCIENCES CIRON DRUGS PVT.LTD S ‘O’ A UNIVERSITY MUMBAI. c ciron PROGRESS SEMINAR ON PowerPoint Presentation: A tablet is a mixture of active substances and excipients, usually in powder form,then pressed or compacted into a solid. There are 3 interrelated groups of tablet excipients anti-adherants , glidants and lubricants to ensure efficient tableting; these are used to promote granule flow, powder adheshion to punch faces and minimize die wall friction . However a lubricant may be defined as a suitable material interposed between 2 rubbing surface will reduce friction arising at the interface. An ideal lubricant should reduce friction effectively with no adverse effects upon formulation. It should be inert and acceptable with respect to other dosage form ingredients. The ideal lubricant should be unaffected by changes in process variables consistent from batch to batch, readily available and cheap. INTRODUCTION PowerPoint Presentation: Aim: The aim of present work is to determine the optimum concentration of magnesium stearate and to sketch out the effect of concentration of magnesium stearate and with different vendor in the formulation of Flecainide acetate 100mg Ph.Eur. To find out the optimum concentration of magnesium stearate and it’s effect on physicochemical parameters and in-vitro drug release. To study changes occurs by vendor having different specific surface area. AIM & OBJECTIVE OBJECTIVE PowerPoint Presentation: PLAN OF WORK Plan of Work Literature Survey Analysis of Innovator Sample Formulation of Tablets Comparison with Innovator Stability Study Worst Case Study Preformulation Study Compatibility Study API Characterization Evaluation of Tablet Precompression Parameters Post compression Parameters PowerPoint Presentation: Molecule Dosage Form Pharmacopoeia flecainide API PH.EUR Flecainide acetate Tablet Tablets PH.EUR Pharmacopoeial Status : FLECAINIDE ACETATE TABLETS Molecule Category Strength Flecainide acetate Tablet Antiarrhythmic Drug 100mg PowerPoint Presentation: Parameters API Characterization Molecular Structure CAS No 54143-56-5 Molecular Formula C 17 H 20 F 6 N 2 O 3 •C 2 H 4 O 2 Chemical Name N-(2-Piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy) benzamide monoacetate Molecular Weigh 414.3427 Description white hygroscopic crystalline powder Crystallinity Crystalline Solubility Soluble in water and in anhydrous ethanol. Freely soluble in dilute acetic acid. Melting Point 148 degree C Bulk/Tapped Density 0.425g/ml / 0.555g/ml Carr’s Index 23.33% FLECAINIDE ACETATE TABLETS PowerPoint Presentation: FLECAINIDE ACETATE TABLETS Innovator Characterization Mechanism Of Action: Flecainide works by blocking the sodium channel in the heart, causing prolongation of the cardiac action potential . This thereby slows conduction of the electrical impulse within the heart. The greatest effect is on the His-Purkinje system and ventricular myocardium . The effect of flecainide on the ventricular myocardium causes decreased contractility of the muscle, which leads to a decrease in the ejection fraction. The effect of flecainide on the sodium channels of the heart increases as the heart rate increases.This is known as use-dependence. This means that flecainide is potentially more useful to break a tachyarrhythmia (because it has increased effect during the fast heart rate) than to prevent a bradyarrhythmia from occurring (because of its lowered effectiveness during slower heart rates). Pack size : For US : Bottle of 60 tablets For Europe: Tablets are packaged in opaque pvc/aluminium blister cards. Each package contains 56 tablets (4 blister cards of 14 tablets each). PowerPoint Presentation: Pharmacokinetics Parameters SI.NO PARAMETERS 1 T max 1 – 6 Hours 2 C max 173 ± 72 mg/ml 3 Elimination half-life 12 Hour ( 12 – 16 hours) 4 Absorption Approximately 90% (throughout GIT) 5 Absolute Bio availability Approximately 85%-90%. 6 Volume of Distribution 3.4 L/Kg 7 Pka 9.3 8 LogP 4.6 9 Plasma protein binding 40% albumin 10 Metabolism liver 11 Route of excretion Urine FLECAINIDE ACETATE TABLETS Conclusion: Based on the solubility and absorption data it can be concluded that flecainide is Class Ic drug PowerPoint Presentation: INNOVATOR DETAILS Parameters Innovator Tablets Brand Name Tambocor Strengths 100mg Lot. No. 8051594 Description White colored tablet with “cc” on one side and “1” and ”2” separated with a deep score line on other side. Composition Flecainide acetate , anhydrous , Micro crystalline cellulose , Colloidal silica, anhydrous , Magnesium stearate , Croscarmellose sodium . Label claim Each film coated tablet contains Flecainide acetate USP -----100mg Avg. weight 260mg  3% Thickness 4.4mm ±0 .5mm diameter 8.5mm Hardness 4-9kg Disintegration time 30sec LOD Not more than 3.0%w/w PowerPoint Presentation: PREFORMULATION STUDY Sr. No Name of the Excipient Ratio API: Expt Initial Observation Final observation Conclusion 40°C/75% RH 2 nd week 4 th week 1 API - 1 --- White White White Compatible 2 API + Lactose monohydrates 1 : 2 White White White Compatible 3 API + Croscaramellose sodium 1 : 1 White White White Compatible 4 API + Kollidon 30 1 : 1 Off white Off white Off white Compatible 5 API +Aerosil 1 : 0.5 White White White Compatible 6 API + Mg. Stearate 1 : 0.05 White White White Compatible Pre-formulation studies on (API) & (Excipients), and their combinations were carried out : PURPOSE OF PREFORMULATION STUDY : To Finalize specifications of active pharmaceutical ingredients (API). To Study the compatibility between active and inactive ingredient (excipients). And To Characterizing the reference product. PowerPoint Presentation: FORMULATION OF fecainide acetate TABLETS Formulation of 9 batches taken: Plan of trails: Totally 9 trails are taken of which 3 different concentrations of magnesium stearate are used procured from 3 different vendors (brand’s).   Trail’s T1, T2, T3 are performed by using 0.5%, 0.8%, 1.25% of magnesium stearate respectively procured from NITIKA chemicals. Trail’s T4, T5, T6 are performed by using 0.5%, 0.8%, 1.25% of magnesium stearate respectively procured from PETERGEVEN’S chemicals. Trail’s T7, T8, T9 are performed by using 0.5%, 0.8%, 1.25% of magnesium stearate respectively procured from FERRO chemicals. API was compensated according to the assay (% Purity of API) Change in API was compensated with MCC PH101. Calculation of required quantity of API equivalent to 100mg = [ 100 × (100 / % w/w assay on dried basis) × 100/(100 - LOD) ] PowerPoint Presentation: BATCH CALCULATION OF T1 , T2 , AND T3   T1 ( 0.5% nitika’s ) ( Kg) T2 ( 0.8% nitika’s ) ( Kg) T3 ( 1.25% nitika’s ) ( Kg) Intra granular       Flecainide acetate 0.1174 0.1174 0.1174 Lactose monohydrates 0.11184 0.11104 0.10950 Croscarmellose sodium ( Ac-di-sol) 0.009 0.009 0.009 Pregelatinized starch ( starch 1500) 0.0069 0.0069 0.0069 Binder solution:       Purified water (65% fluid uptake) 0.159 0.1588 0.158 Extra granular :       Microcrystalline cellulose ( Avicel ph 101) 0.0346 0.0346 0.0346 Croscarmellose sodium ( Ac-di-sol) 0.0069 0.0069 0.0069 Pregelatinized starch (starch 1500) 0.0069 0.0069 0.0069 Hydrogenated vegetable oil (Lubri tab) 0.0046 0.0046 0.0046 Magnesium stearate 0.0015 0.0023 0.00375 Total batch size 0.3 kg 0.3 kg 0.3 kg PowerPoint Presentation: BATCH CALCULATION OF T4 , T5 , AND T6   T4 (0.5%Petergreven’s) (Kg) T5 (0.8% Petergreven’s ) (Kg) T6 (1.25% Petergreven’s ) (Kg) Intra granular :       Flecainide acetate 0.1174 0.1174 0.1174 Lactose monohydrates 0.11184 0.11104 0.10950 Croscarmellose sodium ( Ac-di-sol) 0.009 0.009 0.009 Pregelatinized starch ( starch 1500) 0.0069 0.0069 0.0069 Binder solution :       Purified water (65% fluid uptake) 0.16 0.1588 0.158 Extra granular :       Microcrystalline cellulose ( Avicel ph 101) 0.0346 0.0346 0.0346 Croscarmellose sodium ( Ac-di-sol) 0.0069 0.0069 0.0069 Pregelatinized starch ( starch 1500) 0.0069 0.0069 0.0069 Hydrogenated vegetable oil (Lubri tab) 0.0046 0.0046 0.0046 Magnesium stearate 0.0015 0.0023 0.00375 Total batch size 0.3 kg 0.3 kg 0.3 kg PowerPoint Presentation:   T7 (0.5% Ferro) T8 (0.8% Ferro) T9 (1.25% Ferro) Intra granular       Flecainide acetate 0.1174 0.1174 0.1174 Lactose monohydrates 0.11184 0.11104 0.10950 Croscarmellose sodium(Ac-di-sol) 0.009 0.009 0.009 Pregelatinized starch (starch 1500) 0.0069 0.0069 0.0069 Binder solution:       Purified water (65% fluid uptake) 0.16 0.1588 0.158 Extra granular:       Microcrystalline cellulose (Avicel ph 101) 0.0346 0.0346 0.0346 Croscarmellose sodium(Ac-di-sol) 0.0069 0.0069 0.0069 Pregelatinized starch (starch 1500) 0.0069 0.0069 0.0069 Hydrogenated vegetable oil (Lubri tab) 0.0046 0.0046 0.0046 Magnesium stearate 0.0015 0.0023 0.00375 Total batch size 0.3 kg 0.3 kg 0.3 kg BATCH CALCULATIONS OF T7, T8 AND T9 : PowerPoint Presentation:   7R 1   7R 2   7R 3   Intra granular       Flecainide acetate 0.1174 0.1174 0.1174 Lactose monohydrates 0.11184 0.11184 0.11184 Croscarmellose sodium(Ac-di-sol) 0.009 0.009 0.009 Pregelatinized starch (starch 1500) 0.0069 0.0069 0.0069 Binder solution:       Purified water (65% fluid uptake) 0.16 0.16 0.16 Extra granular:       Microcrystalline cellulose (Avicel ph 101) 0.0346 0.0346 0.0346 Croscarmellose sodium(Ac-di-sol) 0.0069 0.0069 0.0069 Pregelatinized starch (starch 1500) 0.0069 0.0069 0.0069 Hydrogenated vegetable oil (Lubri tab) 0.0046 0.0046 0.0046 Magnesium stearate 0.0015 0.0015 0.0015 Formula recommended for reproducibility batches R 1, R 2, R 3 : PowerPoint Presentation: Sifting of lactose monohydrate (Pharmatose-200) & cros caramellose sodium through 30# Dry mixing Wet granulation using Povidone (kollidone-30) & water as binder solution Drying in tray drier until LOD reaches less than 2% w/w Milling the Granules Prelubrication Blend by adding cros caramellose sodium Lubrication By adding Magnesium stearate Process Flow Chart of experiment Dispensing of all Actives & Inactive Compression Evaluation & packaging (HDPE Container ) PowerPoint Presentation: Material Mesh Size Flecainide acetate # 20 (ASTM 850 µ ) MCC Ph101 # 20 (ASTM 850 µ ) Croscarmellose sodium # 20 (ASTM 850 µ ) Pregelatinized starch # 20 (ASTM 850 µ ) ( Same process was applied for all the 9 trails batches.Manufacturing Process for Flecainide acetate immediate release ta blet.) Weighing: Equipment: Weighing Balance Weigh all the ingredients . Sifting : - Equipment: Sifter attached with S. S. Sieve Sifting of all intra granular portion Manufacturing Process Table No.15: Mesh used in Sifting PowerPoint Presentation: Dry Mixing : - Equipment: RMG Add required quantity of Flecainide acetate, MCC Ph101, Croscarmellose sodium, Pregelatinized and mix for 10 min . Granulation : - Equipment: RMG Add required quantity of purified water to the contents and mix wet mass kneading for 3-4 min. until granules are formed. The amount of water used is noted. Drying : - Equipment: Tray dryer Process parameters are as follows:- Inlet Air Temperature: 55 ±5 º C Product Bed Temperature: 43ºC – 46ºC Outlet Temperature: 47ºC – 50ºC Dry the wet mass in Tray dryer at 55 ±5 0 C inlet temp. for 30 minutes or till the Loss On drying is NMT 3.0-5.0%. Sizing of dried granules : - Equipment: Sifter attached with S. S. Sieve, quadro co mill Set the Sifter with 25 # mesh size, Sift the dried granules through it & pass oversize granules through 813R screen on quadro co mill.. Sifting & Blending (pre-lubrication):- Sifting Equipment: Sifter attached with S. S. Sieve First Sift MCC Ph102, extra granular part of Croscarmellose sodium, Pregelatinized starch are sifted separately using a sifter fitted with sieves( mesh size #20). Blending Equipment: Octagonal blender Mix MCC Ph102, Croscarmellosesodium, Pregelatinizedstarch with the dried granules of stage (VI) for 10 minutes . PowerPoint Presentation: Lubrication:- Blending Equipment: Octagonal blender Add the Magnesium Stearate and Lubritab to the blend and continue blending for another 5 mins . Later, sample was taken and blend uniformity was performed.   Tablet Compression: Compression of tablets is done in the Multiple Rotary Compression machine using 8.5mm round concave shape punch embossed with “cc” on lower punch and “1” and ”2” separated by deep score line on upper punch. Temperature and Humidity is maintained within the limits of: 25  2  C and humidity at 55  5%Rh. Load Flecainide acetate final blend and set a weight of 260 mg fill weight and compress the tablets at an average weight of 260 mg per tablet. PowerPoint Presentation: S.NO B.D T.D C.I H.R Angle of repose(θ) Trail 1 0.470 0.606 22.44 1.28 32.01 Trail 2 0.444 0.571 22.241 1.286 32.0 Trail 3 0.483 0.600 19.50 1.242 34.00 Trail 4 0.483 0.625 22.72 1.293 34.21 Trail 5 0.444 0.555 20.00 1.25 29.34 Trail 6 0.441 0.555 20.54 1.258 30.00 Trail 7 0.4255 0.555 23.33 1.304 29.52 Trail 8 0.492 0.614 19.86 1.2479 29.88 Trail 9 0.428 0.517 17.21 1.207 36.01 Reproducibility batch’s : R-1 0.4255 0.555 23.33 1.304 29.52 R-2 0.492 0.614 19.86 1.2479 29.88 R-3 0.44 0.571 22.94 1.29 28.65 Particle size distribution (psi) : lubricated blend ready for compression: PowerPoint Presentation:   Average weight (mg) Thickness (range in mm) Hardness (Range in kp) Friability (%) D.T (seconds) Limits 252.2-267.8mg 4.4 ±0 .5mm 4-9 kp NMT 1% NMT 15min Trail 1 259.45 4.43-4.56 7.1-8.4 0.17 30 Trail 2 260.01 4.61-4.64 6.3-7.8 0.11 34 Trail 3 261.05 4.61-4.66 6.2-6.9 0.15 36 Trail 4 261.45 4.65-4.70 6.8-7.4 0.13 19 Trail 5 262.6 4.68-4.70 6.8-7.1 0.15 26 Trail 6 259.45 4.62-4.67 6.7-7.2 0.24 25 Trail 7 258.15 4.62-4.74 6.6-7.3 0.24 16 Trail 8 259.78 4.57-4.68 6.2-6.5 0.17 17 Trail 9 259.75 4.71-4.73 6.7-7.3 0.21 24 R-1 259.2 4.60-4.72 6.7-7.5 0.22 15 R-2 261.1 4.60-4.77 6.3-7.7 0.23 16 R-3 260.02 4.56-4.71 6.1-7.8 0.22 16 Physical parameters of TABLET : Average weights, thickness, hardness, friability of tablets of all the 9 trails are noted and listed below. PowerPoint Presentation: Dissolution medium 0.1M HCL Dissolution medium volume 900ml Apparatus USP - 2 (paddle) Speed 100 rpm Temperature 37 o± C Sampling time interval 0,5,10,15,30,45,60 min Dissolution parameters PowerPoint Presentation: Trail’s % Cumulative Drug Released 5 min 10min 15min 30min 45 min 60min Trail 1 90.2 90.6 93.2 93.6 93.8 95.9 Trail 2 90.1 90.50 90.7 91.8 92.6 93.0 Trail 3 87.3 87.8 88.0 88.8 90.8 92.9 Trail 4 89.8 90 92.4 93.9 93.9 95 Trail 5 87.5 91.6 92.9 93.7 94.5 95.5 Trail 6 87.9 90.4 92.1 92.4 92.7 92.8 Trail 7 94.9 95.4 96.3 96.5 96.9 97.5 Trail 8 93 95 96 96 96 97 Trail 9 91 93.8 93.9 94.2 94.2 94.4 R-1 94.4 94.9 95.6 96.1 96.6 97.7 R-2 94.9 95.4 96.3 96.5 96.9 97.5 R-3 94.6 95.5 95.9 96.9 97.5 97.9 In vitro dissolution studies : PowerPoint Presentation: comparative representation of in-vitro drug release for 9 trails, 3 Reproducibility batches : WORK LEFT :: WORK LEFT : ASSAY STABILITY STUDY PowerPoint Presentation: Lachman , L.Liberman . H.A and Kanlg J.L. “The Theory and practice of Industrial pharmacy” Third Edition, vargese Publication Houx Bombay 1987, 293-342. Pahkh Dilip M. “Hand book of Pharmaceutical Granulation Technology” second Edition. Taular and francis London, 247 to 330. Birknire , “In Process Practicle Sizing PAT Technique to study Top and Bottom Spray fluid Bed Granulation Process. American Association of pharmaceutical Scientists Presented, November 10, 2005 www.mt.com/formulating . Rubart M, Zipes DP. Genesis of cardiac arrhythmias, electrophysiologic considerations. In: Bonow RO, Mann DL, Zipes DP, Libby P, eds. Braunwald’s heart disease: a text book of cardiovascular medicine . 9 th ed. Philadelphia, Pa: Saunders Elsevier:2011:chapter 35. John M.hudak , Elden H. Banitt , Jack R. Schmid “ Drug development and history ” the American journal of cardiology volume 53, issue 5 : 27 February 1984, Pages B17–B20. http://www.drugs.com/cdi/flecainide.html#MIOX7WDxw8ws6Qiy.99 http://www.drugbank.ca/drugs/DB01195 . Hand book of excipients ; 2006: 5: 132-135, 211-213, 430-433,731-733, 800-801. References : PowerPoint Presentation: 

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