BILAYER TABLETS OF DOMPERIDONE 1

Mpharm part-ii plan of work

presented by SUBODH S SATHEESH

2ND MPHARMPHARMACEUTICS

ECPS

Department of pharmaceutics

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FORMULATION AND EVALUATION OF BILAYERED TABLETS OF DOMPERIDONE MALEATE

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Bilayer tabletsConventional dosage formDual releaseCombination therapyDelivers drugs of different release profiles

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AdvantagesExtension of conventional dosage formSeparation of incompatible substances Patient compliancePhysical and chemical stability

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Domperidone maleateIUPAC Name- 5- chloro-1- (1- [3- (2- oxo-2, 3- dihydro-

1H-benzo [d] imidazol- 1-yl) propyl]piperidin- 4- yl)- 1Hbenzo[d]imidazol- 2 (3H) – one

Trade name –motilium, domstalroute – oral, iv, rectalbioavailability –13 to 17%Metabolism – Hepatic and intestinalHalflife 7hrsExcretion - renal

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Dopamine receptor antagonistAntiemeticGastro esophageal reflux diseaseGastroparesisHyper prolactemia and cardiac sideeffectsContraindicated with triazole antifungals and macrolide

antibiotics

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OBJECTIVEDeveloping an ideal drug delivery systemPre compression studiesFormulation of bilayer tabletPost compression studies.

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MaterialsDomperidone maleate - DrugHPMC K4MHPMC K100MCross povidonePVP K30StarchSodium starch glycolateMicro crystalline celluloseMagnesium stearate

INSTRUMENTS USEDUV visible spectrophotometer

FT IR spectrophotometer

USP dissolution apparatus

Tablet punching machine

Disintegration apparatus

Roche fibrilator

Monsanto hardness tester

Weighing balance

Melting point apparatus

Vernier calliper

Hot air oven

Digital pH meter

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MethodPre compression studiesFormulation methodsPost compression studies

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Pre-compression studiesPhysical appearanceBulk densityTapped densityCarr’s indexHausner’s ratioAngle of repose

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Angle of repose25 – 30 Excellent31 – 35 good36 – 40 fair41 – 45 passable46 – 55 poor56 - 65 very poor>66 extremely poor

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Compressibility index5 – 15 % - Excellent16 – 17 % - Good18 – 21% - Fair22 – 35% - Poor36 – 38% - Very poor>40% - Extremely poor

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Hausner’s ratio<1.25 - good flow>1.25 - poor flow1.25 – 1.5 - adding glidants improves flow

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ProcedureWet granulation methodIngredients were passed through sieveMixingDryingLayers prepared separatelyCompression

FORMULATIONS

INGREDIENTS IR1 IR 2 IR 3

Ingredients are measured in mgDomperidone 10 10 10

SSG 1 2 1

MCC 10 20 30

Tartazine yellow 0.2 0.2 0.2

Purified water qs qs qs

Lactose 77.8 66.8 57.8

Magnesium stearate

1 1 1

Wieght of IR layer

100 100 100

FORMULATIONSINGREDIENTS SR1 SR 2 SR 3 SR4 SR5 SR 6 SR7 SR8 SR9

Ingredients are measured in mgDomperidone 20 20 20 20 20 20 20 20 20HPMC K 15 M 44.

862 74 - - - - - -

HPMC K 100 M - - - 10 15 20 - - -

Carbopol 934 P - - - - - - 14 17 20

PVP K 30 4 4 4 4 4 4 4 4 4MCC - 62 49.

8- 40 104 11

037 54

Tartazine yellow 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2

Purified water qs qs qs qs qs qs qs qs qsLactose 79 - - 11

470.8

- - 71 48

Magnesium stearate 2 2 2 2 2 2 2 2 2Wieght of SR layer 15

0150 150 15

0150 150 15

0150

150

Total weight 250

250 250 250

250 250 250

250

250

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Invitro Evaluation StudiesWeight variationHardnessFriabilityTablet thicknessDisintegrationDrug contentDissolutionMicrometric propertiesStability studies

SCHEDULE OF WORKSl.No WORK PROPOSED TIME PERIOD

1 Initial analysis of drug , Jan 4 – 6

2 Preformulation analysis Jan 7 – 11

3 Formulation Jan 12 – 24

4 Invitro evaluation Jan 25 – 31

5 Stabilty studies Feb 1-Apr 30

6 Kinetic studies Feb 1 -3

7 Report preparation and editing From Feb 20

8 Rough copy submission May 2

9 Final submission on college May 10

WRITING SCHEDULESl.No Work proposed Time period

1 Introduction Dec 23-31

2 Review of literature Jan 1-16

3 Materials and methods Jan 19-31

4 Bibiliography Feb 1-13

5 Design and coverpages Feb 15-26

6 Result and discussion Mar 1 –Apr 30

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Sources of informationE-journalsCollege libraryArticlesDisserations (RGUHS,JSS)Literature survey

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BIBILIOGRAPHYDeepika K L, P Sanjeev Kumar P. Design Development And

Evaluation of Domperidone maleate Bilayered Tablets, Intl J Pharma and Pharm Sci. 2013;5(4):701-710p

Arvind M, Ganesh KB, Preethi K. Bilayer tablet Evaluation and Review. Intl J Pharm Res. 2013;3(2):21-30 p

Vinoth kumar M, Krishnarajan D, Parthiban KG. Formulation and Evaluation of bilayer Domperidone floating tablets. Intl J Pharm Sci and R. 2011;2(8):2217-2215p

Bhadange M D, Darekar A B, Saudagar R B. Design and Evaluation of bilayer tablets of Nateglinide. Intl J Pharma Sci Res. 2012; 4(2): 1087-1097 p

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Hemashree K B, Someshwara R, Manjunath K. Formulation and evaluation of sustained release Bilayer tablets of venlafaxine HCL. Intl J Phrama Pharm Res. 2015; 3( 2): 153-168 p

Metkar Vishal, Kumar A, Pant P, Pal Deepti, Sahu S. Formulation development and evaluation of Bilayer tablets of lornoxicam. Intl J Drug Dev Res. 2012; 4(2) : 173-179 p 

Sreekanth G P, Anna Balaji. Design and evaluation of bilayered tablets of Simvastatin. Intl J Phrama Analytical Res. 2014; 3(1): 169-176 p

Preethi karwa, Kasture P V. Formulation and evaluation of Zolpidem tartarate. Intl J Pharm Tech Res. 2012;3(4): 1919-1929 p

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