This document discusses the formulation and evaluation of bilayer tablets containing domperidone maleate. Bilayer tablets provide dual drug release and separation of incompatible substances. Domperidone is an antiemetic and used to treat nausea. Various pre-compression studies were conducted on formulations to optimize flow and compressibility. Tablets were developed using wet granulation and contained different polymers for immediate and sustained release layers. Post-compression testing included weight variation, hardness, friability, disintegration and dissolution studies. The project timeline included formulation, evaluation, stability studies and report preparation over 4 months.

1. presented by
SUBODH S SATHEESH
2ND MPHARM
PHARMACEUTICS
ECPS
Department of pharmaceutics
1BILAYER TABLETS OF DOMPERIDONE

2. FORMULATION AND EVALUATION OF
BILAYERED TABLETS OF DOMPERIDONE
MALEATE
BILAYER TABLETS OF DOMPERIDONE 2

3. Bilayer tablets
 Conventional dosage form
 Dual release
 Combination therapy
 Delivers drugs of different release profiles
3BILAYER TABLETS OF DOMPERIDONE

4. Advantages
 Extension of conventional dosage form
 Separation of incompatible substances
 Patient compliance
 Physical and chemical stability
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5. Domperidone maleate
 IUPAC 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, domstal
 route – oral, iv, rectal
 bioavailability –13 to 17%
 Metabolism – Hepatic and intestinal
 Halflife 7hrs
 Excretion - renal
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6.  Dopamine receptor antagonist
 Antiemetic
 Gastro esophageal reflux disease
 Gastroparesis
 Hyper prolactemia and cardiac sideeffects
 Contraindicated with triazole antifungals and macrolide
antibiotics
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7. OBJECTIVE
 Developing an ideal drug delivery system
 Pre compression studies
 Formulation of bilayer tablet
 Post compression studies.
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8. Materials
 Domperidone maleate - Drug
 HPMC K4M
 HPMC K100M
 Cross povidone
 PVP K30
 Starch
 Sodium starch glycolate
 Micro crystalline cellulose
 Magnesium stearate
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9. INSTRUMENTS USED
 UV visible spectrophotometer
 FT IR spectrophotometer
 USP dissolution apparatus
 Tablet punching machine
 Disintegration apparatus
 Roche fibrilator

10.  Monsanto hardness tester
 Weighing balance
 Melting point apparatus
 Vernier calliper
 Hot air oven
 Digital pH meter

11. Method
 Pre compression studies
 Formulation methods
 Post compression studies
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12. Pre-compression studies
 Physical appearance
 Bulk density
 Tapped density
 Carr’s index
 Hausner’s ratio
 Angle of repose
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13. Angle of repose
25 – 30 Excellent
31 – 35 good
36 – 40 fair
41 – 45 passable
46 – 55 poor
56 - 65 very poor
>66 extremely poor
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14. Compressibility index
5 – 15 % - Excellent
16 – 17 % - Good
18 – 21% - Fair
22 – 35% - Poor
36 – 38% - Very poor
>40% - Extremely poor
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15. Hausner’s ratio
<1.25 - good flow
>1.25 - poor flow
1.25 – 1.5 - adding glidants improves flow
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16. Procedure
 Wet granulation method
 Ingredients were passed through sieve
 Mixing
 Drying
 Layers prepared separately
 Compression
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17. FORMULATIONS
INGREDIENTS IR1 IR 2 IR 3
Ingredients are
measured in mg
Domperidone 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 100 100 100

18. FORMULATIONS
INGREDIENTS SR1 SR 2 SR 3 SR4 SR5 SR 6 SR7 SR8 SR9
Ingredients are measured in mg
Domperidone 20 20 20 20 20 20 20 20 20
HPMC K 15 M 44.8 62 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 4
MCC - 62 49.8 - 40 104 110 37 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 qs
Lactose 79 - - 114 70.8 - - 71 48
Magnesium stearate 2 2 2 2 2 2 2 2 2

19. Invitro Evaluation Studies
 Weight variation
 Hardness
 Friability
 Tablet thickness
 Disintegration
 Drug content
 Dissolution
 Micrometric properties
 Stability studies
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20. SCHEDULE OF WORK
Sl.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

21. WRITING SCHEDULE
Sl.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

22. Sources of information
 E-journals
 College library
 Articles
 Disserations (RGUHS,JSS)
 Literature survey
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23. BIBILIOGRAPHY
 Deepika 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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24.  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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