Bilayer tablets are multilayered tablets used in controlled drug delivery

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
4BILAYER TABLETS OF DOMPERIDONE

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
6BILAYER TABLETS OF DOMPERIDONE

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
8BILAYER TABLETS OF DOMPERIDONE

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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