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
5BILAYER TABLETS OF DOMPERIDONE
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.
BILAYER TABLETS OF DOMPERIDONE 7
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
11BILAYER TABLETS OF DOMPERIDONE
12. Pre-compression studies
Physical appearance
Bulk density
Tapped density
Carr’s index
Hausner’s ratio
Angle of repose
12BILAYER TABLETS OF DOMPERIDONE
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
BILAYER TABLETS OF DOMPERIDONE 13
14. Compressibility index
5 – 15 % - Excellent
16 – 17 % - Good
18 – 21% - Fair
22 – 35% - Poor
36 – 38% - Very poor
>40% - Extremely poor
BILAYER TABLETS OF DOMPERIDONE 14
15. Hausner’s ratio
<1.25 - good flow
>1.25 - poor flow
1.25 – 1.5 - adding glidants improves flow
BILAYER TABLETS OF DOMPERIDONE 15
16. Procedure
Wet granulation method
Ingredients were passed through sieve
Mixing
Drying
Layers prepared separately
Compression
16BILAYER TABLETS OF DOMPERIDONE
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
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
22BILAYER TABLETS OF DOMPERIDONE
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
BILAYER TABLETS OF DOMPERIDONE 23
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
BILAYER TABLETS OF DOMPERIDONE 24