This document discusses the design and evaluation of an enteric coated sustained release tablet formulation of fluoxetine hydrochloride using fenugreek mucilage and HPMC K100M polymers. It introduces fluoxetine HCl as a drug requiring long term treatment for psychiatric disorders. The objective was to develop a once-daily tablet using a polymer matrix system. Materials used include fluoxetine, polymers, excipients and coatings. Characterization of the fenugreek mucilage extract is described. Tablets were prepared by direct compression and evaluated for properties like drug release, stability and compatibility studies. The results showed that a combination of fenugreek mucilage and HPMC K100M could achieve drug release over 24 hours, indicating its potential

1. DESIGN AND EVALUATION OF SUSTAINED
RELEASE ENTERIC COATED DOSAGE FORM OF
FLUOXETINE HYDROCHLORIDE
Presented By:
Sanjay. A
1st M pharm
Dept. of Pharmaceutics
J.S.S.C.P,Mysore-15

2. INTRODUCTION
• Successful pharmacotherapy depends on many factors, some of
them are Efficacy, availability of optimal dosage and delivery
system, treatment compliances and reduction of side effects.
• The treatment of Psychiatric illness frequently requires long term
therapy.
• Fluoxetine Hcl is selective serotonin reuptake inhibitor(SSRI) used
in divided daily doses(20mg) every 2 to 3 times for the treatment of
many mental disorders, which requires long term treatment.
• Increased need of patient compliance and demand for improved
therapeutic efficacy of drug it necessitates sustained release drug
delivery system with reduced dose.

3. • The most convenient way to achieve sustained release of
active agent involves physical blending of drug with polymer
matrix, followed by direct compression,
• Different polymers used are HPMC, ethylcellulose and
fenugreek mucilage etc. were tried control drug release up to
24hrs
• In the present study, it was attempted to develop sustained
release enteric coated tablet of fluoxetine HCl to be taken
once a day using combination of fenugreek mucilage and
HPMC K 100M and elucidate it

4. MATERIALS USED
• Fluoxetine HCl
• Ethyl cellulose and HPMC K 100M
• Compritol ATO888
• Cellulose acetate phthalate
• Magnesium srearate
• Talc
• Microcrystalline cellulose

5. The supernatant was separated and concentrated 60*C and it is cooled and
washed with acetone
The upper layer was decanted and centrifuged at 500rpm for 20min
The solution was cooled in refrigerator overnight to settle out undissolved
material
Fenugreek seeds(200g) were soaked in 1.5L of distilled water at room
temperature for 1hr and boiled in water bath to get slurry
EXTRACTION OF FENUGREEK MUCILAGE

6. CHARACTERISATION OF FENUGREEK
MUCILAGE
• Swelling index
• Particle size distribution
• Flow property
• pH
• Viscosity
• Microbial count
• Loss on drying

7. DRUG EXCIPIENTS COMPATABILITY
STUDIES
IR spectroscopyof drug and polymer :
It was conducted using a IR spectrophotometer and
spectrum was recorded in wave lenth region of 4000 –
400 1/cm
Differential scanning colorimetry (DSC) :
DSC was performed using DSC-60 calorimeter to study the
thermal behaviour of Fluoxetine HCl

8. FORMULATION OF TABLETS
• By direct compression method
• All ingredients weighed passed through 100no.
Mesh individually
• Punched by adding talc and Mg Stereate
• The weight of the tablet was 500mg

10. EVALUATION OF FORMULATION
• Weight variation
• Hardness
• Friability
• Disintegration test
• Drug content
• Invitro release studies
• Comparison of drug release data
• Stability studies

11. RESULTS AND DISCUSSION
• Phytochemical, microbial and physicochemical characterization
of fenugreek mucilage:
Dried mucilage was studied for percentage yield, chemical test, particle
size, weight loss on drying, viscosity, pH angle of repose etc

12. DRUG EXCIPIENTS COMPATIBILITY STUDY
• Differential scanning calorimetry(DSC):
DSC patterns of pure drug ,polymer and of their
physical mixture shown in below fig.

13. IR spectroscopy
• The IR spectra of all sample was showed in below
fig.

15. CONCLUSION
• In this study, an attempt was made to develop
sustained release enteric coated tablet of
fluoxetine HCl. Amongst the polymer tested,
fenugreek mucilage and HPMC K M combination
could retard up to 24hr was selected for the
development of formula

16. REFERENCES
• Indian journal of pharmaceutical education and
research vol.3