DESIGN AND EVALUATION OF SUSTAINED RELEASE ENTERIC COATED DOSAGE FORM OF FLUOXETINE HYDROCHLORIDE
Presented By:Sanjay. A1st M pharmDept. of Pharmaceutics J.S.S.C.P,Mysore-15
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.
• 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
MATERIALS USED
•Fluoxetine HCl
•Ethyl cellulose and HPMC K 100M
•Compritol ATO888
•Cellulose acetate phthalate
•Magnesium srearate
•Talc
•Microcrystalline cellulose
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
CHARACTERISATION OF FENUGREEK MUCILAGE
• Swelling index
• Particle size distribution
• Flow property
• pH
• Viscosity
• Microbial count
• Loss on drying
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
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
EVALUATION OF FORMULATION
• Weight variation
• Hardness
• Friability
• Disintegration test
• Drug content
• Invitro release studies
• Comparison of drug release data
• Stability studies
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
DRUG EXCIPIENTS COMPATIBILITY STUDY •Differential scanning calorimetry(DSC):
DSC patterns of pure drug ,polymer and of their physical mixture shown in below fig.
IR spectroscopy •The IR spectra of all sample was showed in
below fig.
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
REFERENCES
•Indian journal of pharmaceutical education and research vol.3