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