INTRODUCTION:Pharmaceutical products designed for oral delivery and
currently available on the prescription and over the counter markets are mostly the
immediate release type, which are designed for IR of drug for rapid absorption.
Disintegrating agents are substance routinely included in tablet formulation to promote
moisture penetration and dispersion of matrix of dosage form in dissolution fluids1.
The oral route of drug administration is the most popular
and successfully used for conventional delivery of drugs. It offers the advantages of
convenience, ease of administration, greater flexibility in the dosage form design, ease of
production, and low cost. The dosage form available for administrations are solutions,
suspensions, powders, tablet and capsules. The physical state of most of being solids, they
are administered in solid dosage form. The solid dosage forms provide best protection to
drugs against temperature, light, oxygen and stress during transportation AIM OF STUDY:Developing a new formula for the Amlodipine tablet IP 5mg immediate release film
coated tablets, by evaluation of trial formulations and invitro dissolution profile.OBJECTIVE OF STUDY:Carrying out literature survey of the drug molecule.
Formulation of the tablets using different trials.
Analyzing the trial samples.
Optimizing the final formula.SUMMARY AND CONCLUSION:Totally 9 (n=9) formulations were prepared with Amlodipine granules ,prepared separately
in a MCG mixer.
Pre compression parameters like Bulk density , Tapped density ,Angle of repose indicate all
formulation show good flow properties.
Tablets are compressed using CADMACH compression machine and tablets are evaluated
for post compression parameters like Weight variation,Hardness,Friability,Disintegration and
Dissolution parameters.
Formulation F1-F6 does not meet the criteria for hardness and disintegration time due to the
improper mixing of lubricant,disintegrant and binder with dry mixture.
Formulations F7-F9 has shown post compression within specified limits of the innovator.The
release profile of the formulations F7-F9 was compared with innovator and all the formulations
has shown a release of 70-95% and formulation F9(Amlodipine=7mg ,Starch=55mg ,Sodium
starch glycolate=3mg,Magnesium Stearate=3mg,Lactose=26.4mg ,Talc=5mg ,Methyl
paraben=0.5mg ,Propylparaben= 0.1mg ,Coloring material(sunset yellow)= 0.005mg ) has
matched the innovator release profile.F9 has 96.87% Drug release.
The compressed tablets packed in blisters and subjected to stability studies at 400C and 75%
RH samples were analyzed at regular intervals as mentioned in stability protocol,and found that
no significant changes observed in any of the studied parameters during the study period,thus it
could be concluded that formulation F9 said to be stable.
From the study, it may concluded that the Amlodipine IP 5mg film coated tablets can be
prepared as immediate release formulations compared to conventional dosage forms
