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ROSUVASTATIN CALCIUM PPT
1. COMPARATIVE EVALUATION OF VARIOUS
SOLUBILITY IMPROVEMENT TECHNIQUES
TO ENHANCE THE DISSOLUTION
PROPERTIES OF ROSUVASTATIN CALCIUM
2. INTRODUCTION
• THE ORAL ROUTE IS MOST COMMON AND
PREFFERED ROUTE FOR DRUG DELIVERY SYSTEM
• PATIENT COMPLIANCE AND DRUG TREATMENTIS
MORE EFFECTIVE WITH ORAL ADMINISTRATION
THAN OTHER ROUTES OF ADMINISTRATION
• ORAL DRUG ABSORPTION FROM SOLID DOSAGE
FORMS DEPENDS ON THE RELEASE OF DRUG
SUBSTANCE FROM THE DELIVERY SYSTEM
3. PURPOSE OF STUDY
• OBJECTIVES:
• TO ENHANCE THE AQUEOUS SOLUBILITY OF
ROSUVASTATIN BY SUITABLE SOLID
DISPERSION TECHNIQUE
• TO DEVELOP ANALYTICAL PROFILE OF
ROSUVASTATIN
• TO CARRY OUT FOLLOWING EVALUATION
PARAMETERS
6. • CHEMICAL NAME:
• (3R,5S,6E)-7-(4-(4-FIUOROPHENYL)-2-(N-
METHYLMETHANESULFONAMIDO)-6-(PROPAN-2-
YL)PYRIMIDIN-5-YL)-3,5-DIHYDROXYHEPT-6-ENOIC ACID
• MOLECULAR FORMULA: C22H28FN3O6S
• MOLECULAR WEIGHT: 481.539gm/mol
• CATEGORY:THE PRIMARY USES OF ROSUVASTATIN
IS FOR THE TREATMENT OF DYSLIPIDEMIA,HMG-CoA
REDUCTSE INHIBITORS
• APPEARANCE: WHITE POWDER
• MELTING POINT:208-209c
7. SOLUBILITY: IT IS INSOLUBLE IN WATER AND
ALCOHOLS,BUT SOLUBLE IN 0.1NNaOH.IT IS FREELY
SOLUBLE IN DIMETHYLFORMAMIDE
Pka:5.9
HALF LIFE:2 to 5 hours
Protein binding: 98-99% primarily to albumin
METABOLISM:Hepatic hydroxylation
ELIMINATION:Renal and fecal
MECHANISM OF ACTION:Rosuvastatin is acompetitive
inhibitor of the enzyme HMG-CoA reductase having a
mechanism of action similar to that of other statins.
SIDEEFFECTS:Nausea,vomiting,constipation,erythema,urtica
ria,leucopenia,etc….
8. METHODOLOGY
• PRE FORMULATION STUDIES:Pre formulations
involves the applications of bio pharmaceutical
principles to the physiochemical parameters of
drug substance are characterized with the goal of
designing optimum drug delivery system
• FORMULATION DEVELOPMENT:Solid dispersions
were prerared by solvent evoporation
method.methonol was used as
solvent.Rosuvastatin dose was taken as
80mg.water soluble polymers such as PEG 4000
and PEG6000
12. FLOW PROPERTIES&CORRESPONDING
ANGLE OF REPOSE
FLOW PROPERTY ANGLE OF REPOSE
EXCELLENT 25-30
GOOD 31-35
FAIR-AID NOT NEEDED 36-40
PASSABLE-MAY HANG UP 41-45
POOR-MUST AGITATE,VIBRATE 46-55
VERY POOR 56-65
VERY,VERY POOR >66
17. RESULTS&CONCLUSION
• A mong the all the formulations F1 formulation containing drug and
PEG4000 in the ratio of 1:0.25 showed good results that is 94.95%in 50
minutes
• As the concentration of polymer increase the drug release was decreased.
• While the formulations containing PEG6000 showed less release
• Data it was evident that F1 formulation is the better formulation.
• The combination of PEG 4000 & PEG6000 was also not producing desired
percentage drug release.
• The formation is following zero order release kinetics