.
AIM: To prepare and evaluate immediate release tablet containing
high dose and low dose of API and to study effect on dissolution
rate and content uniformity.a. Tablet of Aspirin of high doseb.
Tablet of Aspirin of low doseFORMULA: ( a) Each tablet contains
Aspirin = 300mg Excipients = q.s.(b) Each tablet contains Aspirin =
25mg Excipients = q.s.Batch size = 50 tabletsPackaging = Aluminium
strip or Polypropylene strip of 10 tabletsFORMULATION:( a) For high
dose drug:INGREDIENTSQUANTITY GIVEN QUANTITY TAKENROLE OF
INGREDIENTS
Aspirin300mg15gAnalgesic
Starch15.8mg0.79gDiluent
Starch pasteq.sq.sBinder
Lactose15.8mg0.79gDiluent
DCP13.8mg0.69gDisintegrant
Talc8mg0.4gLubricant
Mg stearate4mg0.2gGlidant
Aerosil0.148mg.074gGlidant
(b) For low dose drugINGREDIENTSQUANTITY GIVENQUANTITY TAKENROLE
OF INGREDIENTS
Aspirin25mg1.2gAnalgesic
Starch290.8mg14.5gDiluent
Starch pasteq.sq.sBinder
Lactose15.8mg0.79gDiluent
DCP13.8mg0.69gDisintegrant
Talc8mg0.40gLubricant
Mg stearate4mg0.2gGlidant
Aerosil0.148mg0.074gGlidant
PROCEDURE: METHOD OF PREPARATION: All the ingredients were
weighed accurately. Aspirin, starch powder, lactose, DCP, were
taken in mortar nd pestle and grinded together to have uniform
mixing nd obtain fine powder. 10% of starch paste was prepared and
q.s was added to the fine powder to obtain the lump mass. This lump
mass was then passed through 10# sieve to obtain granules and were
allowed to dry in oven at 60C. Granules were then passed through
20# sieve and retained on 40# sieve. Fines obtained were weighed.
15% of fines were added to the dried granules and pack edt in zip
lock bag and punched into tablets using tablet punching machine.
Tablets were then evaluated.
METHOD OF CHARACTERIZTION: Micromeritical Properties of
granules:i. Carrs Indexii. Hausners ratioiii. Angle of repose
Hardness Friability Dissolution study: Weight Variation Assay
procedure: 20 tablets were weighed and powdered. A quantity of
powder was weighed accurately containing about 0.5g of Aspirin and
30 ml of 0.5M NaOH was added. It was boiled gently for 10 mins. The
excess of alkali was cooled and titrated with 0.5M HCl using phenol
red as an indicator. The operation was repeated without the
substance under examination. The difference between the titrations
represents the amount of NaOH required. FACTOR: 1ml of 0.5M NaOH is
equivalent to 0.04504g of Aspirin LIMITS: NLT 95% and NMT 105% of
stated amount of Aspirin should be present.
OBSEVATION TABLE:WEIGHT VARIATION:Sr No.Weight of tablets
AssayBURETTE READINGFOR HIGH DOSEFOR LOW DOSE
BLANK
BACK
DIFFERENCE
Calculation:
1) Dissolution study:For high dose:SR
NOTIMEABSORBANCCONC.(Gm/100ml)CONC.(mg/100ml)CONC.(mg/900ml)%CPR
For low dose:
SR
NOTIMEABSORBANCCONC.(Gm/100ml)CONC.(mg/100ml)CONC.(mg/900ml)%CPR
COMMENT:1. In case of high dose formulation the physicochemical
characteristics of API determines the formulation characteristics.
If API is poorly flowable and poorly wettable it should be made
hydrophilic by wet granulation method. If API is having good flow
and hydrophilicity it can be formulated by direct compression.2.
The formulation containing low dose/ potent API the excipient
determines the formulation characteristics so excipient which
provides good flow and compressibility should be used for
preparation. Incase of low dose formulation the blend uniformity is
very important to ensure content uniformity so geometric mixing is
advisable.3. In present study the effect of dose of API on the key
parameters like content uniformity and dissolution rate is
investigated.4. The observation shows that
AIM:REQUIREMENTS: Antacid marketed preparation, pH strip,
viscometer, slide, coverslip, dropper, microscope.REFERENCE:
MARKETED FORMULATIONS:1. ABIGEL SUSPENSION:Content: Aluminium
Hydroxide - 250mg Magnesium Hydroxide - 250mg Simethicone -
25mgVolume: 170mlPrice: 49.95/-Company Name: Alpic Biotech
2. GELUSIL MPS SUSPENSION:Content: Dimethicone I.P 50mg
Magnesium Hydroxide I.P 250mg Dried Aluminium Hydroxide Gel 250mg
Sorbitol Solution I.P(70%) 1.25gVolume:170 mlCompany Name:
Pfizer
3. ULGEL ORAL SUSPENSION: Content: Magaldrate 400mg Simethicone
20 mg Volume: 170ml Price: 45.50/- Company Name: AlembicPROCEDURE:
All the marketed preparations were collected and evaluated using
different parametersEVALUATION PARAMETERS: Organoleptic
Characteristics Colour Odour Taste/Flavor Particle Size
Distribution Redispersibility Sedimentation Volume Ratio pH value
Viscosity
OBSERVATION TABLE:1. Particle Size Distribution:Calibration
Factor: No. of divisions of stage micrometer= 10(y) No. of
divisions of eye piece micrometer=7.1(x) (y/x)*10= 10/7.1*10 =
14.08m
FORMULATIONRANGEMEAN(d)NO. OF PARTICLES(f)f*d
GELUSIL
TOTAL
ULGEL
TOTAL
Sedimentation Volume Ratio:FORMULATIONTIME(MINS)H0HUSVR
GELUSIL0
10
20
30
40
50
60
ULGEL0
10
20
30
40
50
60
FORMULATIONEVALUATION PARAMETEROBSERVATION
GELUSILColour
Odour
Flavor
pH
viscosity
No.of inversions
ULGELColour
Odour
Flavor
pH
No.of inversions
viscosity
AIM:REQUIREMENTS: pH strip, viscometer, slide, coverslip,
dropper, microscope, Marketed oral emulsions.REFRENCE:
MARKETED FORMULATIONS:1. CREMAFFIN:Content: Milk Of Magnesia:
11.25ml Liquid Paraffin: 3.75ml Volume: 170ml Price: 57/- Company
Name: Abott2. DUALAXIN:Content: Liquid Paraffin: 1.25ml Magnesium
Hydroxide: 3.75/15ml Volume: 200ml Price: 62.3/- Company Name:
Glenmark
3. ACMEFFIN:Content: Liquid Paraffin: 3.75ml Volume: 170ml
Price: 62/- Company Name: AcmePROCEDURE: All the marketed
preparations were collected and evaluated using different
parameters. EVALUATION PARAMETERS: Organoleptic Characteristics
Colour Odour Taste/Flavor Globule size Type of Emulsion Stability
(Cracking, Creaming, Phase inversion) pH value Viscosity Methods
for Determination Of Type Of Emulsion: Dilution Test Dye test
Flouresence Conductivity
OBSERVATION TABLE:
FORMULATION RANGEMEAN (d)NO. OF GLOBULES(f)f*d
CREMAFFIN
TOTAL
DUOLAXIN
TOTAL
FORMULATIONEVALUATION PARAMETERSOBSERVATION
CREMAFFINColour
Odour
Taste/Flavor
Type of emulsion
Viscosity
pH
Stability
DUOLAXINColour
Odour
Taste/Flavor
Type of emulsion
Viscosity
pH
Stability
