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2. REFERENCES:
1. www.Aaps.pharm sci,2003,5(1),article 7
2. Multiple emulsion :Technology & application by Abraham Aserin.
3. www.wikipedia.com
4. Remington:the science & practice of pharmacy volume-1 ;326
5. Pak.J.pharm sci,vol 21,no.4 october 2008,pp 430-437
6. Bull chem..soc. ethiop .2010,24(1)1-10
3. MATERIALS:
4. THEORY
Introduction
and improving the solubility and dissolution rate of poorly soluble drug.
1. Type of emulsions.
2. Microscopic Test.
3. Globule size.
4. pH determination.
5. stabilityof multiple emulsion.
6 Centrifuge tests.
7. Electrical conductivity tests.
6. DRUG PROFILE
PARAMETER VALUE
dose 600mg
category Anti inflammatory,rubefacient,keratolytic
BCS classification Class I
Poorly soluble in water 0.2 g/100 mL H2O (20 °C),
solubility
Chloroform 0.19 M, ethanol 1.84 M, methanol 2.65 M .
Ionization constant 2.97 at 25Ċ
After oral administration 80-100% will be absorbed in
bioavailability
stomach and in the small intestine
Steady state conc.
Half life 2-4.5 hrs
Protein binding 50-80%
metabolism Salicylic acid is metabolized 80% in liver
excreted mainly by the kidney as salicylic acid, salicyluric
Renal excretion acid, salicylic glucuronides and gentisic acid.
Tmax 2hr
CmaX 1.2 mcg/l
7. FORMULA:-
For preparation of primary emulsion , oil phase consisting of paraffin oil and Span 80 ,was
heated to 55. Aqueous phase consisting of salicylic acid and dextrose was also heated to the same
temperature. Aqueous phase was added to the oil phase drop by drop . (15 min stirr under mechanical
stirrer).
Agitation was continued until cooling to room temperature of 25 oC. For obtaining the multiple emulsion,
primary emulsion was added to the aqueous phase containing hydrophilic surfactant (Tween 80) while
agitating for 10 min. Emulsion was then homogenized at 800 rpm for 5 min and further at 500 rpm for 5
min more.
2. Evaluation Parameters:
.
Freshly prepared primary and multiple emulsions were investigated organoleptically (color, liquefaction
and phase separation). Organoleptic characteristics of both primary and multiple emulsions kept at different
storage conditions, i.e. color, liquefaction and phase separation were noted at various intervals.
Types of emulsions were analyzed by dilution with paraffin oil and water separately and observation
under microscope.
In this study, globule sizes of the multiple emulsions prepared were determined using light
Microscope fitted with a digital camera for the freshly prepared emulsions and for the emulsions
kept at different conditions for 28 days .
2.4 pH determination
The pH value of the freshly prepared emulsions and the emulsions kept at different conditions
were determined by a digital pH-meter. pH measurements were repeated for multiple emulsions
after 28 days of preparation.
Multiple emulsions were analyzed under the microscope to confirm the multiple characters. A drop of
multiple emulsion was placed on the glass slide, diluted with water and covered by a glass cover. A drop of
immersion oil was placed on the cover slide and observed under the microscope.
Stability tests were performed at different storage conditions for both primary and multiple
emulsions. The tests were performed on samples kept at 4 ± 0.1 oC (in refrigerator), 25 ± 0.1oC.
Calibration curve:
It was prepared by taking 100 mg salicylic acid then dissolved in 100ml dis. water. Taken
2ml from above and diluted up to 20ml which produced 100µg/ml. then 1ml was taken & diluted to
10ml which produced 10 ug/ml. taken suitable aliquot like,2ml,4ml,6ml,8ml and 10ml dilute up
to 10ml which produce concentrations,2,4,6,8 & 10 µg/ml respectively and measured the
absorbance by U.V. at 203nm. Plot the graph of Abs v/s Conc and find out the calibration curve
equation.
Calibration curve of Aspirin
(1) Microscopic evaluation shows continuous pink color through out the water phase.
(2) We can find out no. of globules of w/o emulsion of various size moving in the continuous
water phase.
(3) This conforms formation of w/o/w emulsion.
= 1075/100
= 10.75 µm
3.4 pH determination
In this work, both primary and w/o/w multiple emulsions were divided into two samples
separately and these samples were kept at different storage conditions, i.e. at 4 °C in refrigerator,
at 25 °C at room temp.. The samples kept at different storage conditions were observed for a period of
1 month. Samples were observed .
separation.
Microscopic examination had seen that a water soluble dye had been taken up by continous phase & the
inner particles present in globules,which indicated the w/o/w type of emulsion.
Calibration curve
Sr No. Cocentration Absorbance(nm)
((ug/ml)
1 2 0.159
2 4 0.288
3 6 0.359
4 8 0.470
5 10 0.585
Dissolution Profile:
% Drug Release
60.00
50.00
40.00
30.00
20.00
10.00
0.00
0 2 4 6 8
Time (Hr)
EC 1:1 EC 1:0.5 HPMC 1:1 HPMC 1:0.5
% Swelling Index
Time (Hr)
F1 F2 F3 F4
0.5 26.67 23.33 30.00 25.81
1.0 40.00 43.33 46.67 41.94
2.0 46.67 50.00 53.33 48.39
3.0 60.00 63.33 56.67 51.61
4.0 63.33 66.67 63.33 58.06
5.0 63.33 66.67 63.33 58.06
6.0 26.67 23.33 30.00 25.81
% Swelling Index
80
70
% Swelling Index
60
50
40
30
20
10
0
0 1 2 3 4 5 6
Time (hr)
F1 F2 F3 F4
11. CONCLUSION
Aspirin sustained release tablets are prepared using two different rate controlling polymers, Ethyl cellulose and
HPMC with the drug: polymer ratio (1: 1and 1: 0.5) the evaluation is done both in the blend and the prepared
tablets. All the evaluation tests are found to be fall with in the range of standards specified in the pharmacopoeia.
The swelling index study indicates that as the concentration of HPMC increases the swelling of the system is
increased. And both the systems observed a sudden decrease in the weight after 5th hour indicates the
disintegrations or erosion of the matrix. The dissolution study conducted for all the formulations show the
sufficient slow down of the release of the drug achieving the desired target.