5

International Journal of Medicine and Pharmacy, Vol. 1 No.
1, December 2013
59
Formulation and Evaluation of Film Coated Tablets of Azithromycin Usp

P.Palanisamy1
K.Gowdhaman1
B.Jaykar1
R.Margret Chandira1
B.S.Venkateswarlu1
A.Pasupathi1
Abstract
The present investigation is undertaken with an aim to formulation and evaluation of Film
coated tablet of Azithromycin dehydrate. The drug powders were subjected to
Preformulation studies. The Preformulation characteristics are within the
Pharmacopeial specifications. The drugs and excipients compatibility were carried out
by FT-IR studies. The spectra showed that there was no interaction between them. The
drugs and excipients compatibility were carried out by HPLC method and by physical
observation showed that there was no interaction between them. For Azithromycin
dihydrate FC tablets direct granulation was method of choice. Optimization was done
and it was found that release profile was found to be best with super-disintegrant i.e.
Polyvinyl Pyrrolidine and croscarmellose sodium. Film coating of Protectab HP-1
Sunset yellow Lake IPA coating 3 %w/w was done on Azithromycin dihydrate tablets as
to avoid in low humidity condition and geometric mixing is applied to avoid content
uniformity and segregation. Results found that release profile of batch no.ADF9
matches with Innovator product. The Percentage cumulative drug release of batch. No.
ADF9 was found at 45 Minutes 102.98%.
Key words: Azithromycin dIhydrate, Film coated Polyvinyl Pyrrolidine

acroscarmellose sodium.
Introduction
The convenient oral drug delivery has been known for decades is the most widely utilized route
of administration among all the routes. It remains the preferred route of administration in the discovery
and development of new drug candidates. The popularity of oral route is attributed to patient
acceptance, ease of administration, accurate dosing, cost effective manufacturing methods and generally
improve the shelf life of the product(1). Immediate release tablets are designed to disintegrate and release
the drug in absence of any controlling features such as coating or other formulation techniques.
Department of Pharmaceutics, Yercaud Main Road, Salem-636 008, Vinayaka Missions College of
Pharmacy, Vinayaka Missions University, Salem, Tamil Nadu.
American Research Institute for Policy Development
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International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013
Despite a rising interest in controlled-release drug delivery systems, the most common tablets
are those intended to be swallowed whole, disintegrating and releasing their medicaments rapidly in the
gastrointestinal tract. A Disintegrant is a substance in a tablet formulation that enables the tablet to
break up into smaller fragments upon contact with gastrointestinal fluids. Such a rapid rupture of the
tablet matrix increases the surface area of the tablet particles, Thereby increasing the rate of absorption
of the active ingredient and producing the desired therapeutic action (2). The proper choice of
Disintegrant and its consistency of performance are critical to formulation development of immediate
release tablets. In the past, starch was one of the most widely used, Inexpensive, and effective tablet
disintegrants. A high concentration of starch is required to bring about effective disintegration.
Scientists search for disintegrating agents with efficient disintegrating properties at relatively
low concentrations has led to the development of some new compounds with excellent disintegrating
properties is called superdisintegrant. In the present work Azithromycin Dihydrate was chosen as a
model drug. Azithromycin dihydrate is macrolide antibiotic. It is widely used in the treatment of upper
and lower respiratory tract infection, prevention of disseminated Mycobacterium Avium Complex
(MAC) infection in patients with advanced human immunodeficiency virus (HIV) infections &
uncomplicated skin and skin structure infections like Folliculitis, Cellulitis, Erysipelas. Although it is
commonly used drug but the major problem is its bitterness. Oral administration constitutes the
preferred route for administering Azithromycin dihydrate. Due to the decline in the elderly patients
complain that it is difficult for them to take some currently used dosage form such as tablets and
capsules. For this reason the tablets that can rapidly disintegrated. These disintegrating tablet by direct
compression method using Polyvinyl Pyrrolidine and croscarmellose sodium as a super-disintegrant (3-5).
Materials and Methods

Azithromycin dihydrate was procured by Torrent Pharmaceuticals (Ahmadabad, India); Starch,
Pharmatose DCL 15, Microcrystalline Cellulose Powder, Polyvinyl Pyrrolidine and Dibasic Calcium
Phosphate was gifted by FMC Bio-polymer (India); Croscarmellose Sodium, Sodium lauryl sulphate,
Talc, magnesium stearate and aerosol was gifted by Chetan & Chetan (India); HPMC, Titanium
dioxide, Tween 80, Isoprophyl Alcohol and Methylene chloride was gifted by Cabot Sanmer (India).
Spectral Identification (6)

Excipients are integral components of almost all pharmaceutical dosage forms. The successful
formulation of a stable and effective solid dosage form depends on the careful selection of the
excipients, which are added to facilitate administration, to promote the consistent release and
bioavailability of the drug and protect it from degradation.
Infra red spectroscopy is one of the most powerful analytical techniques to identify functional
groups of a drug.
In the present study, the potassium bromide disc (pellet) method was employed. Chemical
stability was confirmed by IR spectrometry.
The results are shown in Figure. No: 2-3
Compatibility Studies (7)

DrugExcipients compatibility was performed using HPLC method and by physical observation.
The results are shown in Table. No: 7
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Protocol for drug-excipients compatibility for Azithromycin dihydrate

Table.No:1 Ratio of Azithromycin dihydrate Excipients Taken For Compatibility Study
Ingredient
Azithromycin dihydrate
: Starch
:Lactose DCL -15
: Dibasic Calcium Phosphate
: MCCP
: Polyvinyl Pyrrolidine
: Croscarmellose Sodium
: Sodium lauryl sulphate
: Talc
: Magnesium stearate
: Aerosil
: Sunset Yellow Lake
: Protectab HP
: All excipients
Ratio
1
1:1
1:1
1:1
1:1
1:1
1:1
1:1
1:1
1:0.5
1:0.5
1:0.5
1:1
Preformulation Studies Of Pure Drug And Excipients (8-9)

Preformulation study relates to pharmaceutical and analytical investigation carried out
proceeding and supporting formulation development efforts of the dosage form of the drug substance.
Preformulation yields basic knowledge necessary to develop suitable formulation for the toxicological
use. It gives information needed to define the nature of the drug substance and provide frame work for
the drug combination with pharmaceutical recipients in the dosage form. Hence, the following
Preformulation studies were performed on the obtained sample of drug.
The results are shown in Table. No: 8-9.
Tablet Manufacturing
Manufacturing Of Azithromycin Dihydrate Tablets
Manufacturing Procedure:
Azithromycin dihydrate tablets using direct compression:
The corresponding amount of drug Azithromycin Dihydrate was screened using screen # 40
mesh. Starch, Lactose DCL -15, Dibasic calcium phosphate and MCCP was pass through # 60 mesh all
the sifted materials into the RMG / Ribbon mixer well for 3 minutes. PVP and IPA Stir it to get clear
solution. Methylene chloride and then filter through muslin cloth. Granulate the dry mixing with binder
solution, mix for 5 minutes at slow speed then continue mixing at high speed till the granulation end
point is reached. End point of granulation to be judged manually. (Take small quantity of granule
mixture makes dump mass). Load the wet mass into the FBD and air dry the mass until complete
evaporation of IPA and then dry at 70C ( In let temperature ) to obtain a LOD of not more than 2.5%.
Sift the dried granules through 16 mesh. Pass retained granules through cadmill by using 2mm screen.
Check the weight of dried granules. Load the dried granules into the double cone blender. Talc, Aerosil
and Cros carmellose sodium through 40 mesh and then load into the blender, mix for 25 minutes.
Magnesium Stearate and pass through 60 mesh, then load into the blender mix for 5 minutes. The tablets
were given to content uniformity and Dissolution test analysis.
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Table No: 2 Formulation of Azithromycin Dihydrate Tablets
INGREDIENTS ADF1
Azithromycin
583.33
dehydrate
Starch
95.58
Lactose DCL 15
75
Dibasic Calcium
Phosphate
Microcrystalline
93.5
Cellulose Powder
Polyvinyl
30
Pyrrolidine
Croscarmellose
Sodium
Sodium
lauryl
6.07
sulphate
Talc
5
Magnesium
11
stearate
Aerosil
4
TOTAL
WEIGHT
ADF2
583.33
ADF3
583.33
ADF4
583.33
ADF5
583.33
ADF6
583.33
ADF7
583.33
ADF8
583.33
ADF9
583.33
80.58
90
-
65.58
105
-
50.58
120
-
95.58
75
80.58
90
65.58
105
50.58
120
50.58
60
60
88.5
83.5
78.5
93.5
88.5
83.5
78.5
78.5
35
40
45
15
30
35
40
45
30
6.07
6.07
6.07
6.07
6.07
6.07
6.07
6.07
6
10
7
9
8
8
5
11
6
10
7
9
8
8
8
8
4
4
903.34mg/ Tablet
Table No: 3 Film Coating for Azithromycin dihydrate FC Tablets

Ingredients
Ingredients
Sunset Yellow Lake
Protectab HP
Polysorbate 80
Purified Water
Quantity(mg)
For One tablet
0.05
1.8
0.8
Qs
Table No: 4 Optimized Parameters for Film Coating for Azithromycin dihydrate FC Tablets
Conditions
Inlet air temperature (C)
Product temperature (C)
Outlet air temperature (C)
Spray rate (ml/min)
Atomizing air pressure (psi)
Pan speed (rpm)
Pre-heating
55-60
55-60
35-60
35-37
Coating
60-65
50-55
55-60
1-2
20
35-37
Drying
50
55-60
50-55
35-37
Post Compression Parameters (10-13):

a) Weight Variation Test:
Twenty tablets were selected randomly from each batch and weighed individually to check for
weight variation. A little variation was allowed in the weight of a tablet according to U.S.
Pharmacopoeia. The following percentage deviation in weight variation was allowed.
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Average weight of a tablet
130 mg or less
>130 mg and <324 mg
324mg or more
63
Percentage deviation
10
7.5
5
b) Tablet Dimensions:
Thickness and diameter were measured using calibrated Vernier calipers. Five tablets of each
formulation were picked randomly and thickness and diameter was measured individually.
The results are shown in Table. No:
10-11.
c) Thickness:
The thickness of the tablets was determined by Vernier calipers. Five tablets from each batch
were used and the average values were calculated. The results are shown in Table. No: 10-11.
d) Hardness:
Hardness indicates the ability of a tablet to withstand mechanical shocks while handling. The
hardness of the tablets was determined using Monsanto hardness tester. It is expressed in kg/cm2. Five
tablets were randomly picked and hardness of the tablets was determined. The results are shown in
Table. No: 10-11.
e) Friability test:
The friability of tablets was determined by using Roche friabilator. It is expressed in percentage
(%). Twenty tablets were initially weighed (Wt) and transferred into friabilator. The friabilator was
operated at 25 rpm for 4 minutes or run up to 100revolutions. The tablets were weighed again (WF).
The % friability was then calculated byW (initial)-W (final)
%F = ___________________100
W (initial)
f) Disintegration test:
The disintegration time for immediate release layer was determined using the disintegration
apparatus. One tablet was placed in each of six tubes placed in a beaker containing 1000 ml of purified
water maintained at 37 20 C and the apparatus was operated. The time taken for the tablets to
disintegrate and pass through the mesh was noted.
Dissolution Technique
Drug is a water insoluble API. 7.4 pH phosphate buffer is taken as dissolution media, which
is listed on OGD website.
Following method was adopted to check dissolution profile.
The results are shown in Table. No: 12-13 & Figure. no: 4-5.
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Table no: 5 Dissolution method for drug
USP Apparatus
Speed
Medium
Sampling times
Analysis
Type II (Paddle)
100 rpm
pH 6.0 sodium phosphate buffer; 900 mL.
10, 15, 20, 30 & 45 Minutes
The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm
15-cm column that contains 5-m packing L1.
Stability Study(14-16) :
Tablets of the final batch were packed in High-Density Polyethylene Containers (HDPE,
60CC) and were subjected to accelerated stability studies.
(40020C/755%RH 1, 2 & 3 Months)
The effects of temperature and humidity with time on the physical and chemical characteristics of the
tablet were evaluated for assessing the stability of the prepared formulation. After each time period, the
samples were tested for Appearance, Dissolution, Assay and Impurities.
Result and Discussion

Table.no: 6 Standard Calibration Curve of Azithromycin Dihydrate
S.No
1
2
3
4
5
6
7
Concentration in ppm
10
20
50
100
120
160
200
Area
139
276
743
1489
1787
2376
2957
*MeanSD n=3
Figure.no:1 Standard Calibration Curve of Azithromycin Dihydrate
Area
Linearity of Azithromycin Dihydrate

y = 14.82x
R = 0.999
3500
3000
2500
2000
1500
1000
500
0
0
50
100
150
200
250
Concentration in PPM
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Ft-Ir Spectroscopy:
The result of FT-IR study for Azithromycin Dihydrate and their excipients are shown in Figure.
No:
Figure No: 2 Azithromycin Dihydrate Pure
Figure No: 3 Azithromycin Dihydrate with All Excipients
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Table No: 7 Compatibility study of Azithromycin Dihydrate with Excipients:
The RS Data of Azithromycin Dihydrate (By HPLC) of 1 month excipients Compatability @

40C-75% RH
Description
Ingredient
Azithromycin dihydrate :
Starch
:Lactose DCL -15
Dibasic Calcium Phosphate
MCCP
Polyvinyl Pyrrolidine
Croscarmellose Sodium
Sodium lauryl sulphate
Talc
Magnesium stearate
Aerosil
Sunset Yellow Lake
Protectab HP
All excipients
Rati
o
Related substance %w/w
White to pale yellow, granular powder
1
Month
25C/60
%RH
*
1:1
1:1
White to pale yellow, granular FF

powder
1:1
1:1
1:1
White to Greyish white , granular

powder
White to Grayish white , granular
powder
1 Month
40C/75
%RH
*
1:3
1:3
1:3
1:0.5
White to pale yellow, granular FF

powder
1:0.5
1:0.5
1:0.5
1:1
Table No: 8 Preformulation Study of Pure Drug (AZITHROMYCIN DIHYDRATE).

S.NO.
1
2
3
4
5
6
Parameters
Bulk Density*
Tapped Density*
Angle of Repose*
Carrs Index*
Hausner Ratio*
Melting Point*
Solubility*
Result
Conclusion
0.655 gm/ml
-----0.71 gm/ml
----18.91
Excellent
10 %
Excellent Flow
1.13
Better Flow
113-115 C
---It is practically insoluble in water, freely soluble in
anhydrous ethanol and in methylene chloride.
*MeanSD (n=6)
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Table No: 9 Preformulation Study of the blend (AZITHROMYCIN DIHYDRATE)

Batch
Code
ADF1
ADF2
ADF3
ADF4
ADF5
ADF6
ADF7
ADF8
ADF9
Bulk
Density*
0.41
0.44
0.44
0.47
0.45
0.46
0.47
0.43
0.48
Tapped
Density*
0.47
0.52
0.51
0.54
0.50
0.53
0.52
0.51
0.53
Angle of
repose*
24.58
25.91
26.86
24.43
24.10
24.77
25.42
24.78
25.45
%
Compressibility*
12.76
15.38
13.72
12.96
12.00
13.20
12.61
12.87
12.75
Loss on
Drying*
2.1
1.9
1.8
1.7
1.6
1.7
1.5
1.7
1.5
Hausner
Ratio*
1.15
1.18
1.16
1.14
1.06
1.15
1.11
1.17
1.12
*MeanSD (n=6)
The physical parameters of drug as well as blends concluded that these were considerably good
to formulate the tablet using direct compression technique.
Table No: 10 Evaluation of Azithromycin Dihydrate Core-Tablets
Batch
No
ADF1
ADF2
ADF3
ADF4
ADF5
ADF6
ADF7
ADF8
ADF9
Weight variation
(mm)**
9025.5
9014.8
9024.9
9024.7
9015.2
9024.8
9024.9
9035.1
9035.2
Diameter
(mm)*
8.390.02
8.280.01
8.390.03
8.470.02
8.380.03
8.390.02
8.490.01
8.590.01
8.390.01
Thickness
(mm)*
6.820.03
6.930.04
6.890.04
6.950.05
6.960.04
6.880.05
6.950.06
6.870.09
6.930.05
Hardness
(kg/cm2 )*
4.510.21
4.520.20
4.500.14
4.510.13
4.530.12
4.520.11
4.510.15
4.520.15
4.530.15
Friability
(%)*
0.25
0.31
0.28
0.32
0.34
0.33
0.35
0.32
0.31
Disintegratio
n Time*
2 mts 23 sec
2 mts 33 sec
3 mts 33 sec
3 mts 55 sec
2 mts 32 sec
2 mts 31 sec
3 mts 12 sec
3 mts 45 sec
4 mts 10 sec
*MeanSD (n=6) **MeanSD (n=20)

Table No: 11 Evaluation of Azithromycin Dihydrate Film Coated-Tablets
Batch
No
ADF1
ADF2
ADF3
ADF4
ADF5
ADF6
ADF7
ADF8
ADF9
Weight variation
(mm)**
9055.6
9045.3
9065.1
9055.1
9055.3
9055.2
9065.2
9065.4
9065.4
Diameter
(mm)*
8.590.01
8.580.03
8.590.02
8.670.03
8.480.02
8.520.02
8.600.02
8.620.03
8.590.02
Thickness
(mm)*
6.920.04
6.990.05
6.980.03
6.990.03
6.990.04
6.980.04
6.990.05
6.970.06
6.980.07
Hardness
(kg/cm2 )*
4.550.22
4.560.22
4.550.17
4.590.18
4.590.17
4.590.18
4.570.19
4.590.13
4.590.17
Disintegration
Time*
4 mts 23 sec
5 mts 33 sec
5 mts 33 sec
6 mts 35 sec
4 mts 32 sec
5 mts 31 sec
5 mts 10 sec
6 mts 12 sec
6 mts 22 sec
*MeanSD (n=6) **MeanSD (n=20)
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Table.No:12 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9
Time
(Minutes)
10
15
20
30
45
ADF1
% Cumulative Amount of Drug Release

ADF2 ADF3 ADF4 ADF5 ADF6
ADF7
ADF8
ADF9
14.98
29.89
42.12
51.43
76.54
18.78
35.67
46.56
55.45
79.89
20.13
38.78
52.34
61.21
83.45
21.12
39.56
54.79
66.65
95.89
21.67
41.98
58.97
78.97
102.98
19.65
37.45
49.56
59.78
84.56
21.23
39.78
53.23
63.12
94.87
16.29
31.78
43.98
52.89
73.76
19.76
37.43
48.76
57.89
80.54
*MeanSD (n=6
Figure.No:4 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9
Dissolution Profile of the Azithromycin dihydrate FC Tablets

ADF1-ADF9
% of Drug Release
120
100
ADF1
80
ADF2
60
ADF3
ADF4
40
ADF5
20
ADF6
0
0
10
20
30
40
50
ADF7
ADF8
Times in Minutes
Table.No:13 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9 with

Innovator Tablet
Time in (Minutes)
10
15
20
30
45
% Cumulative Amount of Drug Release

ADF9
INNOVATOR
21.67
23.78
41.98
45.98
58.97
62.98
78.97
79.89
102.98
100.12
*MeanSD (n=6)
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Figure No: 5 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9 with
Innovator Tablet
% of Drug Release
Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1ADF9 with Innovator Tablet
120
100
80
60
40
20
0
ADF9
INNOVATOR
0
10
20
30
40
50
Times in Minutes
Table No: 14 Assay of the Azithromycin Dihydrate :
Content
Uniformity
SD
1.7
Mean
101.56
RSD
1.7
*MeanSD (n=6)
Tablet (Batch No)
ADF9
INNOVATOR
% of Drug Release*
102.98
101.30
Assay**s
101.2670.435
100.5640.347
*MeanSD (n=6) & *Mean=Not less than 75% ; **Mean = Not less than 80%
Stability Studies
Table No: 15 Stability Studies Data of the Azithromycin Dihydrate Optimized Formulations
(ADF9)
Parameters
Weight variation (mm)**
Diameter (mm)*
Thickness (mm)*
Hardness (kg/cm2)*
Disintegration Time*
Initial
9065.
4
8.590.
02
6.980.
07
4.590.
17
6 mts
22 sec
1st Month
RT
40C
9065. 9055.
1
3
8.590. 8.580.
01
02
6.980. 6.970.
08
07
4.590. 4.580.
17
16
6 mts
6 mts
20 sec
12 sec
2nd Month
RT
40C
9054. 9054.
9
7
8.590. 8.580.
01
02
6.970. 6.970.
07
06
4.580. 4.570.
17
16
6 mts
6 mts
20 sec
07 sec
3rd Month
RT
40C
9054.8 9065.
4
8.590. 8.580.
01
01
6.980. 6.970.
07
06
4.580. 4.570.
17
16
6 mts 17
6 mts
sec
03 sec
*MeanSD (n=6) **MeanSD(n=20)

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Table No: 16 Stability Studies Data of the Assay & Dissolution Study of Azithromycin dihydrate
Optimized Formulations (ADF9)
Parameters
*Assay
*% of Cumulative
Release
Initial
101.267
0.435
102.98
1st Month
RT
40C
101.267 101.247
0.431
0.435
102.95
102.71
2nd Month
RT
40C
101.267 101.223
0.429
0.435
102.94
102.68
3rd Month
RT
40C
101.267 101.267
0.425
0.435
102.91
102.21
*MeanSD (n=6)
Discussion: Assay*Mean=Not less than 75% ; Dissolution**Mean = Not less than 80%.
The results indicated that the, optimized formulated tablets were within the Pharmacopeial
specifications.
Summary and Conclusion

The research work was aimed with formulation and evaluation of Film Coated tablet of
Azithromycin dihydrate. The drug powders were subjected to Preformulation studies. The
Preformulation characteristics are within the Pharmacopeial specifications. The Preformulation studies
were carried out and the results were found to be satisfactory. The drugs and excipients compatibility
were carried out by FT-IR studies. The spectra showed that there was no interaction between them. The
drugs and excipients compatibility were carried out by HPLC method and by physical observation
showed that there was no interaction between them. The drugs Assay and impurity were carried out by
HPLC method. Special care was taken for Azithromycin dehydrate processing in low humidity
condition and geometric mixing is applied to avoid content uniformity and segregation. The bulk
density of the powdered blend was found to be 0.655 gm/ml, tapped density between 0.71 gm/ml for all
formulations. % Compressibility, Hausners ratio to be found between USP limit. Angle of Repose was
found in the range of 18.91 . Hardness was found to be (NMT-4) kg/cm2. The flow properties of the
powdered blend for all the batches were found to be good and free flowing. The weight variation,
hardness and friability of all the formulated tablets within the specified requirements. The disintegration
times for the formulated tablets are within the range of USP. The Azithromycin dihydrate FC tablets
direct granulation was method of choice. Optimization was done and it was found that release profile
was found to be best with two super-disintegrants i.e. Croscarmellose sodium and Polyvinyl Pyrrolidine.
Film coating of Protectab HP-1 Sunset yellow lake IPA coating 3%w/w was done on Azithromycin
dihydrate tablets as to avoid the humidity. Results found that release profile of batch no.ADF9 matches
with Innovator product . The Percentage cumulative drug release of batch. No. ADF9 was found at 45
Minutes 102.98%.
Acknowledgements:
Authors are thankful to Prof (Dr.).B.Jaykar, Principal Vinayaka Missions College of Pharmacy,
Salem, Tamil nadu and providing all the facilities for this research project.
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71
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International Journal of Medicine and Pharmacy, Vol. 1 No.

Formulation and Evaluation of Film Coated Tablets of Azithromycin Usp

Key words: Azithromycin dIhydrate, Film coated Polyvinyl Pyrrolidine

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Materials and Methods

Spectral Identification (6)

Compatibility Studies (7)

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Protocol for drug-excipients compatibility for Azithromycin dihydrate

Preformulation Studies Of Pure Drug And Excipients (8-9)

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Table No: 3 Film Coating for Azithromycin dihydrate FC Tablets

Post Compression Parameters (10-13):

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Result and Discussion

Linearity of Azithromycin Dihydrate

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Figure No: 3 Azithromycin Dihydrate with All Excipients

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

The RS Data of Azithromycin Dihydrate (By HPLC) of 1 month excipients Compatability @

Related substance %w/w

White to pale yellow, granular powder

White to pale yellow, granular powder

White to pale yellow, granular FF

White to pale yellow, granular powder

White to Greyish white , granular

White to pale yellow, granular powder

White to pale yellow, granular powder

White to pale yellow, granular powder

White to pale yellow, granular FF

White to pale yellow, granular powder

White to pale yellow, granular powder

White to pale yellow, granular powder

White to pale yellow, granular powder

Table No: 8 Preformulation Study of Pure Drug (AZITHROMYCIN DIHYDRATE).

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Table No: 9 Preformulation Study of the blend (AZITHROMYCIN DIHYDRATE)

*MeanSD (n=6) **MeanSD (n=20)

*MeanSD (n=6) **MeanSD (n=20)

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

% Cumulative Amount of Drug Release

Dissolution Profile of the Azithromycin dihydrate FC Tablets

Table.No:13 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9 with

% Cumulative Amount of Drug Release

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

*MeanSD (n=6) **MeanSD(n=20)

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Summary and Conclusion

American Research Institute for Policy Development

International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

American Research Institute for Policy Development

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