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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.

1
Department of Pharmaceutics, Yercaud Main Road, Salem-636 008, Vinayaka Missions College of
Pharmacy, Vinayaka Missions University, Salem, Tamil Nadu.

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60 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 Ratio
Azithromycin dihydrate 1
Azithromycin dihydrate : Starch 1:1
Azithromycin dihydrate :Lactose DCL -15 1:1
Azithromycin dihydrate : Dibasic Calcium Phosphate 1:1
Azithromycin dihydrate : MCCP 1:1
Azithromycin dihydrate : Polyvinyl Pyrrolidine 1:1
Azithromycin dihydrate : Croscarmellose Sodium 1:1
Azithromycin dihydrate : Sodium lauryl sulphate 1:1
Azithromycin dihydrate : Talc 1:1
Azithromycin dihydrate : Magnesium stearate 1:0.5
Azithromycin dihydrate : Aerosil 1:0.5
Azithromycin dihydrate : Sunset Yellow Lake
Azithromycin dihydrate : Protectab HP 1:0.5
Azithromycin dihydrate : All excipients 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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62 International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013

Table No: 2 Formulation of Azithromycin Dihydrate Tablets

INGREDIENTS ADF1 ADF2 ADF3 ADF4 ADF5 ADF6 ADF7 ADF8 ADF9
Azithromycin 583.33 583.33 583.33 583.33 583.33 583.33 583.33 583.33 583.33
dehydrate
Starch 95.58 80.58 65.58 50.58 95.58 80.58 65.58 50.58 50.58
Lactose DCL 15 75 90 105 120 - - - - 60
Dibasic Calcium - - - - 75 90 105 120 60
Phosphate
Microcrystalline 93.5 88.5 83.5 78.5 93.5 88.5 83.5 78.5 78.5
Cellulose Powder
Polyvinyl 30 35 40 45 - - - - 15
Pyrrolidine
Croscarmellose - - - - 30 35 40 45 30
Sodium
Sodium lauryl 6.07 6.07 6.07 6.07 6.07 6.07 6.07 6.07 6.07
sulphate
Talc 5 6 7 8 5 6 7 8 8
Magnesium 11 10 9 8 11 10 9 8 8
stearate
Aerosil 4 4 4 4 4 4 4 4 4
TOTAL 903.34mg/ Tablet
WEIGHT

Table No: 3 Film Coating for Azithromycin dihydrate FC Tablets

Ingredients Quantity(mg)
Ingredients For One tablet
Sunset Yellow Lake 0.05
Protectab HP 1.8
Polysorbate 80 0.8
Purified Water Qs

Table No: 4 Optimized Parameters for Film Coating for Azithromycin dihydrate FC Tablets

Conditions Pre-heating Coating Drying


Inlet air temperature (C) 55-60 60-65 50
Product temperature (C) 55-60 50-55 55-60
Outlet air temperature (C) 35-60 55-60 50-55
Spray rate (ml/min) - 1-2 -
Atomizing air pressure (psi) - 20
Pan speed (rpm) 35-37 35-37 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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International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013 63

Average weight of a tablet Percentage deviation


130 mg or less 10
>130 mg and <324 mg 7.5
324mg or more 5
The results are shown in Table. No: 10-11.

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 by-
W (initial)-W (final)
%F = ___________________100
W (initial)
The results are shown in Table. No: 10-11.

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.
The results are shown in Table. No: 10-11.

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

Table no: 5 Dissolution method for drug

USP Apparatus Type II (Paddle)


Speed 100 rpm
Medium pH 6.0 sodium phosphate buffer; 900 mL.
Sampling times 10, 15, 20, 30 & 45 Minutes
Analysis 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.
The results are shown in Table. No: 15-16.

Result and Discussion


Table.no: 6 Standard Calibration Curve of Azithromycin Dihydrate

S.No Concentration in ppm Area


1 10 139
2 20 276
3 50 743
4 100 1489
5 120 1787
6 160 2376
7 200 2957

*MeanSD n=3

Figure.no:1 Standard Calibration Curve of Azithromycin Dihydrate

Linearity of Azithromycin Dihydrate


y = 14.82x
R = 0.999
3500
3000
2500
Area

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

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
1
Rati 1 Month
Ingredient Month
o Related substance %w/w
25C/60 40C/75
%RH %RH
Azithromycin dihydrate 1 White to pale yellow, granular powder * *
Azithromycin dihydrate :
1:1 White to pale yellow, granular powder * *
Starch
Azithromycin dihydrate White to pale yellow, granular FF
1:1 * *
:Lactose DCL -15 powder
Azithromycin dihydrate :
1:1 White to pale yellow, granular powder * *
Dibasic Calcium Phosphate
Azithromycin dihydrate : White to Greyish white , granular
1:1 * *
MCCP powder
Azithromycin dihydrate : White to Grayish white , granular
1:1 * *
Polyvinyl Pyrrolidine powder
Azithromycin dihydrate :
1:3 White to pale yellow, granular powder * *
Croscarmellose Sodium
Azithromycin dihydrate :
1:3 White to pale yellow, granular powder * *
Sodium lauryl sulphate
Azithromycin dihydrate :
1:3 White to pale yellow, granular powder * *
Talc
Azithromycin dihydrate : White to pale yellow, granular FF
1:0.5 * *
Magnesium stearate powder
Azithromycin dihydrate :
1:0.5 White to pale yellow, granular powder * *
Aerosil
Azithromycin dihydrate :
1:0.5 White to pale yellow, granular powder * *
Sunset Yellow Lake
Azithromycin dihydrate :
1:0.5 White to pale yellow, granular powder * *
Protectab HP
Azithromycin dihydrate :
1:1 White to pale yellow, granular powder * *
All excipients

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

S.NO. Parameters Result Conclusion


1 Bulk Density* 0.655 gm/ml ------
2 Tapped Density* 0.71 gm/ml -----
3 Angle of Repose* 18.91 Excellent
4 Carrs Index* 10 % Excellent Flow
5 Hausner Ratio* 1.13 Better Flow
6 Melting Point* 113-115 C ----
It is practically insoluble in water, freely soluble in
7 Solubility*
anhydrous ethanol and in methylene chloride.

*MeanSD (n=6)

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

Batch Bulk Tapped Angle of % Hausner Loss on


Code Density* Density* repose* Compressibility* Ratio* Drying*
ADF1 0.41 0.47 24.58 12.76 1.15 2.1
ADF2 0.44 0.52 25.91 15.38 1.18 1.9
ADF3 0.44 0.51 26.86 13.72 1.16 1.8
ADF4 0.47 0.54 24.43 12.96 1.14 1.7
ADF5 0.45 0.50 24.10 12.00 1.06 1.6
ADF6 0.46 0.53 24.77 13.20 1.15 1.7
ADF7 0.47 0.52 25.42 12.61 1.11 1.5
ADF8 0.43 0.51 24.78 12.87 1.17 1.7
ADF9 0.48 0.53 25.45 12.75 1.12 1.5

*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 Weight variation Diameter Thickness Hardness Friability Disintegratio
No (mm)** (mm)* (mm)* (kg/cm2 )* (%)* n Time*
ADF1 9025.5 8.390.02 6.820.03 4.510.21 0.25 2 mts 23 sec
ADF2 9014.8 8.280.01 6.930.04 4.520.20 0.31 2 mts 33 sec
ADF3 9024.9 8.390.03 6.890.04 4.500.14 0.28 3 mts 33 sec
ADF4 9024.7 8.470.02 6.950.05 4.510.13 0.32 3 mts 55 sec
ADF5 9015.2 8.380.03 6.960.04 4.530.12 0.34 2 mts 32 sec
ADF6 9024.8 8.390.02 6.880.05 4.520.11 0.33 2 mts 31 sec
ADF7 9024.9 8.490.01 6.950.06 4.510.15 0.35 3 mts 12 sec
ADF8 9035.1 8.590.01 6.870.09 4.520.15 0.32 3 mts 45 sec
ADF9 9035.2 8.390.01 6.930.05 4.530.15 0.31 4 mts 10 sec

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

Table No: 11 Evaluation of Azithromycin Dihydrate Film Coated-Tablets

Batch Weight variation Diameter Thickness Hardness Disintegration


No (mm)** (mm)* (mm)* (kg/cm2 )* Time*
ADF1 9055.6 8.590.01 6.920.04 4.550.22 4 mts 23 sec
ADF2 9045.3 8.580.03 6.990.05 4.560.22 5 mts 33 sec
ADF3 9065.1 8.590.02 6.980.03 4.550.17 5 mts 33 sec
ADF4 9055.1 8.670.03 6.990.03 4.590.18 6 mts 35 sec
ADF5 9055.3 8.480.02 6.990.04 4.590.17 4 mts 32 sec
ADF6 9055.2 8.520.02 6.980.04 4.590.18 5 mts 31 sec
ADF7 9065.2 8.600.02 6.990.05 4.570.19 5 mts 10 sec
ADF8 9065.4 8.620.03 6.970.06 4.590.13 6 mts 12 sec
ADF9 9065.4 8.590.02 6.980.07 4.590.17 6 mts 22 sec

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

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

Table.No:12 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9

% Cumulative Amount of Drug Release


Time ADF1 ADF2 ADF3 ADF4 ADF5 ADF6 ADF7 ADF8 ADF9
(Minutes)
10 14.98 18.78 19.65 21.23 16.29 19.76 20.13 21.12 21.67
15 29.89 35.67 37.45 39.78 31.78 37.43 38.78 39.56 41.98
20 42.12 46.56 49.56 53.23 43.98 48.76 52.34 54.79 58.97
30 51.43 55.45 59.78 63.12 52.89 57.89 61.21 66.65 78.97
45 76.54 79.89 84.56 94.87 73.76 80.54 83.45 95.89 102.98

*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
120
% of Drug Release

100 ADF1

80 ADF2
ADF3
60
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

% Cumulative Amount of Drug Release


Time in (Minutes) ADF9 INNOVATOR
10 21.67 23.78
15 41.98 45.98
20 58.97 62.98
30 78.97 79.89
45 102.98 100.12

*MeanSD (n=6)

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Figure No: 5 Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-ADF9 with
Innovator Tablet

Dissolution Profile of the Azithromycin dihydrate FC Tablets ADF1-


ADF9 with Innovator Tablet
120
% of Drug Release

100
80
60
40 ADF9
20 INNOVATOR
0
0 10 20 30 40 50

Times in Minutes

Table No: 14 Assay of the Azithromycin Dihydrate :

Azithromycin dihydrate
Content Mean SD RSD
Uniformity 101.56 1.7 1.7

*MeanSD (n=6)

Tablet (Batch No) % of Drug Release* Assay**s


ADF9 102.98 101.2670.435
INNOVATOR 101.30 100.5640.347

*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 Initial 1st Month 2nd Month 3rd Month
RT 40C RT 40C RT 40C
Weight variation (mm)** 9065. 9065. 9055. 9054. 9054. 9054.8 9065.
4 1 3 9 7 4
Diameter (mm)* 8.590. 8.590. 8.580. 8.590. 8.580. 8.590. 8.580.
02 01 02 01 02 01 01
Thickness (mm)* 6.980. 6.980. 6.970. 6.970. 6.970. 6.980. 6.970.
07 08 07 07 06 07 06
Hardness (kg/cm2)* 4.590. 4.590. 4.580. 4.580. 4.570. 4.580. 4.570.
17 17 16 17 16 17 16
Disintegration Time* 6 mts 6 mts 6 mts 6 mts 6 mts 6 mts 17 6 mts
22 sec 20 sec 12 sec 20 sec 07 sec sec 03 sec
*MeanSD (n=6) **MeanSD(n=20)

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

Table No: 16 Stability Studies Data of the Assay & Dissolution Study of Azithromycin dihydrate
Optimized Formulations (ADF9)

Parameters Initial 1st Month 2nd Month 3rd Month


RT 40C RT 40C RT 40C
*Assay 101.267 101.267 101.247 101.267 101.223 101.267 101.267
0.435 0.431 0.435 0.429 0.435 0.425 0.435
*% of Cumulative
102.98 102.95 102.71 102.94 102.68 102.91 102.21
Release
*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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International Journal of Medicine and Pharmacy, Vol. 1 No. 1, December 2013 71

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