International Journal of Scientific Research in Knowledge, 2(2), pp.

75-82, 2014
Available online at http://www.ijsrpub.com/ijsrk
ISSN: 2322-4541; 2014 IJSRPUB
http://dx.doi.org/10.12983/ijsrk-2014-p0075-0082


75
Full Length Research Paper

A Comparative Evaluation of Drug Release and Permeability of Ethylcellulose,
Cellulose Acetate and Eudragit RS100 Microspheres

Prakash Katakam
1
*, Saousen R. Diaf
1
, Baishakhi Dey
2
, Shanta K. Adiki
3
, Babu R. Chandu
1
, K.P.R. Chowdary
4


1
Faculty of Pharmacy, University of Zawia, Libya
2
School of Medical Science and Technology, IIT Kharaghpur, India
3
Nirmala College of Pharmacy, Guntur, India
4
College of Pharmaceutical Sciences, Andhra University, India
*Corresponding Author: pkatakam9@gmail.com

Received 01 December 2013; Accepted 11 January 2014

Abstract. Present study aims at comparative evaluation of drug release and permeability of diclofenac sodium loaded
ethylcellulose (EC), cellulose acetate (CA) and eudragit (EU) microspheres. Microspheres of EC, CA and EU containing
diclofenac sodium were prepared by an emulsification-solvent evaporation (oil-in-oil, o/o) method and were investigated for a
comparative evaluation of various parameters. The microspheres were found discrete, free flowing, multinucleate, monolithic
and spherical. About 5560% of all microspheres prepared were in the size range of 20+30 (715 m) mesh size. The
encapsulation efficiency was in the range of 97.1106.4% with various polymers. The wall thickness of microspheres was in
the range of 13.69-74.97m which depended on polymer employed and was directly proportional to polymer concentration.
Diclofenac release from the microspheres was slow over longer periods of time and depended on the polymer used and
coat:core ratio. Release was diffusion controlled and followed first order kinetics. Good linear relationships were observed
between percent coat, wall thickness and release rate constant with all the three polymers. The slopes of percent coat vs release
rate (k
1
) plots were found to be 0.4117, 0.2351 and 0.9762; and those of wall thickness (h) vs drug release rate (k
1
) plots were
found 0.2549, 0.1863 and 0.7850 respectively for EC, CA and EU microspheres. The lower the slope the better is the
controlling effect. Cellulose acetate exhibited better release-controlling effect than that of ethylcellulose and eudragit. The
increasing order of diclofenac release rate and permeability observed with various microspheres was, cellulose acetate <
ethylcellulose < eudragit RS100. The possible permeability of drug from the prepared porous micrsopheres could be due to
osmotic pressure generated by diclofenac.

Keywords: Diclofenac sodium, Microspheres, Ethylcellulose, Cellulose acetate, Eudragit RS100 Release kinetics

1. INTRODUCTION

Microspheres are solid, approximately 1 to 1000 m
in size and are made of synthetic and natural
polymeric, waxy or other protective materials both
biodegradable and non-biodegradable (Vyas and
Khar, 2002). The internal structure of microspheres
varies as a function of polymer and the process
employed to prepare them (Brannon-Peppas, 1992).
Reservoir microcapsules have a core of drug coated
with a polymer. Whereas in monolithic microspheres,
the drug is distributed homogeneously throughout the
polymeric matrix. Microspheres have been widely
accepted as a means to achieve oral and parenteral
controlled release (Sau-hung et al., 1987).
Microspheres provide several advantages over other
sustained release systems, especially matrix type
tablets. They can be widely distributed throughout the
gastrointestinal tract, improve drug absorption and
minimize side effects due to localized buildup of
irritating drugs against the gastrointestinal mucosa (Li
et al., 1988).
The rate of drug release from microspheres dictates
their therapeutic action. Release is governed by the
molecular structure of the drug and polymer, the
resistance of the polymer to degradation and the
surface area and porosity of microspheres (Izumikawa
et al., 1991; Pitt and Schindler, 1983). Drug release
from polymeric systems with a variety of geometries
has been described (Cheung et al., 1988). Zero order
release kinetics may be more easily achieved with slab
or rod geometries than spheres. The rate of release
from spheres may result from polymer diffusion or
erosion (Cartensen, 1984; Crank, 1975).
Ethylcellulose, cellulose acetate and eudragit
RS100 are non-toxic, biocompatible polymers with
Katakam et al.
A Comparative Evaluation of Drug Release and Permeability of Ethylcellulose, Cellulose Acetate and Eudragit RS100 Microspheres

76
good film-forming properties and have been
extensively used in coating (Kent and Rowe, 1978)
and microencapsulation (Porter, 1989) to prepare
microspheres. Though they have been studied
(Prakash et al., 2007; Padala et al., 2009; Chowdary
and Ratna 1993; Kawashima, 1989; Hasan, 1992;
Lorenzo-Lamon et al., 1998) individually for
microspheres and controlled release, no reports on
comparative evaluation of their drug release and
permeability characteristics for diclofenac are
available. In the present study a comparative
evaluation of drug release and permeability of
ethylcellulose (EC), cellulose acetate (CA) and
eudragit (EU) microspheres has been made employing
diclofenac sodium as core. Oral controlled release
formulations are needed for diclofenac because of its
short biological half-life of 2.0 hr and gastrointestinal
irritation if present in larger concentrations (Gilman,
1991). In the present investigation a comparative
evaluation of drug release and permeability of
ethylcellulose (EC), cellulose acetate (CA) and
eudragit (EU) microspheres was made by employing
diclofenac sodium as core.

2. MATERIALS AND METHODS

2.1. Materials

Diclofenac sodium was a gift sample from M/s
Roland Pharmacetuicals, Berhampur, India.
Ethylcellulose (Loba Chemie, Mumbai, with an
ethoxy content of 47.5% by weight and a viscosity of
22 cps in a 5% concentration by weight, in a 80:20
toluene-ethanol solution at 25
o
C), cellulose acetate
(Loba Chemie, Mumbai with a viscosity of 100140
cps in a 6% solution in 95% acetone-water mixture at
20
o
C), eudragit RS100 (with a viscosity of 15 mPa s
in a 2% acetone-ethanol (1:1) solution at 25
o
C), n-
hexane (Ranbaxy), acetone (Merck) and liquid
paraffin I.P. were procured from commercial sources.
All other reagents used were of analytical grade.

2.2. Preparation of microspheres

Microspheres of ethylcellulose, cellulose acetate and
eudragit containing diclofenac sodium were prepared
by an emulsification-solvent evaporation (oil-in-oil,
o/o) method. The polymer (EC, CA or EU) (2.0 gm)
was dissolved in acetone (100 mL) to form a
homogeneous polymer solution. The core material,
diclofen
added to the polymer solution (20 mL) and mixed
thoroughly. The resulting mixture was then added in a
thin stream to 200 mL of liquid paraffin contained in a
450 mL beaker, while stirring at 1000 rpm to emulsify
the added dispersion as fine droplets. A Remi medium
duty stirrer with speed meter (Model RQT 124) was
used for stirring. The solvent was then removed by
continuous stirring at room temperature (28 oC) for 3
hr to produce spherical microspheres. The
microspheres were collected by vacuum filtration and
washed repeatedly with n-hexane to remove adhering
liquid paraffin. The product was then air dried to
obtain discrete microspheres. Different proportions of
coat:core materials namely 1:9 (MC1), 2:8 (MC2), 3:7
(MC3), 4:6 (MC4) and 5:5 (MC5) were used in each
case to prepare microspheres with varying coat
thickness.

2.3. Evaluation of microspheres

Diclofenac sodium content in the microspheres was
estimated by using UV-spectrophotometric method
(The United States Pharmacopoeia, 1999) based on
measurement of absorbance at 276 nm in phosphate
buffer of pH 6.8. The method was validated for
linearity, accuracy and precision. The method obeyed
Beer-Lamberts law in the concentration range 1-20
g/mL. When a standard drug solution was assayed
repeatedly (n=6), the mean error (accuracy) and
relative standard deviation (precision) were found to
be 1.2% and 2% respectively. The encapsulation
efficiency was determined by estimating the drug
content in the microspheres and using the formula:

For size distribution analysis, different sizes in a
batch were separated by sieving using a range of
standard sieves. The amounts retained on different
sieves were weighed. Theoretical mean wall thickness
of the microspheres was determined by the method of
Luu et al (1973) using the equation:
( )
( ) | |
1 2
1
d P 1 Pd 3
d P 1 r
h
+

=

where, h = wall thickness (m); r = mean radius of
microspheres (m); d
1
= density of core material
(g/cm
3
); d
2
= density of coat material (g/cm
3
) and P =
proportion of medicament in the microspheres.

The microspheres prepared along with their
diclofenac content, encapsulation efficiency and wall
thickness measurements are given in Table 1. The
microspheres were observed under a scanning electron
microscope (SEM-LEICA, S430, UK). For SEM, the
microspheres were mounted directly on the sample
stub, using double-sided sticking tape, and coated
with gold film (thickness 200 nm) under reduced
pressure (0.001 torr).



International Journal of Scientific Research in Knowledge, 2(2), pp. 75-82, 2014
77
2.4. Drug release study

Release of diclofenac sodium from the microspheres
of size 20/30 was studied in phosphate buffer of pH
6.8 (900 mL) at 37
o
C using an USP XXIV 6-stage
dissolution test apparatus (M/s. Campbell Electronics,
Mumbai) with a paddle stirrer at 100 rpm. A sample
of microspheres equivalent to 100 mg of diclofenac
sodium was used in each test. Samples were
withdrawn through a filter (0.4 m) at different
intervals of time and were assayed at 276 nm for
diclofenac sodium using an Elico UV-visible double
beam spectrophotometer. The drug release
experiments were conducted in triplicates.
From the drug release data, the permeability
coefficient (Pm) for various microspheres was
calculated using the equation as described by Koida et
al (1986).

s
app
A.C
.V.H K
Pm =

where, Pm = permeability coefficient
(cm
2
/min), K
app
= apparent dissolution rate constant
calculated as mg/min from, the slope of the early
linear portion, V = volume of dissolution medium
(cm
3
), H = wall thickness of microspheres (cm), A =
surface area of the microspheres (cm
2
) and Cs =
solubility of the core in the dissolution medium (mg).

3. RESULTS AND DISCUSSION

Ethylcellulose, cellulose acetate and eudragit
microspheres of diclofenac sodium could be prepared
by the emulsification and solvent evaporation method
using acetone as solvent for the polymer as reported
by us (Prakash et al., 2007). The microspheres were
found to be discrete, spherical and free flowing.
Scanning electron microscogram (SEM) showed that
the microspheres prepared by all the three polymers
were nearly spherical with rough microporous surface
(Fig. 1). Regarding the internal structure the nature of
the method indicates that the microspheres produced
were of multinucleate monolithic type.
The sizes could be separated and a more uniform
size range of microspheres could readily be obtained
by sieving. The size distributions were normal in all
the batches with a large proportion, overall about
5560%, in the size range of 20+30 (715 m) mesh
size.


Fig. 1: Scanning electron micrograms of ethylcellulose (A), cellulose acetate (B) and eudragit RS100 (C) microspheres loaded
with diclofenac sodium.

Low coefficient of variation (< 4.7%) in percent
drug content indicated uniformity of drug content in
each batch of microspheres prepared with different
polymers (Table 1). The encapsulation efficiency was
found in the range 97.1103.8% with ethylcellulose,
99.4106.4% with cellulose acetate and
101.4104.2% with eudragit. As the microspheres
were spherical, the theoretical mean thickness of the
wall that surrounds the core particles in the
microspheres was calculated as per Luu et al (1973).
Microspheres prepared employing various ratios of
coat:core in each case (polymer) were found to have
different wall thickness.
Diclofenac release from the microspheres of size
20/30 was studied in phosphate buffer of pH 6.8 for a
period of 12 hr. Diclofenac release from all the
microspheres was slow and spread over extended
periods of time (Table 2). Plots of log percent drug
remaining vs time (Fig. 2) were found to be linear
(r>0.9516) with all the microspheres indicating that
the drug release from these microspheres was
according to first order kinetics with all the three
polymers. In a monolithic microsphere the path length
does not remain constant, since the drug in the center
has a longer path or travel than the drug near the
surface and therefore the rate of release decreases
exponentially with time. The release rates of various
microspheres are given in Table 2. At all coat:core
ratios the release rates were higher with eudragit and
the order of increasing release rates with various
Katakam et al.
A Comparative Evaluation of Drug Release and Permeability of Ethylcellulose, Cellulose Acetate and Eudragit RS100
Microspheres
78
polymers was CA < EC < EU. In each case the
release was depended on the percent of coat and wall
thickness of the microspheres.

Table 1: Coat:core ratio, drug content, encapsulation efficiency and wall thickness of the microspheres prepared.
Microspheres Coat:Core ratio
Percent drug content
Encapsulation
efficiency (%)
Wall thickness
(m)
Theoretical Practical*
ECMC1 1:9 90 88.4 (1.6968) 98.2 18.90
ECMC2 2:8 80 77.7 (1.5444) 97.1 35.50
ECMC3 3:7 70 71.2 (3.6516) 101.7 50.16
ECMC4 4:6 60 61.5 (4.1951) 102.5 63.24
ECMC5 5:5 50 51.9 (2.3121) 103.8 74.97
CAMC1 1:9 90 93.5 (2.139) 103.8 13.69
CAMC2 2:8 80 83.1 (2.0457) 102.1 26.93
CAMC3 3:7 70 69.6 (3.8793) 99.4 39.76
CAMC4 4:6 60 62.3 (4.6548) 103.3 52.17
CAMC5 5:5 50 53.2 (4.1353) 106.4 64.20
EUMC1 1:9 90 93.2 (2.253) 103.5 14.18
EUMC2 2:8 80 81.9 (2.3199) 102.4 27.78
EUMC3 3:7 70 72.6 (2.8925) 103.7 40.83
EUMC4 4:6 60 62.5 (2.72) 104.2 53.35
EUMC5 5:5 50 51.7 (4.091) 101.4 65.39
* Figures in parentheses are coefficient of variation (cv) values.


Fig. 2: Log percent of drug remaining vs. time plots of ethylcellulose (A), cellulose acetate (B) and eudragit RS100 (C)
microspheres. MC1 (), MC2 (A), MC3(), MC 4 () and MC5(* ).

International Journal of Scientific Research in Knowledge, 2(2), pp. 75-82, 2014
79
Table 2: Release characteristics of microspheres prepared.
Microspheres
Mean percent drug released at different time intervals (hr) (%SD), n=3
T
50

(hr)
a

k
1
(hr
-1
)
b

1.0 2.0 4.0 8.0 10.0 12.0
ECMC1 76.814.25 80.155.18 85.035.29 100.005.13 - - 7.09 0.3246
ECMC2
56.903.44 65.773.79 79.114.29 100.004.62 - - 7.37 0.3125
ECMC3
53.443.79 62.504.31 73.464.37 100.005.36 - - 8.21 0.2805
ECMC4
52.082.53 60.964.33 68.964.77 90.034.22 - - 8.74 0.2635
ECMC5
42.672.94 50.773.79 62.433.21 79.114.16 85.014.66 89.784.55 13.91 0.1656
CAMC1
63.564.19 79.233.61 88.484.45 100.004.97 - - 9.63 0.2392
CAMC2
54.363.88 64.464.34 70.365.49 86.874.37 100.005.14 - 11.98 0.1923
CAMC3
50.302.59 61.023.28 68.264.62 83.174.14 89.124.62 100.005.12 14.47 0.1591
CAMC4
48.353.18 56.493.46 65.405.18 80.943.85 86.394.26 91.784.52 14.58 0.158
CAMC5
39.153.31 45.223.11 56.364.73 74.454.28 82.714.76 86.175.18 16.52 0.1394
EUMC1
81.994.75 89.164.39 98.455.35 - - - 3.84 0.5995
EUMC2 76.936.39 83.705.44 94.615.97 - - - 4.86 0.4738
EUMC3 58.653.86 70.384.71 81.673.82 96.383.92 - - 6.54 0.3521
EUMC4 41.983.64 61.193.88 75.564.26 90.084.51 97.575.33 - 9.08 0.2535
EUMC5 38.932.71 56.343.29 63.393.74 80.584.89 96.264.27 - 11.02 0.2089
a
Time for 50% release;
b
First order release rate constant

Good linear relationships were observed between
percent coat (or) wall thickness and release rate
(Fig. 3). The relationships could be expressed by the
following linear equations.
y = 0.4117 x + 39.23 for ethyl cellulose
y = 0.2351 x + 24.26 for cellulose acetate
y = 0.9762 x + 64.72 for eudragit
where, x is percent coat and y is first order release rate
(k
1
hr
-1
) of the microspheres.
y = 0.2549 x + 39.31 for ethyl cellulose
y = 0.1863 x + 25.09 for cellulose acetate
y = 0.7850 x + 69.39 for eudragit
where, x is the wall thickness (m) and y is first order
release rate (k
1
hr
-1
) of the microspheres.


Fig. 3: Relationship between (A) percent coat and release rate and (B) wall thickness and release rate of ethyl cellulose (),
cellulose acetate () and eudragit RS100 (A) microspheres.

The slope of the linear regression between percent
coat and release rate (k
1
) indicates the release
controlling effect of the polymer. The lower the slope
the better is the controlling effect. The slopes were
found to be 0.4117, 0.2351 and 0.9762 respectively
for the coat materials ethylcellulose, cellulose acetate
and eudragit. Similarly from the plots of wall
thickness (h) vs drug release rate (k
1
), the slopes
Katakam et al.
A Comparative Evaluation of Drug Release and Permeability of Ethylcellulose, Cellulose Acetate and Eudragit RS100
Microspheres
80
obtained for ethylcellulose, cellulose acetate and
eudragit microspheres were 0.2549, 0.1863 and
0.7850 respectively. Thus cellulose acetate was found
to have better release controlling effect than the other
two polymers (Pratap et al., 2012). The order of their
effectiveness in controlling drug release was found as
CA > EC > EU. Plots of amount released vs square
root of time (Fig. 4) were found to be linear with all
the three polymers indicating that the drug release
from these microspheres was diffusion controlled.


Fig. 4: Amount released vs. square root of time plots of ethylcellulose (A), cellulose acetate (B) and eudragit RS100 (C)
microspheres. MC1 (), MC2 (A), MC3(), MC 4 () and MC5(*).

Permeability of the microspheres was calculated
based on the release data as described by Koida et al
(1986). Permeability values of various microspheres
are summarized in Table 3. At all ratios of coat:core,
the microspheres of cellulose acetate were less
permeable than those of ethyl cellulose and eudragit
RS100. The order of increasing permeability of the
microspheres was CA < EC < EU. The permeability
of microspheres having porous surface occurs when
drug release is driven by osmotic pressure (Ozturk et
al., 1990). The possibe permeability of drug from the
prepared porous micrsopheres could be due to osmotic
pressure generated by diclofenac.

Table 3: Permeability coefficient (Pm) values of various microspheres prepared.
Microspheres Coat : core ratio
Permeability coefficient, Pm (cm
2
/min) of microscpheres
EC CA EU
MC1 1:9 8.93 5.35 7.15
MC2 2:8 12.43 9.01 13.15
MC3 3:7 16.50 12.32 14.74
MC4 4:6 20.26 15.53 13.78
MC5 5:5 19.68 15.47 15.67

4. CONCLUSION

Ethylcellulose, cellulose acetate and eudragit RS100
microspheres containing diclofenac sodium could be
prepared by the emulsification-solvent evaporation
method using acetone as solvent for the polymer with
an encapsulation efficiency varying between
97.1106.4%. The microspheres were discrete, free
flowing, multinucleate, monolithic and spherical.
Diclofenac release from the microspheres was slow
over longer periods of time and depended on the
polymer used and coat:core ratio. Release was
diffusion controlled and followed first order kinetics.
Good linear relationships were observed between
percent coat, wall thickness and release rate constant
with all the three polymers. Cellulose acetate
exhibited better release-controlling effect than
ethylcellulose and eudragit. The order of increasing
diclofenac release rate and permeability observed with
various microspheres was cellulose acetate <
ethylcellulose < eudragit.

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Katakam et al.
A Comparative Evaluation of Drug Release and Permeability of Ethylcellulose, Cellulose Acetate and Eudragit RS100 Microspheres

82
Prakash Katakam, M.Pharm., Ph.D., has done his Ph.D. (Pharmaceutical Sciences) from Berhampur
University, Orissa, India. Research contribution includes design and biomedical evaluation in vitro and in
vivo, of various controlled release drug delivery systems like subgingival delivery films, microcapsules
and matrix tablets and conventional dosage forms. Other areas of research interest are biomaterials,
bioanalytical method development and natural medicine. He has guided two Ph.D. students and several
M.Pharm students. He has 80 peer reviewed research articles and four Indian patents to his credit. He is a
member of various professional bodies and editorial board member of several international journals.
Presently he is working on biomaterials and their novel modifications for pharmaceutical application.



Saousen R. Diaf, has completed her MSc Pharmaceutical Technology and Pharmacy Science in 2009 from
School of Pharmacy, University of Complutense, Madrid, Spain. She has completed her Master degree in
Pharmacognosy and Natural products in 2006 from College of Pharmacy, University of Alfateh, Tripoli,
Libya. She has been a recipient of Fulbright Exchange Libya Scholarship 2013, University of Nebraska
Medical Center, College of Public Health, Omaha, Nebraska, USA. Her areas of research interest are
Novel Drug Delivery systems and Industrial Pharmacy.




Ms Baishakhi Dey, M.Pharm., is a Faculty of Pharmacy, pursuing her PhD. Her research interests are
mostly in herbal anti-diabetic bio-actives, Nanotechnical approaches to drug delivery, Formulation of
nutraceuticals via innovative process technologies and pharmacoepidemiological surveys on disease
pattern. Currently she is having 12 peer reviewed journal articles, 5 conference papers, 2patents. Ms Dey is
the co-author of two books, and four book chapters.




Shanta Kumari Adiki, PhD, has done her PhD (Pharmaceutical Sciences) from Berhampur University,
India. She has completed her Master degree from Andhra University, India. She has 12 years of rich
experience Research and Teaching and published over 35 research articles in various international journals
and has two Indian patents. Her primary research area is Analytical chemistry and Bioanalytical Method
Development. Her other areas of research interest are formulation development, novel drug delivery
systems and natural products. She is presently guiding two PhD students and has guided several M.Pharm
projects.




Babu Rao Chandu, M.Pharm., Ph.D., has done his Ph.D. (Pharmaceutical Sciences) from Andhra
University, India. During his highly noticeable research experience over 20 years he has published over
140 papers in various international impact journals and one Indian patent. His research areas of interest
include, Phytochemistry, Natural medicine, Drug design and synthesis, Bioanalytical method development
and Formulation of dosage forms. He is a member of various professional bodies and editorial member of
several international journals. He has guided five Ph.D. students and several M.Pharm students.





Chowdary, KPR, M.Pharm., PhD., PGDAS, is a retired professor from University College of
Pharmaceutical Sciences, Andhra University. His primary area of research is Controlled Drug Delivery
Systems. He is well known for his research in the field of Microencapsulation and polymer science. He is
highly specialized in modification of drugs to improve their solubility by complexation. He has produced
over 60 PhDs and guided over 100 M.Pharm research projects.