Vol. 7(29), pp.

2043-2053, 8 August, 2013

DOI 10.5897/AJPP12.1251
ISSN 1996-0816 2013 Academic Journals
http://www.academicjournals.org/AJPP

African Journal of Pharmacy and

Pharmacology

Full Length Research Paper

A comparative evaluation of the quality of ten generic

telmisartan tablets with the brand
Bora Lichanda1, 2, Mi Luo1, 2, Hui Wang1, 2, Qi Pei1, and Bikui Zhang1*
1

Depatment Of Pharmaceutics, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013,China.
2
College Of Pharmaceutical Science, Central South University, Changsha, Hunan 410013, China.
Accepted 24 June, 2013

The objective of this study was to comparatively assess the quality of generic Telmisartan tablets with
the brand. Mean drug content and impurities determination, dissolution tests and solubility tests in four
different media were performed on ten Telmisartan generics and the brand Micardis. High performance
liquid chromatography was used in the determination of Telmisartan content, impurities and solubility
of Telmisartan in the tablets and dissolution apparatus II was used for dissolution tests. Four generics
showed poor solubility and dissolution rate in water, pH 7.5 and pH 4.5; three of them having a
relatively huge number of impurities compared to the brand. The other six generics showed more or
less the same mean drug content, dissolution rate as that of the brand and a better solubility. Three
generics showed to have a comparable number and amount of impurities as that of the brand. The
dissolution profiles of four generics were comparable to that of the brand in two different dissolution
media out of the four media used in the dissolution tests. This study showed that while some generics
may be of inferior quality to that of their brand counterparts, others can be of approximately the same
quality as that of the brand.
Key words: Brand, generic, Telmisartan, dissolution, impurities, quality.

INTRODUCTION
Telmisartan is a potent and selective Angiotensin II
receptor (type AT1) antagonist with no agonist activity. It
is used for the management of essential arterial
hypertension. Telmisartan is highly lipophilic and
practically insoluble in water, its solubility in aqueous
media is greatly influenced by pH. In the range of pH 3-9,
Telmisartan is simply poorly soluble in water; the
maximum solubility can only be attained at low and high
pH. Telmisartan exhibit polymorphism-mainly existing in
either polymorph A or B (Wienen et al., 2000; Tran et al.,
2008).
Generic drugs are copies of their brand name
counterparts which are pharmaceutically equivalent and
bioequivalent to their brand name twins. Two drugs are
pharmaceutically equivalent if they contain the same

amount of the same active ingredient, are identical in

dosage form and route of administration, labeled for the
same indication and are produced under similar purity
and quality standards. On the other hand, bioequivalent
drugs must have a comparable rate and extent at which
the active ingredient is made available at the site of
action (Howland, 2009). Pharmacokinetics parameters
used to measure the bioequivalence between two drugs
are area under the plasma concentration-time curve
(AUC) which determines the extent of absorption in a
given time and the maximum plasma concentration
(Cmax) which appraises the rate of absorption.
Bioequivalence is the key for approving generic drugs,
and is determined by the ratio of the generic AUC and
Cmax to that of its brand name to be between 80%-125%

*Corresponding author. E-mail: zhbk68@yahoo.com.cn; Tel: +860731-88618455.

2044

Afr. J. Pharm. Pharmacol.

range with a 90% confidence interval. The assumption is

that, if the brand and the generic drug will have a similar
rate and extent at which the active ingredient is made
available at the site of action, they will therefore have
similar therapeutic effects (Howland, 2010; Kefalas and
Ciociola, 2011).
WHO (2004) estimated that 30% of the world's
population lack regular access to essential medicine, with
high costs and poor availability of medicines being the
main reasons (Babar et al.,2007; Nguyen et al.,2009). As
a strategy to reduce the costs and the amount of money
used to buy pharmaceuticals, many countries promote
the use of generic drugs (King and Kanavos, 2002). This
strategy to contain drug expenditure seem to work best
for those patients suffering from chronic diseases like
hypertension as there is a possibility for the patients to
remain under medication for the rest of their life (Shrank
et al., 2011; Van Mourik et al., 2010). This effort to
reduce drug expenditure is undermined by the belief that
generic drugs are inferior in quality and safety to their
brand name drugs (Berg et al., 2008; Shrank et al.,
2011); some people even doubting if the process used to
approve generic medicines can guarantee the efficacy
and safeness of generic drugs (Blier, 2007).
Generic drugs can contain different excipients from
those used in their brand name counterparts. Excipients
are inactive materials mixed together with the active
ingredient of the drug product to easy manufacturing
process and improve the performance of the product
(Shah et al., 2010). These excipients can affect the
pharmaceutical characteristics of the drug product either
positively or negatively. Chen et al (2006) observed that
the AUC and Cmax of ranitidine were decreased by 50
and 45% respectively when sorbitol instead of sucrose
was used as a sweetening agent. Even though sorbitol
was shown to have no effect on the AUC of metoprolol
the Cmax of metoprolol was reduced by 23%. This shows
that though two drugs might be containing the same
active ingredient, from the concept that they contain
different types or different amount of the same excipient,
these two drugs might have different pharmaceutical
properties which might influence the drugs in vivo
performance.
Usually after the patent of the brand drug have expired,
the brand company does not disclose its manufacturing
processes. This means that sometimes the generic drug
company and the brand drug company might be using
different manufacturing processes to manufacture the
same drug which may affect the quality and purity of the
drug product. Drugs with poor quality could be fatal to the
well-being of the society and sometimes can lead to the
development of drug resistant strains (Wernsdorfer,
1994). Drugs with little or no active ingredient and those
drugs with poor dissolution rate will actually not be able to
cure the intended disease; whereas those with excessive
active ingredients and impurities can cause adverse

effects to the patients (Po, 2001). The pharmaceutical

quality of the drug product usually prognosticates the in
vivo performance of the product - poor pharmaceutical
quality will mean poor in vivo performance of the product.
Since the motive to choose generic drugs over brand
name drugs is to reduce medical costs, generic drugs
can sometimes be even more costly if they are of poor
quality. Thus the present study aimed at comparatively
evaluating the quality of generic Telmisartan tablets
against the brand.
MATERIALS AND METHODS
Mean content determination
The mean content of Telmisartan in the tablets was determined by
using high performance liquid chromatography (HPLC) method
(Shimadzu, LC-10AT vp-Japan). This is a USP method
(Telmisartan tablets Revision bulletin, 2011) modified to suit our
specifications. 20 Telmisartan tablets were weighed, average
calculated and then powdered. The powder equivalent to 8 mg of
Telmisartan was weighed, then transferred into100 ml volumetric
flask. About 70 ml of the diluent was added then sonicated for 5 min
to dissolve the Telmisartan completely and the volume made up to
the mark with the diluent. It was well mixed by sonication for further
5 min and a portion of the solution was filtered through 0.45 m
filter then injected into the HPLC analytical column C8 (5 m,
4.6150 mm), the elutes were monitored at 298 nm.The mobile
phase consisted of methanol and ammonium dihydrogen
phosphate (65:35) at the flow rate of 1 ml/min. The phosphate
buffer was prepared by dissolving 2 g of ammonium dihydrogen
phosphate in 1000 ml of distilled water then the final pH was
adjusted to 3.0 using 1 M phosphoric acid. The mobile phase was
filtered through 0.45 m Nylon membrane thereafter was degassed
by sonication. 0.005 N of methanolic solution of NaOH was used as
a diluent. The HPLC method was validated for linearity, accuracy
and precision.
The brand drug was obtained from the manufacturer and the
generic drugs were bought from community pharmacies. All the
generic drugs were from the Chinese pharmaceutical companies as
shown in Table 1, all the drugs had a shelf life of more than a year
when they were tested.

Method of validation
Linearity
The linearity response was determined by preparing and injecting
solution with concentration of 0.04, 0.064, 0.08, 0.096 and0.16
mg/ml of standard Telmisartan.

Precision
Precision was measured in terms of repeatability of application and
measurement by preparing and injecting the standard solution of
0.08 mg/ml of Telmisartan six times (Figure 5 to 7).

Accuracy
Accuracy (recovery) study was performed by spiking 80, 100, and

Lichanda et al.

2045

Table 1. Companies of the Telmisartan tablets involved in the study.

Manufacturer
Wanbang Biopharm
Hainan Selection Pharmaceutical Co.
LTD
Beijing Winsunny Pharmaceutical Co.
LTD
Zhengzhou Handou Pharmaceutical
Group CO. LTD
Yichang Changjiang Pharmaceutical
Co. LTD
Chongqing Conquer Pharmaceutical
Co. LTD
Suzhou Chung-Hwa Chemical and
Pharmaceutical Industry Co. LTD
Weightech (HUNAN) Pharmaceutical
Co. LTD
Hunan Dinuo Pharmaceutical Co.
LTD
Tianjin Huajin Pharmaceutical Co.
LTD
Boehringer Ingelheim Pharma Gmgh
and Co.

120% of Telmisartan working standard solution to a

preanalysed sample. The accuracy of the analytical
method was established in triplicate.

Solubility studies
Powder equivalent to 20 mg of Telmisartan was dissolved
in 1 ml of the appropriate respective buffer (pH 1.2,4.5,7.5
or water) in which the solubility of the Telmisartan was to
be determined and kept at 37C for 48 h. Thereafter, the
resulting solution was centrifuged and diluted accordingly,
filtered and injected into the HPLC to determine the
amount of Telmisartan dissolved.

Batch number

Mng. Date

Expire date

1106708

22/06/2011

05/2013

Name used in the

study
Generic1

Telmisartan
strength
40mg

110701

05/07/2011

06/2014

Generic2

80mg

20110105

10/01/2011

12/2012

Generic3

80mg

110708

08/01/2011

06/2013

Generic4

40mg

1108008034

14/08/2011

13/08/2014

Generic5

40mg

110602

30/06/2011

05/2013

Generic6

40mg

52111021

24/09/2011

08/2013

Generic7

40mg

110413

13/04/2011

12/04/2014

Generic8

40mg

110914

19/09/2011

08/2013

Generic9

40mg

1F6789I

20/06/2011

05/2013

Generic10

40mg

902601

02/02/2009

01/2013

Brand

80mg

Impurities determination

Dissolution test

For the number of impurities in each tablet; tablet powder

equivalent to 8 mg was dissolved in 8 ml diluent then a
portion of the solution was filtered and injected into the
HPLC. The remained portion was diluted 1000 times,
filtered then injected into the HPLC to determine the
amount of Telmisartan in the solution which was then used
to determine the percentage of each impurity in the tablet
when compared with the total amount of Telmisartan
contained in the tablet.

The stock solution of standard Telmisartan was diluted

using the appropriate buffer (pH 1.2, 4.5, 7.5 or water) to
obtain solutions containing 0.003, 0.004, 0.005, 0.011,
0.016 and 0.021 mg/ml of Telmisartan. The absorbances of
these solutions were measured at 291, 296, 297 and 298
nm on a UV-spectrophotometer when pH 1.2, 4.5, 7.5 and
water was used, respectively; and the buffer of the
respective media was used as a blank. The linearity was
established over the entire concentration range by plotting
a graph of absorbance versus the corresponding concentrations in each of the used buffer; the data were
statistically evaluated using linear regression analysis and
the method was found to be precise.

2046

Afr. J. Pharm. Pharmacol.

Table 2. Summary of HPLC method validation.

Parameter
-1
Linearity range(mgmL )
1
Slope
1
Intercept
Correlation coefficient
-1
LOD(mgmL )
LOQ(mgmL-1)
Retention time (min)
Tailing Factor
HETP (m)

Results
0.04-0.16
6.1296810-8
-3
04.1330910
0.992777
0.00005
0.000225
6.18
1.5
0.0127

1- of the equation Y=mx+c where y is peak area and x

is concentration

little bit better (Table 7).

Dissolution studies-results
Dissolution in pH 7.5 buffer
Four generics showed poor dissolution rates in this
buffer. The USP (Telmisartan tablets Revision bulletin,
2011) requires that not less than 75% of the labeled
amount is dissolved within 30 min; for these four generics
the cumulative percent of Telmisartan dissolved was less
than 20% after 60 min. The other seven companies
released more than 80% of the labeled amount in 60 min
as shown in Figure 1.

RESULTS

Dissolution in water

Mean content of Telmisartan in the tablets

Six generics and the brand had more than 75% dissolved
in 30 min, the remaining four generics showed a poor
dissolution rate with three of which releasing less than
10% in 60 min. Its illustrations are indicated in Figure 2.

Before it was used for determination of the mean content

of Telmisartan in the samples, the HPLC method was
validated for linearity, precision and accuracy; results are
shown in Tables 2, 3, and 4. The USP (Telmisartan
tablets Revision bulletin, 2011) requires the mean content
of telmisartan in telmisartan tablets to be not less than
95% and not more than 110%. The mean contents of
telmisartan in all the tablets were within the required
range as shown in Table 5.
Impurities determination result
Generic 1 was found as having a huge number of
impurities, followed by generic 9, 5 and 4, whereby
generic 2, 3, and 6 had the lowest number of impurities.
The USP states that individual impurities should not be
more than 0.2% of the Telmisartan amount in the tablet
(Telmisartan tablets Revision bulletin, 2011). Using this
criteria, generic 8 had 2 impurities and generic 4, 9 and
10 had 1 impurity each which were out of the USP
acceptance criteria. The brand had the smallest total
percentage of all impurities followed by generic 2 and 6.
On the other hand, generic 9 had the largest total
percentage of all the impurities coming after generic 8
and 10, as demonstrated in Table 6.

Dissolution in a pH 4.5 buffer

Almost all the companies showed insufficient dissolution
rates in this dissolution buffer, probably due to the low
solubility of the drug in this media. Only three generics
released more than 50% of the labeled amount with
generic 1 being superior to all other generics including
the brand as shown in Figure 3 and 4. The dissolution
rate of four generics was so low that the amount of
Telmisartan dissolved was lower than the range in the
calibration curve used for measurements so they were
not included in the dissolution profile.
Dissolution in pH 1.2 buffer
Although all the companies except one had more than
80% of the labeled amount dissolved after 60 min, only
four companies released more than 75% of the labeled
amount in 30 min. Generic 3 released less than 40% in
60 min. On the other hand, generic 5, 9, 10 and 2
showed fast dissolution rates such that in 10 min the
dissolutions were more or less complete.

Solubility determination results

Dissolution profiles similarity
The tablets of the brand and generic 1, 4 and 7 showed a
significant high solubility in water and pH 7.5 followed by
generic 3 in the same media. The solubilities of all the
generics and the brand were worse in pH 4.5 media
contrary to their solubilities in pH 1.2 media which were a

F2 values were calculated using the equation below to

check the similarity of the dissolution profiles of the
generic companies when compared to that of the brand.
Two dissolution profiles are said to be comparable if the

Lichanda et al.

2047

Table 3. Precision study results (n=6).

Mean conc. injected

-1
(mgmL )
0.0803

Mean of the amount found

-1
(mgmL )
0.0755

Percentage of amount found

RSD (%)

94.04

0.73

Table 4. Recovery study results (n=3).

Level
80%
100%
120%

Pre analyzed sample

(mgmL-1)
0.0374
0.0375
0.0372

Std added
-1
(mgmL )

The amount found

-1
(mgmL )

Percentage of
amount recovered

SD

RSD (%)

0.0320
0.0397
0.0479

0.068
0.074
0.084

98.6
96.1
98.8

0.001
0.004
0.005

1.47
5.40
5.90

Table 5. Mean content of Telmisartan in the

tablets.

Company
Generic 1
Generic 2
Generic 3
Brand
Generic 4
Generic 5
Generic 6
Generic 7
Generic 8
Generic 9
Generic 10

Amount of telmisartan
in percentage
98.4731
95.0753
95.0180
97.0928
95.6414
95.6791
96.2126
102.9542
100.3801
95.7394
102.1129

f2 value is within the 50-100 range.

F2=
Where, n stands for the number of time points and t is the
time under consideration. R is the reference drug and T is
the test drug.
In pH 7.5 and 4.5 buffers, only generic 3 and generic 8,
respectively, had comparable dissolution profiles as that
of the brand. Generics 1, 4 and 7 had a similar drug
release profile as that of the brand in both water and pH
1.2 buffers. Then again generic 3 and generic 6 had
comparable profiles only in water and pH 1.2 buffers,
respectively. There was no generic drug which had a
similar profile to that of the brand in all the four media
(Table 8).

DISCUSSION
Even though the mean content of all the samples were
within the specified range, some of the samples showed
insufficient dissolution rates. Four generics (generic 2, 5,
9 and 10) showed poor dissolution rates in water, pH 4.5
and 7.5 buffers which collaborated with their solubilities in
these media. Fast dissolution rate shown by most of the
samples in pH 1.2 buffers predicts easy dissolution of
these tablets in the stomach which has approximately the
same pH. In a study of absorption of Telmisartan in rats,
a very small amount of Telmisartan was observed to be
absorbed in the stomach and the absorption was
somewhat decreased by food intake (Shimasaki, 1999).
In this account, even though it might not be the same in
human, those generics with high dissolution rate in the
acidic media and poor dissolution rate in other media,
their absorption and hence their bioavailability can be
affected by anything which can raise the stomach pH
(Horter and Dressman, 2001; Ming et al., 2009).
The use of different excipients or using the same
excipients in different ratios might be one of the reasons
for the observed differences in solubilities and dissolution
rates among the samples. For instance, the type and
amount of disintegrant used (Ahmed et al., 2000), the
mode of incorporation of the disintegrant into the drug
formulation (Rahman et al., 2011) and the effect of pH on
the disintegrant (Zhao and Augsburger, 2005) can affect
the disintegration rate of the tablet, consequently affecting its dissolution rate. In an attempt to optimize a
formulation containing Telmisartan, Pandya and
Chaudhari (2012) showed that using different alkalizers
at different ratios affected the solubility and so dissolution
of the Telmisartan formulation. Differences in the stability
of drug products can also cause significant differences in
drug content and in vitro drug release profiles especially
after the drug products has been exposed to high
temperature and humidity conditions (Twagirumukiza et

2048

Afr. J. Pharm. Pharmacol.

Table 6. Impurities results.

Company

No. of impurities

Brand
Generic 1
Generic 2
Generic 3
Generic 4
Generic 5
Generic 6
Generic 7
Generic 8
Generic 9
Generic 10

5
9
3
3
7
8
2
5
5
8
6

Impurities
Percentage of all
impurities
0.080
0.497
0.098
0.142
0.458
0.313
0.105
0.210
0.629
0.784
0.543

No. of impurities out of

acceptance criteria (USP)
0
0
0
0
1
0
0
0
2
1
1

Table 7. Solubility results (mgmL-1).

Company
Brand
Generic1
Generic2
Generic3
Generic4
Generic5
Generi6
Generic7
Generic8
Generic9
Generic10

pH 1.2
0.400
0.567
0.533
0.023
0.300
0.867l
0.433
0.467
0.667
0.015
0.533

pH 4.5
0.300
0.093
0.010
0.433
0.030
0.005
0.030
0.050
0.026
0.010
0.011

MEDIA
pH 7.5
>20
>20
0.017
8.050
>20
0.013
3.000
>20
1.900
0.213
0.120

Water
>20
>20
0.005
3.333
>20
0.034
5.333
>20
6.333
0.007
0.077

Table 8. Relative f2 values.

Sample
Generic 1
Generic 2
Generic 3
Generic 4
Generic 5
Generic 6
Generic 7
Generic 8
Generic 9
Generic 10

pH7.5
f2
Similarity
37.98
NO
16.16
NO
71.62
YES
36.61
NO
14.5
NO
29.1
NO
40.2
NO
47.4
NO
16.3
NO
15.3
NO

f2
59.7
9
60
74.4
9.3
35.2
85.3
47.5
12
9.2

Results
Water
pH4.5
Similarity
f2
Similarity
YES
30.7
NO
NO
49.2
NO
YES
NO
YES
38.9
NO
NO
NO
NO
33.8
NO
YES
34.2
NO
NO
53.2
YES
NO
NO
NO
NO

f2
51
14.8
29.3
66.6
9.6
52.9
64.5
48
17.7
18

pH 1.2
Similarity
YES
NO
NO
YES
NO
YES
YES
NO
NO
NO

Lichanda et al.

Figure 1. Comparative dissolution profiles of eleven Telmisartan tablets manufactured by different

companies in phosphate buffer (pH 7.5).

Figure 2. Comparative dissolution profiles of eleven Telmisartan tablets manufactured by different companies
in distilled water.

2049

2050

Afr. J. Pharm. Pharmacol.

Figure 3. Comparative dissolution profiles of eleven Telmisartan tablets manufactured by different companies in
phosphate buffer (pH 4.5).

Figure 4. Comparative dissolution profiles of eleven Telmisartan tablets manufactured by different

companies in hydrochloric acid (pH 1.2).

Lichanda et al.

mAU

50

25

Minutes
Figure 5. Typical chromatogram of telmisartan (0.08mg/ml) standard.

mAU

50

25

4
Minutes

Figure 6. Typical telmisartan chromatogram (0.08 mg/ml)-brand.

2051

2052

Afr. J. Pharm. Pharmacol.

mAU

50

25

Minutes
Figure 7. Typical telmisartan chromatogram (0.08mg/ml)-generic 1.

al., 2009; Lima et al., 2008).

Impurities can cause side effects and sometimes can
be fatal to the patient. The fact that the tablets showed
different number of impurities in different percentages,
some of which exceeding the allowed amount, suggests
that these companies have different sources of active
ingredient with different impurity profiles. Increased
amount of impurities in a drug product may introduce
unforeseen effects which might affect the drug efficacy
and safety such as drug-drug interactions, patient-drug
interaction to mention but a few.
The brand and 70% of the generic samples showed
sufficient dissolution rate in pH 7.5 buffers and water and
some of the generics showed a better dissolution rate
than that of the brand in pH 1.2 and 4.5 buffers. Though
there was no any generic drug which had a comparable
dissolution profile as that of the brand in all the four
media, similarity factor revealed that four generics had a
comparable profile as that of the brand in two different
media as shown in the results. This is different from the
results obtained by Patel et al. (2010) in which no generic
showed a similar dissolution profile as that of the brand in
any of the media used. In pH 7.5 buffer and water, three
generics showed high solubilities as that of the brand,
whereby in pH 1.2 and 4.5 buffers, some of the generics
demonstrated better solubilities than that of the brand. In
spite of having the lowest total percentage of all the

impurities put together, three generics a lower number of

impurities than the brand and approximately the same
total percentage of all impurities combined together. This
implies that, some generics in some areas have an
approximately the same quality as that of the brand, and
sometimes generic drugs in some areas are of better
quality than the brand.
This study had some limitations. One of which was the
use of in vitro dissolution test as a replacement for in vivo
bioavailability. Even though good dissolution may indicate
good bioavailability but poor dissolution does not always
mean poor bioavailability, the latter should be supported
by in vivo bioavailability tests. The unknown storage
conditions of the tablets before they were bought might
have influenced the results. Since the same four generics
showed poor dissolution rate in three media and better
dissolution rates in one medium, this limitation is less
important. On top of all that, excipients used in the
formulations and the impurities were not identified and
studied as they can greatly influence the quality and
safety of the drug product.
Conclusion
Four (generic 2,5,9,10) out of ten generics, even though
showed fast dissolution rates in pH 1.2 buffer, their

Lichanda et al.

dissolution rates in the other dissolution media were

insufficient, including pH 7.5 which is the recommended
buffer in the United states pharmacopeia; their dissolution
profiles were not comparable to that of the brand in any
of the buffers used. The four generics demonstrated poor
solubilities in all the media and a relatively huge number
of impurities were observed in these generics. This
connote that the quality of these four generics is
questionable and hence the call for post marketing
surveillance as away to make sure that drugs are always
safe and effective.
ABBREVIATIONS
AUC, Area under the plasma concentration-time curve;
Cmax, maximum plasma concentration; HPLC, high
performance liquid chromatography.
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