PROJECT WORK SEMINAR

Presented By
A.SaiDatri
B.SivaParvathi
CH.Gopi
MD.Ansari
L.Seshu
B.Dinesh
P.Upendra
Under the gUidance of
Mr. CH.Sathya surya prasad
M.Pharm
Department of Pharmaceutics

 Abstract
 Introduction
 Literature
 Drug profile
 Scope and object
 Experimental section
Preformulation studies
Analytical method development
Formulation development
Pre compression studies
Post compression studies
 Conclusion
12may2013 vikas college of pharmacy 2
Contents

vikas college of pharmacy 3
Abstract
Many anti diabetic drugs including sulfonylureas, Rosiglitazone and even
Insulin have been suspected to have adverse cardiovascular effects. Lactic
acidosis is the feared adverse effect of the biguanide drugs with high doses. We
suggest that the mean plasma concentrations of metformin over a dosage
interval be maintained below 2.5 mg/L in order to minimize the development of
this adverse effect. The present research work was an attempt to design a novel
formulation to improve the oral therapeutic efficacy with optimal control of
plasma drug level which contains anti diabetic drug like Metformin HCl tablet
formulation has been developed consisting of different polymers. The
quantitative estimation of metformin HCL by using uv spectrophotometry. This
dosage form was prepared from optimized formula was found to be best
suitable method for to maintain the sustained release of the dosage form.

Key words:Key words: Sustained release, Metformin HCl, HPMC K4, HPMC K100,
HPMC K15

Introduction
4vikas college of pharmacy

3.Introdution
Sustained-release oral delivery systems are designed to achieve
therapeutically effective concentrations of drug in the systemic circulation over
an extended period of time. Possible therapeutic benefits of a properly designed
SR dosage form include low cost, simple processing, improved efficacy,
reduced adverse events, flexibility in terms of the range of release profiles
attainable, increased convenience and patient compliance [1,2]. Many
innovative methods have been developed for obtaining modified drug release.
Diabetes is one of the major causes of death and disability in the world.
World Health Organization estimate for the number of people with diabetes
worldwide, in 2000, is 171 million, which is likely to be at least 366 million by
2030 (Ritu et al., 2009). Non insulin dependent (Type 2) diabetes mellitus is a‐
heterogeneous disorder characterized by an underlying insufficiency of insulin.
What is diabetes ?What is diabetes ?
Diabetes is a metabolic disorder, characterized by high levels of blood glucose
i.e. > 200mg/dl resulting from defects in insulin production, insulin action, or
both.

Types of Diabetes:Types of Diabetes:
 Type 1
 Type 2
Gestational
diabetes
Other Types
 Latent Autoimmune Diabetes in Adults (LADA)
 Diabetes Caused by Genetic Defects of the Beta Cell
 Diabetes Caused by Genetic Defects in Insulin Action
 Diabetes Caused by Diseases of the Pancreas
 Diabetes Caused by Endocrinopathies
 Diabetes Caused by Medications or Chemicals
 Diabetes Caused by Infections
 Rare Immune-mediated Types of Diabetes

-Complications
-Pathophysiology
-Symptoms and causes
-Diagnosis of Diabetes Mellitus
Fasting blood glucose test (FBGT)
Oral glucose tolerance test (OGTT)

Treatment statistics
In the case of type 1 diabetes, insulin levels are grossly
deficient. Thus type 1 diabetes is invariably treated
with insulin which include Regular insulin, Insulin
analogs, Pre-mixed insulin, Short peptide mimics.
Type 2 diabetes is frequently associated with
obesity. Serum insulin levels are normal or
elevated, so this is a disease of insulin
resistance. A number of treatment options
may be employed. Mainly oral medication
therapy and in chronic cases insulin therapy.

Drawbacks of monotherapy
• High dose is required
• High frequency of administration
• High cost
• Toxic reactions
• Poor patient compliance
• Chances of missing of dose between
intervals
• Chances of drug resistance
• Accumulation of the drug

Literature

S.No TITLE NAME
OF THE
AUTHOR
YEAR
OF
PUBLIS
HMENT
SCOPE AND
OBJECTIVE
1. Updated Review:
Improved Glycemic
Control
with Repaglinide-
Metformin in Fixed
Combination
for Patients with
Type 2 Diabetes
John W.
Richard III
and Philip
Raskin
2011 Repaglinide/metformin
combination therapy is
more effective and
better tolerated than
other approaches to
treatment with
improved glucose
control (reductions
in A1C and fasting
glucose levels), less side-
effects
(hypoglycemia), and
improved compliance
and cost.

2 Formulation and
evaluation of bilayer
tablets of Metformin
HCl
Jayaprakash.s,
mohamed
halith.s
2011 To enhance the
bioavailability and
therapeutic activity with
low frequency of
administration
3
Bilayer tablet
formulation of
metformin
hydrochloride and
glimepiride: A novel
approach to improve
therapeutic efficacy
Durga Prasad
Pattanayak*
and Subash C.
Dinda
2011
Metformin and
glimepiride tablets
simultaneously targets
insulin resistance and
insulin deficiency of type
2 diabetes, which may
account for the greater
effects on glycaemia.

4 Comparison of
repaglinide and
metformin
combination tablet
versus
repaglinide and
metformin as
separate tablets in
healthy volunteers
Xu Hongfei 2011 The aim of this clinical trial
is to investigate the
bioequivalence of
repaglinide and metformin
combination tablet versus
repaglinide and
metformin as coadministered
tablets after meal.
5 Development and
evaluation of two
layered tablet
of glimepiride and
metformin
hydrochloride for
the treatment of
hyperglycemia
S.
Mohideen1,
T.Satyanaray
ana1, P.
Suresh
Kumar1, S.
Navneetha
Krishnan1,
R.
Mahalaxmi2,
S. Pavani1*
2011 The basic aim of any Bi-layer
tablet formulation is to
separate physically or
chemically
incompatible ingredients and
to produce repeat action or
prolonged action tablet.
13
vikas college of pharmacy

6 formulation and
evaluation of
mucoadhesive
microcapsules of
metformin
hcl with gum
karaya
ashok
kumar.a*1,
balakrishn
a.t1, rajiv
jash1,
t.e.g.k
murthy2,
anil
kumar.a3
and b.
sudheer4
2011 mucoadhesion has been a topic of
interest in the design of drug
delivery systems to prolong the
residence time of the dosage form at
the site of application or absorption
and to facilitate
intimate contact of the dosage form
with the underlying absorption
surface to improve the
bioavailability of drugs
7 Sulfonyl ureas-
Oral anti Diabetes
drugs- are
associated with
heart failure and
death riscks
Joel
Fuhrman,
M.D.
2009 In the past few years, several studies
have found that certain diabetes drugs
may carry increased CV risks
compared to others. A recent study of
over 90,000 type 2 diabetics
compared the CV effects in
individuals treated with either
metformin or sulfonyl ureas. These
researchers found an increased
likelihood of death from any cause in
the patients treated with sulfonyl
ureas
14

8 Formulation
and
Evaluation of
Transdermal
Patch of
Repaglinide
Shailesh T.
Prajapati,
Charmi G.
Patel, and
Chhagan
N. Patel
2011 Transdermal patch of Repaglinide was
prepared to sustain the release and
improve bioavailability of drug and
patient compliance.To reduce adverse
effects and to avoid the hepatic first-
pass metabolism The need for
transdermal delivery of Repaglinide is
further justified
due to the requirement of maintaining
unfluctuating plasma concentrations
for effective management of blood
sugar for long period in diabetic
patients.
9 Design and
evaluation of
mucoadhesive
microspheres
of repaglinide
for oral
controlled
release
Vimal K.
Yadav1*,
Brajesh
Kumar1,
S.K.
Prajapati
1, Kausar
shafaat1
2011 Microencapsulation is to achieve
controlled release and drug targeting &
to prolong the residence time of the
dosage form at the site of application
or absorption and to facilitate intimate
contact of the dosage form with the
underlying absorption surface to
improve and enhance the
bioavailability of drugs 15

10 Formulation and
evaluation of floating
drug delivery system
of
Metformin
Hydrochloride
D. B. Raju,
R. Sreenivas
and M. M.
Varma
2010 Retention of drug delivery
systems in the stomach
prolongs the overall
gastrointestinal transit
time, thereby resulting in
improved bioavailability.
11 Formulation of
Extended-Release
Metformin
Hydrochloride
Matrix Tablets
Basavaraj K
Nanjwade*,
Sunil R
Mhase and
FV Manvi
2011 As It belongs to class III of
Biopharmaceutical
Classification System (BCS)
having high water solubility
and low permeability . For
drugs that are highly water
soluble, bothhydrophilic and
hydrophobic matrix systems
are widely used in oral
controlled release drug
delivery to obtain a desirable
drug release.

Selection of drugs
• Metformin HCl

Drawbacks of drugs
Metformin HCl
 Low bioavailability (50-60%)
 Maximum absorption in duodenum and poor absorption in
colon
 Lactic acidosis when given to renal impairement patients
 High incidence of concomitant gastro intestinal symptoms such
as abdominal discomfort, nausea, diarrhoea
 Short plasma elimination half life 1.5 to 4.5hrs.
 There is a need for administration 2 or 3 times per day when
larger doses are required can decrease patient compliance.
 BCS class III drug

Drug Profile

Scope and object

The main scope of the present
investigation is to target the site to improve
therapeutic efficacy & to enhance the
bioavailability with reduced dose of
Metformin HCl sustained release tablets.
scope

Objects
To design Metformin HCl SR tablets
To develop analytical method and to perform interaction studies for drug and
polymer (IR Spectral studies)
To conduct Pre-formulation studies for the drug.
To select and optimize the manufacturing method.
To detertmine rate of dissolution
To optimize best sustained release formulation
To evaluate the prepared tablet as per pharmacopoeial standards

Experimental
section

• Organoleptic properties
• Solubility determination
• Flow properties
• Bulk density
• Tapped density
• True density
• Carr’s index
• Hausner’s ratio
• Purity determination
• Melting point
• Stability and compatability studies
Preformulation studies

API PARAMETER STANDARD VALUES OBSERVED VALUES
METFORMIN
HCl
Appearance Full white Full white
Texture Amorphous Amorphous
Solubility Freely soluble in
water
Freely soluble in
water
State Solid Solid
Melting point 222 to 2260
C 225+0.50
c
% Purity 99.99% 98%
λmax 232nm 232nm
Preformulation studies for Metformin HCl

API Angle
of
repose
Bulk
density
(g/ml)
Tappe
d
density
(g/ml)
True
density
(g/ml)
Carr
’s
index
Compre
ssibility
index
(%)
Hausn
er’s
ratio
Drug
conte
nt
(%)
Meltin
g point
Metform
in HCl
24.5o
0.285 0.331 0.198 26.3 27.15 1.37 97.5 225+0.
50
c
Preformulation studies for Metformin HCl

Stability studies

IR Spectral studies

• UV/Visible Spectrophotometric method
Analytical methods

34
Concentration
(µg/ml)
Absorbance
0 0
2 0.180
4 0.356
6 0.532
8 0.709
10 0.887
Calibration curve for the estimation of the Metformin HCl
with pH 6.0 Phosphate buffer by UV spectrophotometer

Calibration curve for the estimation of the Metformin
HCl with pH 6.0 Phosphate buffer by UV/ VIS
spectrophotometer

Formulation
Development

Formulation of Metformin HCl with HPMC K4
S.NO INGREDIENTS K4 M1
(mg)
K4 M2
(mg)
K4 M3
(mg)
K4 M4
(mg)
K4 M5
(mg)
1 Metformin HCl 350 350 350 350 350
2 HPMC K4 10% 20% 30% 40% 50%
3 Sodium CMC 10 10 10 10 10
4 PVP K 30 10 10 10 10 10
5 Lactose 140 105 70 35 ----
6 Magnesium
stearate
2% 2% 2% 2% 2%
7 Talc 2% 2% 2% 2% 2%
Total tablet
weight
565 565 565 565 565

(mg)
K15 M2
(mg)
K15 M3
(mg)
K15 M4
(mg)
K15 M5
(mg)
1 Metformin HCl 350 350 350 350 350
2 HPMC K15 10% 20% 30% 40% 50%
3 Sodium CMC 10 10 10 10 10
4 PVP K 30 10 10 10 10 10
5 Lactose 140 105 70 35 ----
6 Magnesium
stearate
2% 2% 2% 2% 2%
7 Talc 2% 2% 2% 2% 2%
Total tablet
weight
565 565 565 565 565

(mg)
K100 M2
(mg)
K100 M3
(mg)
K100 M4
(mg)
K100
M5
(mg)
1 Metformin HCl 350 350 350 350 350
2 HPMC K100 10% 20% 30% 40% 50%
3 Sodium CMC 10 10 10 10 10
4 PVP K 30 10 10 10 10 10
5 Lactose 140 105 70 35 ----
6 Magnesium
stearate
2% 2% 2% 2% 2%
7 Talc 2% 2% 2% 2% 2%
Total tablet
weight
565 565 565 565 565

1. Direct compression
Selection of Method of dosage forms

Precompression
parameters

• Angle of repose
• Bulk Density
• True density
• Compressibility Index
• Total Porosity
• Drug content evaluation
Pre compression studies

Formulat
ion
Angle of
repose
Bulk
density
(g/ml)
Tapped
bulk
density
(g/ml)
Compres
sibility
index
(%)
Total
porosity
(%)
Drug
content
(%)
K4 M1 24.5º 0.285 0.331 13.5 36.5 97.5
K4 M2 25.5º 0.289 0.335 12.5 37.2 95.5
K4 M3 25.2º 0.283 0.332 12.2 36.2 96.5
K4 M4 24.5º 0.278 0.328 11.5 35.1 98.2
K4 M5 24.8º 0.269 0.321 13.2 36.5 98
Characterization Of Metformin HCl Granules Formulated With
HPMC K4

Formulat
ion
Angle of
repose
Bulk
density
(g/ml)
Tapped
bulk
density
(g/ml)
Compress
ibility
index (%)
Total
porosity
(%)
Drug
content
(%)
K15 M1 24.5º 0.285 0.331 13.5 36.5 97.5
K15 M2 25.5º 0.289 0.335 12.5 37.2 95.5
K15 M3 25.2º 0.283 0.332 12.2 36.2 96.5
K15 M4 24.5º 0.278 0.328 11.5 35.1 98.2
K15 M5 24.8º 0.269 0.321 13.2 36.5 98
HPMC K15

Formulat
ion
Angle of
repose
Bulk
density
(g/ml)
Tapped
bulk
density
(g/ml)
Compress
ibility
index (%)
Total
porosity
(%)
Drug
content
(%)
K100 M1 24.5º 0.285 0.331 13.5 36.5 97.5
K100 M2 25.5º 0.289 0.335 12.5 37.2 95.5
K100 M3 25.2º 0.283 0.332 12.2 36.2 96.5
K100 M4 24.5º 0.278 0.328 11.5 35.1 98.2
K100M5 24.8º 0.269 0.321 13.2 36.5 98
HPMC K100

Post compression
studies

• Wight variation test
• Content uniformity
• Hardnees
• Friability
• Disintegration
• Thickness
• In vitro studies
Post compression studies

Formulation Weight
variatio
n (mg)
Hardne
ss
(kg/cm2
)
Friabilit
y (%)
Thickne
ss
Drug content
(%)
K4 M1 564±0.7
9
6.0±1.02 0.89±0.0
1
3.43±0.0
6
97.23±0.23
K4 M2 565±0.9
8
6.0±1.02 0.75±0.0
1
3.87±0.0
6
98.23±0.23
K4 M3 564±0.6
9
6.0±1.02 0.79±0.0
1
3.76±0.0
6
95.87±0.23
K4 M4 565±0.7
8
6.0±1.02 0.82±0.0
1
3.87±0.0
6
96.45±0.23
K4 M5 565±0.9
1
6.0±1.02 0.89±0.0
1
3.63±0.0
6
99.03±0.23
Post compression studies for Metformin HCl with HPMC K4

49
Formulation Weight
variation (mg)
Hardness
(kg/cm2)
Friability
(%)
Thickness Drug content
(%)
K15 M1 565±0.89 6.0±1.02 0.9±0.01 3.63±0.06 97.63±0.23
K15 M2 565±0.98 6.0±1.02 0.86±0.01 3.78±0.06 98.73±0.23
K15 M3 564±0.67 6.0±1.02 0.75±0.01 3.62±0.06 95.07±0.23
K15 M4 566±0.43 6.0±1.02 0.79±0.01 3.91±0.06 95.95±0.23
K15 M5 565±0.89 6.0±1.02 0.94±0.01 3.53±0.06 99.18±0.23

Formulation Weight
variation
(mg)
Hardness
(kg/cm2)
Friability (%) Thickness Drug
content
(%)
K100 M1 563±0.89 6.0±1.02 0.9±0.01 3.67±0.06 98.63±0.33
K100M2 565±0.78 6.0±1.02 0.86±0.01 3.78±0.06 96.73±0.83
K100 M3 564±0.67 6.0±1.02 0.85±0.01 3.82±0.06 95.07±0.55
K100 M4 565±0.43 6.0±1.02 0.76±0.01 3.91±0.06 97.95±0.23
K100 M5 565±0.89 6.0±1.02 0.85±0.01 3.93±0.06 99.48±0.23

In vitro studies

Dissolution
medium
Time
(min)
% Of Metformin HCl Released
K4 M5 K15 M5 K100 M5
Simulated
Gastric
Fluid
15 7 2 5
30 10 4 8
45 13 6 12
60 15 7 14
75 18 8 15
90 21 9 17
105 22 10 19
120 24 11 21
Comparision of % release of Metformin HCl in
0.1N HCl

Comparision of % release of Metformin HCl in
0.1N HCl

54
Dissolution
medium
Time
(hr)
K4 M1 K4 M2 K4 M3 K4 M4 K4 M5
Simulated
Gastric Fluid
1 29.94 27.54 24.17 20.76 17.98
2 33.21 30.75 28.69 25.34 23.12
Simulated
Intestinal
Fluid
3 54.81 53.94 49.00 47.26 41.16
4 65.57 63.24 57.69 53.91 48.36
5 82.77 76.08 64.98 57.98 52.98
6 98.62 87.53 83.64 72.24 64.02
7 98.47 96.29 83.96 73.08
8 98.27 89.94 81.61
9 99.14 88.44
10 90.96
11 94.06
12 97.76
%Release of Metformin HCl with HPMC K4 by Direct compression
method

%Release of Metformin HCl with HPMC K4 by
Direct compression method

Dissolution
medium
Time
(hr)
K15 M1 K15 M2 K15 M3 K15 M4 K15 M5
Simulated
Gastric
Fluid
1 21.19 19.95 15.99 12.32 10.98
2 26.51 24.75 21.55 19.76 15.22
Simulated
Intestinal
Fluid
3 51.90 49.87 46.67 43.48 42.03
4 62.36 57.70 54.78 50.98 48.36
5 77.80 67.60 59.14 57.94 55.89
6 86.65 84.53 76.89 66.39 64.04
7 97.87 92.83 87.77 81.57 70.20
8 99.15 96.38 86.95 75.81
9 98.94 90.62 85.51
10 96.05 88.01
11 97.05 91.10
12 96.53
13
14
%Release of Metformin HCl with HPMC K15 by Direct compression method

58
Dissolution
medium
Time
(hr)
K100 M1 K100 M2 K100 M3 K100 M4 K100 M5
Simulated
Gastric
Fluid
1 27.14 24.95 21.07 19.92 16.98
2 32.63 27.21 25.64 23.54 21.12
Simulated
Intestinal
Fluid
3 54.52 51.61 48.42 44.35 42.90
4 66.14 58.00 57.11 50.12 48.37
5 83.35 74.29 62.94 60.85 57.93
6 98.04 87.19 76.94 69.60 69.86
7 98.12 90.14 81.89 76.05
8 99.34 87.57 81.70
9 95.89 88.53
10 99.60 93.95
11 97.07
12 100.21
13
14
%Release of Metformin HCl with HPMC K100 by Direct compression method

59

60
Conclusion

61
The following conclusions were drawn from results obtained;
 The present study was carried out to develop Metformin HCl SR
tablets to improve therapeutic efficacy. The selection of method is to
target specific site with a reduced dose.
It requires better to improve therapeutic efficacy. From the literature of
Metformin Hcl best to treat type 2 diabetes. The drug Metformin HCl
and polymers like HPMC K4, K15, K100 and different super
disintegrants such as SSG, Cross povidone, CCS are compatible with
each other.
The tablets were formulated for sustained release of Metformin HCl
with HPMC K4, K15, K100 at different concentrations were selected.
All the formulation have shown both pre-compression and post-
compression characters with in acceptable limits.


Metformin HCl tablets prepared with HPMC K4, K15, K100 in
different percentages. Among all the formulations formulated, K15 M5
sustained the release for 16hr and fulfilled my objective of this work.
The ability of the used polymers to sustain the release is as follows
HPMC K15 > HPMC K100 > HPMC K4
The study shows that the release of Metformin HCl in the
physiological environment of duodenum is due to the use of HPMC K15.
Because the absorption is more in duodenum, the use of this polymer can
overcome lactic acidosis in gastric environment
.
 The tablet is the best dosage form to treat type 2 diabetes. Because it
was reported to the reduced dose increases the therapeutic efficacy.

1.Updated Review: Improved Glycemic Control with Repaglinide-Metformin in
Fixed Combination for Patients with Type 2 Diabetes: John W. Richard III and
Philip Raskin
2. Bilayer tablet formulation of metformin hydrochloride and glimepiride: A novel
approach to improve therapeutic efficacy : Durga Prasad Pattanayak* and Subash
C. Dinda
3.Journal of pharmacy and pharmacology:A site-specific controlled-release system
for metformin: Giacomo Di Colo, Ylenia Zambito, Andrea Baggiani,Vera
Carelli,Maria Francesca Serafini
5.An overview of metformin in the treatment of type 2 diabetes mellitus,david son
MB,Peters AL.: pubmed articles
6. Biguanide: From Wikipedia, the free encyclopedia
7. Bioavailability of metformin. Comparison of solution, rapidly dissolving tablet,
and three sustained release products.Pentikainen PJ: pubmed articles
8. Clinical pharmacokinetics of metformin.Graham GG, Punt J: pubmed articles
63
Bibliography

64
9. Comparative tolerability profiles of oral antidiabetic agents:Krentz AJ,Ferner
RE, Bailey CJ: pubmed articles
10. Formulation and evaluation of bilayer tablets of Metformin HCl :
Jayaprakash.s, mohamed halith.s
11. Comparison of repaglinide and metformin combination tablet versus
repaglinide and metformin as separate tablets in healthy volunteers : Xu Hongfei
12. Development and evaluation of two layered tablet of glimepiride and
metformin hydrochloride for the treatment of hyperglycemia : S. Mohideen1,
T.Satyanarayana1, P. Suresh Kumar1, S. Navneetha Krishnan1,R. Mahalaxmi2, S.
Pavani1
13. formulation and evaluation of mucoadhesive microcapsules of metformin hcl
with gum karaya : ashok kumar.a*1, balakrishna.t1, rajiv jash1, t.e.g.k murthy2,
anil kumar.a3 and b. sudheer4
14. formulation and evaluation of sustained release bilayer tablets of metformin hcl
and pioglitazone hcl : n.n.rajendra, r.natarajan r. subashini, hitesh patel
15. Formulation and Evaluation of Transdermal Patch of Repaglinide : Shailesh T.
Prajapati, Charmi G. Patel, and Chhagan N. Patel
16. Design and evaluation of mucoadhesive microspheres of repaglinide for oral
controlled release : Vimal K. Yadav1*, Brajesh Kumar1, S.K. Prajapati 1, Kausar
shafaat1

65
17.Lucile Packard childrens hospital at Stanford:Overview of Diabetes from healthy
library
18.Over view on Diabetes :National Diabetes Information Clearinghouse (NDIC)
19.Over view on Diabetes : WebMD
20.Drugs for diabetes: Diabetic Mediterranean Diet
21.Hope for diabetics: New drug increases body’s ability to lower blood sugar: Express
India.com
22.From Medscape Diabetes & Endocrinology Major Milestones in Diabetes: 2010
23.June 29, 2006 Pharmaceuticals Diabetes: A 21st Century Epidemic by Morgan
Stanley
24.Overview on Type 2 Diabetes: About drugs.com
25.Type 2 Diabetes Mellitus : Romesh Khardori, MD, PhD, FACP; Chief Editor:
George T Griffing from web MD
26.International journal of drug discovery and herbal res earch (ijddhr) 1(1): jan-mar:
(2011), 1-4; bilayer tablet formulation of metformin hydrochloride and glimepiride: a
novel approach to improve therapeutic efficacy by durga prasad pattanayak
27.Invited articles jan 2012 vol 60; Gopi Krishna Panickera, Dilip R Karnada,b,
Vaibhav Salvia, Snehal Kotharia reviewed Cardiovascular Risk of Oral Antidiabetic
Drugs: Current Evidence and Regulatory Requirements for New Drugs.

66
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