INFLUENCE OF AYURVEDIC ANTIDIABETIC AGENT ON THE PHARMACODYNAMICS OF GLIMEPIRIDEJing Zang
The present study is planned to explore the influence of ayurvedic antidibetic drug Madhumehari on the pharmacodynamics of glimepiride. Wistar albino rats of either sex were induced diabetes with alloxan and were used. The study was done in two phases, acute phase and chronic phase. In acute phase the diabetic rats were divided into six groups each consisting of 6. The diabetic control (Group-I) was treated with 0.5%W/V CMC suspension orally. To the diabetic group II, III and IV glimepiride 4mg/kg body wt, madhumehari 100mg/kg body wt. and madhumehari 200mg/kg body wt. were administered orally respectively. Groups V and VI were given orally the combination of glimepiride 4mg/kg body wt + madhumehari 100mg/kg body wt and glimepiride 4mg/kg body wt + madhumehari 200mg/kg body wt. In chronic study the protocol was similar to that of acute study but treatment was given for 7 days. Blood samples were collected from retro orbital plexus at predetermined time intervals for serum glucose level estimation after the oral dosing of glimepiride. The combination of glimepiride + madhumehari has shown antidiabetic activity at 3rd hour. Glimepiride when administered along with madhumehari 100 & 200mg orally the fall in serum glucose level was found to be more significant when compared with the per se treatment of glimepiride, madhumehari 100 & 200mg in both acute and chronic studies. From the above study it may be concluded that there is additive type of Pharmacodynamic interaction is possible between glimepiride and madhumehari.
Background and aim: Diabetes Mellitus [DM] is a metabolic disorder characterized by disturbances in carbohydrate, protein and lipid metabolism and by complications like micro vascular (retinopathy, neuropathy and nephropathy) and macro vascular (heart attack,stroke and peripheral vascular disease) complications. Coriandrum sativum Linn has been claimed to possess antidiabetic properties in Traditional System of Medicine. This study aimed to evaluate molecular interaction of linalool in C.sativum and targeted protein related to Type 2 DM.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
Protein and peptide drug delivery system (PPDDS)Sagar Savale
Protein and Peptide drug delivery system are the Novel drug Delivery
System. Proteins and peptides are the most abundant components of
biological cells. They exist functioning such as enzymes, hormones, structural element and immunoglobulin.
INFLUENCE OF AYURVEDIC ANTIDIABETIC AGENT ON THE PHARMACODYNAMICS OF GLIMEPIRIDEJing Zang
The present study is planned to explore the influence of ayurvedic antidibetic drug Madhumehari on the pharmacodynamics of glimepiride. Wistar albino rats of either sex were induced diabetes with alloxan and were used. The study was done in two phases, acute phase and chronic phase. In acute phase the diabetic rats were divided into six groups each consisting of 6. The diabetic control (Group-I) was treated with 0.5%W/V CMC suspension orally. To the diabetic group II, III and IV glimepiride 4mg/kg body wt, madhumehari 100mg/kg body wt. and madhumehari 200mg/kg body wt. were administered orally respectively. Groups V and VI were given orally the combination of glimepiride 4mg/kg body wt + madhumehari 100mg/kg body wt and glimepiride 4mg/kg body wt + madhumehari 200mg/kg body wt. In chronic study the protocol was similar to that of acute study but treatment was given for 7 days. Blood samples were collected from retro orbital plexus at predetermined time intervals for serum glucose level estimation after the oral dosing of glimepiride. The combination of glimepiride + madhumehari has shown antidiabetic activity at 3rd hour. Glimepiride when administered along with madhumehari 100 & 200mg orally the fall in serum glucose level was found to be more significant when compared with the per se treatment of glimepiride, madhumehari 100 & 200mg in both acute and chronic studies. From the above study it may be concluded that there is additive type of Pharmacodynamic interaction is possible between glimepiride and madhumehari.
Background and aim: Diabetes Mellitus [DM] is a metabolic disorder characterized by disturbances in carbohydrate, protein and lipid metabolism and by complications like micro vascular (retinopathy, neuropathy and nephropathy) and macro vascular (heart attack,stroke and peripheral vascular disease) complications. Coriandrum sativum Linn has been claimed to possess antidiabetic properties in Traditional System of Medicine. This study aimed to evaluate molecular interaction of linalool in C.sativum and targeted protein related to Type 2 DM.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
Protein and peptide drug delivery system (PPDDS)Sagar Savale
Protein and Peptide drug delivery system are the Novel drug Delivery
System. Proteins and peptides are the most abundant components of
biological cells. They exist functioning such as enzymes, hormones, structural element and immunoglobulin.
Pharmacokinetics and pharmacodynamics of Biotechnological drugs-SnehalTidke
Pharmacokinetics and pharmacodynamics of biotechnological drugs along with appliations- Proteins and peptides, monoclonal antibodies, oligonucleotides, gene therapy and vaccines
Protein and peptide drug delivery systemSagar Savale
Protein and Peptide drug delivery system are the Novel drug Delivery System. Proteins and peptides are the most abundant components of biological cells. They exist functioning such as
enzymes, hormones, structural element and immunoglobulin. The distinction between peptides and proteins is having a peptide contains less than 20 amino acids, having a molecular weight less, while a protein possesses 50 or more amino acids and its molecular weight lies above this value. The most of pharmaceutical proteins and peptides are absorbed IM, IV and Subcutaneous route of Absorption, but the oral route is more convenient for absorption of protein as compared to other. Various problems associated with administration of protein and peptide drugs are needed to overcome by different pharmaceutical approaches. Several approaches available for
maximizing pharmacokinetic and pharmacodynamics properties are chemical modification,
formulation vehicles, mucoadhesive polymeric system, use of enzyme inhibitors, absorption
enhancers, penetration enhancers etc.
proteins are chains of amino acids, each joined to it
neighbor by a specific type of covalent bond. The
polymerization of L-α-amino acids by peptide
bonds forms the structural framework of proteins. The
term protein is used for molecules composed of over 50
amino acids. The term peptide is used for molecules
composed of less than 50 amino acids.
The chemical and structural complexities involved
demand an effective delivery system in which the
physicochemical and biologic properties, including
molecular size, conformational stability, solubility,
sensitivity to light, moisture and heat, biological half-life,
immunogenicity, dose requirements, susceptibility to
break down in both physical and biological environments,
requirement for specialized mechanisms for transport
across biological membranes are to be considered.
Peptide and Protein Structure
It is essential to have an idea about structure of protein
and peptide in order to deal with various problems
encountered while developing drug delivery system.
The proteins are relatively large molecules with complex
structure. The peptide chains in peptides and proteins are
seldom linear and adapt a variety of specific folded three
dimensional patterns and conformations.
All peptides and proteins are polymers of amino acids
connected via amide linkages referred to as peptide
bonds.
• Primary structure: It denotes the number and
specific sequence of amino acids.
• Secondary structure: Arrangement of individual
amino acids along the polypeptide backbone.
• Tertiary structure: Three dimensional
arrangement of a single protein molecule.
• Quaternary structure: Proteins that contain two
or more polypeptide chains associated by noncovalent
forces
discusses about the interaction of certain drugs with some food materials and explains in detail about the effect of food on absorption, distribution, metabolism and excretion. Also dicsussed about the pharmacodynamic and pharmacogenomic aspects
What is Pharmacovigilance ?
It is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse reaction with pharmaceutical products.
"Pharmacovigilance”
( Pharmakon - drug + vigilare - to keep watch)
Aim and Scope
Patient care • to improve patient care & safety in relation to medicines & all medical & para-medical interventions
Public health • to improve public health & safety in relation to the use of medicines in public health
Risk benefit assessment • to contribute to the assessment of benefit, harm, effectiveness and risk of medicines risk benefit assessment
Communication • to promote understanding, clinical training & effective communication to health professionals & the public
Pharmacokinetics and pharmacodynamics of Biotechnological drugs-SnehalTidke
Pharmacokinetics and pharmacodynamics of biotechnological drugs along with appliations- Proteins and peptides, monoclonal antibodies, oligonucleotides, gene therapy and vaccines
Protein and peptide drug delivery systemSagar Savale
Protein and Peptide drug delivery system are the Novel drug Delivery System. Proteins and peptides are the most abundant components of biological cells. They exist functioning such as
enzymes, hormones, structural element and immunoglobulin. The distinction between peptides and proteins is having a peptide contains less than 20 amino acids, having a molecular weight less, while a protein possesses 50 or more amino acids and its molecular weight lies above this value. The most of pharmaceutical proteins and peptides are absorbed IM, IV and Subcutaneous route of Absorption, but the oral route is more convenient for absorption of protein as compared to other. Various problems associated with administration of protein and peptide drugs are needed to overcome by different pharmaceutical approaches. Several approaches available for
maximizing pharmacokinetic and pharmacodynamics properties are chemical modification,
formulation vehicles, mucoadhesive polymeric system, use of enzyme inhibitors, absorption
enhancers, penetration enhancers etc.
proteins are chains of amino acids, each joined to it
neighbor by a specific type of covalent bond. The
polymerization of L-α-amino acids by peptide
bonds forms the structural framework of proteins. The
term protein is used for molecules composed of over 50
amino acids. The term peptide is used for molecules
composed of less than 50 amino acids.
The chemical and structural complexities involved
demand an effective delivery system in which the
physicochemical and biologic properties, including
molecular size, conformational stability, solubility,
sensitivity to light, moisture and heat, biological half-life,
immunogenicity, dose requirements, susceptibility to
break down in both physical and biological environments,
requirement for specialized mechanisms for transport
across biological membranes are to be considered.
Peptide and Protein Structure
It is essential to have an idea about structure of protein
and peptide in order to deal with various problems
encountered while developing drug delivery system.
The proteins are relatively large molecules with complex
structure. The peptide chains in peptides and proteins are
seldom linear and adapt a variety of specific folded three
dimensional patterns and conformations.
All peptides and proteins are polymers of amino acids
connected via amide linkages referred to as peptide
bonds.
• Primary structure: It denotes the number and
specific sequence of amino acids.
• Secondary structure: Arrangement of individual
amino acids along the polypeptide backbone.
• Tertiary structure: Three dimensional
arrangement of a single protein molecule.
• Quaternary structure: Proteins that contain two
or more polypeptide chains associated by noncovalent
forces
discusses about the interaction of certain drugs with some food materials and explains in detail about the effect of food on absorption, distribution, metabolism and excretion. Also dicsussed about the pharmacodynamic and pharmacogenomic aspects
What is Pharmacovigilance ?
It is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse reaction with pharmaceutical products.
"Pharmacovigilance”
( Pharmakon - drug + vigilare - to keep watch)
Aim and Scope
Patient care • to improve patient care & safety in relation to medicines & all medical & para-medical interventions
Public health • to improve public health & safety in relation to the use of medicines in public health
Risk benefit assessment • to contribute to the assessment of benefit, harm, effectiveness and risk of medicines risk benefit assessment
Communication • to promote understanding, clinical training & effective communication to health professionals & the public
Pharma cokinetics of drugs assignment helpNicole Valerio
This assignment is aiming to identify and discuss pharma cokinetics of drugs given to a patient suffering from asthma, GERD and hypothyroidism. Case study is already been given, drugs given to the patient are protonix, synthroid and metaclopromide.
Catharanthus roseus Combination Therapy with Orthodox Oral Hypoglycemic Drugs...Ram Sahu
Most of the chronic diseases including diabetes mellitus are difficult to treat successfully with orthodox drugs. Investigation in complementary and alternative medicines is now being intensified to proffer lasting solution. Natural products and their derivatives may be considered as a potential source of novel compounds which can combine with orthodox drugs to enhance their hypoglycemic effect. To investigate the complementary and synergistic effect of Catharanthus roseus (C. roseus) leaves extract with oral hypoglycemic synthetic drugs sulphonylurea (glibenclamide) and biguanide (metformin). Experimental induction of diabetes in rats using alloxan model was employed. Five rats each of six groups were used. Group I received distilled water only. Groups II, III and IV received 250 mg/kg of methanol extract, 100 mg/kg of biguanide (metformin) and 1 mg/kg of sulphonylurea (glibenclamide), respectively. Groups V and VI received extract-metformin and extract-glibenclamide combination at doses as above, respectively. Administration of the six groups was carried out once daily for seven days. At 2, 12, 24, 72 and 168 h, fasting blood glucose was determined using a glucometer. When compared with control alone, all medicaments significantly (p<0.05) lowered blood glucose levels. The highest percentage reduction in blood glucose (64.9%) occurred with extract-biguanide (metformin) combination. The leaves extract of C. roseus – biguanide (metformin) combination offered a promising novel approach to diabetes mellitus treatment.
Obesity is a multifactorial disorder of energy balance, in which long-term calorie intake exceeds energy output. The generally accepted benchmark is the body mass index (BMI).
ABSTRACT
Over the last decade, diabetes mellitus has emerged as an important clinical and public health
problem throughout the world. The aim of the study is perceive the Potentiality of a newer oral
Antihyperglycemic combination therapy over conventional therapy in type 2 diabetes. The
prospective study was conducted over a period of six months in the department of Medicine,
Guntur City Hospital. The prevalence of type2 diabetes was high in male 65.79 % than female
34.21%. Majority of the patients (23.68 %) belonged to age group of 51–55 years. Majority of
patients (55.26%) having a family history of Diabetes. Majority of patients receiving Combination
of Glibenclamide + Metformin (60.53%), evaluated for effect on FPG for both combinations. The
mean changes in FPG were noted. In the same way effect on HbA1c also noted. Mean changes in
for every month HbA1c will be noted. Our study reveals that Combination therapy with Metformin
plus Glimepiride is more effective than Glibenclamide plus Metformin; in improving glycemic
control in type 2 diabetes, while also allowing a reduction of the dosage of each drug.
Metformin 500mg tablets smpc taj pharmaceuticalsTaj Pharma
Metformin Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Metformin Dosage & Rx Info | Metformin Uses, Side Effects -: Indications, Side Effects, Warnings, Metformin - Drug Information - Taj Pharma, Metformin dose Taj pharmaceuticals Metformin interactions, Taj Pharmaceutical Metformin contraindications, Metformin price, Metformin Taj Pharma Metformin 500mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Metformin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
FORMULATION DEVELOPMENT AND EVALUATION OF CARVEDILOL PHOSPHATE GASTRO RETENTI...
A study on metfromin
1. Terzetto Pharma Metrics Private Limited
A study on Me
(1, 1-Dimethylbiguanide
reported adverse events as observed in
Eudravigilance database
Contract Research Organization
NIVETHA CHELLAPATHY
07.07.2016
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A study on Metformin
Dimethylbiguanidemonohydrochloride)
reported adverse events as observed in
Eudravigilance database
Contract Research Organization / Terzetto Pharma Metrics
CHELLAPATHY AND BANU PRIYA
Main, Horamavu, Bangalore 560043
monohydrochloride)
reported adverse events as observed in
3. Terzetto Pharma Metrics Private Limited
A study on Metformin (1, 1
monohydrochloride) reported adverse events as observed in
Eudravigilance database
Abstract
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose
To study the adverse reaction reported for metformin in different type of SOC (System
Organ Classification). Method :
Database of suspected adverse drug reaction reports. These data are segregated into
individual cases and cases based on reaction groups such as age, sex, group and
geographic origin.
Introduction
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma gluc
Reference source not found.
Terzetto Pharma Metrics Private Limited | 142/2,2nd
Main, Horamavu, Bangalore 560043
| www.tpmet.com
A study on Metformin (1, 1-Dimethylbiguanide
monohydrochloride) reported adverse events as observed in
Eudravigilance database
antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose
o study the adverse reaction reported for metformin in different type of SOC (System
Method : Data was extracted and complied from the European
Database of suspected adverse drug reaction reports. These data are segregated into
individual cases and cases based on reaction groups such as age, sex, group and
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma gluc
Reference source not found.)
.
Main, Horamavu, Bangalore 560043
Dimethylbiguanide
monohydrochloride) reported adverse events as observed in
antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose. Objective :
o study the adverse reaction reported for metformin in different type of SOC (System
ata was extracted and complied from the European
Database of suspected adverse drug reaction reports. These data are segregated into
individual cases and cases based on reaction groups such as age, sex, group and
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma glucose(
Error!
4. Terzetto Pharma Metrics Private Limited
Therapeutic Class: Biguanides
Chemical Name: 1, 1-Dimethylbiguanide monohydrochloride
Molecular Formula: C4H
Mechanism of action
Metformin decreases hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and
utilization.
Pharmacokinetics
The absolute bioavailability of a Metformin
fasting conditions is approximately 50% to 60%.Food decreases the extent of and slightly
delays the absorption of Metformin. 90% of the absorbed drug is eliminated via the renal
route within the first 24 hours, with
hours. In blood, the elimination half
source not found.)
.
In 1957, metformin was studied in several trials in
glucose in patients with type 2 diabetes.
Company and initially it was prescribed in
acidosis and deaths increased, Metformin was removed from USA and many other
Terzetto Pharma Metrics Private Limited | 142/2,2nd
Main, Horamavu, Bangalore 560043
| www.tpmet.com
Biguanides
Dimethylbiguanide monohydrochloride
H11N5. HCI
Metformin decreases hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and
The absolute bioavailability of a Metformin hydrochloride 500 mg tablet given under
fasting conditions is approximately 50% to 60%.Food decreases the extent of and slightly
delays the absorption of Metformin. 90% of the absorbed drug is eliminated via the renal
route within the first 24 hours, with a plasma elimination half-life of approximately 6.2
hours. In blood, the elimination half-life is approximately 17.6 hours(
Error! Reference
studied in several trials in Paris and has shown to lower blood
glucose in patients with type 2 diabetes. Metformin was manufactured by small
and initially it was prescribed in France and Scotland. As number of lactic
increased, Metformin was removed from USA and many other
Main, Horamavu, Bangalore 560043
Metformin decreases hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and
hydrochloride 500 mg tablet given under
fasting conditions is approximately 50% to 60%.Food decreases the extent of and slightly
delays the absorption of Metformin. 90% of the absorbed drug is eliminated via the renal
life of approximately 6.2
Error! Reference
and has shown to lower blood
Metformin was manufactured by small France
As number of lactic
increased, Metformin was removed from USA and many other
5. Terzetto Pharma Metrics Private Limited
countries. Metformin was approved in Canada in 1972
found.)
, but did not receive approval by the
for type 2 diabetes until 1994.
Glucophage was the first branded formulation of metformin to be marketed in the United
States, beginning on March 3, 1995.
most influential has been the UK Pro
As a result, metformin rose
diabetes. The drug’s anti
confirmed. In 2012 diabetes
drug of the first choice for all
Manufacturer Information
Metformin hydrochloride
by Bristol Myers Squibb,
Pharm, Aurobindo Pharma Ltd
Ltd,Sandoz, Sun Pharm Inds
Inds (in),Ivax Sub Teva Pharms
Provident, Nostrum Pharms Llc
Ltd, Granules India, Sun Pharm Inds Inc
Pharms Inc, Glenmark Generics
Labs,Amneal Pharms Ny
Pharma, Sun Pharm Inds Ltd
Ltd, Takeda Pharms Use, Teva Pharms
Ab, and Merck Sharp Dohme
129 patent family members in 33 countries
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Main, Horamavu, Bangalore 560043
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Metformin was approved in Canada in 1972(
Error! Reference source not
but did not receive approval by the U.S. Food and Drug Administration
for type 2 diabetes until 1994. Produced under license by Bristol
Glucophage was the first branded formulation of metformin to be marketed in the United
States, beginning on March 3, 1995. Many studies were performed, and among them the
most influential has been the UK Prospective Diabetes study.
rose as the first choice of treatment for obese patient with type 2
The drug’s anti-atherosclerotic and cardio protective effects have b
diabetes experts in USA and Europe declared that metformin is the
drug of the first choice for all patients with type 2 diabetes(Error! Reference source not found.
Information
Metformin hydrochloride is the generic ingredient in sixteen branded drugs marketed
, Apotex, Ranbaxy Labs Ltd, Torrent Pharms
Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co
Sun Pharm Inds, Torrent Pharms Ltd, Teva, Atlas Pharms Llc
Ivax Sub Teva Pharms, Santarus Inc, Indicus Pharma, Impax Labs
Nostrum Pharms Llc, Zydus Pharms Use, Watson Labs Florida
Sun Pharm Inds Inc, Actavis Labs Fl Inc, Mylan Pharms
Glenmark Generics, Chartwell Life Sic, Andrx Labs Llc
Amneal Pharms Ny, Alkem, Zydus Hlthcare, Dr Reddys Labs Inc
Sun Pharm Inds Ltd, Inventia Hlthcare, Aurobindo, Macleods Pharms
Teva Pharms Use, Novo Nordisk Inc, Sb Pharmco
Merck Sharp Dohme, and is included in eigthy-five NDAs.. This ingredient has
129 patent family members in 33 countries(
Error! Reference source not found.
Main, Horamavu, Bangalore 560043
Error! Reference source not
Food and Drug Administration (FDA)
Bristol-Myers Squibb,
Glucophage was the first branded formulation of metformin to be marketed in the United
ormed, and among them the
as the first choice of treatment for obese patient with type 2
effects have been
experts in USA and Europe declared that metformin is the
Error! Reference source not found.)
.
is the generic ingredient in sixteen branded drugs marketed
Torrent Pharms, Mylan , Torrent
Cspc Ouyi Pharm Co, Ipca Labs
Atlas Pharms Llc, Sun Pharm
Impax Labs, Elizabeth,
Watson Labs Florida, Barr,Lupin
Mylan Pharms Inc,Sciegen
Andrx Labs Llc, Watson
Dr Reddys Labs Inc, Marksans
Macleods Pharms
Sb Pharmco, Astrazeneca
. This ingredient has
Error! Reference source not found.)
.
6. Terzetto Pharma Metrics Private Limited
Current patent holders
Ranbaxy Laboratories Limited, New Delhi
source not found.)
Torrent Pharm,Ahmedabad
Takeda pharms, USA – May 12, 2009
Pharmacoeconomics
Records of the Drug Controller General (India) show that between 1961 and February
2013, approved a total of 1,125 FDC formulations. The first metformin FDC was
approved in November 1996. Since then, of the 42 anti
metformin formulations.
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
1,144 anti-diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/57
anti-diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
anti-diabetes SDFs.
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
1,144 anti-diabetes products in the market. Of these, 575 we
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
anti-diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
anti-diabetes SDFs(
Error! Reference source not found.
Terzetto Pharma Metrics Private Limited | 142/2,2nd
Main, Horamavu, Bangalore 560043
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Current patent holders
Ranbaxy Laboratories Limited, New Delhi-Patent NO : 6559187(
Error! Refere
Ahmedabad – Approval date Dec,30 /2009
May 12, 2009
Records of the Drug Controller General (India) show that between 1961 and February
2013, approved a total of 1,125 FDC formulations. The first metformin FDC was
approved in November 1996. Since then, of the 42 anti-diabetes FDCs approved, 25 are
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/57
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
Error! Reference source not found.)
.
Main, Horamavu, Bangalore 560043
Error! Reference
Records of the Drug Controller General (India) show that between 1961 and February
2013, approved a total of 1,125 FDC formulations. The first metformin FDC was
diabetes FDCs approved, 25 are
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
diabetes products in the market. Of these, 575 were FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
Data from ‘PharmaTrac’ (November 2007 to October 2012) however revealed as many as
re FDC and 569 were ‘Single
Dose Formulations’ (SDF). Metformin FDCs comprised 93 per cent (536/575) of the
diabetes FDCs and metformin SDFs comprised only 22 per cent (123/569) of the
7. Terzetto Pharma Metrics Private Limited
Indian data shows that metformin FDCs dominated over metformin SDFs by a ratio of
3:1 between the years 2007
diabetes drugs sold in volume.
In 2012, annual sales volume of metformin FDCs is 455.4(millions of unit), but SDFs
sales volume is 148.0(millions of units). Countries like England and Australia
(15.60) annual sale is more than the FDCs annual sale (0.30)
not found.)
.
Data collection
The drug substance information was extracted and compiled from the European database
of suspected adverse drug reaction report
information on metformin was updated within years 2013 to 2016.
The information available in the above website was collected from adverse drug reactions
of substances, stating the data available for
individual cases and cases based on reaction groups such as age, sex, reporter group and
geographic origin.
Interpretation
Based on the data collected from the European database of suspected adverse drug
reaction of Metformin, 15,375 ADR cases
group between 18-64 yrs (
More female patients (51.1%) had experienced adverse drug
(43.5%). Among these cases
ADR than European economic area
Terzetto Pharma Metrics Private Limited | 142/2,2nd
Main, Horamavu, Bangalore 560043
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Indian data shows that metformin FDCs dominated over metformin SDFs by a ratio of
3:1 between the years 2007-’12. In 2012, metformin FDCs comprised 56% of oral
diabetes drugs sold in volume.
In 2012, annual sales volume of metformin FDCs is 455.4(millions of unit), but SDFs
sales volume is 148.0(millions of units). Countries like England and Australia
15.60) annual sale is more than the FDCs annual sale (0.30)(
Error! Reference source
The drug substance information was extracted and compiled from the European database
of suspected adverse drug reaction reports (website: www.adrreports.eu). The
information on metformin was updated within years 2013 to 2016.
The information available in the above website was collected from adverse drug reactions
of substances, stating the data available for metformin. The data w
individual cases and cases based on reaction groups such as age, sex, reporter group and
Based on the data collected from the European database of suspected adverse drug
15,375 ADR cases have been reported. Among these cases, age
yrs (39.5%) and 65-85 yrs (40.9%) maximum cases was reported.
51.1%) had experienced adverse drug reaction than
43.5%). Among these cases non-European economic area (54.3%)
ADR than European economic area(
Error! Reference source not found.
Main, Horamavu, Bangalore 560043
Indian data shows that metformin FDCs dominated over metformin SDFs by a ratio of
’12. In 2012, metformin FDCs comprised 56% of oral
In 2012, annual sales volume of metformin FDCs is 455.4(millions of unit), but SDFs
sales volume is 148.0(millions of units). Countries like England and Australia SDFs
Error! Reference source
The drug substance information was extracted and compiled from the European database
s (website: www.adrreports.eu). The
The information available in the above website was collected from adverse drug reactions
The data was segregated into
individual cases and cases based on reaction groups such as age, sex, reporter group and
Based on the data collected from the European database of suspected adverse drug
been reported. Among these cases, age
maximum cases was reported.
reaction than male patients
has reported more
Error! Reference source not found.)
.
8. Terzetto Pharma Metrics Private Limited
System Organ Classification:
SOC is the highest level of
retrieval. There are 26 SOC.
Etiology (e.g., SOC
Manifestation site (e.g., SOC
Purpose (e.g., SOC
The total Number of cases reported is 34,819.
Classification(SOC), Metabolism and nutrition disorders was found to have reported the
maximum number of cases
age group between
group(54.08%)reported more cases than male patient group(41.20%).
reporting group is HCP(85.50%).The highest frequency of cases was reported from
European Economic area(57.60%).
Second SOC with maximum number of adr reported was General disorders and
administration site conditions, in which more cases reported in age group between 18
64 years 1,320(42.7%) and female
than male patients (42.60%)
non- HCP (26.98%).The highest frequency of cases was reported form Non European
Economic area (66.87%).
In Gastrointestinal Disorder
cases are reported in age group between 18
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System Organ Classification:
is the highest level of the hierarchy that provides the broadest concept for data
There are 26 SOC. SOCs comprise groupings by:
Etiology (e.g., SOC Infections and infestations)
Manifestation site (e.g., SOC Gastrointestinal disorders)
Purpose (e.g., SOC Surgical and medical procedures)
The total Number of cases reported is 34,819.Among 26
Metabolism and nutrition disorders was found to have reported the
maximum number of cases 6,961, in which maximum number of cases
age group between 18-64 years 3,494(50%) and also female patient
group(54.08%)reported more cases than male patient group(41.20%).
reporting group is HCP(85.50%).The highest frequency of cases was reported from
a(57.60%).
Second SOC with maximum number of adr reported was General disorders and
administration site conditions, in which more cases reported in age group between 18
64 years 1,320(42.7%) and female patients (52.76%) reported maximum number of cases
42.60%).Healthcare Professional (70.65%) is significantly high than
26.98%).The highest frequency of cases was reported form Non European
In Gastrointestinal Disorder, 3048 cases were reported. Among the
cases are reported in age group between 18-64 years. Female patients
Main, Horamavu, Bangalore 560043
the hierarchy that provides the broadest concept for data
Among 26 System Organ
Metabolism and nutrition disorders was found to have reported the
maximum number of cases was reported in
and also female patient
group(54.08%)reported more cases than male patient group(41.20%).The highest
reporting group is HCP(85.50%).The highest frequency of cases was reported from
Second SOC with maximum number of adr reported was General disorders and
administration site conditions, in which more cases reported in age group between 18 –
52.76%) reported maximum number of cases
significantly high than
26.98%).The highest frequency of cases was reported form Non European
reported. Among them 1,378(45.21%)
64 years. Female patients group (58.53%) is
9. Terzetto Pharma Metrics Private Limited
significantly high than the male patients
reported by HCP and 56% of cases are reported
2,895 cases was reported in Investigational
under 18-64 years age group and 53.67% cases were reported in female patients
group.67.87% cases was reported by HCP and 1,994(68.87%) cases was reported from
Non European Economic area.
In Renal and Urinary disorders SOC
1,433(50.5%) cases are reported in age group between 64
groups(54%)was significantly high than the male patients group(42%).82.89% case
reported by HCP and 1,554(54.81%) cases was reported from European Economic area.
2,426 cases was reported in Nervous system disorder SOC, in which 1,051(43.32%) cases
reported in age group between 64
patients group and 1,788(73.70%) cases are reported by HCP. Non European Economic
area (57.79%) is highly significant than European Economic
In Injury, poisoning and procedural complications SOC, 2,084 c
them 50% cases are reported in age group between 18
(53.67%) are more significant than male
HCP and 68.52% cases are reported from Non European Economic area.
In Cardiac disorder and psychiatric disorder SOC
age group between 18 –
reported (46% and 49%) significant number of cases than male patient
reported by HCP and 68.5 % of cases are reported from Non European Economic area.
In Respiratory, thoracic and mediastinal disorder, Skin and subcutaneous tissue disorder
and Vascular disorder SOC, maximum number of cases are reported in age group
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significantly high than the male patients group (38.25%). 2,332(76.5%) cases was
reported by HCP and 56% of cases are reported from Non European Economic
2,895 cases was reported in Investigational SOC, in which 43.10% cases are reported
64 years age group and 53.67% cases were reported in female patients
67.87% cases was reported by HCP and 1,994(68.87%) cases was reported from
ropean Economic area.
In Renal and Urinary disorders SOC, 2835 cases were reported. Among them
1,433(50.5%) cases are reported in age group between 64-84 years. Female patients
groups(54%)was significantly high than the male patients group(42%).82.89% case
reported by HCP and 1,554(54.81%) cases was reported from European Economic area.
2,426 cases was reported in Nervous system disorder SOC, in which 1,051(43.32%) cases
reported in age group between 64 – 84 years. 55.31% cases are reported in female
patients group and 1,788(73.70%) cases are reported by HCP. Non European Economic
area (57.79%) is highly significant than European Economic area (42.20%).
In Injury, poisoning and procedural complications SOC, 2,084 cases are reported. Among
them 50% cases are reported in age group between 18-64 years.
53.67%) are more significant than male patients (38.77%).1, 655 cases are reported by
HCP and 68.52% cases are reported from Non European Economic area.
In Cardiac disorder and psychiatric disorder SOC, 43.1% and 59.8% cases are reported in
64 years respectively. In both SOC, Female patients group
46% and 49%) significant number of cases than male patient
ported by HCP and 68.5 % of cases are reported from Non European Economic area.
In Respiratory, thoracic and mediastinal disorder, Skin and subcutaneous tissue disorder
and Vascular disorder SOC, maximum number of cases are reported in age group
Main, Horamavu, Bangalore 560043
38.25%). 2,332(76.5%) cases was
European Economic area.
SOC, in which 43.10% cases are reported
64 years age group and 53.67% cases were reported in female patients
67.87% cases was reported by HCP and 1,994(68.87%) cases was reported from
reported. Among them
84 years. Female patients
groups(54%)was significantly high than the male patients group(42%).82.89% cases was
reported by HCP and 1,554(54.81%) cases was reported from European Economic area.
2,426 cases was reported in Nervous system disorder SOC, in which 1,051(43.32%) cases
. 55.31% cases are reported in female
patients group and 1,788(73.70%) cases are reported by HCP. Non European Economic
42.20%).
ases are reported. Among
64 years. Female patients
cases are reported by
HCP and 68.52% cases are reported from Non European Economic area.
59.8% cases are reported in
64 years respectively. In both SOC, Female patients group
46% and 49%) significant number of cases than male patients.80% cases are
ported by HCP and 68.5 % of cases are reported from Non European Economic area.
In Respiratory, thoracic and mediastinal disorder, Skin and subcutaneous tissue disorder
and Vascular disorder SOC, maximum number of cases are reported in age group
10. Terzetto Pharma Metrics Private Limited
between 18 – 64 years and 54.4% are reported in female patient group. Maximum
numbers of cases are reported by HCP in Non European Economic area.
In Blood and lymphatic system disorder and Infection and infestations
cases are reported in 65-84 years
49.5% cases are reported in male patients whereas in Infection and infestations 57.1
cases are reported in female patients. 65
and 73.7% cases are reported fro
In Eye disorder, Hepatobiliary disorder and Musculoskeletal and connective tissue
disorder 47.6% cases are reported in age group between 18
Musculoskeletal and connective tissue
patients group whereas in Hepatobiliary disorder maximum number of cases reported in
male patients group (48%). Maximum
European Economic area.
40-50% cases in Pregnancy, puerpe
medical procedures are reported in age group between 18
reported in female patients group.
European Economic area (
359 cases are reported in
polyps) SOC, in which 42.61% cases reported in 65
number of cases are reported both in male and female pa
reported by HCP. 74.9% cases reported from Non European Economic area.
Congenital, familial and genetic disorder, Endocrine disorder, Immune system disorder,
Product issues and Reproductive system and breast disorder in thes
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64 years and 54.4% are reported in female patient group. Maximum
reported by HCP in Non European Economic area.
In Blood and lymphatic system disorder and Infection and infestations, 51.7
84 years age group. In Blood and lymphatic system disorder
49.5% cases are reported in male patients whereas in Infection and infestations 57.1
are reported in female patients. 65 – 86% of reports were reported by HCP.53.7 %
are reported from Non European Economic area.
In Eye disorder, Hepatobiliary disorder and Musculoskeletal and connective tissue
disorder 47.6% cases are reported in age group between 18-64 years. In Eye disorder and
Musculoskeletal and connective tissue disorder 55.8% cases were reported in female
patients group whereas in Hepatobiliary disorder maximum number of cases reported in
48%). Maximum numbers of cases were reported by HCP from Non
50% cases in Pregnancy, puerperium and perinatal conditions and Surgical and
medical procedures are reported in age group between 18- 64 years and 68% cases
reported in female patients group. Maximum numbers of cases are reported by HCP. Non
area (68%) is highly significant than European Economic area.
359 cases are reported in Neoplasm, benign, malignant and unspecified(incl cysts and
polyps) SOC, in which 42.61% cases reported in 65-85 years age group and equal
number of cases are reported both in male and female patients group. 61% of cases are
74.9% cases reported from Non European Economic area.
, familial and genetic disorder, Endocrine disorder, Immune system disorder,
Product issues and Reproductive system and breast disorder in these SOC 41.8% cases
Main, Horamavu, Bangalore 560043
64 years and 54.4% are reported in female patient group. Maximum
reported by HCP in Non European Economic area.
, 51.7% and 41.3%
age group. In Blood and lymphatic system disorder
49.5% cases are reported in male patients whereas in Infection and infestations 57.1%
86% of reports were reported by HCP.53.7 %
In Eye disorder, Hepatobiliary disorder and Musculoskeletal and connective tissue
64 years. In Eye disorder and
% cases were reported in female
patients group whereas in Hepatobiliary disorder maximum number of cases reported in
reported by HCP from Non
rium and perinatal conditions and Surgical and
64 years and 68% cases
reported by HCP. Non
ficant than European Economic area.
, benign, malignant and unspecified(incl cysts and
85 years age group and equal
tients group. 61% of cases are
74.9% cases reported from Non European Economic area.
, familial and genetic disorder, Endocrine disorder, Immune system disorder,
e SOC 41.8% cases
11. Terzetto Pharma Metrics Private Limited
are reported in 18 – 64 years age group and significant number cases are reported in
female patients. Maximum
Familial and genetic disorder in
European Economic area.
Least number of cases reported in following SOCs ,
circumstances SOC, 43.7% and 50.6% cases are reported in 18
51.8% of cases are reported in female patients. Maximum
by HCP and 76.8% cases are reported from Non European Economic area.
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64 years age group and significant number cases are reported in
female patients. Maximum numbers of cases are reported by HCP. Except Congen
disorder in all SOC maximum number of cases reported from Non
European Economic area.
Least number of cases reported in following SOCs , Ear and labyrinth disorder and Social
circumstances SOC, 43.7% and 50.6% cases are reported in 18-64 years age group.
ses are reported in female patients. Maximum numbers of cases are
by HCP and 76.8% cases are reported from Non European Economic area.
Main, Horamavu, Bangalore 560043
64 years age group and significant number cases are reported in
reported by HCP. Except Congenital,
all SOC maximum number of cases reported from Non
Ear and labyrinth disorder and Social
64 years age group.
numbers of cases are reported
by HCP and 76.8% cases are reported from Non European Economic area.
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