Dr Muhammad Saadat

Diabetes MellitusA World wide epidemic : 

10/9/2009 Diabetes MellitusA World wide epidemic FROM: DR. MUHAMMAD SAADAT BUSINESS MANAGER, SQUARES, HIMONT PHARMACEUTICALS (PVT.) LTD., KARACHI, PAKISTAN

NIDDM A MAJOR PROBLEM : 

NIDDM A MAJOR PROBLEM Type 2 diabetes constitutes about 85%-95% of all diabetes in developed countries and even higher percentage in developing countries.

SULPHONYLUREAS : 

SULPHONYLUREAS “In NIDDM patients, the gold standard over the years has been sulfonylureas” REF: * Asia Pacific Diabetes Experts Meeting Barcelona 1998

1st & 2nd GENERATION SULPHONYLUREAS : 

1st & 2nd GENERATION SULPHONYLUREAS Gliclazide Insulin Release Pattern Cannot achieve an ideal physiological insulin release due to sharp rise and sharp decline in Insulin secretion. Tolbutamide Insulin Release Pattern

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10/9/2009 HIMONTPROUDLY INTRODUCESPamaryl Glimepiride 3rd and The Latest Generation of SUs R “To suit your patients’ changing physiological needs”

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Tight Glycemic control while Changing Insulin Requirements “Blood glucose levels are Closely regulated in health despite the varying demands of food, fasting & exercise”.** * Walter & Israel ** P.K (Second edition) Less insulin is required More insulin is required Less insulin is required Following overnight fast Post prandial Exercise

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Provides control with less insulin Endogenous Insulin secretion (U/ml) Blood glucose decrease (%) Diabetes Research & clinical practice 28 suppl. (1995) S115- S137 High insulin levels with other sulfonylureas are responsible for Early secondary failure High risk of hypoglycemia Cardiovascular complications Glimepiride Pamaryl 10 8 6 4 2 0 5 10 15 20 25 Glipizide 180  g/kg PO (n=13) Gliclazide 180  g/kg PO (n=14) 0.11 Pl.BG ratio 0.07 Pl.BG ratio 0.03 Pl.BG ratio Pamaryl 90  g/kg PO (n=16)

High Cardiac Safety : 

High Cardiac Safety Pamaryl is highly specific for Pancreas B-cells and does not effect the cardiovascular K+-ATP channels, thus providing high cardiac safety. % CV events Glimepiride Pamaryl

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â Provides glycemic control to suit your patients’ changing physiological needs Rapid Onset of Action Tight Glycemic Control Reduced Risk of Hypoglycemia Insulin Saving Effect Cardiovascular Friendly True Once Daily Dose

Thank You : 

Thank You

Back Up Slides : 

Back Up Slides

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Insulin sensitising effects Pamaryl increases the action of insulin at both receptor & post receptor site Insulin mimetic effects Pamaryl increases the number of GLUT4 transport molecules. Glucagon Pamaryl has a reduced effect on the release of insulin antagonist glucagon. Pronounced extra pancreatic effects INSULIN SAVING EFFECT glimepiride Pamaryl

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Unique Mode Of Action Continuos on & off mechanism Different binding site at B-cell receptors. 2.5 times greater association to receptors. 8-9 times rapid dissociation from binding proteins. glimepiride Pamaryl 24 hours glycemic control with reduced risk of hypoglycemia

Diabetes Mellitus : 

Diabetes Mellitus Definition Diabetes mellitus is a metabolic disease characterized by Hyperglycemia Resulting from defects in insulin secretion , insulin action or both. Classification of Diabetes Mellitus (IDDM) or type I (NIDDM) or type II Gestational diabetes ( during pregnancy)

WHY ALARMING INCREASE IN DIABETES IN DEVELOPING COUNTRIES : 

WHY ALARMING INCREASE IN DIABETES IN DEVELOPING COUNTRIES Urbanization Population aging Unhealthy diet Obesity Sedentary life-style IDF

Type II Diabetes : 

Type II Diabetes Causes of hyperglycemia in NIDDM. Impaired insulin secretion from pancreas Increased glucose production in liver. Increased resistance resulting decreased uptake of glucose by muscles and adipose tissues.

KEY ISSUES IN TYPES 2 DIABETES MANAGEMENT : 

KEY ISSUES IN TYPES 2 DIABETES MANAGEMENT Early Patient identification. To achieve optimal glycemic control in newly diagnosed, switchover and combination therapy patients. To prevent long term complications of diabetes. Ongoing patients monitoring & life style management.

Management of Type II Diabetes : 

Management of Type II Diabetes Objectives HbA1c < 6.5% FBS < 110 mg/dl 2hrs PP < 145 mg/dl Lifestyle modifications Diet , Discipline Therapeutics (Next Slide)

Therapeutics : 

Therapeutics

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1st & 2nd GENERATION SULPHONYLUREAS More side effects Frequent episodes of hypoglycemia Early secondary failure Insulin resistance Cardiac effects Weight gain Poor compliance (2 to 3 doses a day)

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Glimepiride responds to changing physiological needs REF: Annals of Pharmacotherapy 1997;31:671-676. Gabriel. E . Sonnenberg Post prandial: 25% increase in post prandial insulin release Fasting: No clinically meaningful increase in fasting insulin Exercise: Brings the physiological response to exercise closer to normal Glimepiride restores physiological insulin release pattern

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The Highest Quality Glimepiride PAMARYL R

FACTORS AFFECTING THE EFFICACY OF ORAL DOSAGE FORMS : 

FACTORS AFFECTING THE EFFICACY OF ORAL DOSAGE FORMS FACTORS Physical Characteristics of raw material Chemical Characteristics of raw material Purity Stereo-chemical Compositions Auxiliaries Dissolution rate An ideal oral dosage form should have 100% dissolution in 30 minutes. CLINICAL IMPLICATIONS Impact on Clinical effect Impact on Clinical effect Safety, Tolerability &disintegration rate Rate of absorption & clinical effect

SOME FACTS ON PAMARYL : 

SOME FACTS ON PAMARYL High Quality Raw Material sourcing (identical, physical, chemical & stereo-chemical characteristics to Brand leader). Auxilaries from European sources Formulation developed over 6 months period yielding identical disintegration/dissolution characteristics to Brand Leader.

HIGH QUALITY RAW : 

HIGH QUALITY RAW PARAMETERS Amaryl Pamaryl Micronization 10 microns 10 microns *Cis-Glimepiride <0.5% <0.5% (In-active form) Trans-Glimepiride 98.5% 98.5% (Active form) +- 0.4% +-0.4% Total Impurities <1.5% 1.5% (Cis+sulphonamide) *(Some marketed Glimepiride products contain up to 20% of Cis-form). R

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Quality Comparison of Amaryl Raw Material by IR

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Quality Comparison of Pamaryl Raw Material by IR

Quality Comparison of Pamaryl with Other Brands : 

Quality Comparison of Pamaryl with Other Brands * Range 95-105% R

Pamaryl Vs AmarylDISSOLUTION TIME : 

Pamaryl Vs AmarylDISSOLUTION TIME R %

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High Quality Product Superior service package for patients & physicians Cost effective WHY PAMARYL R

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Diabetes Detection Drives HbA1c Programs Local/Foreign Speaker Programs Latest medical journals/articles on diabetes from Himont IDIS. Continuous Medical Education Programs Staged Diabetes Management for physicians Lifestyle management program for patients (Pamaryl Club) Patient awareness booklets and movies SUPERIOR SERVICES PACKAGE