How drugs work? Or How do they  ‘know’  to go from my stomach to my head and not my foot?
Basic Biopharmaceutics The Adventure Begins
Objective of Drug Therapy <ul><li>To deliver the right drug, in the right concentration, to the right site of action and a...
Clinical Trials <ul><li>10-15 years from lab to US patients </li></ul><ul><li>Only 1 in 5000 compounds make it to human te...
 
Generic Medications <ul><li>Patent on parent agent </li></ul><ul><li>Hatch-Waxman Act 1984 </li></ul><ul><li>Pharmaceutica...
Types of Drug Action <ul><li>React physically </li></ul><ul><li>React chemically </li></ul><ul><li>Modify metabolic activi...
Receptors  <ul><li>Cellular material at the site of action </li></ul><ul><li>Lock & key </li></ul><ul><ul><li>Agonist </li...
Concentration & Effect <ul><li>Blood concentration – time profile </li></ul><ul><ul><li>MEC minimum effective concentratio...
….OR  <ul><li>The time taken for 50% of the drug to be eliminated </li></ul><ul><li>The time taken for the drug concentrat...
 
 
Bioequivalence Terms <ul><li>Bioavailability </li></ul><ul><li>Bioequivalency </li></ul><ul><li>Pharmaceutical equivalent ...
Pharmacokinetics  Pharmacodynamics <ul><li>How a drug Moves </li></ul><ul><li>What the body does to a drug </li></ul><ul><...
Absorption  Distribution <ul><li>Gastric emptying </li></ul><ul><li>Intestinal movement rate </li></ul><ul><li>Blood flow ...
Metabolism  Excretion <ul><li>Liver </li></ul><ul><ul><li>Enzyme induction </li></ul></ul><ul><ul><li>Enzyme inhibition </...
Factors Affecting Drug Response <ul><li>Age </li></ul><ul><li>Gender </li></ul><ul><li>Pregnancy </li></ul><ul><li>Genetic...
Adverse Drug Reactions <ul><li>CNS effects </li></ul><ul><li>Hepatotoxicity </li></ul><ul><li>Hypersensitivity or Allergy ...
Drug-Drug Interactions Urinary Re-absorption Enzyme inhibition Gastric pH Intestinal Metabolism GFR Renal Secretion Enzyme...
Drug-Diet Interactions Specific Foods Protein Inc.GFR Dec.reabsorption Dec.secretion in the kidney Food Mix Protein Carboh...
Drug Disease States Hypo- Hyper- Effect on drug elimination Effect on plasma protein binding Creatinine levels Cardiovascu...
<ul><li>Types of drug action </li></ul><ul><ul><li>Receptors </li></ul></ul><ul><ul><li>Concentration & effect </li></ul><...
Precipitating Event 1 st  Week SRJC Professional Program <ul><li>35yr old, average wt to ht male presents to clinic with f...
<ul><li>MED List:  APAP 1000mg qid prn HA,  Mylanta prn gastritis, Inderal 20mg BID, </li></ul><ul><li>OTC herbal aphrodis...
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Basic biopharmaceutics, pharmacokinetics, pharmacodynamics

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Basic biopharmaceutics, pharmacokinetics, pharmacodynamics

  1. 1. How drugs work? Or How do they ‘know’ to go from my stomach to my head and not my foot?
  2. 2. Basic Biopharmaceutics The Adventure Begins
  3. 3. Objective of Drug Therapy <ul><li>To deliver the right drug, in the right concentration, to the right site of action and at the right time to produce the desired effect. </li></ul><ul><li>(of course in the right patient!) </li></ul>
  4. 4. Clinical Trials <ul><li>10-15 years from lab to US patients </li></ul><ul><li>Only 1 in 5000 compounds make it to human testing </li></ul><ul><li>Only 1 in 5 tested in humans is approved </li></ul><ul><li>Testing Phases in Humans </li></ul><ul><ul><li>Phase I (ADME) </li></ul></ul><ul><ul><li>Phase II (w/dz) </li></ul></ul><ul><ul><li>Phase III (Special study) </li></ul></ul><ul><ul><li>Phase IV (post-mkt) </li></ul></ul>
  5. 6. Generic Medications <ul><li>Patent on parent agent </li></ul><ul><li>Hatch-Waxman Act 1984 </li></ul><ul><li>Pharmaceutical Co </li></ul><ul><ul><li>ANDA filed with FDA </li></ul></ul><ul><ul><ul><li>Bioequivalent </li></ul></ul></ul><ul><ul><ul><li>Labeling Review </li></ul></ul></ul><ul><li>Pharmaceutically equiv. </li></ul><ul><li>Therapeutically equiv. </li></ul>
  6. 7. Types of Drug Action <ul><li>React physically </li></ul><ul><li>React chemically </li></ul><ul><li>Modify metabolic activity & enzyme systems </li></ul><ul><li>Change osmolarity of blood </li></ul><ul><li>Interfere with normal cell function </li></ul><ul><li>Modify ion channels </li></ul><ul><li>Modify creation, release or control of neurotransmitters or hormones </li></ul>
  7. 8. Receptors <ul><li>Cellular material at the site of action </li></ul><ul><li>Lock & key </li></ul><ul><ul><li>Agonist </li></ul></ul><ul><ul><li>Antagonist </li></ul></ul><ul><li>The Love Cocktail </li></ul>
  8. 9. Concentration & Effect <ul><li>Blood concentration – time profile </li></ul><ul><ul><li>MEC minimum effective concentration </li></ul></ul><ul><ul><li>MTC minimum toxic concentration </li></ul></ul><ul><ul><li>Onset of action </li></ul></ul><ul><ul><li>Therapeutic window </li></ul></ul><ul><ul><li>Duration of action </li></ul></ul><ul><ul><li>Half-life </li></ul></ul><ul><ul><ul><li>The time taken for the drug </li></ul></ul></ul><ul><ul><ul><li>Concentration to decline by 50% </li></ul></ul></ul>Time Blood level
  9. 10. ….OR <ul><li>The time taken for 50% of the drug to be eliminated </li></ul><ul><li>The time taken for the drug concentration to fall to half the original value </li></ul><ul><ul><li>After 4 half lives, elimination is 94% complete </li></ul></ul><ul><ul><li>After 7 half lives, elimination is 99% complete </li></ul></ul><ul><ul><li>After 1 half life, elimination is_____complete </li></ul></ul>
  10. 13. Bioequivalence Terms <ul><li>Bioavailability </li></ul><ul><li>Bioequivalency </li></ul><ul><li>Pharmaceutical equivalent </li></ul><ul><li>Pharmaceutical alternative </li></ul><ul><li>Therapeutic equivalent </li></ul>
  11. 14. Pharmacokinetics Pharmacodynamics <ul><li>How a drug Moves </li></ul><ul><li>What the body does to a drug </li></ul><ul><li>ADME </li></ul><ul><ul><li>Absorption </li></ul></ul><ul><ul><li>Distribution </li></ul></ul><ul><ul><li>Metabolism </li></ul></ul><ul><ul><li>Excretion </li></ul></ul><ul><li>Diffusion </li></ul><ul><ul><li>Passive diffusion </li></ul></ul><ul><ul><li>Active transport </li></ul></ul><ul><li>How a drug Behaves </li></ul><ul><li>What the drug does to the body </li></ul><ul><ul><li>Beneficial </li></ul></ul><ul><ul><li>Toxic </li></ul></ul>
  12. 15. Absorption Distribution <ul><li>Gastric emptying </li></ul><ul><li>Intestinal movement rate </li></ul><ul><li>Blood flow rate </li></ul><ul><li>Permeability of tissue membranes </li></ul><ul><li>Protein binding </li></ul>
  13. 16. Metabolism Excretion <ul><li>Liver </li></ul><ul><ul><li>Enzyme induction </li></ul></ul><ul><ul><li>Enzyme inhibition </li></ul></ul><ul><li>Gall bladder </li></ul><ul><ul><li>Stores metabolites </li></ul></ul><ul><ul><li>Enterohepatic cycling </li></ul></ul><ul><li>First-Pass metabolism </li></ul><ul><li>Kidneys </li></ul><ul><ul><li>Nephron </li></ul></ul><ul><ul><li>Glomerular filtration rate </li></ul></ul>
  14. 17. Factors Affecting Drug Response <ul><li>Age </li></ul><ul><li>Gender </li></ul><ul><li>Pregnancy </li></ul><ul><li>Genetics </li></ul><ul><li>Body weight </li></ul><ul><li>Psychological factors </li></ul>
  15. 18. Adverse Drug Reactions <ul><li>CNS effects </li></ul><ul><li>Hepatotoxicity </li></ul><ul><li>Hypersensitivity or Allergy </li></ul><ul><li>GI effects </li></ul><ul><li>Nephrotoxicity </li></ul><ul><li>Hematological effects </li></ul><ul><li>Drug dependence </li></ul><ul><li>Teratogenicity </li></ul><ul><li>Carcinogenicity </li></ul><ul><li>Idiosyncrasy </li></ul>
  16. 19. Drug-Drug Interactions Urinary Re-absorption Enzyme inhibition Gastric pH Intestinal Metabolism GFR Renal Secretion Enzyme induction Displacemt and effect Binding in GIT GI empty Excretion Metabolism Distribution Absorption
  17. 20. Drug-Diet Interactions Specific Foods Protein Inc.GFR Dec.reabsorption Dec.secretion in the kidney Food Mix Protein Carbohydrate Fat Calories Food Hi fat meals Level of nourishment AdminTime Gastric emptying Gastric motility Dosage form Interacting chemically Excretion Metabolism Distribution Absorption
  18. 21. Drug Disease States Hypo- Hyper- Effect on drug elimination Effect on plasma protein binding Creatinine levels Cardiovascular Disorders Decrease Blood Flow erratic absorptn liver metabolm Cirrhosis Obstructive jaundice Acute viral hepatitis Thyroid Renal Circulatory Hepatic
  19. 22. <ul><li>Types of drug action </li></ul><ul><ul><li>Receptors </li></ul></ul><ul><ul><li>Concentration & effect </li></ul></ul><ul><ul><li>Pharmacokinetics & dynamics </li></ul></ul><ul><ul><ul><li>Absorption, distribution,metabolism, excretion </li></ul></ul></ul><ul><ul><ul><li>Factors affecting drug responses </li></ul></ul></ul><ul><li>Adverse drug reactions </li></ul><ul><ul><li>Interactions </li></ul></ul><ul><li>CASE STUDY! </li></ul>Summary Slide
  20. 23. Precipitating Event 1 st Week SRJC Professional Program <ul><li>35yr old, average wt to ht male presents to clinic with facial flushing, anxiety, palpitations, mild temporal HA </li></ul><ul><li>Hx: S/P Hep C in remission </li></ul><ul><li>Personal Hx: unremarkable </li></ul><ul><li>Social Hx: smokes ½ ppd, coffee 4-6 cups </li></ul><ul><li>Drinks tangerine juice with a splash of lime </li></ul><ul><li>VS: BP 146/90 P 99 T normal </li></ul>
  21. 24. <ul><li>MED List: APAP 1000mg qid prn HA, Mylanta prn gastritis, Inderal 20mg BID, </li></ul><ul><li>OTC herbal aphrodisiac </li></ul><ul><li>Dx: anxiety reaction frequently ppts migraine </li></ul><ul><li>POINTS TO PONDER </li></ul><ul><ul><li>Treatment plan? </li></ul></ul><ul><ul><li>Lifestyle modifications? </li></ul></ul><ul><ul><li>Pharmacokinetics? </li></ul></ul><ul><ul><li>Factors altering drug response? </li></ul></ul>

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