BIOPHARMACEUTICS
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| 🇬🇧 | 🇬🇧 |
| It includes the color, density, hardness, and melting and boiling points. | Physical properties |
| Describes its "potential" to undergo some chemical change or reaction by virtue of its composition. | Chemical properties |
| Produces blood levels similar to those produced by intramuscularly administered sodium ampicillin or ampicillin trihydrate | Oral amoxicillin |
| Bioavailability may be measured based on selected __ measurements to reflect the rate and extent to which __ becomes available to employ its desired therapeutic effect at the intended site of action. | PK (pharmacokinetic), API (Active Pharmaceutical Ingredient) |
| Fate of the drug: | Liberation Absorption Distribution Metabolism Elimination Response/Reuptake Toxicity |
| The study of pharmacokinetics involve these approaches: | 1 Experimental approach 2 Theoretical approach |
| 1 Experimental Approach vs 2 Theoretical Approach | 1 Development of biologic sampling techniques Analytical methods for the measurement of drugs and metabolites Procedures that facilitate data collection and manipulation 2 Development of pharmacokinetic models that predict drug disposition after drug administration (math and computer techniques are heavily utilized) |
| Differentiate In Vitro from In Vivo studies | An in vitro study occurs in a controlled environment, such as a test tube or petri dish. In In Vivo, It refers to tests, experiments, and procedures that researchers perform in or on a whole living organism, such as a person, laboratory animal, or plant. |
| In vivo is Latin for | “within the living.” |
| Biopharmaceutics involves factors that influence | The design of the drug product Stability of the drug within the drug product The manufacture of the drug product The release of the drug from the drug product The rate of dissolution/release of the drug at the absorption site Delivery of drug to the site of action |
| The fraction (or percentage) of the administered dose of drug that reaches the systemic circulation | Bioavailability |
| API + PA (excipients) will affect __ | The final drug product’s performance |
| The study of Pk differences of drugs in various population groups is termed __ | Population pharmacokinetics |
| Involves measuring plasma antibiotic concentrations at a specific time in a dosing regimen and dosing in special populations - To individualize dosing | Dose optimization |
| PK is also applied to __ for very potent drugs such as those with a narrow therapeutic range, in order to optimize efficacy and to prevent any adverse toxicity. | Therapeutic drug monitoring (TDM) |
| In Pk, Some drugs frequently monitored: | 1 aminoglycosides (kidney injury, hearing impairment and vestibular toxicity) 2 anticonvulsants,(phenytoin) 3 cancer chemotherapy drugs |
| An important element in determining individual or population pk, drug concentrations are measured in the ff Samples: | 1 Milk 2 Saliva 3 Plasma (most common) 4 Urine |
| The fraction (or percentage) of the administered dose of drug that reaches the systemic circulation | Bioavailability |
| Serves as an important DIAGNOSTIC TOOL in the clinical evaluation of patients treated with critical-dose drugs | Drug concentration monitoring |
| Sampling of biologic specimens METHODS | 1 Invasive methods - Blood - Spinal fluid - Synovial fluid - Tissue biopsy, or any biologic material that requires parenteral of surgical intervention in the patient 2 Non-invasive methods - Urine - Saliva - Feces - Expired air - Or any biologic material that can be obtained without parenteral or surgical intervention |
| An indirect method to ascertain the bioavailability of the drug - Rate and extent of drug excreted in urine reflects the rate and extent of systemic drug absorption | Measurement of drugs in urine |
| Reflect drug that has not been absorbed after an oral dose or drug that has been expelled by biliary secretion after systemic absorption. | Measurement in feces |
| Approximates the free drug rather than Cp because only free drug diffuses into the saliva | Drug levels in saliva |
| A helpful method to detect overdosing of legal medications, poisoning or substance of abuse (opiates) . | Forensic drug measurements |
| It is the most direct approach to assessing the Pk of the drug in the body | Measurement of drug and metabolite concentrations (levels) in the Blood Serum, or Plasma |
| 1 Obtained by venous puncture and contains anticoagulant such as heparin or EDTA 2 Component: | 1 Whole blood 2 All the cellular and protein elements of blood |
| 1 The liquid obtained from whole blood after it is allowed to clot and the clot is removed 2 Component: | 1 Serum 2 Does not contain cellular elements, fibrinogen, or the other clotting factors from the blood |
| 1 The liquid supernatant obtained after centrifugation of non-clotted whole blood that contains an anticoagulant 2 Component: | 1 Plasma 2 It is the noncellular liquid fraction of whole blood and contains all the proteins including albumin |
| Plasma vs Serum | 1 Plasma is the liquid, cell-free part of blood that has been treated with ANTI-COAGULANTS 2 Serum is the liquid part of the blood AFTER COAGULATION, therefore devoid of clotting factors as fibrinogen |
| Why are drug concentrations more often measured in plasma rather than whole blood or serum? | It is the most direct approach to assess the pk of drug in the body PLASMA perfuses all the tissues of the body, including the cellular elements in the blood Small molecules in the blood are carried thru the plasma Changes in the drug concentration in plasma will reflect changes in tissue drug concentrations. Measuring the plasma drug level is a responsive method of monitoring the course of therapy. |
| What is the relationship of drug concentrations to drug response? | The measurement of drug concentrations confirms effect of the drug dose |
| Drug in blood exists in two forms: | Bound and unbound. A drug's efficiency may be affected by the degree to which it binds to the proteins within blood plasma. The less bound a drug is, the more efficiently it can traverse cell membranes or diffuse. |
| 1 Common blood proteins that drugs bind to are: 2 Act as transporters | 1 human serum albumin, lipoprotein, glycoprotein, and α, β‚ and γ globulins. 2 enzyme, proteins etc |
| What is the differences between the concentrations in the plasma of? 1 Bound drug 2 Unbound drug | . 1 Take too long to effect and may accumulate and cause toxicity 2 Gives therapeutic effect |
| Benzodiazepines duration in: 1 Urine 2 Oral Fluid 3 Hair | . 1) 1-14 days 2) 0-36 hours 3) 7 - 90 days |
| What is the Importance of Monitoring the plasma drug concentrations? | 1 Compliance monitoring 2 Individualizing therapy – during early therapy and during dosage changes 3 Diagnosing under-treatment 4 Avoiding toxicity 5 Monitoring and detecting drug interactions 6 Guiding withdrawal of therapy - allow for the adjustment of the drug dosage - to individualize and optimize therapeutic drug regimens. - When there is alterations in physiologic functions, monitoring may provide a guide to the progress of the disease state - enable the investigator to modify the drug dosage accordingly. |
| It is generated by obtaining the drug concentration in plasma samples taken at various time intervals after a drug product is administered. | Plasma drug concentrations - Time Curve |
| In the graph, As the drug reaches the general systemic circulation, plasma drug concentrations will __ | Rise up to a maximum |
| Is the difference between the onset time and the time for the drug to decline back to MEC | Duration of drug action |
| The MAXIMUM and MINIMUM drug concentrations achieved during repeated dosing cycles | Peak and trough concentrations |
| The difference between peak drug concentration and MEC | Intensity of pharmacologic effect |
| Is the concentration between MEC and MTC | Therapeutic window |
| The ratio between the toxic and therapeutic dose. | Therapeutic index |
| The time of maximum drug concentration in the plasma; is the rough average rate of drug absorption | Peak plasma level time |
| Is related to the dose, the rate constant for absorption, and the elimination constant of the drug. | Peak plasma level (Cmax) |
| Is the time of maximum drug concentration in the plasma and is a rough marker of average rate of drug absorption | Time for peak plasma level (Tmax) |
| API + PA (excipients) will affect __ | The final drug product’s performance |
| Involves measuring plasma antibiotic concentrations at a specific time in a dosing regimen and dosing in special populations - To individualize dosing | Dose optimization |
| PK is also applied to __ for VERY POTENT DRUGS such as those with a NARROW therapeutic range, in order to optimize efficacy and to prevent any adverse toxicity. | Therapeutic drug monitoring (TDM) |
| Serves as an important DIAGNOSTIC TOOL in the clinical evaluation of patients treated with critical-dose drugs | Drug concentration monitoring |
| It is generated by obtaining the drug concentration in plasma samples taken at VARIOUS TIME INTERVALS after a drug product is administered. | Plasma drug concentrations - Time Curve |
| The MAXIMUM and MINIMUM drug concentrations achieved during repeated dosing cycles | Peak and trough concentrations |
| Is the difference between the ONSET TIME and the time for the drug to decline back to MEC | Duration of drug action |
| The difference between PEAK DRUG concentration and MEC | Intensity of pharmacologic effect |
| Is related to the dose, the rate constant for absorption, and the elimination constant of the drug. | Peak plasma level (Cmax) |
| Rate constants TWO PARAMETERS | 1 Fluid Volume that will dilute the drug (v) 2 Elimination rate of drug (k) per unit of time |
| Why use Pharmacokinetic models? | 1 To stimulate the RATE PROCESS of drug ADME to predict drug concentration in the body 2 Predict plasma, tissue, and urine drug level with any dosage regimen 3 Calculate the optimum dosage regimen for each patient individually 4 Estimate the possible accumulation of drugs and metabolites 5 Correlate drug concentration with pharmacologic or toxicologic activity 6 Evaluate differences in the rate or extent of availability between formulations (bioequivalence) 7 describe how changes in physiology or disease affect the absorption, distribution or elimination of the drug 8 explain drug interaction |
| Rate constants TWO PARAMETERS | 1 Fluid Volume that will dilute the drug (v) 2 Elimination rate of drug (k) per unit of time |
| Types of Pharmacologic Models | 1 Empirical Models 2 Physiologically based models 3 Compartment models |
| A model which is EXPERIENCE-BASED practical but not useful | Empirical model |
| A model which is used for concentrations of drug in the LIVER but have limitations | Physiologically-based models |
| A model which is used as representation; simple and useful | Compartment models |
| Compartment models TYPES | 1 Caternary models 2 Mamillary models 3 Physiologic Pk models |
| Are used to represent the overall rate processes of drug entry into and exit from the compartment | Rate constants |
| Drug can move between the central/plasma compartment to ad from the tissue compartment. Drug in central compartment + Drug in tissue compartment = Total Amount of Drug | Two-Compartment Model |
| Rate constants TWO PARAMETERS | 1 Fluid Volume that will dilute the drug (v) 2 Elimination rate of drug (k) per unit of time |