ABSORPTION OF DRUGS FROM LUNGS.pptx
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The document summarizes key aspects of drug absorption from the lungs. It notes that the lungs have a large surface area and thin membrane barriers that facilitate rapid absorption of drugs into the bloodstream. Drugs can be inhaled as gases or aerosols. Absorption depends on factors like the drug's solubility in blood and the difference in its partial pressures in the alveoli and blood vessels. Macromolecules may be absorbed via active or passive transport through lung cells or spaces between cells.
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Gastrointestinal absorption of drugs
The document discusses gastrointestinal absorption of drugs. It describes the major absorption sites in the gastrointestinal tract as the stomach, small intestine, and large intestine. It then explains the various mechanisms of drug absorption including passive diffusion, carrier-mediated transport (facilitated diffusion and active transport), ionic diffusion, ion pair transport, and endocytosis. Carrier-mediated transport uses carrier proteins or enzymes to transport drugs against or along a concentration gradient. The small intestine is noted as the primary site of drug absorption due to its large surface area and longer transit time compared to other sites.
Drug Absorption from the Gastrointestinal Tract
Drug absorption from the gastrointestinal tract can be influenced by many factors. The drug must first disintegrate, dissolve, and permeate the gastrointestinal membranes before being absorbed into systemic circulation. The rate of absorption is determined by the slowest of these steps. Factors that can affect absorption include the drug's physicochemical properties, dosage form characteristics, and patient factors like gastrointestinal pH, transit time, and presence of food or enzymes. Understanding these biopharmaceutical factors is important for optimizing drug product design and therapeutic efficacy.
pH partition theory of drug absorption
The document discusses the pH partition theory of drug absorption from the gastrointestinal tract. The theory states that a drug's absorption is governed by its dissociation constant (pKa), the lipid solubility of its unionized form, and the pH of the absorption site. According to the theory, only the unionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its unionized form depends on the drug's pKa and the pH of the solution based on the Henderson-Hasselbalch equation. While the pH partition theory explains many observations, it has limitations such as not accounting for the presence of an unstirred water layer and virtual membrane pH at the absorption
Rate limiting steps in drug absorption [autosaved]
Rate limiting steps in drug absorption 1.Disintegration time
2.Dissolution and solubility
3.Physical and chemical nature of active drug substance
4.Nature of excipients
5.Method of granulation
6.Dissolution test conditions
7.Gastric emptying
Effects of Protein Binding
Extensive plasma protein binding causes drugs to remain primarily in the central blood compartment, resulting in lower volumes of distribution. The degree of protein binding affects the apparent volume of distribution and half-life of drugs. Drugs that strongly bind to plasma proteins like albumin tend to have lower volumes of distribution and longer half-lives compared to weaker binding drugs. Protein binding decreases the amount of free drug available for distribution to tissues and renal excretion, prolonging the drug's presence in the body. Liver and kidney diseases can impair protein synthesis and binding, altering the pharmacokinetics of drugs.
methods of determining drug absorption ppt
The document discusses various in vitro, in vivo, and in situ methods for determining drug absorption. In vitro methods include physicochemical techniques like measuring partition coefficients as well as more complex methods like using everted intestinal sacs or cell culture models. In vivo methods directly measure drug levels in blood/urine over time or indirectly via pharmacological response. In situ techniques simulate in vivo conditions by perfusing drug solutions through an intestinal segment while keeping the blood supply intact. The document provides detailed descriptions of techniques like the everted sac method, Caco-2 cell cultures, and Doluisio intestinal perfusion method.
c ADVANCED BIOPHARMACEUTICS AND PHARMACOKINETICS PRESENTATION BY- NARAYAN R K...
INTRODUCTION
Excretion is defined as the process whereby drugs and/or their metabolites are irreversibly transferred from internal to external environment.
Excretion of unchanged or intact drug is important in the termination of its pharmacological action.
The principal organs of excretion are kidneys. Excretion of drug by kidneys is called as renal excretion.
Excretion by organs other than kidneys such as lungs, biliary system, intestine, salivary glands and sweat glands is known as nonrenal excretion. Almost all drugs and their metabolites are excreted by the kidneys to some extent or the other.
Some drugs such as gentamicin are exclusively eliminated by renal route only.
Agents that are excreted in urine are –
1. Water-soluble.
2. Non-volatile.
3. Small in molecular size (less than 500 Daltons).
4. The ones that are metabolised slowly
The basic functional unit of kidney involved in excretion is the nephron. Each kidney comprises of one million nephrons.
Each nephron is made up of the glomerulus, the proximal tubule, the loop of Henle, the distal tubule and the collecting tubule.
Glomerular Filtration :
Glomerular filtration is a non-selective, unidirectional process whereby most compounds, ionised or unionised, are filtered except those that are bound to plasma proteins or blood cells and thus behave as macromolecules.
The driving force for filtration through the glomerulus is the hydrostatic pressure of the blood flowing in the capillaries. Out of the 25% of cardiac output or 1.2 litres of blood/min that goes to the kidneys via renal artery, only 10% or 120 to 130 ml/min is filtered through the glomeruli, the rate being called as the glomerular filtration rate (GFR).
The GFR can be determined by an agent that is excreted exclusively by filtration and is neither secreted nor reabsorbed in the tubules. The excretion rate value of such an agent is 120 to 130 ml/min. Creatinine, inulin, mannitol and sodium thiosulphate are used to estimate GFR of which the former two are widely used to estimate renal function.
Intranasal drug delivery system
Nasal drug delivery is a method of administering drugs through the nose for local or systemic effects. It avoids first-pass metabolism and provides rapid drug absorption. Liquid nasal formulations like solutions, suspensions, and sprays are most common. Powders can also be used with insufflators or dry powder inhalers. Various animal models are used to evaluate nasal absorption and bioavailability. Nasal delivery enhances drug bioavailability for molecules that are not well-absorbed orally.
Recommended
Gastrointestinal absorption of drugs
The document discusses gastrointestinal absorption of drugs. It describes the major absorption sites in the gastrointestinal tract as the stomach, small intestine, and large intestine. It then explains the various mechanisms of drug absorption including passive diffusion, carrier-mediated transport (facilitated diffusion and active transport), ionic diffusion, ion pair transport, and endocytosis. Carrier-mediated transport uses carrier proteins or enzymes to transport drugs against or along a concentration gradient. The small intestine is noted as the primary site of drug absorption due to its large surface area and longer transit time compared to other sites.
Drug Absorption from the Gastrointestinal Tract
Drug absorption from the gastrointestinal tract can be influenced by many factors. The drug must first disintegrate, dissolve, and permeate the gastrointestinal membranes before being absorbed into systemic circulation. The rate of absorption is determined by the slowest of these steps. Factors that can affect absorption include the drug's physicochemical properties, dosage form characteristics, and patient factors like gastrointestinal pH, transit time, and presence of food or enzymes. Understanding these biopharmaceutical factors is important for optimizing drug product design and therapeutic efficacy.
pH partition theory of drug absorption
The document discusses the pH partition theory of drug absorption from the gastrointestinal tract. The theory states that a drug's absorption is governed by its dissociation constant (pKa), the lipid solubility of its unionized form, and the pH of the absorption site. According to the theory, only the unionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its unionized form depends on the drug's pKa and the pH of the solution based on the Henderson-Hasselbalch equation. While the pH partition theory explains many observations, it has limitations such as not accounting for the presence of an unstirred water layer and virtual membrane pH at the absorption
Rate limiting steps in drug absorption [autosaved]
Rate limiting steps in drug absorption 1.Disintegration time
2.Dissolution and solubility
3.Physical and chemical nature of active drug substance
4.Nature of excipients
5.Method of granulation
6.Dissolution test conditions
7.Gastric emptying
Effects of Protein Binding
Extensive plasma protein binding causes drugs to remain primarily in the central blood compartment, resulting in lower volumes of distribution. The degree of protein binding affects the apparent volume of distribution and half-life of drugs. Drugs that strongly bind to plasma proteins like albumin tend to have lower volumes of distribution and longer half-lives compared to weaker binding drugs. Protein binding decreases the amount of free drug available for distribution to tissues and renal excretion, prolonging the drug's presence in the body. Liver and kidney diseases can impair protein synthesis and binding, altering the pharmacokinetics of drugs.
methods of determining drug absorption ppt
The document discusses various in vitro, in vivo, and in situ methods for determining drug absorption. In vitro methods include physicochemical techniques like measuring partition coefficients as well as more complex methods like using everted intestinal sacs or cell culture models. In vivo methods directly measure drug levels in blood/urine over time or indirectly via pharmacological response. In situ techniques simulate in vivo conditions by perfusing drug solutions through an intestinal segment while keeping the blood supply intact. The document provides detailed descriptions of techniques like the everted sac method, Caco-2 cell cultures, and Doluisio intestinal perfusion method.
c ADVANCED BIOPHARMACEUTICS AND PHARMACOKINETICS PRESENTATION BY- NARAYAN R K...
INTRODUCTION
Excretion is defined as the process whereby drugs and/or their metabolites are irreversibly transferred from internal to external environment.
Excretion of unchanged or intact drug is important in the termination of its pharmacological action.
The principal organs of excretion are kidneys. Excretion of drug by kidneys is called as renal excretion.
Excretion by organs other than kidneys such as lungs, biliary system, intestine, salivary glands and sweat glands is known as nonrenal excretion. Almost all drugs and their metabolites are excreted by the kidneys to some extent or the other.
Some drugs such as gentamicin are exclusively eliminated by renal route only.
Agents that are excreted in urine are –
1. Water-soluble.
2. Non-volatile.
3. Small in molecular size (less than 500 Daltons).
4. The ones that are metabolised slowly
The basic functional unit of kidney involved in excretion is the nephron. Each kidney comprises of one million nephrons.
Each nephron is made up of the glomerulus, the proximal tubule, the loop of Henle, the distal tubule and the collecting tubule.
Glomerular Filtration :
Glomerular filtration is a non-selective, unidirectional process whereby most compounds, ionised or unionised, are filtered except those that are bound to plasma proteins or blood cells and thus behave as macromolecules.
The driving force for filtration through the glomerulus is the hydrostatic pressure of the blood flowing in the capillaries. Out of the 25% of cardiac output or 1.2 litres of blood/min that goes to the kidneys via renal artery, only 10% or 120 to 130 ml/min is filtered through the glomeruli, the rate being called as the glomerular filtration rate (GFR).
The GFR can be determined by an agent that is excreted exclusively by filtration and is neither secreted nor reabsorbed in the tubules. The excretion rate value of such an agent is 120 to 130 ml/min. Creatinine, inulin, mannitol and sodium thiosulphate are used to estimate GFR of which the former two are widely used to estimate renal function.
Intranasal drug delivery system
Nasal drug delivery is a method of administering drugs through the nose for local or systemic effects. It avoids first-pass metabolism and provides rapid drug absorption. Liquid nasal formulations like solutions, suspensions, and sprays are most common. Powders can also be used with insufflators or dry powder inhalers. Various animal models are used to evaluate nasal absorption and bioavailability. Nasal delivery enhances drug bioavailability for molecules that are not well-absorbed orally.
Invitro invivo insitu method
This document discusses various in vitro, in vivo, and in situ methods used to study drug absorption. It describes several in vitro techniques like partition coefficient studies, artificial membrane models, and cell culture models. It also explains various in vivo methods like direct blood/urine sampling and indirect pharmacological response studies in animals. Finally, it covers in situ techniques like intestinal perfusion that better simulate in vivo conditions compared to in vitro models. The document provides detailed descriptions of specific methods like the everted sac technique, diffusion cell method, and stomach perfusion studies in rats.
Protein binding interactions
introduction
mechanisms of protein drug binding
binding of drugs
binding of drugs to blood components
determination of protein drug binding
factors affecting
significance
Pharmacokinetics I-ADME
Okay, let's solve this step-by-step:
1) Phenobarbital is a weak acid with pKa = 7.4
2) The pH of urine is 6.4
3) To calculate the percentage of ionized (A-) form, use the Henderson-Hasselbalch equation:
log([A-]/[HA]) = pKa - pH
4) pKa - pH = 7.4 - 6.4 = 1
5) antilog(1) = 10
6) Ratio of [A-]/[HA] = 10
7) [A-]/([A-] + [HA]) = 10/(10 + 1) = 10/11
8
solubility & Pka presentation
This document discusses key concepts in solubility and dissolution including:
- Definitions of solubility, saturated solutions, and intrinsic solubility. Solubility is affected by temperature, pressure, and particle size.
- The importance of solubility and dissolution in drug absorption and bioavailability. Modification techniques to improve solubility including changes in particle size, crystal habit, chemical modifications, and use of adjuvants.
- Explanations of partition coefficient (LogP/LogKo/w), pKa, and the Henderson-Hasselbalch equation and how they relate to a drug's ionization, absorption, and excretion. pKa indicates a drug's acid or base strength and ionized state
Clearance and renal excretion
The document discusses clearance and renal excretion of drugs. It defines clearance as the volume of fluid cleared of the drug per unit time. Renal clearance is the volume of plasma cleared of the drug by the kidneys per unit time. The kidney is the major organ of excretion. Renal clearance can provide information about the mechanisms of renal excretion such as filtration, secretion, and reabsorption. The clearance concept is used to describe the elimination of drugs by various organs.
Dissolution
This document discusses dissolution, which is defined as the process by which a solid substance solubilizes in a given solvent. Key points include:
- Drugs are classified into BCS classes based on their solubility and permeability. The four classes are high/high, high/low, low/high, and low/low.
- Noyes-Whitney and Hixson-Crowell equations describe dissolution kinetics under non-sink and sink conditions. Factors like surface area, diffusion coefficient, and concentration gradients impact dissolution rate.
- In vitro dissolution testing uses apparatus like baskets, paddles, and flow-through cells per BP and USP methods to simulate in vivo conditions and assess
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An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
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This document provides an overview of drug stability for a pharmaceutical chemistry and pharmaceutics course. It defines drug stability as the ability of a dosage form to maintain its physical, chemical, therapeutic, and microbial properties during storage and usage. It discusses factors that influence stability such as temperature, pH, moisture, light, and packaging. It also describes different types of instability like physical changes, chemical degradation through hydrolysis, oxidation, or isomerization, and microbial contamination. The document aims to help predict and ensure drug stability.
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Zero, First Order & Mixed Order Kinetic
Rates & Order Of Kinetics
Pharmacokinetic Models
Application Of Pharmacokinetic
Techniques for enhancement of dissolution rate
The document discusses various techniques to enhance the dissolution rate of drugs, which is important for predicting bioavailability. It describes the process of dissolution and factors that influence the rate based on the Noyes-Whitney equation. Several methods are covered, including increasing surface area through particle size reduction, using surfactants, solid dispersions, polymorphism, molecular encapsulation, salt formation, and nanosuspensions. Enhancing dissolution rate can improve drug efficacy by increasing bioavailability.
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This document discusses in vitro-in vivo correlations (IVIVCs). It defines IVIVC as a predictive mathematical model relating an in vitro property (e.g. dissolution rate) to an in vivo response (e.g. absorption rate). The document outlines the significance of IVIVCs in reducing bioequivalence studies and supporting biowaivers. It describes different levels of IVIVC (A, B, C) and parameters that can be correlated (dissolution rate to absorption rate; percent dissolved to percent absorbed). The document provides examples of IVIVC case studies and concludes that current regulatory guidelines only apply to oral dosage forms, while further research is needed to develop IVIVCs for other drug products.
Physiological factors of drug absorption
A presentation given by a group of students of Faculty of Pharmacy, University of Dhaka, Bangladesh.
This presentation discussed with different physiolgical factors of drug absorption, structure of membrane the drug crosses, different transport mechanism etc
Properties of GI tract, pH partition hypothesis
Drug absorption from the gastrointestinal (GI) tract depends on several physiological factors:
1) Gastric emptying and intestinal transit time influence drug absorption by determining how long drugs remain in areas where absorption can occur. Faster emptying and transit generally increase absorption rate.
2) Water fluxes in the GI tract can impact drug dissolution and movement within the lumen, affecting absorption. Considerable water is secreted in the small intestine and mostly reabsorbed.
3) The permeability of drugs is affected by their solubility, ionization state, and lipophilicity, which determine how well drugs can pass through membranes according to the pH partition hypothesis. However, the microclimate pH at the membrane surface can differ
Methods of Assessing Bioavailability
1. Measurement of Bioavailability:
Direct and indirect methods may be used to assess drug bioavailability. The in-vivo bioavailability of a drug product is demonstrated by the rate and extent of drug absorption, as determined by comparison of measured parameters, e.g., concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects.
For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
The design of the bioavailability study depends on the objectives of the study, the ability to analyze the drug (and metabolites) in biological fluids, the pharmacodynamics of the drug substance, the route of drug administration, and the nature of the drug product.
Pharmacokinetic and/or pharmacodynamic parameters as well as clinical observations and in-vitro studies may be used to determine drug bioavailability from a drug product.
1.1. Pharmacokinetic methods:
These are very widely used and based upon the assumption that the pharmacokinetic profile reflects the therapeutic effectiveness of a drug. Thus these are indirect methods. The two major pharmacokinetic methods are:
The major pharmacokinetic methods are:
Plasma / blood level time profile.
o Time for peak plasma (blood) concentration (t max)
o Peak plasma drug concentration (Cmax)
o Area under the plasma drug concentration–time curve (AUC)
Urinary excretion studies.
o Cumulative amount of drug excreted in the urine (Du)
o Rate of drug excretion in the urine (dDu/dt)
o Time for maximum urinary excretion (t)
C. Other biological fluids
1.2. Pharmacodynamic methods:
IT involves direct measurement of drug effect on a (patho) physiological process as a function of time. Disadvantages of it may be high variability, difficult to measure, limited choices, less reliable, more subjective, drug response influenced by several physiological & environmental factors.
They involve determination of bioavailability from:
Acute pharmacological response.
Therapeutic response.
1.3. In-vitro dissolution studies
Closed compartment apparatus
Open compartment apparatus
Dialysis systems.
1.4. Clinical observations
Well-controlled clinical trials
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This document discusses modified release drug products, including extended release and delayed release dosage forms. It defines modified release as altering the timing and/or rate of drug release. Extended release aims for twice daily dosing by providing continuous drug levels while delayed release releases the drug at a time other than promptly after administration. The document discusses various extended release drug delivery technologies like coated beads, multilayer tablets, microencapsulation, embedding in eroding matrices, plastic matrices, complexation, and osmotic pumps. It emphasizes the importance of in vitro-in vivo correlations and bioequivalence studies in evaluating these modified release products.
P h partition hypothesis
The document discusses the pH partition hypothesis, which states that the absorption of drugs across biomembranes is governed by the drug's dissociation constant (pKa), lipid solubility of the un-ionized form, and the pH of the absorption site. According to the hypothesis, only the un-ionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its un-ionized form can be calculated using the Henderson-Hasselbach equation based on the drug's pKa and the pH. However, the pH partition theory is an oversimplification and does not always accurately predict drug absorption behavior.
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Invitro invivo insitu method
This document discusses various in vitro, in vivo, and in situ methods used to study drug absorption. It describes several in vitro techniques like partition coefficient studies, artificial membrane models, and cell culture models. It also explains various in vivo methods like direct blood/urine sampling and indirect pharmacological response studies in animals. Finally, it covers in situ techniques like intestinal perfusion that better simulate in vivo conditions compared to in vitro models. The document provides detailed descriptions of specific methods like the everted sac technique, diffusion cell method, and stomach perfusion studies in rats.
Protein binding interactions
introduction
mechanisms of protein drug binding
binding of drugs
binding of drugs to blood components
determination of protein drug binding
factors affecting
significance
Pharmacokinetics I-ADME
Okay, let's solve this step-by-step:
1) Phenobarbital is a weak acid with pKa = 7.4
2) The pH of urine is 6.4
3) To calculate the percentage of ionized (A-) form, use the Henderson-Hasselbalch equation:
log([A-]/[HA]) = pKa - pH
4) pKa - pH = 7.4 - 6.4 = 1
5) antilog(1) = 10
6) Ratio of [A-]/[HA] = 10
7) [A-]/([A-] + [HA]) = 10/(10 + 1) = 10/11
8
solubility & Pka presentation
This document discusses key concepts in solubility and dissolution including:
- Definitions of solubility, saturated solutions, and intrinsic solubility. Solubility is affected by temperature, pressure, and particle size.
- The importance of solubility and dissolution in drug absorption and bioavailability. Modification techniques to improve solubility including changes in particle size, crystal habit, chemical modifications, and use of adjuvants.
- Explanations of partition coefficient (LogP/LogKo/w), pKa, and the Henderson-Hasselbalch equation and how they relate to a drug's ionization, absorption, and excretion. pKa indicates a drug's acid or base strength and ionized state
Clearance and renal excretion
The document discusses clearance and renal excretion of drugs. It defines clearance as the volume of fluid cleared of the drug per unit time. Renal clearance is the volume of plasma cleared of the drug by the kidneys per unit time. The kidney is the major organ of excretion. Renal clearance can provide information about the mechanisms of renal excretion such as filtration, secretion, and reabsorption. The clearance concept is used to describe the elimination of drugs by various organs.
Dissolution
This document discusses dissolution, which is defined as the process by which a solid substance solubilizes in a given solvent. Key points include:
- Drugs are classified into BCS classes based on their solubility and permeability. The four classes are high/high, high/low, low/high, and low/low.
- Noyes-Whitney and Hixson-Crowell equations describe dissolution kinetics under non-sink and sink conditions. Factors like surface area, diffusion coefficient, and concentration gradients impact dissolution rate.
- In vitro dissolution testing uses apparatus like baskets, paddles, and flow-through cells per BP and USP methods to simulate in vivo conditions and assess
IVIVC
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
Drug stability
This document provides an overview of drug stability for a pharmaceutical chemistry and pharmaceutics course. It defines drug stability as the ability of a dosage form to maintain its physical, chemical, therapeutic, and microbial properties during storage and usage. It discusses factors that influence stability such as temperature, pH, moisture, light, and packaging. It also describes different types of instability like physical changes, chemical degradation through hydrolysis, oxidation, or isomerization, and microbial contamination. The document aims to help predict and ensure drug stability.
PHARMACOKINETICS: BASIC CONSIDERATION & PHARMACOKINETIC MODELS
Plasma Drug Concentration Time Profile
Pharmacokinetic Parameter
Pharmacodynamic Parameter
Zero, First Order & Mixed Order Kinetic
Rates & Order Of Kinetics
Pharmacokinetic Models
Application Of Pharmacokinetic
Techniques for enhancement of dissolution rate
The document discusses various techniques to enhance the dissolution rate of drugs, which is important for predicting bioavailability. It describes the process of dissolution and factors that influence the rate based on the Noyes-Whitney equation. Several methods are covered, including increasing surface area through particle size reduction, using surfactants, solid dispersions, polymorphism, molecular encapsulation, salt formation, and nanosuspensions. Enhancing dissolution rate can improve drug efficacy by increasing bioavailability.
In-Vivo In-Vitro Correlation
This document discusses in vitro-in vivo correlations (IVIVCs). It defines IVIVC as a predictive mathematical model relating an in vitro property (e.g. dissolution rate) to an in vivo response (e.g. absorption rate). The document outlines the significance of IVIVCs in reducing bioequivalence studies and supporting biowaivers. It describes different levels of IVIVC (A, B, C) and parameters that can be correlated (dissolution rate to absorption rate; percent dissolved to percent absorbed). The document provides examples of IVIVC case studies and concludes that current regulatory guidelines only apply to oral dosage forms, while further research is needed to develop IVIVCs for other drug products.
Physiological factors of drug absorption
A presentation given by a group of students of Faculty of Pharmacy, University of Dhaka, Bangladesh.
This presentation discussed with different physiolgical factors of drug absorption, structure of membrane the drug crosses, different transport mechanism etc
Properties of GI tract, pH partition hypothesis
Drug absorption from the gastrointestinal (GI) tract depends on several physiological factors:
1) Gastric emptying and intestinal transit time influence drug absorption by determining how long drugs remain in areas where absorption can occur. Faster emptying and transit generally increase absorption rate.
2) Water fluxes in the GI tract can impact drug dissolution and movement within the lumen, affecting absorption. Considerable water is secreted in the small intestine and mostly reabsorbed.
3) The permeability of drugs is affected by their solubility, ionization state, and lipophilicity, which determine how well drugs can pass through membranes according to the pH partition hypothesis. However, the microclimate pH at the membrane surface can differ
Methods of Assessing Bioavailability
1. Measurement of Bioavailability:
Direct and indirect methods may be used to assess drug bioavailability. The in-vivo bioavailability of a drug product is demonstrated by the rate and extent of drug absorption, as determined by comparison of measured parameters, e.g., concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects.
For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
The design of the bioavailability study depends on the objectives of the study, the ability to analyze the drug (and metabolites) in biological fluids, the pharmacodynamics of the drug substance, the route of drug administration, and the nature of the drug product.
Pharmacokinetic and/or pharmacodynamic parameters as well as clinical observations and in-vitro studies may be used to determine drug bioavailability from a drug product.
1.1. Pharmacokinetic methods:
These are very widely used and based upon the assumption that the pharmacokinetic profile reflects the therapeutic effectiveness of a drug. Thus these are indirect methods. The two major pharmacokinetic methods are:
The major pharmacokinetic methods are:
Plasma / blood level time profile.
o Time for peak plasma (blood) concentration (t max)
o Peak plasma drug concentration (Cmax)
o Area under the plasma drug concentration–time curve (AUC)
Urinary excretion studies.
o Cumulative amount of drug excreted in the urine (Du)
o Rate of drug excretion in the urine (dDu/dt)
o Time for maximum urinary excretion (t)
C. Other biological fluids
1.2. Pharmacodynamic methods:
IT involves direct measurement of drug effect on a (patho) physiological process as a function of time. Disadvantages of it may be high variability, difficult to measure, limited choices, less reliable, more subjective, drug response influenced by several physiological & environmental factors.
They involve determination of bioavailability from:
Acute pharmacological response.
Therapeutic response.
1.3. In-vitro dissolution studies
Closed compartment apparatus
Open compartment apparatus
Dialysis systems.
1.4. Clinical observations
Well-controlled clinical trials
Modified release drug products
This document discusses modified release drug products, including extended release and delayed release dosage forms. It defines modified release as altering the timing and/or rate of drug release. Extended release aims for twice daily dosing by providing continuous drug levels while delayed release releases the drug at a time other than promptly after administration. The document discusses various extended release drug delivery technologies like coated beads, multilayer tablets, microencapsulation, embedding in eroding matrices, plastic matrices, complexation, and osmotic pumps. It emphasizes the importance of in vitro-in vivo correlations and bioequivalence studies in evaluating these modified release products.
P h partition hypothesis
The document discusses the pH partition hypothesis, which states that the absorption of drugs across biomembranes is governed by the drug's dissociation constant (pKa), lipid solubility of the un-ionized form, and the pH of the absorption site. According to the hypothesis, only the un-ionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its un-ionized form can be calculated using the Henderson-Hasselbach equation based on the drug's pKa and the pH. However, the pH partition theory is an oversimplification and does not always accurately predict drug absorption behavior.
Protein binding
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1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
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- 1. ABSORPTION OF DRUGS FROM LUNGS P:3 U:2 Vedanti S. Gharat T. Y. B. Sc. Biotechnology Roll No. - 20 Exam seat No. - 005018
- 2. INTRODUCTION • The lung is the only organ through which the entire cardiac output passes. • The lungs serve as a major site of administration for a number of agents given for both local and systemic effects. • Drugs can be inhaled as gases (e.g., volatile anesthetics) or as aerosols (suspended liquid droplets or solid particles).
- 4. • Before the inhaled drug can be absorbed into the blood from the lung periphery, it has several barriers to overcome: lung surfactant, surface lining fluid, epithelium, interstitium and basement membrane and the endothelium. • The number of alveoli ranges from 200 million to 600 million, resulting in an enormous epithelial surface area. • Absorption of agents from the lung is facilitated by the large surface area of the pulmonary alveolar membranes (50–100 m²), the limited thickness of these membranes (approximately 0.2 µ), and the high blood flow to the alveolar region. • Pulmonary absorption of volatile anesthetics across the alveolar–capillary barrier is very rapid because of the relatively high lipid–water partition coefficients an small molecular radii of such agents.
- 5. • The driving force for diffusion is a combination of the blood– air partition coefficient (which is a measure of the capacity of blood to dissolve drug) and the difference in partial pressure between the alveoli and the arterial and venous blood. • While these properties promote efficient gas exchange through passive transport, they also provide a mechanism for efficient drug delivery to the bloodstream. • Agents with high blood–air partition coefficients require more drug to be dissolved in the blood for equilibrium to be reached.
- 7. • Although the mechanism of absorption is unknown, it has been hypothesized that macromolecules either pass through the cells via absorptive transcytosis (adsorptive or receptor mediated), paracellular transport between bijunctions or trijunctions, or through large transitory pores in the epithelium caused by cell injury or apoptosis. • Thus, the high bioavailability of macromolecules deposited in the lung (10–200 times greater than nasal and gastrointestinal values) may be due to its 1. enormous surface area 2. very thin diffusion layer 3. slow surface clearance and 4. antiprotease defence system.
- 9. REFERENCE • Modern Pharmacology With Clinical Applications 5th edition book. • https://www.ncbi.nlm.nih.gov - Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications. • IMAGES were taken from Google.