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What condition is more dangerous due to its effects on ion and molecule balance?
What condition is more dangerous due to its effects on ion and molecule balance?
What is the correct definition of osmolarity?
What is the correct definition of osmolarity?
Which of the following variables influences osmotic pressure?
Which of the following variables influences osmotic pressure?
Which term refers to the concentration measured in moles per kilogram?
Which term refers to the concentration measured in moles per kilogram?
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What does the equation $c_{os} = \sum c \cdot n$ represent in terms of theoretical osmolarity?
What does the equation $c_{os} = \sum c \cdot n$ represent in terms of theoretical osmolarity?
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What is NOT allowed to come in contact with the HEPA filter?
What is NOT allowed to come in contact with the HEPA filter?
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What is the minimum distance required between essential materials within the LAC to prevent contamination?
What is the minimum distance required between essential materials within the LAC to prevent contamination?
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What should be done to prevent contamination of sterilized products?
What should be done to prevent contamination of sterilized products?
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Which of the following is part of the sterilization process mentioned?
Which of the following is part of the sterilization process mentioned?
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What is indicated when a filter seems blocked?
What is indicated when a filter seems blocked?
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What should be the source of heating mentioned in the content?
What should be the source of heating mentioned in the content?
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Which factors contribute to the prevention of pyrogens entering the product?
Which factors contribute to the prevention of pyrogens entering the product?
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What type of microorganisms are categorized as pyrogens?
What type of microorganisms are categorized as pyrogens?
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What does a buffer solution primarily maintain?
What does a buffer solution primarily maintain?
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Which method is commonly used to determine the amount of tonicity adjusting agent?
Which method is commonly used to determine the amount of tonicity adjusting agent?
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Which is the first step in adjusting tonicity for eye drops?
Which is the first step in adjusting tonicity for eye drops?
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In tonicity adjustment, what is the D-value (ΔT) for a 1% drug concentration that leads to a ΔT of 0.138?
In tonicity adjustment, what is the D-value (ΔT) for a 1% drug concentration that leads to a ΔT of 0.138?
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What is the average drug concentration mentioned in the prescription for Pilocarpine hydrochloride?
What is the average drug concentration mentioned in the prescription for Pilocarpine hydrochloride?
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The estimated D-value (ΔT) for the prescribed concentration indicates that the solution is:
The estimated D-value (ΔT) for the prescribed concentration indicates that the solution is:
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Which of the following best describes one of the methods for measuring tonicity adjustment?
Which of the following best describes one of the methods for measuring tonicity adjustment?
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What is the purpose of estimating the 'gap' in the process of tonicity adjustment?
What is the purpose of estimating the 'gap' in the process of tonicity adjustment?
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What condition affects the osmotic pressure of a solution?
What condition affects the osmotic pressure of a solution?
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What isotonicity value does lacrimal fluid and human blood correspond to?
What isotonicity value does lacrimal fluid and human blood correspond to?
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What is the value for isotonic solutions of sodium chloride in freezing-point depression calculations?
What is the value for isotonic solutions of sodium chloride in freezing-point depression calculations?
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What does a hypotonic solution typically have compared to an isotonic solution?
What does a hypotonic solution typically have compared to an isotonic solution?
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What freezing point depression value indicates a hypotonic solution?
What freezing point depression value indicates a hypotonic solution?
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Which of the following is essential for the compounding of eye drops?
Which of the following is essential for the compounding of eye drops?
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Which colligative property is essential for tonicity adjustment in solutions?
Which colligative property is essential for tonicity adjustment in solutions?
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What is a key characteristic of isotonic solutions relating to body fluids?
What is a key characteristic of isotonic solutions relating to body fluids?
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What is the isotonicity value that corresponds to lacrimal fluid and human blood?
What is the isotonicity value that corresponds to lacrimal fluid and human blood?
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Which of the following expresses a solution that is hypotonic?
Which of the following expresses a solution that is hypotonic?
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What does the equation ΔT = L_iso * c represent in the context of isotonic solutions?
What does the equation ΔT = L_iso * c represent in the context of isotonic solutions?
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What freezing point depression corresponds to isotonic solutions similar to body fluids?
What freezing point depression corresponds to isotonic solutions similar to body fluids?
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Which of the following solutions would be considered hypertonic?
Which of the following solutions would be considered hypertonic?
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In tonicity adjustment for eye drops, which property is essential for ensuring compatibility with body fluids?
In tonicity adjustment for eye drops, which property is essential for ensuring compatibility with body fluids?
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What happens to the freezing point of the body fluid when the delta T is equal to 0?
What happens to the freezing point of the body fluid when the delta T is equal to 0?
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To maintain isotonicity while compounding eye drops, which aspect is emphasized?
To maintain isotonicity while compounding eye drops, which aspect is emphasized?
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Which type of preparations must be pyrogen-free?
Which type of preparations must be pyrogen-free?
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What is the primary method to prevent microorganism entry in sterile manufacturing processes?
What is the primary method to prevent microorganism entry in sterile manufacturing processes?
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Which aspect of the controlled working environment is critical for maintaining cleanliness?
Which aspect of the controlled working environment is critical for maintaining cleanliness?
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What is the maximum permitted number of individual bacterial cells in a controlled working environment according to EU guidelines?
What is the maximum permitted number of individual bacterial cells in a controlled working environment according to EU guidelines?
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Why is final depyrogenation often considered impossible in many cases?
Why is final depyrogenation often considered impossible in many cases?
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What is the relationship between working and non-working conditions in a clean room?
What is the relationship between working and non-working conditions in a clean room?
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Which of the following is not a requirement for pharmacies preparing sterile preparations?
Which of the following is not a requirement for pharmacies preparing sterile preparations?
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What constitutes a controlled working environment essential for sterile preparations?
What constitutes a controlled working environment essential for sterile preparations?
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Which statement about air quality in clean rooms is true?
Which statement about air quality in clean rooms is true?
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What defines the air quality in sterile preparation areas?
What defines the air quality in sterile preparation areas?
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Study Notes
Tonicity Adjustment
- Tonicity adjustment is based on comparing colligative properties to a standard.
- Lacrimal fluid and human blood have a specific isotonicity value.
- Solutions with the same colligative properties are considered isotonic.
Osmosis
- Osmosis is the movement of water through a semipermeable membrane, from an area of high water concentration to an area of low water concentration.
- An aqueous solution in contact with body fluids and tissue membranes.
- Isotonic solutions result in balance.
- Hypotonic solutions result in hydration, while hypertonic solutions result in dehydration.
- Aqueous solutions must be isotonic.
Osmotic Pressure of Solutions
- Van't Hoff equation: π = R * T * m * n
- π... osmotic pressure (kPa)
- R... universal gas constant (J/mol·K)
- T... absolute temperature (K)
- m... molality of the solution (mol/kg)
- n... number of particles resulting from dissolution.
- The equation only applies to non-electrolytes.
Modification for Electrolytes
- Van't Hoff equation for electrolytes: π = R * T * m * i
- i... Van't Hoff's factor for correction
- i depends on the dissociation level and concentration of particles (ions)
- Interionic attractions and solvation influence the value of i.
- Calculating i theoretically is challenging.
Modification for Electrolytes (Dissociation Level)
- Influence of dissociation level: i = 1 + a(n-1)
- a... coefficient of dissociation
- n... number of particles (ions).
Colligative Properties
- Colligative properties depend only on the number of particles in the solution.
- Colligative properties include osmotic pressure elevation, boiling point elevation, vapor pressure depression, and freezing point depression.
- These properties are often used for tonicity adjustment.
Freezing Point Depression
- Freezing point depression of an aqueous solution: ΔT = Kf * i * m
- ΔT...freezing-point depression
- Kf...molal freezing-point depression constant of water.
- i...Van't Hoff's factor for correction.
Estimation of ΔT
- For diluted aqueous solutions, molality (m) can be replaced by molar concentration (c).
- The value of ΔTiso depends on the valency of the electrolyte.
Law of Colligative Properties
- Solutions with the same colligative properties are isotonic.
Tonicity Adjustment of Eye Drops
- Eye drop compounding requires the addition of necessary excipients, adhering to general pharmacopoeial requirements.
- Adding isotonic solution adjusters as necessary is a critical part of compounding eye drops.
- Practitioners must also adhere to specific requirements.
- Also consider buffering of eye drops to maintain appropriate pH levels, and adjusting viscosity as needed.
Estimation of Freezing-Point Depression
- Isotonic solutions have a specific ΔT value.
- Any solution with the same ΔT value is also isotonic.
- Solutions with ΔT values lower or higher than this isotonic value are considered hypotonic or hypertonic, respectively.
Determination of Tonicity Adjusting Agent
- The amount of tonicity adjusting agent can be determined in various ways, including the freezing-point depression method (ΔT, D-value), the sodium chloride equivalent method (E-value), and the isotonic solution method (V-value).
Basic Steps for Tonicity Adjustment of Eye Drops
- Estimate drug contribution
- Estimate the “gap” in isotonicity
- Determine the concentration of the adjusting agent
- Calculate the mass of the adjusting agent
- Edit the final eye drop prescription.
Prescription
- Pilocarpine hydrochloride (0.20 g) is a sample prescription for eye drops.
- Water for injection (to 10.0 mL) is measured for the stated prescription.
Tonicity Adjustment (Drug Contribution)
- Determine the percent concentration of the drug/compound in a table.
- Read the D-value (AT) caused by the compound.
- Calculate the D-value (AT) caused by the prescribed concentration of the compound/drug
- It is important to verify this is hypotonic when compared to the isotonic solution.
Tonicity Adjustment (Estimation of “Gap”)
- Subtract the compound D-value from the desired isotonic D-value (AT) in an isotonic solution.
- Decide on the appropriate tonicity adjuster, e.g., sodium chloride (NaCl)
Tonicity Adjustment (Concentration of Adjuster)
- Read the D-value (AT) caused by NaCl in the table.
- Calculate the concentration of sodium chloride needed to give the remaining freezing point depression to achieve isotonicity for the eye drops.
Tonicity Adjustment (Mass of Adjuster)
- Calculate the mass of sodium chloride needed for the desired volume of eye drops (e.g., 10 mL).
Editing Eye Drop Prescription
- Write a total composition of the eye drops, including the drug, sodium chloride, preservative, and water.
Compounding
- Compounding Procedures for eye drops.
TASK
- Homatropine hydrobromide (0.1 g) and water for injection (to 10.0 mL) is part of a Task to calculate the mass of the tonicity adjustment needed for multidose eye drops and compose the complete recipe.
Composition of Infusions
- Infusions involve direct application of substances into the bloodstream.
- Infusion solutions are aqueous.
Effects of Infusions on Hydration
- Osmolality is the concentration of solutes per kilogram of solvent.
- Osmolarity is the concentration of solutes per liter of solution.
- Hyperosmolality may result in a loss of water.
- Hypoosmolality may result in a loss of some ions.
- Colloidal osmotic pressure influences fluid balance.
Osmotic Effect
- Osmotic pressure is affected by the concentration of particles.
- Effective osmolarity uses either osmol/kg or osmol/L, whichever is appropriate.
Theoretical Osmolarity
- The theoretical osmolarity of a solution depends on its constituents' molarity and particle number.
Theoretical Osmolarity - Example
- Calculate the theoretical osmolarity of glucose and sodium chloride solutions.
Estimation of Osmolarity
- Example calculation of osmolarity of a Ringer-lactate solution
- Ringer-Lactate solution is composed of NaCl, KCl, CaCl2.6H2O, and Na lactate
- Consider the composition, molar mass, molar concentration, and ion count when calculating osmolarity.
Effects of Dissolves Substances
- Small molecules and ions are non-metabolized after administration.
- Macromolecules exert a minimum osmotic effect.
- The rate of metabolism of molecules determines their osmotic effect, which can decrease over time as metabolites are changed.
Sterilization of Eye Drops
- Appropriate sterilization methods for eye drops.
Efficiency of Bacteria Retentive Filtration Methods
- Factors influencing the efficiency of bacteria retentive filtration, including contamination level, filter reliability, filtration capacity, and filtration pressure limits.
Laminar Air-Flow Cabinet (LAC)
- Class A refers to aseptic conditions.
- Air should be HEPA filtered and laminar to prevent contamination.
- The LAC must be cleaned and disinfected regularly.
Aseptic Technique Rules
- Proper cleaning and disinfection procedures for the LAC.
Arrangement of Devices
- Essential materials should be kept close together within the LAC for proper airflow during the aseptic process.
Sterilization by Filtration
- Instructions for sterilizing solutions by filtration, including safety precautions.
Manufacturing of Parenterals
- Principles of pyrogen prevention to prevent contamination for parenteral products during manufacturing.
Controlled Working Environment
- Maintaining a sterile working environment is critical to preventing microbial contamination.
- The clean room's total particulate count (of a given size) is the critical parameter.
- EU Guidelines specify requirements for the clean room environment.
- Specific rules apply for the proper handling and movement of materials within each designated zone to prevent contamination.
Monitoring Microbial Contamination
- Methods for measuring microbial contamination levels, including CFU/m³.
Technological Operations
- Procedures for the preparation of working areas and equipment.
- Steps for the preparation of containers, closures, and products.
Quality of Product
- Procedures to ensure that the final product meets quality standards, including microscopic and in-process tests.
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Description
Test your knowledge on osmolarity, osmotic pressure, and the sterilization process. This quiz covers fundamental concepts and definitions that affect ion and molecule balance in biological systems, as well as contamination prevention in sterilized environments.
