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Questions and Answers
What is the total freezing point depression caused by 1% pilocarpine and 2% procaine combined?
What is the total freezing point depression caused by 1% pilocarpine and 2% procaine combined?
How much sodium chloride is required for a 30 mL solution to achieve isotonicity?
How much sodium chloride is required for a 30 mL solution to achieve isotonicity?
How many milliliters of 0.9% sodium chloride are needed to make the eye drops isotonic?
How many milliliters of 0.9% sodium chloride are needed to make the eye drops isotonic?
What is the freezing point depression caused by a 1% solution of sodium chloride?
What is the freezing point depression caused by a 1% solution of sodium chloride?
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What is the calculated freezing point depression of an unadjusted solution of pilocarpine and procaine?
What is the calculated freezing point depression of an unadjusted solution of pilocarpine and procaine?
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What type of water is primarily used at the industrial scale for injectable products?
What type of water is primarily used at the industrial scale for injectable products?
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Which of the following is NOT a critical attribute of injectable products?
Which of the following is NOT a critical attribute of injectable products?
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What preservation method is commonly used in bacteriostatic water for injection?
What preservation method is commonly used in bacteriostatic water for injection?
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What is the percentage concentration of sodium chloride solution needed to achieve isotonicity for the described eye drops?
What is the percentage concentration of sodium chloride solution needed to achieve isotonicity for the described eye drops?
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What is the method used for purifying water for injections aimed at ensuring sterility?
What is the method used for purifying water for injections aimed at ensuring sterility?
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What is a characteristic of an isotonic solution?
What is a characteristic of an isotonic solution?
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Which factor is solely dependent for colligative properties?
Which factor is solely dependent for colligative properties?
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What is the primary method used to adjust the tonicity of a hypotonic drug solution?
What is the primary method used to adjust the tonicity of a hypotonic drug solution?
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How is osmolality expressed in a solution?
How is osmolality expressed in a solution?
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What is the approximate osmolarity range for adults?
What is the approximate osmolarity range for adults?
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What happens to red blood cells in a hypertonic solution?
What happens to red blood cells in a hypertonic solution?
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Which colligative property is modified with a freezing point depression of 1.86°C?
Which colligative property is modified with a freezing point depression of 1.86°C?
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What is the effect of osmotic pressure elevation on a solution?
What is the effect of osmotic pressure elevation on a solution?
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What is the correct order of primary operations involved in freeze drying?
What is the correct order of primary operations involved in freeze drying?
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Which statement about freeze-dried products is false?
Which statement about freeze-dried products is false?
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During the secondary drying phase in freeze drying, what is primarily removed?
During the secondary drying phase in freeze drying, what is primarily removed?
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What is a common characteristic of bulking agents added to freeze-dried formulations?
What is a common characteristic of bulking agents added to freeze-dried formulations?
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What happens to partially inserted rubber closures after the freeze-dry cycle is complete?
What happens to partially inserted rubber closures after the freeze-dry cycle is complete?
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What is the shelf-life storage condition for reconstituted freeze-dried products?
What is the shelf-life storage condition for reconstituted freeze-dried products?
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What processing method is commonly used to manufacture SVI antibiotics like injectable cephalosporins?
What processing method is commonly used to manufacture SVI antibiotics like injectable cephalosporins?
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What is the freezing-point depression of a 1 %w/v acetylcysteine solution?
What is the freezing-point depression of a 1 %w/v acetylcysteine solution?
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How much sodium chloride is required to make the final product isotonic at 10 mL volume?
How much sodium chloride is required to make the final product isotonic at 10 mL volume?
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What concentration of drug is needed to produce each 1 mL ampoule containing 20 mg of the drug?
What concentration of drug is needed to produce each 1 mL ampoule containing 20 mg of the drug?
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What is the total mass of the drug required to prepare 330 mL of solution containing 20 mg/mL?
What is the total mass of the drug required to prepare 330 mL of solution containing 20 mg/mL?
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Using the equation provided for isotonic adjustment, what does 'a' represent?
Using the equation provided for isotonic adjustment, what does 'a' represent?
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What is the freezing point depression value for a 1 %w/v sodium chloride solution?
What is the freezing point depression value for a 1 %w/v sodium chloride solution?
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What would be the total volume of the solution including the 10% extra required for the trial?
What would be the total volume of the solution including the 10% extra required for the trial?
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What is the correct formula to calculate the isotonic adjustment mass W?
What is the correct formula to calculate the isotonic adjustment mass W?
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For the preparation of the solution, which vehicle is used?
For the preparation of the solution, which vehicle is used?
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What is the significance of preparing the solution isotonic with sodium chloride?
What is the significance of preparing the solution isotonic with sodium chloride?
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What is the freezing point depression caused by a 1.0 %w/v solution of anhydrous glucose?
What is the freezing point depression caused by a 1.0 %w/v solution of anhydrous glucose?
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How much sodium chloride is needed to make a 1.5 %w/v lidocaine hydrochloride solution isotonic?
How much sodium chloride is needed to make a 1.5 %w/v lidocaine hydrochloride solution isotonic?
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What does the variable 'a' represent in the equation for isotonic solutions?
What does the variable 'a' represent in the equation for isotonic solutions?
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Which of the following values correctly represents 'b' in the context of isotonicity calculations?
Which of the following values correctly represents 'b' in the context of isotonicity calculations?
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What is the calculated weight/volume percentage of adjusting substance needed for isotonicity when using a potassium chloride solution?
What is the calculated weight/volume percentage of adjusting substance needed for isotonicity when using a potassium chloride solution?
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If 1.0 %w/v of lidocaine hydrochloride has a freezing point depression of 0.338 °C, what is the total freezing point depression for a 1.5 %w/v solution?
If 1.0 %w/v of lidocaine hydrochloride has a freezing point depression of 0.338 °C, what is the total freezing point depression for a 1.5 %w/v solution?
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How much anhydrous glucose is required per 100 mL to achieve isotonicity with 1.0 %w/v potassium chloride?
How much anhydrous glucose is required per 100 mL to achieve isotonicity with 1.0 %w/v potassium chloride?
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What is the purpose of the adjusting substance in creating isotonic solutions?
What is the purpose of the adjusting substance in creating isotonic solutions?
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In isotonicity calculations, what does 'W' denote?
In isotonicity calculations, what does 'W' denote?
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What is the freezing point depression of a 1.0 %w/v solution of lidocaine hydrochloride?
What is the freezing point depression of a 1.0 %w/v solution of lidocaine hydrochloride?
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Study Notes
Sterile Products
- Sterile products come in various forms including liquids, dry powders for reconstitution, and semisolids (ointments and gels).
- Learning outcomes include discussing the types and critical components, osmotic pressure, vehicles, pH and preservation on formulation of sterile products, and the role of packaging materials.
- Small volume injectables (SVIs) are packaged in vials, ampoules, syringes, cartridges, or bottles. They are often terminally sterilized or aseptically filtered, and 80% or more of SVIs are commercially prepared through these methods.
- SVIs typically contain the active ingredient, a solvent system (often aqueous), and a few excipients. Injection routes include intravenous (IV), subcutaneous (SC), intramuscular (IM), and others.
- Large volume injectables (LVIs) contain more than 100 mL and are often used for intravenous infusion, dialysis, or irrigations. LVIs typically contain electrolytes, sugar, amino acids, blood products, and fatty lipid emulsions.
- Components of sterile products include the drug, solvent, solubilizer, preservative, antioxidant, buffer, tonicity adjuster, and diluent.
- Critical attributes of injectable products include osmotic pressure, vehicle, pH, preservation, packaging, sterility tests (including pyrogens), and tests for sub-visible particles.
- Osmotic pressure is a colligative property, solely dependent on the number of particles, not their size or weight. For non-dissociating solutes, osmotic pressure is directly proportional to molality.
- Hypotonic solutions have a lower osmotic pressure than body fluids, leading to cell swelling and lysis.
- Isotonic solutions have the same osmotic pressure as body fluids and are preferred for ophthalmic, nasal, and parenteral solutions.
- Hypertonic solutions have a higher osmotic pressure than body fluids, leading to cell shrinkage.
- The freezing point depression method is used to adjust the tonicity of hypotonic drug solutions to make them isotonic.
- Different drugs have different freezing point depression values and require varying amounts of adjusting substance.
Product Types
- Small Volume Injectables (SVI): Contain 100 mL or less.
- Large Volume Injectables (LVI): Contain more than 100 mL.
Components of Sterile Products
- Drug
- Solvent
- Solubilizer
- Preservative
- Antioxidant
- Buffer
- Tonicity adjuster
- Diluent
Critical Attributes of Injectable Products
- Osmotic pressure
- Vehicle
- pH
- Preservation
- Packaging
- Sterility testing (including pyrogens)
- Tests for sub-visible particles
Vehicle/Solvent Systems
- Aqueous (Water for Injection)
- Purified water, Water for Injection
- Sterile water for injection, Bacteriostatic water for injection
- Non-aqueous (Oils)
- Vegetable oils, solid paraffin, saponification, iodine values
- Solubilizers
pH Control: Buffers
- Maintain drug solubility and prevent precipitation
- Maintain drug stability and prevent chemical degradation
- Examples of buffer systems and their pH ranges are provided.
Preservation
- Maintain product sterility
- Required for multiple-dose products
- Combining antimicrobial preservatives and adjunctive heat treatment
- Examples of preservatives, such as Phenol, m-Cresol, and others, and their concentration ranges.
Antioxidants
- Minimizing or terminating free radical auto-oxidation
- Examples are sodium bisulphite, ascorbic acid, disodium EDTA
- Protect against oxidation and degradation
Solids
- Preparation methods: Freeze drying, Power-filled
- Reconstitution with a diluent (sterile water for injection)
- Stability considerations for freeze dry products (shelf life)
Packaging
- Protection and stability
- Convenient delivery (e.g., syringes, vials)
- Minimizes contamination risk (single-dose vs multi-dose)
- Materials (glass, rubber, and plastic)
- Advantages and disadvantages of each.
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Description
This quiz explores sterile products used in pharmacy, including small and large volume injectables. Learn about their formulation components, packaging materials, and various routes of administration. Understanding these essentials is key to mastering sterile product preparation and application.
