Parenteral Incompatibility & Available Injections
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Questions and Answers

What is the primary function of lyophilization in the context of drying powdered products?

  • To increase the product's weight
  • To remove water through sublimation (correct)
  • To evaporate water by boiling
  • To freeze the product at room temperature

    • Which of the following is NOT a requirement for vehicles used in parenteral injections?

  • Must be non-toxic
  • Should not affect activity of medicinal agents
  • Should be irritating to tissues (correct)
  • Must be sterile and pyrogen free

    • Which component is primarily prohibited from use in parenteral ingredients?

  • Antioxidants
  • Buffers
  • Solubilizers
  • Coloring agents (correct)

    • What is the first step in the lyophilization process?

    <p>Freezing an aqueous product</p> Signup and view all the answers

    Which type of water is specifically designed for injections?

    <p>Bacteriostatic Water for Injection USP</p> Signup and view all the answers

    Which of the following is NOT considered a tonicity material for injections?

    <p>Sterile Water</p> Signup and view all the answers

    What characteristic must solvents for injection possess?

    <p>Non-sensitizing</p> Signup and view all the answers

    What is a quality that all vehicles for parenteral injections must have?

    <p>Be sterile and free from particles</p> Signup and view all the answers

    Which description best fits small volume parenterals (SVP)?

    <p>Come in either solution, suspension, or emulsion forms.</p> Signup and view all the answers

    What is a potential consequence of chemical incompatibility in injections?

    <p>Formation of toxic compounds.</p> Signup and view all the answers

    Which of the following factors can help prevent incompatibilities in injections?

    <p>Controlling all factors that lead to incompatibilities.</p> Signup and view all the answers

    Which statement is true regarding large volume parenterals (LVP)?

    <p>They usually require careful manipulation and preparation.</p> Signup and view all the answers

    What is one characteristic of premixed small volume parenterals?

    <p>They involve minimal manipulation before administration.</p> Signup and view all the answers

    Which of the following is NOT a typical consequence of physical incompatibility?

    <p>Therapeutic inactivity.</p> Signup and view all the answers

    What is the primary purpose of large volume parenterals?

    <p>To replenish body fluids and electrolytes.</p> Signup and view all the answers

    Which of the following statements about storage conditions is true for injections?

    <p>Certain injections require refrigeration to maintain stability.</p> Signup and view all the answers

    What is the primary purpose of using Large-Volume Parenterals (LVP) for maintenance therapy?

    <p>To provide total parenteral nutrition for long-term feeding</p> Signup and view all the answers

    Which components are included in Total Nutrient Admixtures (TNA)?

    <p>Carbohydrates, proteins, fats, electrolytes, and trace elements</p> Signup and view all the answers

    For patients experiencing severe dehydration due to vomiting or diarrhea, what is the recommended water requirement per kilogram?

    <p>25-40 mL/Kg</p> Signup and view all the answers

    What do Large-Volume Parenterals help substitute in patients with heavy losses of bodily fluids?

    <p>Both electrolytes and glucose</p> Signup and view all the answers

    In cases where oral feeding is postponed for weeks, what type of nutrition is typically provided?

    <p>Total parenteral nutrition (TPN)</p> Signup and view all the answers

    What is the purpose of refrigeration in the context of antimicrobial agents?

    <p>It slows down the microbial growth.</p> Signup and view all the answers

    Which of the following is NOT a reason to implement tonicity agents in parenteral formulations?

    <p>To increase the potency of antimicrobial agents.</p> Signup and view all the answers

    Which microbial organisms were used to test the effectiveness of an antimicrobial system?

    <p>Candida albicans and Staphylococcus aureus.</p> Signup and view all the answers

    What is a key indicator that an antimicrobial agent added was effective?

    <p>No significant increase in microorganisms.</p> Signup and view all the answers

    Which of the following is NOT a potential tonicity agent mentioned?

    <p>Calcium carbonate</p> Signup and view all the answers

    What is the primary purpose of using water-miscible vehicles in drug formulations?

    <p>To increase drug solubility and reduce hydrolysis</p> Signup and view all the answers

    What pH range can lead to tissue necrosis when using injectable formulations?

    <p>pH &lt; 3.0</p> Signup and view all the answers

    Which of the following is NOT considered a water-miscible solvent?

    <p>Cotton seed oil</p> Signup and view all the answers

    Which of these agents is used to prevent microbial growth in drug formulations?

    <p>Mercury reagents</p> Signup and view all the answers

    What consequence can occur if the pH of an injectable formulation is above 9.0?

    <p>Tissue necrosis</p> Signup and view all the answers

    What is the main function of antioxidants in pharmaceutical formulations?

    <p>To prevent the oxidization process</p> Signup and view all the answers

    Which type of vehicles are described as pure, sterile, and pyrogen free, and used for IM injections?

    <p>Nonaqueous vehicles</p> Signup and view all the answers

    Which one of the following is a potential risk when using nonaqueous vehicles?

    <p>Irritation and allergic reactions</p> Signup and view all the answers

    What is a major consideration when adding buffers to pharmaceutical formulations?

    <p>To prevent degradation and maintain pH stability</p> Signup and view all the answers

    Which of the following is an example of a water-soluble antioxidant?

    <p>Sodium bisulfite</p> Signup and view all the answers

    Study Notes

    Parenteral Incompatibility

    • Physical incompatibility: Visible changes in solution appearance like precipitation, color change, or gas formation.
    • Chemical incompatibility: Chemical changes leading to toxicity or therapeutic inactivity, not always visible.
      • Includes hydrolysis, complexation, oxidation, photolysis, and API reacting with light.
    • Therapeutic incompatibility: Change in activity, like cortisone antagonizing heparin.
    • Preventing incompatibilities: Control factors that lead to incompatibility.

    Available Injections

    • Hundreds of injections available.
    • Small Volume Parenterals (SVP) (25-50 mL).
      • Can be solutions, suspensions, emulsions, or solids.
      • Premixed, ready-to-use, requiring little or no manipulation.
      • Little wastage.
      • Limited flexibility in quantity/concentration.
      • Some products require thawing, possibly in a microwave.
    • Large Volume Parenterals (LVP)
      • Flexible but requires manipulation, requiring sterility.
      • Usually for intravenous infusion to replenish body fluids, electrolytes, or provide nutrition.
      • Volume: 100 mL-1 L or more per day.
      • Should not contain bacteriostatic or pharmaceutical additives, including coloring agents.
      • Must meet standards for particulate matter.
      • Packaged in hermetic containers of high quality.
      • Filled in slight excess for easy withdrawal.
      • Sterilized powders for solutions/suspensions are packed as lyophilized or freeze-dried.
      • Specific labeling regulations apply.

    Lyophilization (Freeze-drying)

    • Process of drying where water is sublimed from the product after freezing.
    • Steps:
      • Freezing an aqueous product.
      • Evacuate the chamber using a vacuum.
      • Introduce heat to sublimate ice into a cold condensing surface.

    Parenteral Ingredients/Necessities

    • Vehicle: Depends on the dosage form used.
    • Buffers: Maintain pH, stability, and prevent degradation.
    • Antioxidants: Prevent oxidation by blocking the process or being oxidized faster than the drug.
    • Antibacterial agents: Prevent microbial growth and multiplication.
    • Tonicity materials: Dextrose, glycerin, mannitol, NaCl. Ensure cells do not expand or shrink and maintain volume.
    • Surfactants: Egg and soybean phospholipids and lecithin.
    • Thickeners.
    • Preservatives: Used in multi-dose containers.
    • Solubilizers, protectants, wetting agents, emulsifiers, local anesthetics, etc.
    • Do not use color.

    Vehicles for Injection

    • Solvent criteria: Non-irritating, non-toxic, non-sensitizing, no pharmacological activity, and does not affect the medicinal agents' activity.
    • Must be sterile, particle, and pyrogen-free.
    • Aqueous Vehicles:
      • Water is the most frequently used and preferred.
      • Types of water for injections:
        • Water for Injection USP/Purified Water USP.
        • Sterile Water for Injection USP (SWFI).
        • Bacteriostatic Water for Injection USP.
        • Sterile Water for Irrigation.
    • Water-miscible vehicles:
      • Ethanol, propylene glycol, polyethylene glycol 300.
      • Used to increase drug solubility and/or reduce hydrolysis.
    • Nonaqueous Vehicles:
      • Pure, sterile, pyrogen-free, and particulate-free.
      • Must remain clear when cooled to 10°C.
      • Primarily used for intramuscular injections.
      • Can be irritating and cause allergic reactions.
      • Examples: Peanut oil (dimercaprol), cottonseed oil (estradiol cypionate), castor oil (estradiol valerate).

    Buffers

    • Maintain pH, stability, and prevent degradation.
    • Considerations: chemical interactions and effective pH range.
    • Blood pH: 7.4.
      • pH > 9.0 can cause tissue necrosis.
      • pH < 3.0 can cause extreme pain and phlebitis.

    Antioxidants

    • Prevent the oxidation process by:
      • Blocking the process.
      • Being oxidized faster than the drug.
    • Examples (water-soluble): Ascorbic acid, sodium sulfite, sodium bisulfite.
    • Examples (oil-soluble): Butylated hydroxytoluene and hydroxyanisole.
    • Displace air with inert gas (N2) to prevent oxidation.

    Antibacterial Agents

    • Prevent microbial growth and multiplication.
    • Use limited concentrations of antibacterial agents.
      • Mercury reagents: Phenylmercuric nitrate 0.01%.
      • Chlorobutanol, phenol, or cresol 0.5%.
    • Effectiveness varies with formulation.
    • Refrigeration slows growth but does not prevent it.

    Antibacterial Agents Testing

    • Determine the effectiveness of an antimicrobial system for parenteral:
      • Inoculate with a known number of organisms (Candida albicans, Aspergillus niger, Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus).
      • Incubate at 32°C and examine.
      • An effective antibacterial agent will result in no significant increase in microorganisms.

    Tonicity Agents

    • Ensure cells don't expand or shrink, maintaining cell volume.
    • Routes requiring isotonicity: Intrathecal, intraarticular, and intradermal.
    • Reduce pain of injection and tissue irritation.
    • Reduce hemolysis of blood cells.
    • Prevent electrolyte imbalance.
    • Include buffers.
      • Examples: Sodium chloride (0.9%), potassium chloride, dextrose (5.5%), mannitol, sorbitol, lactose.

    Protectants

    • Maintain the structure of certain APIs.
    • Contain electrolytes, carbohydrates, and nutritional components like proteins and fatty emulsions.

    Large-Volume Parenterals (LVP)

    • Used for maintenance and replacement therapy.

    Maintenance Therapy

    • For surgery patients, recovering patients, and unconscious patients.
    • Provides all essential nutrients to minimize tissue breakdown and maintain normalcy.
    • Total parenteral nutrition (TPN) provided if oral feeding is impossible.
    • Total nutrient admixtures (TNA) include all substrates necessary for nutritional support.
    • Nutrients are mixed in a single IV bag for convenient administrations.

    Replacement Therapy

    • Replaces losses of water and electrolytes due to conditions like vomiting, diarrhea, burns, and AIDS.
    • Includes:
      • Water requirements: 25-40 mL/kg.
      • Electrolyte requirements: K 100 mEq; Na 135-170 mEq.
      • Caloric requirements: 5% dextrose.

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    Week 11 - Parenteral PDF

    Description

    This quiz explores parenteral incompatibilities, focusing on physical, chemical, and therapeutic aspects. It also covers available injections, including Small Volume and Large Volume Parenterals, and their characteristics. Understand the factors that contribute to incompatibility and how to prevent them.

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