Pharmaceutical Preparations and Solubility
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Pharmaceutical Preparations and Solubility

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Questions and Answers

What is the primary method of preparing water for parenteral products?

  • Deionization or demineralization
  • Filtration or sterilization
  • Reverse osmosis or distillation (correct)
  • Boiling or autoclaving
  • What is the purpose of adding solvents miscible with water in parenteral formulations?

  • To enhance the bacteriostatic properties of the solution
  • To increase the viscosity of the solution
  • To improve the pH of the solution
  • To solubilize certain drugs and reduce hydrolysis (correct)
  • What is the primary use of Ethyl alcohol in parenteral preparations?

  • As an antibacterial agent for solutions
  • As a pH adjuster for solutions
  • As a solvent for certain drugs (correct)
  • As a preservative for solutions
  • What is the purpose of Bacteriostatic Water for Injection, USP?

    <p>To provide a bacteriostatic effect in solutions</p> Signup and view all the answers

    What is the primary difference between Ringer's Injection, USP, and Lactated Ringer Injection, USP?

    <p>The presence of sodium lactate in Lactated Ringer Injection</p> Signup and view all the answers

    Why is a warning statement required on the label of certain injections containing a bacteriostatic agent?

    <p>Due to the risk of toxicity in neonates</p> Signup and view all the answers

    What is the primary use of Sodium Chloride Injection, USP?

    <p>As an electrolyte replenisher and plasma volume expander</p> Signup and view all the answers

    What is the purpose of Lactated Ringer Injection, USP?

    <p>To provide a fluid and electrolyte replenisher and a systemic alkalizer</p> Signup and view all the answers

    What is the primary difference between Sterile Water for Injection, USP, and Bacteriostatic Water for Injection, USP?

    <p>The presence of a bacteriostatic agent in Bacteriostatic Water for Injection</p> Signup and view all the answers

    What is the primary use of Ringer's Injection, USP?

    <p>As a vehicle for other drugs or as an electrolyte replenisher and plasma volume expander</p> Signup and view all the answers

    Study Notes

    Preparation of Parenteral Products

    • Unstable drugs in solution can be prepared as a dry powder for reconstitution with a solvent at the time of administration or as a suspension.
    • If a drug is unstable in water, a solvent in which the drug is insoluble can be used instead.

    Types of Injections

    • Aqueous solutions can be injected directly into the bloodstream.
    • Blood-immiscible liquids, such as oleaginous injections and suspensions, can interrupt the normal flow of blood and are generally restricted to non-IV administration.

    Factors Affecting Onset and Duration of Action

    • The chemical form and physical state of the injection (solution or suspension) can affect the onset and duration of action.
    • Drugs that are very soluble in body fluids have a more rapid onset of action.
    • Aqueous solutions have a more rapid onset of action than oleaginous solutions.
    • Aqueous suspensions are more rapid-acting than oleaginous suspensions.

    Repository or Depot Preparations

    • Long-acting injections are used to reduce the frequency of injections.
    • These preparations are designed to release the drug slowly over time.

    General Procedure for Preparation of Parenteral Products

    • The preparation room must be free from particulate matter and microorganisms.
    • Laminar air flow systems and UV radiation can be used to remove dust and microorganisms.
    • Room walls and benches must be cleaned with antimicrobial agents.
    • Workers must wear sterilized clothes, disinfected gloves, and masks.

    Steps Involved in Preparation

    • Cleaning and sterilizing all equipment and containers.
    • Purity of ingredients must be ensured.
    • Compounding of the preparation involves adding small quantities first and then larger quantities to form a solution.
    • Filtration using millipore membrane filters removes microorganisms.
    • Distribution of the preparation into final containers (bottles, ampoules, plastic bags).
    • Glass is preferred for containers due to its high temperature during sterilization.
    • Amber-colored glass is used for photo-labile drugs.

    Sterilization of Parenteral Products

    • Sterilization is the process of killing or removing microorganisms.
    • Sterilization methods include dry or moist heat.

    Preparation of Injections

    • Solutions and suspensions of drugs intended for injection are prepared in a similar manner to solutions and disperse systems.
    • Solvents or vehicles must meet special purity and other standards to ensure safety by injection.

    Vehicles for Parenteral Products

    • Water is the vehicle of greatest importance for parenteral products and must meet USP specifications.
    • Water-miscible vehicles, such as ethyl alcohol, polyethylene glycol, and propylene glycol, can be used to solubilize certain drugs and reduce hydrolysis.
    • Examples of vehicles include Sterile Water for Injection, Sodium Chloride Injection, Bacteriostatic Water for Injection, Ringer's Injection, and Lactated Ringer Injection.

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    Description

    Learn about preparing unstable drugs for administration, including reformulation into dry powders, suspensions, and solutions in various solvents. Understand the importance of solvent selection for drug stability.

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