Pharmaceutical Preparations and Solubility

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

Reverse osmosis or distillation

What is the purpose of adding solvents miscible with water in parenteral formulations?

To solubilize certain drugs and reduce hydrolysis

What is the primary use of Ethyl alcohol in parenteral preparations?

As a solvent for certain drugs

What is the purpose of Bacteriostatic Water for Injection, USP?

To provide a bacteriostatic effect in solutions

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

The presence of sodium lactate in Lactated Ringer Injection

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

Due to the risk of toxicity in neonates

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

As an electrolyte replenisher and plasma volume expander

What is the purpose of Lactated Ringer Injection, USP?

To provide a fluid and electrolyte replenisher and a systemic alkalizer

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

The presence of a bacteriostatic agent in Bacteriostatic Water for Injection

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

As a vehicle for other drugs or as an electrolyte replenisher and plasma volume expander

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.

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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