Parenteral Drug Production: Formulation and Manufacturing Process

Posted on May 27, 2025 in Information Systems

Parenteral Drug Formulation Components

Active Pharmaceutical Ingredients (APIs)

  • Parenteral Agents

Vehicles and Solvents

  • Aqueous Vehicles: Purified Water for Injection
  • Non-Aqueous Vehicles: Ethanol, Polyethylene Glycols (PEG 200, 400, 600), Glycofurol
  • Soluble Oils: Vegetable Oils, Esters

Excipients and Pharmaceutical Aids

  • Solubilizing Agents

    • Cosolvents
    • Surfactants
    • Acids
    • Bases
    • Amino Acids

  • pH Regulators

    • Acids
    • Regulating Bases
    • Buffer Mixtures

  • Isotonicity Agents

    • Inorganic (e.g., Sodium Chloride)
    • Organic Compounds

  • Preservatives

    • Alcohols
    • Phenols
    • Esters
    • Quaternary Ammonium Compounds

  • Antioxidants

    • Lipophilic: Tocopherols, Phenolic Compounds, Esters
    • Hydrophilic: Chelating Agents, Oxygen Scavengers

  • Other Additives

    • Anesthetic Agents
    • Cytoprotective Agents
    • Vitamin C (Ascorbic Acid)
    • Viscosifying Agents

Parenteral Drug Manufacturing Process

1. Preliminary Operations

  • 1.1. Aseptic Area Sterilization

    • Gassing with Glycols
    • Nebulization with Formalin

  • 1.2. Material and Equipment Sterilization

    • Washing and sterilization of packaging materials (glass, rubber stoppers)
    • Washing and sterilization of machinery (stainless steel reactor)
    • Washing and sterilization of accessories (syringes, silicone tubes, sterile filters)
    • All items are washed and autoclaved.

2. Drug Dispersion Preparation

  • 2.1. Machinery

    • Stainless Steel Reactor

  • 2.2. Type of Preparation

    • Solution
    • Suspension
    • Emulsion

3. Drug Dispersion Filtration

Applicable for solutions or freeze-dried products, but not for suspensions.

  • 3.1. Filtration Accessories

    • Clarifying Filters
    • Sterilizing Filters

  • 3.2. Filtration Rate and Sterilization Method

    • Terminal Sterilization: Clarifying Filtration
    • Aseptic Handling: Sterilizing Filtration

4. Drug Dosage and Packaging

  • 4.1. Packaging Types

    • Open Blister Packs
    • Closed Blister Packs
    • Vials

  • 4.2. Dosing Machinery

    • Liquid Dispensing: For injections (e.g., replacement injections, extemporaneous reconstitutable solutions)
    • Solid Dispensing: Piston-disc, Twin-screw systems

5. Freeze-Drying Process

  • Packaging

    • Blister packs (various types)

  • Machinery

    • Lyophilizer

6. Closed Package Sealing

  • Blister Packs: Fusion of the branch and strip sealing
  • Vials: Sealed with rubber stoppers

7. Terminal Sterilization

  • Autoclave

8. Exterior Washing and Drying

  • Immersion in purified water
  • Drying in an oven

9. Finished Product Quality Control

  • Appearance of the product and packaging
  • Integrity of the packaging
  • Presence of particulate matter in suspension

10. Final Packaging

  • Manual Packaging: Cartons, Boxes
  • Automatic Packaging: Blister Packs