Injectable Solution Dosage Form

We offer comprehensive services for direct to injectable solution formulations, including single-dose and multi-dose vials for both aqueous and non-aqueous formulations. Our expertise covers formulations that are preservative-free and preservative-based. Our services include solubility studies, composition design and optimization, process design and optimization, accelerated prototype stability studies (conducted per guidelines), hold time and compatibility studies, in-use studies, preservative efficacy studies, dilution compatibility studies, and product container closure system identification, selection, and finalization. Additionally, we provide support for scale-up activities and manufacturing of clinical batches in a current Good Manufacturing Practice (cGMP) environment. The lifecycle of the drug product is given below:

Pre-formulation studies

Solubility enhancement studies include:

• Buffer and pH modification: Examine the solubility of drug substances utilizing buffers such as acetate or phosphate.
• Complexation: To enhance the solubility of poorly water-soluble drug compounds, one can utilize complexing agents.
• Surfactants or solubilizers: To enhance the solubility of poorly water-soluble drug compounds, one can utilize surfactants or solubilizers.
• Co-solvency: To enhance the solubility of poorly water-soluble drug compounds, one can utilize co-solvents.

Prototype development and manufacturing process optimization

• Qualitative and Quantitative composition finalization: Finalizing formulation based on pre-formulation outcomes to ensure optimal composition.
• Order of addition: Determining ingredient sequence to maintain desired physicochemical properties.
• Container closure finalization: Selecting packaging that ensures product safety, prevents particulate contamination, and avoids drug-preservative adsorption.
• Oxygen sensitive studies: Using inert gas to replace oxygen in headspace for oxidation-prone drugs.
• pH sensitivity studies: Optimizing pH range through stability testing to ensure product integrity.
• Hold time and compatibility with contact parts: Assessing interaction with filters, tubing, gaskets, and containers to ensure material compatibility and product stability.
• Temperature excursion studies: Assessing product stability under temporary temperature deviations during storage or transport.
• Antioxidant effectiveness study: Testing varying antioxidant levels (0%, 50%, 100%) to ensure protection against oxidation.
• Preservative effectiveness study: Evaluating preservative concentrations (100%, 75%, 50%) to confirm microbial control.
• Sterilization feasibility study: Evaluating preservative concentrations (100%, 75%, 50%) to confirm microbial control.
• Filter validation: Ensuring filters do not interact with or adsorb drug components while removing contaminants.

Stability studies

• Prototype stability studies (ICH): Monitoring long-term stability under ICH conditions for shelf-life assurance.
• Freeze thaw and thermal cycling: Simulating extreme conditions to assess transport resilience.
• Photo-stability studies: Testing light sensitivity to confirm photostability or risk of degradation.
• In-use stability studies: Evaluating multi-dose product integrity after opening and repeated use.
• Reconstitution and dilution stability studies: Assessing stability post-dilution to ensure effectiveness during infusion.

Vacuum Filtration Assembly

Moist heat Sterilization Fedegari Terminal Sterilizer

Dry heat Sterilization Memmert Dry heat Sterilizer

• Analytical method development:
  Developing reliable methods to test drug concentration, purity, and stability for quality control.
• Analytical method validation:
  Validating methods to ensure accuracy, precision, and regulatory compliance.
• Analytical Method Transfer:
  Transferring validated methods across sites to maintain consistency and support scale-up and inspections.

• Test Parameters

  • Description
  • Identification
  • Assay
  • Antioxidant content
  • Preservative content
  • Related substances
  • pH
  • Osmolality
  • Color and Clarity
  • Content Uniformity (UOD)
  • Particulate matter
  • Bacterial Endotoxin Test (BET)
  • Sterility
  • Anti-Microbial Effectiveness Testing (AET)
  • Container closure integrity test
  • Container content
  • Viscosity
  • Residual solvents
  • Elemental impurities
  • Extractables and leachable

• Key Instruments

  • HPLC & UPLC’s-UV, PDA, RI, CAD (Make: Agilent / Water’s)
  • Particle Size Analyser (Make: Malvern; Model: Sizer 3000)
  • Particle Size Analyser (Make: Malvern; Model: Zeta sizer Nano ZSP)
  • Polarized Light Microscope (Make: Axio Lab 5; ZEN software)
  • Viscometer (Make: Brookfield; Model: DV Next; RV; CP)
  • pH meter (Orion Star A211/Thermo).
  • UVVisible spectrophotometer (Shimadzu, UV-2600)
  • Gas chromatography (Make: Agilent; Model: 8890)
  • Osmometer (K-7400S, Knauer GmbH)
  • Stability chambers including Photostability chamber (Make: Thermolab)
  • Volumetric and Coulometric KF Auto titrator (Make: Metrohm make)
  • FT-IR (Make: Shimadzu)