Category/Classification: Medical Device (Class IIa) / inhalation solution for nebulization
Dosage form: Sterile, preservative-free unit-dose ampoules, 5 mL
Composition per 5 mL:
- Sodium chloride 3% w/v
- Sodium hyaluronate 0.1% w/v (medium molecular weight)
- Water for injection q.s. | pH 6.5–7.5 | controlled high osmolality
Key technical advantages
- Mucosal hydration & protection via hyaluronate to improve tolerability of hypertonic saline
- Aseptic filtration with cleanroom filling (Grade A/B)
- Snap-off ampoules for single-use to minimize contamination
Intended use (descriptive): To help thin and clear viscous airway secretions and support mucus clearance. Use only with an appropriate nebulizer as directed by a clinician.
Critical Quality Attributes (CQAs)
- Sterility: no growth
- Viscosity range suitable for consistent aerosolization
- Aerosol performance (MMAD): 3–5 μm (with compatible nebulizer)
- Container compatibility: extractables/leachables within limits
Packaging: Box of 20 × 5 mL ampoules + IFU
Storage/Shelf-life: Store at 15–25 °C; do not freeze; 24-month shelf-life; use immediately after opening
Basic warnings: Not for injection; do not use with heated steam devices; discontinue and seek advice if bronchospasm/burning occurs
Regulatory (template): CE-marked device/ISO 13485 manufacturing (mock)
Internal codes: SKU: PM-3-20A | GTIN (mock): 0-1234567-00002-0 | GS1 DataMatrix
Manufacturing overview (high-level):
- Dissolve NaCl & sodium hyaluronate in sterile water with controlled mixing and de-aeration
- Adjust pH/osmolality/viscosity → 0.22 μm sterile filtration
- Aseptic fill into LDPE unit-dose ampoules → heat-seal → (optional) terminal irradiation per material specs
- Release tests: sterility, osmolality, viscosity, pH, visual inspection, aerosol performance
Performance tests: Nebulizer output rate & MMAD on a standard jet nebulizer; user tolerability assessment under lab conditions