Budesonide Soft Mist Inhaler

Budesonide Soft Mist Inhaler, 100mg

Soft Mist Inhalers are typically a novel, multidose, propellant free, liquid inhaler that represents a new category of inhaler devices.

Key Points of Our Development:

  • MKPPL has designed a formulation/ matrix of the drug, lipid and pulmonary surfactants in a complete aqueous base.
  • The 100 % potency of this nanosuspension is 0.25 mg/ml and 0.5 mg/ml.
  • The size of our nanoparticle based suspension is in between 60 nm to 120 nm with a D90 value of 80 nm and a polydispersity index of 0.103.
  • The formulation can be modified to minimize blocking at the
    delivery nozzle and uniformity in drug distribution.

Benefits of Budesonide loaded Solid lipid nano-suspension:

  1. Lower oropharyngeal drug deposition and loss.
  2. Higher lung deposition of drug.
  3. Free of any solvents.
  4. Completely aqueous based formulation.
  5. Free from Cyclodextrin

Why SMIS are Considered More Effective?

  • Hydrofluoroalkane Pressurised Metered Dose Inhaler (HFA-pMDIs) and Dry-Powder Inhalers (DPIs) are associated with high oropharyngeal deposition and lower lung deposition whereas Soft Mist have higher lung deposition and lower oropharyngeal loss.
  • DPIs have powder that can be sensitive to moisture and pMDIs uses propellant, which have toxic side effects. On the other hand, SMIS do not utilise powder form and are propellant-free

Additional Information

Documentation Available:

DMF in CTD Format

Dosage Form

Nano particles (for suspensions)

Packaging

Soft Mist Inhaler

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