What Are Respules?
- Respules are single-dose liquid medication containers designed for use with a nebulizer.
- They contain a measured amount of medication in liquid form, which is converted into a fine mist for inhalation.
- This method allows direct delivery of the drug to the lungs, making it highly effective for treating respiratory conditions like asthma, COPD (Chronic Obstructive Pulmonary Disease), bronchitis, and croup in children.
How Do Respules Work?
1. The respule is opened and emptied into the nebulizer’s chamber.
2. The nebulizer machine transforms the liquid medication into a mist using compressed air or ultrasonic waves.
3. The patient inhales the mist through a mouthpiece or face mask, ensuring deep penetration into the lungs.
Manufacturing of Respules
Respules are manufactured using pharmaceutical aseptic processing, ensuring sterility and precise dosing. The process involves multiple steps:
1. Formulation of the Active Drug Solution
• The active pharmaceutical ingredient (API) (e.g., budesonide, salbutamol) is dissolved or suspended in a sterile aqueous base.
• Excipients (inactive ingredients) are added to maintain stability, pH balance, tonicity, and sterility.
2. Sterilization & Filtration
• The solution is filtered through 0.22-micron filters to remove microbial contamination.
• Some formulations undergo heat sterilization or aseptic filtration to ensure purity.
3. Filling into Respule Containers
• Blow-Fill-Seal (BFS) Technology is commonly used.
• In this process, the plastic ampoule (respule) is formed, filled, and sealed in a single sterile environment to prevent contamination.
4. Quality Control & Packaging
• Each batch is tested for sterility, potency, pH, viscosity, and particle size.
• Approved units are packaged in foil pouches to protect against moisture and light.
Excipients in Respules
Excipients are inactive substances added to enhance stability, absorption, and usability. The exact excipients vary based on the medication. Here are common ones:
1. Buffers & pH Adjusters
• Sodium chloride – Adjusts tonicity to match bodily fluids.
• Sodium citrate – Helps maintain pH stability.
• Citric acid – Prevents pH fluctuations.
2. Preservatives (for multi-dose vials only, not single-use respules)
• Benzalkonium chloride (BAC) – An antimicrobial preservative, but rarely used in nebulized solutions due to potential lung irritation.
• EDTA (Ethylenediaminetetraacetic acid) – Helps prevent oxidation and microbial growth.
3. Stabilizers & Surfactants
• Polysorbate 80 – Improves solubility of poorly soluble drugs like budesonide.
• Lecithin – Sometimes used as an emulsifier in lipid-based formulations.
4. Solvents & Vehicles
• Sterile Water for Injection (SWFI) – Primary base for most respules.
• Ethanol (rarely used) – Improves solubility in some formulations.
• Propylene glycol – May be present in some formulations as a solvent.
Example: Composition of Budecort 0.5 mg Respules
| Ingredient | Function |
| Budesonide (0.5 mg) | Active ingredient – reduces inflammation. |
| Sodium chloride | Adjusts tonicity to match body fluids. |
| Disodium edetate (EDTA) | Prevents oxidation. |
| Citric acid | pH stabilizer. |
| Polysorbate 80 | Solubilizer for budesonide. |
| Water for injection | Solvent and base. |
More in Pharmasciences.in