Metered Dose Inhaler Pharmaceutics Presentation.pptx

Description: The document presents a comprehensive overview of Metered Dose Inhalers (MDIs), a novel drug delivery system designed for delivering medication directly into the lungs. The presentation covers the device's structure, applications, formulation aspects, and manufacturing process.

MDIs are primarily used to treat respiratory conditions like asthma and Chronic Obstructive Pulmonary Disease (COPD). The device delivers medications such as bronchodilators (Salbutamol) and corticosteroids (Fluticasone propionate), either individually or in combination.

The device consists of several key components including a canister, actuator, metering valve, and actuator nozzle. When the patient presses the canister while breathing in, the drug formulation in propellants is released through the actuator nozzle as a spray plume.

The formulation can be either a solution or suspension in liquefied propellants, with the benefit of achieving homogeneous formulation. However, there are challenges with drug solubility in HFA (Hydrofluoroalkane) propellants, which limits the drug amount. To overcome this, surfactants or complexation aids are used to increase drug solubility.

The manufacturing process involves careful consideration of chemical stability, especially for protein-based drugs that require additional care during micronization to preserve their three-dimensional conformation. The filling process can be done through cold filling (at 60 degrees) or pressure filling methods. In cold filling, the active compound, propellant, and excipients are chilled before filling, while pressure filling involves creating a drug/propellant concentrate that is filled and then sealed with a valve.

The document also discusses various excipients used in the formulation, including sodium carboxymethylcellulose, polyvinyl alcohol, and polyvinylpyrrolidone (PVP). Special attention is given to the transition from CFC to HFA systems, noting that conventional excipients approved for CFC formulations may be insoluble in HFA systems.

1. Novel Drug Delivery System Metered Dose Inhaler Presented by Preetham Anton A 560020511563

2. Metered Dose Inhaler Device Deliver medication into lungs Used for Asthma C hronic obstructive pulmonary disease (COPD) Medication Bronchodilator (Salbutamol) Corticosteroids (Fluticasone propionate) Combination

3. Formulation Solution Suspension (liquefied propellant) Benefits – Homogenous formulation Basic requirement Containers Propellants Metering Valves Formulating Solution I ncreasing the drug concentration in a formulation ( Not possible )

4. Drugs - HFA propellants ( Not Soluble ) Limits drug amount Surfactants or complexation aids – increase drug solubility Conventional excipients – CFC Formulation Approved Insoluble in HFA System Methods of preparation Chemical stability of the drug. Protein (Additional Care) Micronizing ( Heat liable) Preserve three dimensional conformation

5. Spraying drying with another agent sodium carboxymethylcellulose polyvinyl alcohol, and/or polyvinylpyrrolidone (PVP) Filling Metered Dose inhaler Filled by Liquefying the propellant Reduced temperature Elevated pressure Cold filling ( Active compound, propellant and excipients) – chilling & filling 60 degree Additional propellant – added at same temperature

6. Canister sealed with valve In pressure filling drug/propellant concentrate Produced and filled Valved is crimped on canister Additional propellant is filled through the valve ( gassing ) Pressure filling (Inhalation aerosol)