Over view of Meter dose Inhaler Regulation in US and EUROPE.
Introduction
A metered-dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs, in the form of a short burst of aerosolized medicine that is usually self-administered by the patient via inhalation. It is the most commonly used delivery system for treating asthma, chronic obstructive pulmonary disease (COPD) and other respiratory diseases. Metered-dose inhaler products contain therapeutically active ingredients dissolved or suspended in a propellant, a mixture of propellants, or a mixture of solvents, propellants, and/or other excipients in compact pressurized aerosol dispensers. MDI is composed of mainly essential components:
Figure 1: …show more content…
And in europe it is filling through decentralize procedure. Meter dose inhaler is regulated by European medicinal agency(EMA) and it is monitored by Committee for proprietary medicinal products(CPMP) The regulatory requirements for abbreviated new drug application (ANDA) for Meter dose inhaler submitted into the CTD and modules requires for that is given below:
Modue:1: As per Regional Industry criteria
Table of Contents of the Submission Including Module 1
Documents Specific to Each Region (for example, application forms, prescribing information)
Module 2: Quality overall summary and Clinical overview:
In general, the Quality Overall Summary (QOS) is an outline of data presented in Module3. Summary of drug Substance, Summary of drug Product should be given. And in clinical overview data of bioavability and bioequivalence should be given.
Module 3: Quality section: The quality section contains chemistry, manufacturing, control test(CMC) data that are described below:
• Pharmaceutical developments:
1. Moisture content: The effect of moisture content on product performance on stability should be evaluated.
2. Delivered dose: This test should be performed to evaluate the uniformity of delivered
Introduction
A metered-dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs, in the form of a short burst of aerosolized medicine that is usually self-administered by the patient via inhalation. It is the most commonly used delivery system for treating asthma, chronic obstructive pulmonary disease (COPD) and other respiratory diseases. Metered-dose inhaler products contain therapeutically active ingredients dissolved or suspended in a propellant, a mixture of propellants, or a mixture of solvents, propellants, and/or other excipients in compact pressurized aerosol dispensers. MDI is composed of mainly essential components:
Figure 1: …show more content…
And in europe it is filling through decentralize procedure. Meter dose inhaler is regulated by European medicinal agency(EMA) and it is monitored by Committee for proprietary medicinal products(CPMP) The regulatory requirements for abbreviated new drug application (ANDA) for Meter dose inhaler submitted into the CTD and modules requires for that is given below:
Modue:1: As per Regional Industry criteria
Table of Contents of the Submission Including Module 1
Documents Specific to Each Region (for example, application forms, prescribing information)
Module 2: Quality overall summary and Clinical overview:
In general, the Quality Overall Summary (QOS) is an outline of data presented in Module3. Summary of drug Substance, Summary of drug Product should be given. And in clinical overview data of bioavability and bioequivalence should be given.
Module 3: Quality section: The quality section contains chemistry, manufacturing, control test(CMC) data that are described below:
• Pharmaceutical developments:
1. Moisture content: The effect of moisture content on product performance on stability should be evaluated.
2. Delivered dose: This test should be performed to evaluate the uniformity of delivered