Inhaler Manufacturing Process - Inhalation medication is quite popular and an effective way of treating respiratory medical illnesses such as asthma, and Chronic obstructive pulmonary disease (COPD). There are many different kinds of inhalers available in the current market. Since technology is fastening and rapidly making everything automotive, the pharmaceutical industry is also under the positive influence of advancing science. So, it is definitely going to progress the inhaler manufacturing process.

While designing a manufacturing process, there are tons of factors contributing to the cost, raw materials being used, R&D, labor cost, advanced packaging, and many more. Even though it is a tedious process, it will be simplified in this blog. First of all, let’s discuss inhalers.

What is an Inhaler and its Uses?

The inhaler also referred to as puffer, pump, or allergy spray is used directly in the target region of the body. Mainly they are prescribed for treating asthma and chronic obstructive pulmonary disease (COPD). Inhalers basically help in lowering the inflammation in the airways and make breathing easy. Also, it is the most effective way for delivering medication directly to the respiratory system.

Different types of Inhalers -

Metered dose inhalers (MDIs) - These are usually cheaper and they use slow inspiratory flow. But it has a low dosage. Easier to use and no preparation is required. But it does not contain any dose counters.
Dry powder inhalers (DPIs) - These are easy to use but designing a DPI is much more difficult and challenging. There are fewer side effects and are used to treat acute asthma conditions.
Soft mist inhalers - They release slow-moving mist and contain liquid formulation. Also, it has a dosage indicator. The dosage entering the body is much higher than other types of inhalers but it is difficult to load.
Nebulizers - It is used for delivering liquid medication into the lungs and comes in a product called respules. These nebulizers convert liquid medicines into the mist. Also, it reduces the inflammation in the lungs.

In addition, as you can see there are pros and cons to each inhaler's device. So, the manufacturing process will depend upon what kind of inhalers you want! However, Large-scale manufacturing needs expertise and the best staff to handle the inhaler manufacturing process.

What are the main steps involved in Inhaler Production at a Large Scale?

Development phase & Formulation - The main gain while developing a new inhaler product is safety and effectiveness while maintaining the shelf life. While formulating, there is a principle of quality by design (QbD) for the robust development process of new products. Coming to the formulation, there are different factors that must be taken into consideration -

Target action (local or systemic action)
Therapeutic development
APIs stability in the delivery system

Manufacturing Process - There are different kinds of methods that can be used while manufacturing.

Clinical Phase - For checking and collecting data regarding different parameters of a new inhaler product.

Methods of Inhaler Manufacturing Process

In this blog, we are mainly covering the manufacturing of MDIs (metered dose inhalers). However, the process is quite similar to other kinds of inhaler manufacturing. Now, Let's start with the method in inhalation device production -

COLD FILLING METHOD - In this method, both concentrated drugs, liquefied propellants, and excipients are mixed within the vessel at a very low temperature. Then, just in a single step, the filling and metered valve are found in the canister and crinkled.
PRESSURE FILLING METHOD - Here, at nearly normal temperature, the concentrated drugs, excipients, and volatile propellants are mixed under pressure within the vessel. But here the filling is done in an already pre-crimped metering valve.

Both of these methods have their own pros and cons. Generally, the method is preferred depending upon the composition, equipment in hand, etc.

What After Inhalation Device Manufacturing?

Before making these inhalers publically, there are a few steps that need to be followed as per industry standards and by law. The step is quality control and clinical trials. Also, There are majorly three steps that involve in the clinical trials which start with-

Proof of Concept and Clinical Phase - In this, the staff checks the performance, and effectiveness and compares the desired results versus the actual results. Generally, there are three phases of a clinical trial conducted.

Now, Quality Control and further Development - In this data generated by clinical trials, some changes will be introduced in the different steps of manufacturing. These steps help in improving the overall safety and effectiveness of an inhaler before launching in the market.

List of Some Common Inhalers Formulation Available!

Nutra Respiro is the leading respiratory pharma company that mainly deals in the PCD Pharma Franchise for respiratory products. Following is the list of some inhalers and respules products being manufactured in our own plant.

Conclusion

At last, we hope you get all the information regarding the inhaler manufacturing process. Inhalers are the common treatment for asthma and COPD. However, the overall process has become much more systematic and the quality of these inhalers has been increasing tremendously over the years of development and technology. We are 100% assured that over the next decades the process of inhaler manufacturing will become totally automatic and make these products safe, effective, and affordable.

Frequently Asked Questions (FAQ)

Question - What are the raw materials used in manufacturing inhalers?

Answer - There are three main components for an inhaler - a plastic actuator, a metal canister, and metering.

Question - What are the types of inhalers available on the market?

Answer - There are three main types of inhalers: soft mist inhalers (SMIs), dry powder inhalers (DPIs), and Metered dose inhalers (MDIs)

Inhaler Manufacturing Process

What is an Inhaler and its Uses?