Advantages of MDPI over DPI

Which is a better solution MDPI or DPI and why? Many a times i come across this question. Let me try to answer this (to the best of my knowledge) with some technical facts. Hope you’ll find this article useful. Let me have your views/queries in the form of message/comments.

Easy to use:

The MDPI already contains a blister strip with the Blend. 60 doses are ready for use. The patient only opens the Outer case, automatically the device indexed and pealed the strip and the patient can get its portion of powder. Only one (1) handling step to get the powder inhaled.

The DPI, container must be loaded with a capsule (capsule size 3) into the device. The capsule is in the blister. The capsule needs to be pushed out of the pocket of the blister strip. Further the capsule needs to be inserted into the device. The device is activated by a push button. After the release of the push button the capsule is pierced and the patient gets its drug. As you can see- far more handling steps to the drug application.

The performance of all DPI and MDPI are mostly based on the number of handling failures and not as it is written in the literature the FPD, ED, APSD etc.. Less handling steps a device requires, surely less handling failure occurs.

All the new MDPI devices at mematec have only 3 steps. Open, inhale and close!!!

Moisture protection:

In most common device we have 3 different carrier systems. 1) Blister based or disc based – this means powder blend is directly filled into the cavity and sealed by an Aluminum lid foil. 2) The capsule - which is filled in a capsule filling machine and packed in a blister (or bulk pack in a bottle). 3) The bulk device - which has a container with approx. 800 to 1000mg powder blend contained. The bulk container is sealed with an Alu foil.?

Blister- or disc-based carriers: The powder is directly filled into the strip. After filling the cavity is sealed with an Alu foil. This can be done even in low moisture environment. The protection last longer in comparison to the capsule.

Capsules: At the capsule filling machine it is difficult to apply a low moisture atmosphere. You have to use the HPMC capsule. The regular HGC is not suitable. It will become brittle when it is handled in low humidity and stored over a long time. In addition electrostatic charges become an issue during the filling process in the capsule machine.?

Bulk device: A bulk device is filled with auger filler. The container is also sealed with an Aluminum foil. The difference to the disc or blister-based device is the moisture barrier after the first use. While in a blister strip or disc every cavity is protected, whereas in the case of bulk device the whole device container is protected, but the metering chamber does allow a certain permeability of moisture.?

Handling of powder on the machine:?

Normally these kinds of powders are very sensitive to moisture and very cohesive. Regular filling system available in the market does not efficiently handle such powder blends especially spray dried powders.

In the meantime, different companies are going to offer Standard Capsule filling machines for such applications. The most common filling systems will use a filling principle which will do a “fluidization of the powder”. On regular capsule machines the powder properties need to be formulated to have a defined powder flow which allows a homogenous filling level in the powder bed. The latest version of capsule filling machine has so called drum filling systems which are less sensitive to the powder height in the powder bed.?For the preparation of the powder bed and a defined powder compatibility for the transfer of the powder out of the bowl into the capsule is required. The challenge of the powder bed preparation is to keep a constant density in the bowl even after continuous dispensing the powder into the capsule. For example, taking a dosator system which is more or less cutting out by the dosator tube the powder slug. The refill of the takenout powder to the same tapped density is required to achieve best fill results. This is a huge challenge for most machines!!

This is different in the strip-or disc-filling. First of all, none of these machines are standard machines. All of them are customized. Only a few Companies are going to offer such machines. The price is based on the number of produced machines, which of course is different as the capsule machine. The basic price is mostly times 2 -3 of the equivalent capsule filling machine.

The filling principle on the latest version of such machines follows the principle of the fluidization of powder.

Mematec offers for all their MDPI devices, the needed equipments for manufacturing the device at site. This step is a big help for our customers to be fast and effective.??

We'll be happy to answer your queries.

Mematec GmbH, August-Müller-Stra?e 24, 71691 Freiberg am Neckar, Germany. Website: https://www.mematec-solutions.com/ Email:?[email protected] ; [email protected] ?? Call: +91 9829090933; +49 7141 72921?????

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