Will FDA (Food and Drug Administration) or other authorities accept a file with data from this instrument?
Yes, they will. It is adopted by the European Pharmacopeia 7.4, § 2.9.25 and is to be adopted by the US Pharmacopeia. Nicorette and Rugby Nicotine gums are registered in all countries with dissolution data from our Chewing Apparatus. In the European Pharmacopeia another machine is described. It differs in: poorer specifications and no default settings. It is not commercially available. It has some similarities to the FIA / Erweka Chewing Apparatus, but many points differ.
Advantages with the FIA / Erweka Chewing Apparatus are:
- It is well known by FDA and other authorities worldwide
- It gives reproducible results with low standard deviations
- It is sized to fit the analytical laboratory
- It is silent
- It has transparent dissolution cells for good visibility
- Operating height to achieve a comfortable working environment
- Easy to prepare and fast to reload and warm up for effective use
- It is well documented; examples of use
- Parameters easily changed
Good support is given for method development
How can we perform Instrument Qualification and Operation Qualification (IQ/OQ)?
Normally this is done by the customer with minor support from the distributor. IQ/OQ documents for the Chewing Apparatus may be supplied by the distributor. They can also help you with the tests.
Will we get any further support with method development?
You will get free expert support via e-mail. We respond as quickly as possible. You can also get paid support with method development, including chemical analysis, from our training and method development centers. Please ask for advice via email@example.com.
Questions about technical details:
(Some of the questions below are discussed in the Manual. A good advice is to read the manual carefully before starting with any experiments).
How can we arrange the supply of compressed air?
In the manual you will find the specification for compressed air needed. Many laboratories have compressed air connections in their buildings. For a 6-cell Chewing Apparatus, compressed air of 6 bar (84 psi) and minimum 100 liter per minute is required.
Normally a standard compressor is placed in a room, separated from the laboratory. Preferably it is sound insulated. In the laboratory a permanent installation is preferable made with a reduction valve and a manometer for read-out. A water trap is mounted at the reduction valve. These items can all be found in a standard hardware store.
For a 1-cell Apparatus a large tube with compressed air may be used or a compressor of “Silent Air”-type installed in the laboratory. All models from 2007 and onwards have a suitable reduction valve with manometer and water trap mounted on the carrier.
What is the use of Support Nets?
Support Nets are needed for reproducible results. The gum is likely to slip off if it is not used. The nets are cheap and made of inert nylon.
How many pair of jaws do we need?
It depends on how much you use the Chewing Apparatus. The operator replaces the used jaws with clean and qualified ones after each run. Batch wise cleaning is recommended. One batch of jaws is recommended to last for two weeks. One batch is then cleaned and qualified while another batch is being used. Needed is then two batches. We recommend for a 6-cell Chewing Apparatus 120 pairs of jaws and for a 1- or 2-cell apparatus 60 pairs. To start a smaller number of jaws can be tried.
Where can we get Dissolution Standard Gums?
Currently samples of well-known medical gums as reference material are the best. On request we will suggest a suitable gum that is available in your territory.
What is the correct gap between the jaws?
The gap depends on the volume of the gum and the formulation. The correct settings are found with the approach of test, adjust and retest. The in-vitro-profile should be correlated to the in-vivo-profile. Support Nets are used most of the time. A too narrow gap will often be destroy the nets (Picture 1). A too wide gap will result in poor mastication, a lost grip on the chewing gum and resulting in slow release of substance (Picture 2). The best result is when the chewing gum appears on the lower jaw (Picture 3).