CDE registration number of InhaLac 500
* : * : admin * : 2019/12/06 8:55:17 * : 29
CDE registration number of InhaLac 500！
On the last day of May 2019, InhaLac 500 of Meggle inhalation lactose was registered and published by CDE. The registration number is F20190000232.
At this point, the German representative office in Shanghai has already obtained 22 product registration numbers for the original auxiliary platform! Among them, the lactose corresponding to the four registration numbers is a lactose product dedicated to dry powder inhalation.
So let's find out more about InhaLac 500!
As is known to all, as the first choice of excipients for commercial inhalation powder products, lactose is most commonly used as a diluent and carrier for drugs, as well as a "third component" that enhances the delivery effect. InhaLac 500 brought to you by Meguiro is an ultra-micronized product suitable for use as the "third component". It is a product that pulverizes lactose with a larger particle size by air jet to meet specific functional requirements.
Why chose fine lactose as a kind of ‘third component’ in dry powder inhalation?
Micronized lactose is an important component in inhalation powder formulations. For common carrier-type formulations, due to the existence of many inter-particle forces between the micronized drug and the surface of the carrier, they will cause the micronized drug to be excessively bound to the carrier particles, making it difficult to detach the drug, resulting in low delivery efficiency .
The addition of micronized lactose can be used as a substitute for micronized drugs, combined with the high surface energy site ('Active Site') of the carrier lactose surface, thereby effectively reducing the binding effect between the micronized drugs and the carrier and improving the dispersion. Effect to achieve effective drug delivery. Although the amount of micronized lactose is small (usually about 5-10%), it is an indispensable and important member.
What are the relative advantages of InhaLac 500?
Scientific, strict and systematic quality control makes this product have good inter-batch stability, excellent functionality, and better product stability, as follows:
1. Strict particle size control: D50<5um, D90 <10um, which is closer to the particle size distribution of micronized drugs;
2. Better performance: Compared with traditional products, it has a significantly larger specific surface area (5.30 m2 / g), which can better meet user demand for DPI products;
3. Longer shelf life: The micronized lactose InhaLac 500 has a shelf life of 18 months, which is even more advantageous when it is stored and transferred. And usually the validity period of similar products is only 6 months.
About MEGGLE
The well-known family-owned German company Meggle Group was founded in 1887. During these 130 years, it has adhered to scientific and rigorous quality control, kept pace with the times, innovated, and valued user cooperation and common development. It is this consistent persistence. Today, German Meggle has suddenly become the world's leading manufacturer of pharmaceutical excipients. The rich product line of German Meggle, with 8 strains and more than 30 specifications, covers various fields such as solid preparations, inhalation powder sprays, lyophilized powder injections and so on. Meggle is a long-term partner you can trust.
The world of lactose, The world of Meggle
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