Aero Flo®by Kerry – Inhalation Grade Lactose
Dry Powder Inhalers (DPI) and Lactose
Using a dry powder inhaler (DPI) for drug delivery can provide many advantages over traditional oral delivery of pharmaceuticals. DPI’s also offer advantages over older respiratory delivery methods such as those using nebulizers or pressurized CFC containing aerosols. This is due to the fact that dry powder inhalers allow for the potential to deliver a wider range of drugs than these older methods. Typically, with DPI’s, the active ingredient and a carrier are blended and used to fill the inhaler; or with some inhalers, a capsule or blister that includes one singular dose. During use, the dose delivery is performed by the patient simply inhaling, or is assisted by a burst of air, depending on the type of inhaler used.
Pharmaceutical Lactose has often been used as a carrier in these applications due to its inertness, low cost, availability, particle size, and patient tolerability. However, two of the most important characteristics of the formula are: dose uniformity, and the efficiency of delivering the drug (i.e. the amount of drug that reaches the patients lungs relative to the amount in the starting dose). The selection of the grade of lactose used as a carrier will most certainly have an effect on both of these characteristics.
Kerry Introduces Aero Flo® Grades of Inhalation Lactose
Aero Flo® Brand Inhalation Grades of lactose are specifically developed for dry powder inhalation (DPI) applications. Kerry’s unique processing also maintains the crystallinity of the lactose, which can be a critical factor when formulating DPI’s.
Kerry has a long, and well established history of supplying world class lactose, mainly for oral solid dose & capsule filling applications. There is however, a growing demand for lactose that is suitable for developing dry powder inhalers.
In these applications, particle size, and crystal morphology play a critical role in delivering the API to the lungs, without interfering with the absorption of the drug itself.
However, we also recognize that there are important considerations to be factored in to the manufacture of the lactose, based on the API itself, as well as the design of the intended delivery device. The physical properties of the lactose can have a dramatic effect on the pulmonary delivery of the API, if the lactose is not properly paired with consideration to both (API and device) of these.
Kerry’s standard grades of lactose designed for pulmonary delivery of drugs are listed below. These grades are specially engineered to have specific particle size ranges, as well as microbiological and endotoxin specifications that are demanded in these DPI applications.
As the particle size is the key differentiator between all of the Aero Flo® grades, the other chemical attributes can be grouped as either derived from Monohydrate Lactose or Anhydrous Lactose, as per the table below. There are four inhalation grades lactose that are monohydrate lactose based (*plus a micronized version); and two inhalation grades that are based on Anhydrous lactose.
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Particle Size Curves
See the full brochure on “Aero Flo® by Kerry – Inhalation Grade Lactose” here
(click the picture to download the brochure)
Source: Kerry brochure “Aero Flo® by Kerry – Inhalation Grade Lactose”
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