Aero Flo 35 Monohydrate
Lactose MonohydrateProduct Application: Dry Powder Inhalation
Product Certification: Gluten-free,Kosher,Rennet free
Pharmaceutical Category: Filler,Inhalation Grade
Aero Flo 35 Monohydrate is recommended as an excipient, filler, and carrier for dry powder inhalation applications. Lactose is a disaccharide obtained from the whey fraction of milk consisting of one glucose and one galactose moiety. Aero Flo 35 Monohydrate meets all requirements of the current National Formulary, the European Pharmacopeia, and the Japanese Pharmacopeia. All ingredients are certified rennet free.
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, they 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.