What is anhydrous lactose used for?
In the pharmaceutical industry, lactose is used to help form tablets because it has excellent compressibility properties. It is also used to form a diluent powder for dry-powder inhalations. Lactose may be listed as lactose hydrous, lactose anhydrous, lactose monohydrate, or lactose spray-dried.
What is the use of anhydrous lactose in the formulation?
Anhydrous lactose is also well suited for formulations containing moisture sensitive drugs, due to the absence of crystal water. It is the recommended form of lactose for dry granulation because its brittle nature allows re-compaction without loss of tabletability.
How is anhydrous lactose made?
Anhydrous lactose for direct compression is usually produced by drying a lactose solution on the surface of a heated drum. This results in a product composed of agglomerated small crystals of anhydrous b-lactose, with some anhydrous a-lactose present.
Where does anhydrous lactose come from?
This chapter discusses the lactose, anhydrous. Lactose is a sugar obtained from milk, and can be obtained either as a crystalline anhydrous or monohydrate species. Anhydrous lactose can be obtained as either the α-lactose or β-lactose modification, although the α-form is most often used in pharmaceutical applications.
Is anhydrous lactose safe?
Lactose monohydrate is a crystallized form of milk sugar. It’s commonly used as a filler for medications and added to packaged foods, baked goods, and infant formulas as a sweetener or stabilizer. This additive is widely considered safe and may not cause symptoms in those who are otherwise lactose intolerant.
What is the difference between lactose and lactose anhydrous?
Lactose is a kind of sugar found naturally in dairy products such as milk, cheese and cream. Lactose consists of two different sugars: glucose and galactose, which are chemically linked together. Anhydrous lactose is lactose that has no water in it 1.
What is the difference between lactose anhydrous and lactose monohydrate?
When a highly concentrated solution of lactose is crystallized at temperatures above 93.5°C, crystals of β-lactose are exclusively formed. Particles with crystalline β-lactose are more brittle than α–lactose monohydrate crystals andthey do not contain crystal water. Β-Lactose is often referred to as anhydrous lactose.
Is anhydrous lactose hygroscopic?
The alpha-lactose anhydrous stable was hygroscopic at 75% RH and initially formed hard cakes which became friable during storage. The unstable form of anhydrous alpha-lactose was hygroscopic at all levels of RH studied but did not cake.
Is anhydrous lactose the same as lactose monohydrate?
Crystals of pure β-lactose have a characteristic kite-like form as shown in figure 3. Particles with crystalline β-lactose are more brittle than α–lactose monohydrate crystals andthey do not contain crystal water. Β-Lactose is often referred to as anhydrous lactose.
Is anhydrous lactose gluten free?
Nonmedicinal ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Gluten free.
Can I have lactose monohydrate if I’m lactose intolerant?
What is the difference between alpha and beta lactose?
Lactose has two anomers (stereo-isomers), α and β, differing only in the configuration of the hydroxyl group at the anomeric hemiacetal carbon. α has an axial hydroxyl whereas β hydroxyl is equatorial (Figure 1). 1-3 The β-isomer is obtained by crystallization above 93.5° C as a non-hygroscopic anhydrous form.
Is the anhydrous lactose monograph approved by the USP?
Having reached Stage 6 of the PDG process, the Anhydrous Lactose monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts. Changes from the existing USP–NF monograph include:
Which is the best brand of anhydrous lactose?
DFE Pharma offers anhydrous lactose under the brandnames Lactopress® Anhydrous and SuperTab® AN. The specialty range products offer a selection of particle size distributions for improved flow or low dusting.
Why is anhydrous lactose good for dry granulation?
Anhydrous lactose is also well suited for formulations containing moisture sensitive drugs, due to the absence of crystal water. It is the recommended form of lactose for dry granulation because its brittle nature allows re-compaction without loss of tabletability.
Which is the best type of lactose for compression?
Anhydrous lactose offers the best compactability of all grades of lactose, and it is well suited to direct compression applications. Anhydrous lactose is also well suited for formulations containing moisture sensitive drugs, due to the absence of crystal water.