NEW from MEGGLE: Lactose LE – Lactose Monohydrate Low Endotoxin

Lactose Monohydrate Low Endotoxin (LE) from MEGGLE Excipients

Lactose is a well known excipient as bulking agent in freeze-dried parenteral products
(REF www.pharmaexcipients.com)

Superior Microbiological Quality – Lactose LE suitable for inhalation and parenteral applications

Lactose LE is MEGGLE’s protective sieved product, which is not specified in PSD, but in microbiological quality and endotoxins. Due to the characteristics of the product, Lactose LE is suitable for use in inhalation and parenteral applications. It is therefore a good starting material if you want to perform your own milling or fractionation to achieve a certain PSD.

Lactose LE’s cryoprotective properties and bulking agent potential make it advantageous for specialized applications.

Additionally, product characteristics have been also proven to be advantageous for other applications. In that respect, the protective properties and the possibility of using lactose as a bulking agent are particularly popular.

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Key Benefits:

High purity grade
Low bioburden, low endotoxin
Q3D statement for inhalation and parenteral applications
Conforms to Ph. Eur., USP-NF, JP, and ChP
Listed in FDA inactive ingredient database for inhalation and parenteral applications
Usage for stabilization and protectant in temperature sensitive production processes

Applications:

DPI formulations
Parenteral/Injectables
(Thin-film) freeze-drying and spray-drying (high dose formulations and sensitive APIs)

Lactose is listed in the FDA Inactive Ingrdient Database (IID) for parenteral and ophthalmic applications

Excipients which are suitable to stabilize products during freezedrying (lyophilization) and spray-drying, and which are approved by regulatory agencies for parenteral formulations are highly limited. The FDA regulatory requirements for parenteral formulations are quite strict: they must be proven safe, non-toxic, sterile, pyrogen-free and particle-free. Notably, lactose is listed in the FDA Inactive Ingredient Database (IID) for parenteral and ophthalmic applications. β-Lactoglobulin (BLG) is monitored as marker allergen/milk protein, levels are below LOQ (0.010 ppm).

Low Bioburden through crucial designed production processes

Due to crucial design of production processes and sourcing of raw material, Lactose LE shows very low bioburden. It is therefore well suited for the manufacturing of parenteral final dosage forms. Notably, the market authorization holder (MAH) is obliged to ensure sterility in its final dosage form.

Contact our specialist team for support and a comprehensive information package and required documentations.

Sugars for protection during drying and as bulking agent

Cryoprotectants/Stabilizers are substances that show a molecular protection for sensitive ingredients regarding damage caused by freezing and spray-drying.

Lactose may work as a protectant via different effects, amongst the most prominent are water replacement, forming a glass-like amorphous structure during freezing or providing osmotic protection. Additionally, lactose molecules can engage in hydrogen bonding interactions with water molecules.

Remarkably, whilst lactose is a reducing sugar and the risk of the Maillard reaction should be taken into account for certain molecules, there is a multitude of applications. It can be used as protection during freeze drying or spray-drying, similar to other dissacharides like Sucrose, Trehalose and the sugar alcohol Mannitol.