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Respitose® SV014

Large lactose crystals

Excellent flow

Deagglomeration

Inhalation

Product information

Respitose® SV014 is a sieved inhalation-grade lactose grade with excellent flow properties and very large lactose crystals. It’s optimal flow properties provides opportunities for application in reservoir devices or to maintain the required flow and content uniformity in high dose inhalation formulations.

This product can also be utilized as a “sweepener”, where the lactose deagglomerates the drug particles in an inhalation device during inhalation, propelling the drug into the respiratory tract. Respitose® SV014 is produced in a dedicated facility in Veghel, the Netherlands. Respitose® SV014 is a valuable addition to our portfolio of available solutions to help you identify the most optimal dry powder inhalation formulation faster.

Optimal flow

The combination of tomahawk shaped particles and strictly controlled particle size profile provide the excellent flow properties of Respitose® SV014.

Range of application options

Respitose® SV014 can be applied in drug formulations released by reservoir devices, to create a good flowing formulation. In a high dose formulation for inhalation, Respitose® SV014 can compensate for the reduced flow of the formulation. The coarse particles of Respitose® SV014 can also play a role in the de-agglomeration of drug particles in a formulation, thereby facilitating the delivery to the respiratory tract. Technical support of DFE pharma is available to explore other applications.

Complies with Ph.Eur., USP-NF and JP.

Product types: Sieved lactose
Excipient functionality: Carrier
Dosage forms: Inhalation

Typical product data

Particle size distribution (μm)

D10: 245
D50: 365
D90: 545

Bulk density (g/L)

Bulk density (g/L): 720

Tapped density (g/L)

Tapped density (g/L): 810

Carr’s index (-)

Carr’s index (-): 12

Documentation

ALBA Pharmaceutical lactose
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GMO Statement lactose
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GMP+ DMV - Fonterra Excipients B.V. Borculo
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Halal DFE Pharma B.V. Borculo
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ICHQ3D Elemental Impurities Inhalation Lactose - Lactohale® (EU)
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MSDS Lactose monohydrate
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DFE Pharma Brochure DPI View
Product Specification Lactohale 230
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Free from Foot and Mouth Disease lactose
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