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Parteck® M DPI EMPROVE EXPERT Ph Eur,BP,JP,USP,E 421

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Description

Parteck® M DPI excipient is part of the Parteck® range of functional excipients developed specifically for solid dose applications. It is a versatile carrier for dry powder inhalation (DPI) formulations engineered from mannitol.

Parteck® M DPI Emprove® Expert features low microbial and endotoxin limits which makes it especially suitable for high-risk applications. In addition, it is supported by the Emprove® Program and documentation, helping to minimize regulatory and quality-associated risks in biopharmaceutical and pharmaceutical manufacturing.

Parteck® M DPI particles are designed to improve the flow and release characteristics of active pharmaceutical ingredients (APIs) in drugs delivered via dry, inhaled powders.

No reducing sugars, no incompatibility issues.

Reducing sugars are a major threat to the stability of small molecule APIs with primary amine groups. Lactose is one such reducing sugar. Mannitol, another non-reducing sugar alternative, in general still contains trace levels of reducing sugar impurities of up to 0.10% according to pharmacopeia. In contrast, Parteck® M DPI is designed to limit impurities to a maximum level of 0.05%, as granted by the CoA specification. Actual values are typically even lower.

Other benefits of our Parteck® M DPI:

  • Low water content & hygroscopicity
  • Synthesized from plant-based raw materials
  • 3-year shelf life
  • High API delivery to the lungs

Additional information

Manufacturer

Merck KGaA

Quality

EP, JP, USP

Cas-No

69-65-8

Einecs

200-711-8

Composition

Mannitol

Dosage Form

dry powder inhalation, Inhalation

Function

Versatile carrier for dry powder inhalation application

Documents and Links

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