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Surface modification of lactose inhalation blends by moisture.

C P Watling¹, J A Elliott, C Scruton

¹Pfizer Institute for Pharmaceutical Materials Science, Department of Materials Science and Metallurgy, University of Cambridge, Cambridge CB2 3QZ, UK.

International Journal of Pharmaceutics

|February 17, 2010

Summary

Lactose inhalation powders degrade significantly with increased relative humidity (RH), losing fine particles and surface area. Even at 32% RH, lactose powders showed instability, impacting pharmaceutical applications.

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Area of Science:

Pharmaceutical Science
Materials Science
Physical Chemistry

Background:

Lactose is a common excipient in dry powder inhaler formulations.
Understanding the stability of lactose powders under various environmental conditions is crucial for drug delivery.
Moisture uptake can alter the physical properties of powders, affecting their performance.

Purpose of the Study:

To determine the relative humidity (RH) conditions for stable lactose inhalation blends.
To characterize surface changes in lactose powders due to water condensation during storage.
To assess the impact of RH on lactose powder properties relevant to inhalation.

Main Methods:

Storage of milled and sieved lactose powders at RH levels from 32% to 100%.
Analysis of surface property changes using BET nitrogen adsorption.
Microscopic examination via environmental scanning electron microscopy (ESEM).
Particle size distribution analysis using laser diffraction.

Main Results:

Specific surface area decreased with increasing RH, with a 62% drop at 100% RH and 34% at 32% RH.
A reduction in fine particles (<5 micrometers) was observed, correlating with surface area decrease.
Particle smoothing (coarse particles) and solid bridging (fine particles) were identified as key mechanisms.
Lactose inhalation blends demonstrated instability even at 32% RH.

Conclusions:

Lactose inhalation blends are sensitive to moisture, with significant degradation occurring at 32% RH.
Observed changes in particle properties, such as reduced fine particle fraction, may affect drug release.
The instability of lactose powders at moderate RH poses potential challenges for the pharmaceutical industry.