MEGGLE InhaLac® Dry Powder Inhalation (DPI) Excipients

MEGGLE’s extensive portfolio of InhaLac® high quality crystalline lactose-based DPI excipients are specifically designed to support dry powder inhalation formulations.

These sieved, milled and micronized lactose monohydrates are presented in a wide range of particle sizes and are particularly suitable for use in pulmonary dry powder inhalers and nasal drug delivery systems.

Dry powder inhalation challenges

Inhalation aerosols enable needle-free systemic delivery of small molecule drugs as well as therapeutic peptides and proteins.

Effective performance of a dry powder inhaler largely depends on the carrier material (excipient) used for the drug formulation. Lactose monohydrate has become an industry standard in dry powder inhalation (DPI) formulation development, which needs to overcome a series of ongoing challenges. These include:

• Formulation stability
• Delivery efficacy
• Easy powder handling in production
• Advantageous powder characteristics
• High microbial quality and purity

Using lactose as a DPI excipient meets these challenges by not only improving performance efficiency of the DPI inhaler, but also facilitating powder handling during production.

InhaLac^® for dry powder inhalation

MEGGLE’s highly controlled production process produces a range of precisely quantified high quality grades for inhalation with narrow particle size distribution (PSD).

The registered InhaLac^® brand of DPI lactose monohydrates offers a broad spectrum of precisely tailored sieved, milled and micronized grades that are centered on median particle sizes ranging from 215 µm (InhaLac^® 70) all the way down to ≤5 µm in the micronized InhaLac^® 500.

Across the range, MEGGLE inhalation grade lactose offer a range of user benefits:

• Highly controlled and homogenous powder characteristics
• Highest microbial quality including low endotoxins
• A broad spectrum of particle sizes
• Customized product specifications possible

InhaLac® DPI excipient range

There are ten products in the InhaLac^® DPI lactose range.

Sieved DPI lactose monohydrates

• InhaLac^® 70: With a typical median particle size of approximately 215 μm, virtually free of fines (particles sized under 15 μm) and a narrow particle size distribution (Span: 0.8) making it well suited to cyclone-based inhalation devices.
• InhaLac^® 120: Featuring a median particle size of around 130 μm, narrowly distributed particle size (Span: ≤ 1.0) and low fines content.
• InhaLac^® 160: Median particle size of around 110 μm, narrowly distributed particle size (Span: ≤ 1.0) and a fines content between 3 – 5 %.
• InhaLac® 230: Median particle size of around 100 μm, narrowly distributed particle size (Span: ≤ 1.0) and a fines content between 3 – 5 %.
• InhaLac® 251: MEGGLE’s finest sieved DPI lactose grade has a median particle size of approximately 50 μm and is characterized by a higher fines content (>10 %) and broader particle size distribution.

Milled DPI lactose monohydrates

• InhaLac^® 140: Featuring a median particle size of around 50 μm, narrowly distributed particle size (Span: ≤ 1.0) and low fines content, making it an ideal carrier for capsule and blister-based formulations.
• InhaLac^® 150: Featuring narrow PSD with a typical x₅₀ of around 24 μm (Span: ≤ 1.0) and low fines content, also ideal carrier for capsule and blister formulations.
• InhaLac^® 300: a lactose grade with 90 % of the particles between 35–50 μm (Sympatec) or 40–56 μm (Malvern).
• InhaLac® 400: A finely milled alpha-lactose monohydrate with a typical median particle size of x₅₀ = 8 μm, PSD span of 3.5 and high fines proportion (73%).

Micronized DPI lactose monohydrate

• InhaLac® 500: A micronized alpha-lactose monohydrate with a median particle size of x₅₀ ≤ 5 μm, making it particularly suitable for soft pellet DPI formulations that offer promising alternatives for conventionally applied interactive mixtures in dry powder inhalation.

Standards and packaging

All sieved and milled InhaLac® products feature guaranteed minimum shelf lives of 24 months before need for retest with micronized InhaLac® 500 having a minimum shelf life of 18 months.

All products are delivered in 6,10, 15 or 25Kg cartons with various combination of double PE-EVOH-PE Inliner and/or aluminum laminated (OPP-ALU-PE) inliner (see Packaging and Stability Table below).

All MEGGLE dry powder inhalation products conform to the USP-NF monograph “Lactose Monohydrate”. This monograph is harmonized between USP-NF, Ph. Eur. and JP. The management system of MEGGLE Wasserburg has been certified as meeting the requirements of GMP and GDP according to EXCiPACT™.

MEGGLE also offers a range of DPI-focused services, including customization of inhalation grade lactose, and testing of analytical parameters in conformance with the lactose monograph.

Resources

Click on Lactose-based excipients for dry powder inhalation for further information.
Click on Sieved lactose for pulmonary and nasal drug delivery for further information.
Click on Milled lactose for pulmonary and nasal drug delivery  for further information.
Click on Micronized lactose for dry powder inhalation for further information.
Click on InhaLac® Range  to download brochure.