MEGGLE InhaLac® lactose-based excipients for dry powder inhalation
Products & Services | MEGGLE Excipients & Technology
MEGGLE’s wide of InhaLac® high quality crystalline lactose-based 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 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.
- Formulation stability
- Delivery efficacy
- Easy powder handling in production
- Advantageous powder characteristics
- High microbial quality and purity
Using lactose as an excipient meets these challenges by not only improving performance efficiency of the 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) in which the particles retain individual identities and behaviors.
The registered InhaLac® brand of lactose monohydrates offers a broad spectrum of sieve cuts and 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.
There are seven products in the InhaLac® DPI lactose range.
Sieved 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. Suitable for capsule or blister formulations.
- InhaLac® 160: Median particle size of around 110 μm, narrowly distributed particle size (Span: ≤ 1.0) and a fines content between 3 – 5 %. Suitable for capsule or blister formulations.
- InhaLac® 230: Median particle size of around 100 μm, narrowly distributed particle size (Span: ≤ 1.0) and a fines content between 3 – 5 %. Suitable for capsule or blister formulations.
- InhaLac® 251: MEGGLE’s finest sieved 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. Suitable for capsule or blister formulations.
Milled and micronized lactose monohydrates
- 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%).
- InhaLac® 500: A micronized alpha-lactose monohydrate featuring similar cumulative distribution and distribution density curves to InhaLac 400 but centered on a slightly larger median particle size of x50 ≤ 5 μm, making it particularly suitable for soft pellet formulations that offer promising alternatives for conventionally applied interactive mixtures in dry powder inhalation.
All sieved and milled InhaLac products do have a retest date of 24 months. The micronized grade InhaLac® 500 having a retest date 18 months which is outstanding for this kind of product.
All products are delivered in 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 monograph “Lactose Monohydrate” in the USP-NF.). This monograph is harmonized between USP-NF, Ph. Eur. and JP. The management system of Molkerei MEGGLE Wasserburg has been certified as meeting the requirements of GMP and GDP according to EXCiPACT™.