MEGGLE InhaLac® high quality lactose for dry powder inhalation

MEGGLE’s wide range of InhaLac® high quality crystalline lactose-based excipients are specifically designed to support dry powder inhaler (DPI) 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 offers the potential for 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.

Use of specific DPI lactose can help overcome a series of ongoing formulation challenges that include stability, delivery efficacy, and maintaining high microbial quality and purity.

Using lactose as an excipient meets these challenges by not only improving performance efficiency of dry powder inhalers, while 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 DPI 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 <105 µm in the milled or micronized InhaLac^® 400/500.

MEGGLE now offers ten different grades of its InhaLac® pharma grade lactose excipient optimised for dry powder inhalation applications. The wide range of particle sizes and surface characteristics make it easier than ever for DPI drug developers to find the right combination for the final formulation.

DPI sieved lactose monohydrates

• InhaLac^® 70, the coarsest sieved product for DPI formulations. This lactose crystal powder features a typical median particle size of approximately 215 μm, is virtually free of fines (particles sized under 15 μm) and shows 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 a fines content between 3 – 5 %. 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 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. Suitable for capsule or blister formulations.

DPI milled lactose monohydrates

• InhaLac® 140: An inhalative lactose monohydrate) with mean particle size of approximately 50 μm.
• InhaLac® 150: An inhalative lactose monohydrate) with mean particle size of approximately 24 μm.
• InhaLac® 300: A recently developed fine-milled lactose excipient to support dry powder inhalation (DPI) formulations with specific particle size distribution with 90% of particles between 40 and 56 µm (Malvern) and characterized by the typical flow- and surface-characteristic of milled lactose grades to bridge the gap between medium sized carrier lactoses and fine milled grades for DPI.
• InhaLac® 400: A finely DPI milled lactose (alpha-lactose monohydrate) with a typical median particle size of x₅₀ 8 μm, PSD span of 3.5 and high fines proportion (73%).

DPI micronized lactose monohydrates

• 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 x₉₀ ≤ 10 μm, making it particularly suitable for soft pellet dry powder inhaler formulations that offer promising alternatives for conventionally applied interactive mixtures in dry powder inhalation.

Resources

Click on  Highest quality for dry powder inhalation for further information on DPI lactose portfolio.
Click on Sieved lactose for pulmonary and nasal drug delivery for information on sieved InhaLac® grades.
Click on Milled lactose for pulmonary and nasal drug delivery for information on milled InhaLac® grades.
Click on Micronized lactose for dry powder inhalation for information on micronized InhaLac® grades.
Click on InhaLac®  Technical Brochure to download pdf brochure.