Description
A specialized fine grade of crystalline lactose monohydrate used as the carrier particle in dry powder inhaler (DPI) formulations. The micronized API (typically 1 to 5 microns) adheres to the larger carrier (typically 50 to 100 microns) in a controlled adhesive blend that releases the API as a respirable aerosol on inhalation.
White to off-white crystalline powder with tightly controlled particle size distribution and a defined fines fraction. Slightly sweet, freely soluble in water. Selected and processed to deliver consistent dispersion performance on the DPI device used by the customer.
We supply pharmaceutical inhalation-grade Lactose Monohydrate from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production. Inhalation grade is produced on dedicated lines under tighter microbiological and endotoxin control than the standard pharmaceutical grade.
Common market grades cover coarse carrier (D50 typical 80 to 150 microns), medium carrier (D50 typical 50 to 80 microns), fine carrier (D50 typical 30 to 50 microns), and milled fines (D50 below 10 microns, blended into the carrier to engineer the adhesive force between API and carrier).
Bulk and reduced-MOQ shipments. Batch-level COA covering identification, assay, specific rotation, loss on drying, full particle size distribution by laser diffraction, fines fraction, bulk and tapped density, endotoxin, microbiology, and full source documentation against USP, EP, JP, and BP monographs.
Introduction
Inhalation-Grade Lactose Monohydrate is the only large-volume excipient with an approved regulatory history for delivery to the human lung, and it has been the dominant DPI carrier since the first marketed dry powder inhaler products in the late 1960s. The pharmacopoeial monograph appears as an inhalation-specific grade alongside oral pharmaceutical lactose.
Production starts with pharmaceutical-grade alpha-lactose monohydrate that is sieved, milled, and air-classified to a tightly defined particle size distribution. The fines fraction (typically below 10 microns) is engineered by separate processing and reintroduced at controlled ratios to tune the adhesive force between API and carrier in the final blend.
Listed in USP-NF, EP, JP, and BP monographs as a separate inhalation grade with tighter microbiology, endotoxin, and particle size specifications than the standard pharmaceutical monograph. Pharmaceutical inhalation grades require dedicated production lines, full BSE/TSE source documentation, and segregation from oral pharmaceutical and food-grade production.
DPI formulation centers on the adhesive blend: micronized API in the 1 to 5 micron respirable range adheres to the larger carrier during blending and storage, and detaches under the shear of inhalation airflow. The fines fraction occupies the high-energy adhesion sites on the carrier surface, leaving the API on lower-energy sites from which it detaches more readily.
Strategic position: the standard DPI carrier across reference inhaled drug brands and generic DPI development. Lot-to-lot consistency on particle size distribution and fines content is the principal qualification criterion above price.
Where it is used
- Carrier particle in dry powder inhaler (DPI) capsule formulations
- Carrier in blister-based DPI devices
- Carrier in reservoir-based multi-dose DPI devices
- Fines additive to engineer API-carrier adhesion force
- Carrier for asthma and COPD bronchodilator formulations
- Carrier for inhaled corticosteroid formulations
- Carrier for combination DPI products
- Carrier in generic and biosimilar DPI development
Technical data
| Item | Specification |
|---|---|
| Appearance | White or almost white crystalline powder |
| Compliance | USP/NF, EP, JP, BP current edition (inhalation grade) |
| Identification | Conforms to pharmacopoeial tests |
| Assay (lactose, dried basis) | ≥ 99.5% |
| Specific rotation | +54.4° to +55.9° (anhydrous basis) |
| Loss on drying | 4.5% to 5.5% |
| Sulfated ash | ≤ 0.1% |
| Protein and light-absorbing impurities | Passes test |
| Particle size (D50) | 30 to 150 microns (grade dependent) |
| Fines fraction (below 10 microns) | Per grade specification |
| Heavy metals (as Pb) | ≤ 5 mg/kg |
| Endotoxin | ≤ 5 EU/g |
| Total aerobic count | ≤ 10 CFU/g |
| Yeast and mould | ≤ 10 CFU/g |
| E. coli, Salmonella | Absent |
| BSE/TSE | Free, supported by source documentation |
| Source | Bovine milk whey, segregated inhalation production line |
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