Lactose Monohydrate: The Classic Filler for Solid Oral Dosage Forms
Lactose monohydrate is the most widely used filler-diluent in the global pharmaceutical industry. Available in multiple grades — from milled for wet granulation to spray-dried for direct compression — it offers a well-characterised, regulatory-accepted platform for tablet and capsule manufacturing. Its long track record, consistent supply, and predictable behaviour in formulation make it the default filler against which alternatives are benchmarked.
Product Profile
| CAS Number | 64044-51-5 (10039-26-6) |
|---|---|
| Molecular Formula | C₁₂H₂₂O₁₁·H₂O |
| Appearance | White to off-white crystalline powder |
| Function | Filler / diluent / carrier |
| Typical Use Level | 15–90% w/w depending on dose and formulation type |
| Compendial Grade | EP / USP-NF / JP |
Formulation Applications
Milled grades of lactose monohydrate (e.g., 200 mesh) are used in wet granulation, where they dissolve partially in the granulating fluid and recrystallize upon drying, forming strong inter-particle bonds. Spray-dried lactose provides the flow and compressibility needed for direct compression, though it requires careful control of moisture content (typically 4.5–5.5% for the monohydrate). Lactose is also used as a carrier for dry powder inhalation (DPI) formulations, where specific particle size distributions (typically 50–200 µm with controlled fines) are critical for aerodynamic performance. The key compatibility limitation is the Maillard reaction: lactose should not be used with primary or secondary amines, as the reducing sugar reacts to form brown discolouration and degradation products.
Why Source from TCS
TCS supplies lactose monohydrate in multiple pharmaceutical grades to formulators across Europe. Available in standard packaging with flexible quantities for R&D through production scale. Contact us with your grade requirements and volume needs.
FAQ
What information should be included in an inquiry for Lactose Monohydrate –64044-51-5?
A useful inquiry normally includes the product name, target application, estimated quantity, destination market, and any specific documentation or packaging requests.
How is Lactose Monohydrate –64044-51-5 usually evaluated for sourcing?
This product is positioned for excipient sourcing where formulation fit, dosage form, handling, and repeat purchasing requirements need to be reviewed together with commercial supply conditions.
What documentation and commercial points are commonly reviewed before buying Lactose Monohydrate –64044-51-5?
For excipient sourcing, teams usually discuss the intended dosage form, formulation role, packaging format, order volume, and the routine documentation needed for qualification and purchasing.
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