Product Description
DuraLac® H is an anhydrous lactose grade specifically designed for direct compression tablet manufacture, providing excellent compactibility, good flowability, and high storage stability. It is produced by roller-drying a lactose solution at high temperature to form anhydrous beta-lactose and alpha-lactose crystals, which are then milled and sieved to optimize powder flow and compactibility. It complies with the monograph "Lactose, anhydrous" in various pharmacopoeias and is suitable for directly compressed and dry granulated formulations.
DuraLac® H has a particle size distribution that meets specified requirements, with less than 20% of particles smaller than 45 µm, 40-65% of particles smaller than 150 µm, and at least 80% of particles larger than 250 µm.
DuraLac® H exhibits moderate flowability and can be further improved with the addition of lubricants and/or glidants. It also demonstrates good powder compressibility, resulting in tablets with higher hardness yield compared to other lactose grades.
Applications:
The recommended applications for DuraLac® H are:
1. Low to medium dose direct compression (DC) formulations: DuraLac® H is specifically developed for direct compression processes, making it suitable to produce tablets with low to medium doses of active pharmaceutical ingredients (APIs).
2. Dry granulation (roller compaction, slugging): DuraLac® H can be used in dry granulation processes, such as roller compaction and slugging, where the lactose is compacted without the use of any liquid binder. This makes it a suitable excipient to produce granules.
3. Capsule filling and sachets: DuraLac® H can also be used in capsule filling applications, where it can be directly filled into capsules along with other ingredients. Additionally, it can be used in sachets, which are small packets containing a single dose of a powdered or granulated substance.
Overall, DuraLac® H is recommended for formulations that require low water content and can be directly compressed or dry granulated.
Source: MEGGLE's brochure.
