By MEGGLE Excipients
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MEGGLE sieved lactose for powder preparations
MEGGLE’s huge range of lactose-based excipients includes several sieved and other formulations that are particularly suitable for powder applications, such as capsules and sachets.
Capsules and sachets are trending as more popular dosages and offer opportunities for gaining market share. Furthermore, powder applications are especially important for early stage developments and clinical trials medication, where final formulation has yet to be finalized.
Lactose advantages for capsule and sachet applications
Although tablets account for the majority of solid oral dosage forms, powder preparations, such as capsules and sachets, present developers with viable alternative dosage delivery options. This is particularly important in early stage formulation development and preparation of clinical trial material, where capsules provide an ideal choice.
When developing a powder preparation, processability of the final powder blend, as well as content uniformity and avoiding powder segregation is imperative to a successful development. This is critical for pediatric and geriatric medicines that emphasize need for enhanced delivery methods that circumvent impaired tablet-swallowing.
Lactose provides the ideal excipient material to preserve long term integrity of the capsule, exhibiting limited interaction with gelatin and offering an ideal capsule filler for formulators around the world. The same advantages apply for Hydroxypropylmethylcellulose (HPMC) capsules, which are gaining ground for many applications.
Ensuring content uniformity
The keys to content uniformity are suitable particle size distribution (PSD) as well as bulk density. Both parameters are essential to a successful formulation development. Therefore the correct excipient technology choice can overcome content uniformity issues.
MEGGLE has decided to contribute to these needs in a meaningful way by providing a wide range of lactose grades for this kind of applications.
Off the shelf or tailored sieved lactose grades
As MEGGLE aims to achieve ultimate customer satisfaction, it has partnered with leading capsule-filling-machine-manufactures in order to provide expertise from both ends; material and processing. By partnering with these companies, MEGGLE is also able to tweak and improve its products, which leads to improved off-the-shelf products but gives the customers also the option to choose a tailor-made grade for even better performance.
In order to provide consistent functionality, MEGGLE has implemented a rigorous quality system.
High speed capsule filling
MEGGLE lactose has been proven as suitable for high speed capsule filling applications. Highly tailored and powder-engineered sieved Lactose grades provide ideal balance between key powder properties such as density, flow, and cohesiveness.
In an extensive case study (AAPS 2019), researchers investigated high-speed filling material performance of a formulation comprising low dosage, ultrafine example API Vitamin B2 in combination with coarse, lubricated lactose diluent SacheLac® 80, using an MG2 Planeta dosator capsule filling machine.
They analyzed popular capsule sizes #1, #3, and #4 at three discrete filling speeds (15k, 38k, and 50k capsules per hour from a single filling unit) at different time points according to content and weight uniformity and further performance-related parameters. All results indicated easy capsule filling at high efficiency and quality standards under given equipment design and compendial requirements.
Powder preparations portfolio
MEGGLE lactose grades suitable for powder preparation applications, such as high speed capsule and sachet filling, are available under the trade names PrismaLac® 40, CapsuLac® 60, SacheLac® 80 and SpheroLac® 100.
Meggle can provide 1Kg samples of all four grades on request (see Resources)
Click on MEGGLE Powder Preparations Portfolio for technical information and sample request form .