MEGGLE has it. Lactose for powder preparations.
Although tablets account by far for the majority of solid oral dosage forms, powder preparations, such as capsules and sachets, present viable options to the developer.
Traditionally capsules made up of gelatin have been used, whereas lactose is more than suitable as capsule filler, based on its limited interaction with gelatin capsules, preserving the capsule integrity over time. This has clearly not changed for Hydroxypropylmethylcellulose (HMPC) capsules, which have gained a lot of popularity.
Capsules are of special interest for early stage developments and clinical trials medication, where on a final formulation has not been decided yet.
Trend: Capsule and Sachet formulation for children and elderly people.
Furthermore, patient centric medicines for children and elderly, which allow for circumventing impaired tablet-swallowing can be developed by the use of capsule and sachets. Life cycle management also acknowledges these kinds of dosage forms, which may lead to gaining market share for well-established drugs, which have been around for a while. 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.
Key for content uniformity: Suitable particle size distribution as well as bulk density.
MEGGLE has decided to contribute to these needs in a meaningful way by providing a range of lactose grades which differ in particle size distribution as well as bulk density. Both parameters are essential to a successful development. If chosen correctly, content uniformity issues may be a minor obstacle or do not bother at all. In order to provide consistent functionality MEGGLE has implemented a rigorous quality system, which exceeds current Good Manufacturing Practice (GMP) requirements by far.
MEGGLE´s expertise: Off the shelf products or tailor-made 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.
MEGGLE´s sieved Lactose grades offer great features in high speed capsule filling.
Maximum comfort using MEGGLE Lactose in high speed capsule filling is guaranteed: Especially designed, sieved Lactose grades allow for balancing important powder properties as density, flow or cohesiveness in your specific recipe. In an extensive case study (AAPS 2019) using a MG2 Planeta dosator capsule filling machine material performance of a formulation comprising low dosage, ultrafine example API Vitamin B2 and coarse, lubricated Lactose diluent SacheLac 80 was investigated. Popular capsule sizes #1, #3, and #4 have been analyzed at 3 discrete filling speeds (15, 38, and 50k capsules/filling unit/h) 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.