MG2 and Skyepharma: low dosages, high technology

23.05.2016

Skyepharma, a Company specialized in inhalation and oral drugs, chose MG2 to address its needs for production of pilot and clinical batches for its inhalation pharmaceutical product pipeline and collaborative projects with third parties.

Skyepharma, a Company specialized in inhalation and oral drugs, chose MG2 to address its needs for production of pilot and clinical batches for its inhalation pharmaceutical product pipeline and collaborative projects with third parties. Planeta with MultiNETT, MG2’s machine, was identified as the most effective solution due to its dosing accuracy and flexible format.
    

The protagonists of the story
Skyepharma is an experienced independent developer of inhalation and modified-release oral products. It works in partnership with its licensees and partners to enable the development and commercialization of innovative and technically-challenging pharmaceutical products using advanced technological approaches. MG2 is a market leader in the design and marketing of capsule fillers and end-of-line solutions. The two companies met during an industry event, where they laid the foundations for a project leading to the Bolognese manufacturer installing Planeta capsule filler at Skyepharma’s R&D facility near Basel, Switzerland. MG2’s Planeta machine was chosen after an evaluation of several different options because it offered flexibility in dosing different kinds of inhalation products and good overall performance characteristics.

Skyepharma’s experience with Planeta: performance and flexibility
Rudi Müller-Walz, Head of Formulation & Process Development, said since the Planeta machine went into operation it has provided Skyepharma with the level of performance and reliability it needs. As well as ensuring the required dosage accuracy and uniformity, the Planeta offers a major “plus” for Skyepharma in respect of scalability. The model chosen by Skyepharma is configured to produce 12.000 capsules per hour, but it can be readily upgraded to give an output up to 100.000 capsule per hour adding a new module. Compaction is a major consideration and potential drawback when powders for pulmonary delivery applications are filled into capsules. MG2 was able to offer Skyepharma a specific micro-dosing unit to enable continuous operation for filling of small masses of powder into capsules (from 8 to 50 mg in Skyepharma’s current applications) without compaction issues. Other modules to handle different product forms such as pellets, micro tablets, tablets and liquids can also be fitted to Planeta equipment.
    
Skyepharma says it is particularly important in the development of new powder formulations for inhalation applications to have 100% control of the fill-weight in order to achieve the degree of precision necessary to produce robust formulation performance data. Therefore Skyepharma’s machine was equipped with MultiNETT, the most advanced solution available on the market. This capacitive system checks in-process the net fill-weight of each capsule. The real-time self- adjustment system corrects the dosator volume in order to achieve the best fill performance and ensures that the fill-weight of each capsule is within the required acceptance parameters. The MultiNETT system is kept continuously and automatically calibrated by a statistical gravimetric net weight control system, equipped with two weighing cells for measuring the empty and filled capsules. In addition to the level of automation Skyepharma was attracted by the fact the human-machine interface on the Planeta is easy to handle and the batch reports generated contain all the relevant information required concerning the process conditions and output. According to Skyepharma’s expertise the development of capsule-based drug products requires a filling process that can be readily scaled-up to industrial scale. Furthermore development companies also have to deal with the disparate physical properties of different drug formulations. It was therefore important for Skyepharma to choose a capsule-filler with sufficient flexibility, having good adaptability in the development phase, but also the capability to scale-up seamlessly to larger batch sizes within a reasonable time and representative of later full-scale production. In conclusion, during the last year Skyepharma has experienced good results with the Planeta, also partly because of the good After Sales support received from MG2.