Skyepharma, a UK specialist in inhalation and oral drugs, has chosen MG2 to address its needs for the production of pilot and clinical batches of inhalation products and for collaborative projects with third parties.
MG2's Planeta machine was identified as the most effective solution due to its dosing accuracy and flexible format.
Skyepharma works in partnership with its licensees and partners to enable the development and commercialisation of innovative and technically-challenging pharmaceutical products using advanced technology.
MG2 is a market leader in the design and marketing of capsule fillers and end-of-line solutions.
The two firms met during an industry event, where they laid the foundations for a project leading to the Italian machinery manufacturer installing a Planeta capsule filler at Skyepharma’s R&D facility near Basel, Switzerland.
Rudi Müller-Walz, SkyePharma's Head of Formulation & Process Development, said the Planeta machine provides the firm with the level of performance and reliability it needs. As well as ensuring the required dosage accuracy and uniformity, the Planeta also offers a major 'plus' for Skyepharma in respect of scalability. The model chosen is configured to produce 12,000 capsules/hour, but it can be readily upgraded to give an output of 25,000 capsules/hour or even up to 100,000 capsules/hour by adding a new module.
Compaction is a major consideration and a 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 (8mg to 50mg) 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 to achieve the degree of precision necessary to produce robust formulation performance data.
Skyepharma’s machine was equipped with MultiNett, a capacitive system that checks in-process the net fill-weight of each capsule. The real-time self-adjustment system corrects the dosator volume 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 further controlled by a statistical gravimetric system, equipped with two load-cells for measuring the empty and filled capsules individually even at high speed and with low fill-weights.
In addition to the level of automation, Skyepharma was also attracted by the easy to handle human-machine interface on the Planeta and the batch reports generated that contain all the relevant information required concerning the process conditions and output.
According to Skyepharma, 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 the firm to choose a capsule-filler with sufficient flexibility, having good adaptability in the development phase, but also the capability to scale-up to larger batch sizes within a reasonable timeframe.