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MIXING EQUIPMENT


HIGH SHEAR MIXING IN THE PHARMACEUTICAL INDUSTRY


With more than 75 years’ experience supplying pharmaceutical companies, from the global leaders to small highly specialised companies, Silverson high shear mixers have benefitted many in this industry


ilverson Machines has an unrivalled knowledge of the particular requirements of pharmaceutical applications and regulatory bodies and our standard mixers offer a high level of hygienic construction. For more advanced requirements we offer a range of specially designed Ultra-Hygienic mixers and have the flexibility to custom build equipment to meet exact mixing requirements.


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Recently, a pharmaceutical company which produces an ibuprofen suspension in sugar syrup product purchased a Silverson in-tank Batch mixer. The company had been developing this new product with the use of traditional agitators and had been using kaolin, a type of silicate material, to keep the product in suspension and make it more stable. Ideally, they wanted to remove the kaolin from the formulation and reduce the ibuprofen particles down to a much smaller size, but this was not possible with the agitator they were using as it did not provide the shear energy needed to reduce particle size.


They had been creating a premix of water, ibuprofen, kaolin and an emulsifier commonly used in oral medication. After a lengthy mixing time, the solution was then incorporated into a sugar syrup which was produced in a


separate vessel using


another agitator to dissolve the sugar into warm water. The heating of the water and cooling of the sugar syrup before addition to the ibuprofen mixture further increased processing times. The company were mixing batches of 150 litres, but were keen to increase this and remove the kaolin from the formulation. They knew their current process and mixing equipment would make this increase very difficult to achieve, so they contacted Silverson. At first, there was a discussion with the company about doing some trials with a in-


12 JUNE 2023 | PROCESS & CONTROL and Prozac.


These generic pharmaceutical suspensions are viscous products which pose the challenge of producing an adequate dispersion without agglomerates in varying batch sizes and viscosities. The company first contacted Silverson back in 2014, when they were just beginning to test their application and trialled a Silverson Laboratory mixer. At the same time they were also testing their application using other competitor high shear mixing equipment.


tank Batch mixer, as it was decided this would be most suitable for their application. But before a trial could be arranged the company found out that their counterpart in Pakistan had purchased a Silverson mixer and it was producing high-quality products and great results. On this basis the company immediately purchased the recommended Batch mixer.


Once the mixer was delivered the company used it for this application and the results were significantly better than they had previously achieved with the agitator. The Batch mixer was able to reduce the ibuprofen particles down to between 2 - 5 microns in a much shorter mixing time and the sugar solution could be made at ambient


temperature, further reducing processing time and costs. The company was able to achieve the desired stable suspension they were aiming for without the need to add the Kaolin. Another company has


purchased multiple Silverson mixers for their pharmaceutical application. Their most recent purchase, two Ultra-Hygienic In-Line mixers, were brought after successfully scaling up their laboratory process to full scale production.


The company produces generic pharmaceutical suspensions in liquid form as an alternative to pharmaceutical tablets such as Claritin


The FMX50 powder/liquid mixer (above) An example of Silverson’s high shear batch mixer (below, left)


Evidently, Silverson had performed better than the competition, as the company returned the following year to purchase the Laboratory mixer for batch formulation work. Shortly after that they returned again to trial a Verso, a laboratory-scale In-Line mixer, which they also purchased for their inline formulation work.


As all Silverson equipment is engineered to the same fine tolerances, once the company had concluded their batch formulation work, they easily scaled up the process from the laboratory to 200 litre batches for small scale production of the suspensions using a BX60 in-tank Batch mixer, which they purchased in 2018. A few years later, at the end of 2022 the company returned again to scale up their inline process. They purchased a Silverson Flashmix for full scale production. The FMX50 powder/liquid mixer is used on 4000 litre batches containing 175kg of active powders. The mixture can be anywhere between 25 – 75°C and therefore the viscosity of the mixture varies widely depending on the suspension being produced and the formulation, but is mostly in the range of 500 – 10,000 cps.


Not only is the company now using Silverson rather than a competitor for full scale production, they continue to grow their production line using Silverson mixers. At the beginning of 2023 two additional Ultra Hygienic In-Line mixers were purchased by the company to be installed into their production lines.


Silverson Machines E: sales@silverson.co.uk www.silverson.co.uk


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