Recently, a pharmaceutical company which produces an ibuprofen suspension in sugar syrup was having production challenges. The company had been developing a 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 increase stability. 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 their agitator since it did not provide the shear energy needed to reduce particle size.
Agitators Lead to Agitation
Their existing process posed several challenges:
- Due to equipment limitations, creating a premix of water, ibuprofen, kaolin, and a commonly used oral medication emulsifier was necessary.
- Mixing the premix required a lengthy amount of time.
- A separate vessel with an additional agitator was needed to produce a sugar syrup by dissolving sugar into warm water.
- Processing times were prolonged due to the heating of the water for the syrup and subsequent cooling of the sugar syrup before adding to the ibuprofen mixture.
The company was mixing batches of 150 liters 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.
The Silverson team advised conducting trials with an in-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 was now producing high-quality products with great results. On this basis, the company immediately purchased the recommended Batch mixer.
From Trial to Triumph: Transformative Mixing Results
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 all without the need to add the kaolin.
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