How to make Pharmaceutical Tablet Coatings

Summary

Discover the Silverson method for pharmaceutical tablet coating, which ensures uniformity and consistency. Utilizing high-shear mixers, the process dissolves sugar or polymers, disperses additives, and minimizes particle size for efficient spray coating. Silverson mixers offer rapid solution preparation, batch consistency, and are easily cleaned for versatility. They meet stringent sanitary standards and can be customized to fit FDA requirements and customer specifications.

Takeaways

• 💊 Silverson mixers are used for pharmaceutical tablet coating, including traditional sugar, film, and complex enteric coatings.
• 🔄 The mixers ensure a uniform and consistent mix with fine particle sizes suitable for spray coating systems.
• 🚀 Rapid dissolution of sugar or polymer in water or organic solvents is a key step in the process.
• 🎨 The addition of other ingredients like plasticizers and colorants is facilitated by the mixer for a homogenous mix.
• 🌀 High shear action of Silverson mixers minimizes particle size and ensures batch uniformity.
• 🚫 Prevents issues like flecking from uneven dispersion of colorant by achieving complete uniformity.
• ⏱️ The mixers complete the solution preparation faster than conventional mixers, ensuring batch to batch consistency.
• 🔄 The same mixer can be used for dispersing tablet binding agents such as HPMC.
• 🧼 Silverson mixers are easily cleaned and can be customized to include CIP systems for hygiene.
• 🛡️ Built to high sanitary standards, meeting or exceeding regulatory guidelines, with full FDA documentation available.
• 💼 Custom-built equipment is available to suit specific customer requirements.

Q & A

What types of tablet coatings can be prepared using Silverson mixers?

Silverson mixers can be used to prepare traditional sugar-based coatings, film coatings, and more complex formulations such as enteric coatings.

What is the key factor in achieving a successful pharmaceutical tablet coating?

The key factor is getting a uniform, consistent mix with a particle size fine enough to pass through spray coating systems.

How do Silverson mixers ensure a uniform and consistent mix in the coating process?

Silverson mixers use high shear action to minimize particle size and achieve complete uniformity, preventing issues like flecking from uneven dispersion of colorants.

What is the typical process for making a tablet coating using a Silverson mixer?

The process typically involves dissolving sugar or polymer in water or organic solvents, adding plasticisers and colorants, and using the high shear action of the Silverson mixer to disperse and mix all ingredients uniformly.

How does the mixing time with a Silverson mixer compare to conventional mixers?

The solution is completed in a fraction of the time compared to conventional mixers.

How does Silverson equipment ensure batch-to-batch consistency?

The high shear action and uniform mixing provided by Silverson mixers ensure consistent results from batch to batch.

Can Silverson mixers be used for applications other than coating preparation?

Yes, the same mixer is often used for the dispersion of tablet binding agents such as HPMC.

What are the benefits of using Silverson mixers in terms of cleaning and maintenance?

Silverson mixers are easily cleaned between batches or when changing colors, and they can be customized to incorporate CIP (Clean-In-Place) systems.

Are Silverson mixers compliant with regulatory standards?

Yes, Silverson equipment is built to the highest sanitary standards, meeting or exceeding all regulatory bodies' guidelines, and can be supplied with full FDA documentation packages.

How can customers find out more or customize their Silverson mixer equipment?

Customers can visit the Silverson website or contact the company directly to find out more or discuss custom equipment requirements.