Skyepharma invests in new tablet coating technology

Saint-Quentin-Fallavier, France: – Fully featured CDMO Skyepharma Productions S.A.S. (Skyepharma) is extending its range of tablet coating technologies by adding an O’HARA Technologies LC M50 machine.

The new machinery will allow Skyepharma to provide tailored  film coatings even to small batches of oral solid doses.

Need for tablet coating

Film coating of solid oral drugs is a well-established process in the pharmaceutical industry.

Tablet coating is generally the last process in tablet manufacture, following compression. Coating allows manufacturers to:

• Protect tablets from external degradation, using a physical barrier,
• Seal hygroscopic pills against humidity
• Modulate API release (active ingredient): sustained, delayed, etc.
• Color the tablet to ease its visual identification and safety, or for cosmetic reasons
• Make it easier to swallow and mask any intrinsic unpleasant taste or smell

O’HARA Labcoat LC M50 pan coater

The O’HARA tablet coating machine meets this need with multiple interchangeable pans, allowing it to cover small scale (0.2 to 2 kg) to mid-size scale (15 to 50kg) batch sizes. In addition, the O’Hara pan coater is data integrity certified, GMP compliant and ATEX, thus fully suitable for both aqueous and organic coatings.

“The recent acquisition of the O’Hara pan coater equipment will definitely fill a gap for the manufacture of small to mid-size batches at Skyepharma. This will particularly be suitable for orphan drug products developed for rare diseases requiring a small batch size,” commented Vanessa BOURGEAUX, Project Manager in pharmaceutical development department at Skyepharma.

Coating formulation expertise

In addition to a wide range from benchtop equipment to high-capacity industrial pans, Skyepharma has developed a unique expertise in pharmaceutical coating thanks to its development experts.

Depending on client needs, Skyepharma can formulate the most appropriate coating solutions with high quality pharma-grade excipients to reach targeted coated tablets’ attributes.

Additionally, using a Failure Mode Effect Analysis (FMEA) approach, Skyepharma’s formulation team can identify the critical process parameters that are specific to the drug product to develop an optimal and robust process for the routine manufacturing of coated tablets.

Improving bioavailability, decreasing toxicity and side effects, or designing and improving the release profile of the drug, are key objectives for formulators. This can be done, for example, through gastro-resistant polymers keeping the active ingredient intact in the stomach and releasing it in the intestine.  They can also protect the gastric mucosa from irritating by the active ingredients.

About Skyepharma Production

Skyepharma Production S.A.S. (Skyepharma) is a  specialist CDMO with particular expertise and capabilities in oral solid dosage forms, being a key  player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.

Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.

As an integrated CDMO, The company’s vision is to help solve healthcare industry complexity with a mission to provide a dedicated and results-oriented team to deliver advanced oral dosage services to the healthcare industry through state-of-the-art facilities, scientific expertise and open, transparent relationships. All of this is summed up in its strapline: ‘Expert and Agile CDMO partner for tailor-made solutions’.

The Skyepharma CDMO offer in solid oral dosage formats encompasses the whole value chain, including Formulation Development & Process Design, Analytical Development, Scale-up, Manufacturing, Packaging, Serialisation and Aggregation.

Skyepharma also provides a range of support services that help  client companies from early stage development (up to phase III), through scale-up and full commercial manufacturing and packaging to market introduction, including controlled substance handling, QbD methodology (FMEA, FTA, DOE), Troubleshooting, regulatory services, validation, registration and warehousing services.

Learn more at: www.skyepharma.fr

Resources

Click on Coating oral solid drugs to protect and optimize: Mastering the coating process for more information.
Click on O’HARA Labcoat™ M Tablet Coating Systems for further machine information.