Q&A Bilayer Tablet Manufacturing

Source: AbbVie

By Dr. Éanna Ó Maitiú, Technical Operations Manager, at AbbVie Cork, Ireland

Q: What is bilayer tableting and what are the primary reasons for choosing this dosage form?

A: A bilayer tablet involves the compression of two formulations into a single solid oral tablet, while maintaining a physical separation of the formulations by layering one on top of the other. It enables the controlled delivery of either a single or of multiple active pharmaceutical ingredients within a single tablet.  This is particularly beneficial when, for example, one of the tablet layers provides an immediate release and the second layer a sustained release delivery.

Bilayer is considerably more convenient for patients due to receive multiple medications or longer-lasting profiles in a single dosage form and has the added benefit of improved patient compliance.

Q: What are some of the manufacturing challenges for bilayer?

A: Manufacturing bilayer tablets has its own unique challenges.  Based on our experiences at AbbVie Contract Manufacturing, additional formulation and development activity is often required and this may be associated with formulation development coupled with equipment and process optimization.  The types of technical challenges we’ve identified solutions for include tablet delamination, cross-contamination layers, layer separation, maintaining acceptable weight and depth control, and achieving acceptable yields and throughput.

Q: How do you overcome those challenges?

A: Having significant technical expertise and an array of equipment within our development and commercial manufacturing network has been key to overcome these challenges..   We continue to invest in the state-of-the-art equipment and technologies, and we’ve customized equipment which has enabled the development and successful commercialization of several products. 

Q: What type of equipment should a contract manufacturing organization have to produce bilayer dosage forms?

A: The type of equipment ultimately depends on the tablet formulation and the development phase of the product.  At AbbVie, we have an extensive range of equipment to support both development and commercial scale activities.   For early development activity we process blends in the 1kg range and scale-up for any subsequent development and commercialization work.  We would typically produce 8,000 to 20,000 tablets per hour on our development presses and would scale incrementally to approximately 600,000 tablets per hour.

Q: Are there any additional considerations when evaluating a CDMO for bilayer manufacturing?

A: From the customer’s point of view, the Safety and Quality compliance practices and standards employed by AbbVie are key and we consistently perform and deliver in this regard.  In addition, we have automated data acquisition and analysis capability, modern quality control and development laboratories, powder containment solutions, and onsite warehousing.

Q: What is the typical timeframe to scale up bilayer dosage form for commercial manufacture?

A: This is very much product-dependent, but the process can generally take between 1.5 and 3 years. If stability testing and clinical are excluded, commercial manufacturing can likely be achieved within 12- 18 months.

Q: Are there any special considerations regarding cleaning for bilayer?

A: When manufactured in our commercial GMP facilities, our contract customers’ products adhere to the AbbVie cleaning standards. This includes cleaning recipe and method development, cleaning verification, and test method transfer and validation.

Q: What bilayer projects is AbbVie Contract Manufacturing involved in?

A: While we don’t discuss our clients’ projects, we have four bilayers in development at our Cork location along with a multitude of other solid oral dosage programs being run concurrently across our remaining five facility locations which span both Europe and North America.

AbbVie Contract Manufacturing has experience with bilayer manufacturing for clients at its high-technology solid dose manufacturing plant in Cork, Ireland, Ludwigshaven, Germany, Lake County, Illinois and Barceloneta, Puerto Rico. Contact the experts at AbbVie to discuss your bilayer manufacturing needs at www.abbviecontractmfg.com or at 1-847-380-7589

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