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Biomembrane Fabrication by the Solvent-assisted Lipid Bilayer SALB Method
Published on: December 1, 2015
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Review of bilayer tablet technology.
Admassu Abebe1, Ilgaz Akseli2, Omar Sprockel1
1Bristol-Myers and Squibb Company, Drug Product Science and Technology, New Brunswick, NJ, USA.
International Journal of Pharmaceutics
|December 28, 2013
Summary
Bilayer tablets offer advanced oral drug delivery, improving patient compliance and enabling combination therapies. Manufacturing these complex dosage forms requires careful control over formulation, compression, and equipment for optimal product quality.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Manufacturing Science
Background:
- Oral delivery of bilayer (and multilayer) tablets is increasingly adopted for both branded and generic pharmaceutical products.
- Factors driving this trend include advanced drug delivery strategies, enhanced patient compliance, and the facilitation of combination therapies.
Purpose of the Study:
- To provide a comprehensive overview of the current state-of-the-art in bilayer tablet technology.
- To highlight the benefits of bilayer oral dosage forms and discuss challenges and advancements in their manufacturing.
- To offer a roadmap for bilayer tablet manufacturing, guiding formulation design, process parameter selection, and equipment choice.
Main Methods:
- Review of current literature and industry practices in bilayer tablet manufacturing.
- Discussion of critical manufacturing aspects: material properties, lubrication, layer sequencing, thickness and weight control, and compression forces.
- Exploration of bilayer tablet characterization complexities, particularly at layer interfaces, and analysis of manufacturing equipment features and control strategies.
Main Results:
- Identification of key challenges in manufacturing complex bilayer tablet systems, from formulation to process control.
- Description of various manufacturing equipment capabilities and control strategies specific to bilayer tablet production.
- Presentation of essential considerations for material properties, layer interactions, and compression dynamics.
Conclusions:
- Successful manufacturing of advanced bilayer tablets necessitates meticulous attention to formulation, material science, and process engineering.
- Technological advancements in tablet presses and control systems are crucial for overcoming manufacturing hurdles and ensuring high product quality.
- A structured approach, including a manufacturing roadmap, is vital for optimizing the development and production of bilayer oral dosage forms.
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