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Novel Orally Disintegrating Tablets Produced Using a High-Pressure Carbon Dioxides Process.
Masanori Kobayashi1,2, Daisuke Shinozuka2, Hiromu Kondo1
1Pharmaceutical Research and Technology Labs., Astellas Pharma Inc.
Chemical & Pharmaceutical Bulletin
|October 2, 2018
Summary
High-pressure carbon dioxide (CO2) can lower polymer glass transition temperature, enabling the creation of orally disintegrating tablets (ODTs). This new CO2-assisted tablet formation scheme (CATS) offers a gentler manufacturing alternative.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Polymer Chemistry
Background:
- High-pressure carbon dioxide (CO2) is known to reduce the glass transition temperature (Tg) of polymers.
- This property suggests potential applications in polymer processing and formulation.
- Orally disintegrating tablets (ODTs) require specific tablet characteristics for rapid disintegration in the mouth.
Purpose of the Study:
- To investigate if CO2-induced Tg depression facilitates interparticle bridging for ODT manufacturing.
- To evaluate the feasibility of using high-pressure CO2 for producing ODTs.
- To establish optimal conditions for a novel CO2-assisted tablet formation scheme (CATS).
Main Methods:
- Examined Tg depression in copolyvidone (Kollidon®) and Soluplus® using high-pressure CO2.
- Prepared placebo ODTs and assessed tablet properties (hardness, disintegration, porosity, appearance) before and after CO2 treatment.
- Determined optimal pressure, temperature, and treatment time for the CO2 process.
Main Results:
- Both Kollidon® and Soluplus® exhibited significant Tg depression under high-pressure CO2.
- Optimal conditions for ODT manufacture using Kollidon® were identified: 45°C, <8 MPa, and <30 min.
- Successful production of ODTs was achieved using the developed CO2 treatment process.
Conclusions:
- The Carbon Dioxide Assisted Tablet Formation Scheme (CATS) is a viable new method for manufacturing ODTs.
- CATS utilizes CO2-induced Tg depression for interparticle bridging and tablet formation.
- This process is advantageous for temperature- and humidity-sensitive drugs and functional drug particles, offering an alternative to conventional high-temperature/humidity methods.
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