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Evaluation of a novel sugar coating method for moisture protective tablets
Masaki Ando1, Rina Ito, Yuichi Ozeki
1Pharmaceutical Research & Technology Laboratory, Sanwa Kagaku Kenkysho Co. Ltd., 363 Shiosaki, Hokusei-cho, Inabe-city, Mie 511-0406, Japan. m_andoh@mb3.skk-net.com
International Journal of Pharmaceutics
|January 30, 2007
Summary
A new one-step dry-coating method (OSDRC) creates moisture-protective sugar-coated tablets using amorphous sucrose. This innovative process simplifies manufacturing while enhancing tablet stability against moisture.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Conventional sugar coating processes for tablets are complex and time-consuming.
- Developing moisture-protective tablets is crucial for drug stability and shelf-life.
- Amorphous sucrose offers potential as a coating material but requires investigation of its physical properties under compression.
Purpose of the Study:
- To develop a novel, simplified method for producing moisture-protective sugar-coated tablets.
- To evaluate the physicochemical properties of amorphous sucrose when used in a one-step dry-coating process.
- To assess the moisture barrier capabilities of tablets manufactured using amorphous sucrose and OSDRC technology.
Main Methods:
- Utilized a novel one-step dry-coating (OSDRC) manufacturing method.
- Employed amorphous sucrose as the outer layer material for OSDRC tablets.
- Investigated isothermal crystallization, water vapor permeability, tensile strength, and disintegration time of compressed amorphous sucrose.
Main Results:
- Amorphous sucrose tablets exhibited crystallization behavior similar to amorphous powder, influenced by compression pressure.
- Crystallized amorphous sucrose at 200 MPa demonstrated significant moisture protection, reducing water vapor permeability by over 1/2000 compared to conventional formulations.
- Physicochemical characteristics, including moisture barrier properties, were dependent on amorphous and additive content.
Conclusions:
- The novel OSDRC technology combined with amorphous sucrose effectively produces moisture-protective sugar-coated tablets.
- This simplified manufacturing approach offers a viable alternative to conventional sugar coating methods.
- The developed method is highly useful for creating stable, moisture-resistant pharmaceutical dosage forms.
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