NGHIÊN CỨU ẢNH HƯỞNG CỦA KÍCH THƯỚC HẠT VÀ LỰC NÉN VIÊN ĐẾN TÍNH CHẤT BỀ MẶT LIÊN KẾT CỦA VIÊN NÉN HAI LỚP

Summary
In recent years, the drug manufacturers in Vietnam have become more and more interested in bilayer tablet products. In the production of this dosage form, the key challenge is how to limit the layers’ penetration to each other at the interface while the two layers can still be tightly bonded togive desired strength to the tablet. The current study aimed to determine the influence of the granule size and of the compression force on the interfacial properties of the bilayer tablets.
Six granule batches of different sizes and colors were prepared by the wet granulation process. Those were employed to prepare nine tablet batches that differ in granule size in each layer. In addition, nine tablet batches (with the same granule size in both layers) were also prepared with different compression forces. The results showed that the granule size in the second layer played a more important role than the first layer in creating bonding at the interface as well as in tablet strength. The smaller the granule size in the second layer resulted in less friable bilayer tablets. With the same granule size, the pre-compression force (first layer) played a crucial role in the formation of the interfacial bonding. A low pre-compression force provided flexibility in adjusting the main compression force, as well as a better bonding strength at the interface. The conclusions obtained in this study can be applied to the practice of formulating and manufacturing two-layer tablets at manufacturing sites in Vietnam.
Keywords: Bilayer tablet, granule size, interfacial bonding strength.

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