Evaluation of a Weakly Cationic Exchange Poly (Methacrylic Acid-Co-Divinylbenzene) Resin as Filler- Binder for Direct Compression Tablets

Purpose: To evaluate a weakly cationic exchange poly(methacrylic acid-co-divinylbenzene) resin (PMD) as a new filler-binder for direct compression tablets. Methods: Powder properties of PMD and MCC were characterized. Tablets made from PMD and MCC with and without propranolol hydrochloride were evaluated for diameter, thickness, friability, assay, disintegration, dissolution and compression behavior. Results: Tablets made from PMD (thickness: 3.54 - 4.46 mm) were thicker than those of MCC (2.93 - 3.33 mm). At compression pressures ≥ 309 MPa, the crushing strength of PMD tablets was so high that it exceeded the capacity of the tester (500 N). PMD tablets rapidly disintegrated (0.43 - 9.56 min), but MCC tablets did not disintegrate within 60 min. The crushing strength of PMD tablets containing 10 and 100 mg propranolol hydrochloride was 406.1 and 177.9 N, respectively, which were lower than that of tablets without the drug. Tablets made from PMD also exhibited faster drug dissolution. The slopes of the linear portions of Heckel plots for PMD and MCC were comparable (5.02×10-3 and 5.12×10-3 MPa-1), respectively. Conclusion: PMD has good compressibility at high compression pressures, which should make it a suitable filler-binder for direct compression tablets.