Novel applications of locally sourced montmorillonite (MMT) clay as a disintegrant in the formulation of pharmaceutical product

Abstract

This work explores the application of a locally sourced raw material, montmorillonite (MMT) clay, as a disintegrant in the formulation of an analgesic pharmaceutical product - paracetamol. The raw MMT was refined and treated with 0.IM NaCl to yield sodium montmorillonite (NaMMT) and the powder properties established in this work were compared with those of purified kaolinite (KO) clay and a reference standard disintegrant – maize starch (MS). Separately, the NaMMT, KO and MS powders were employed as  disintegrants to compound paracetamol tablets. Some of the physical properties of the tablets were determined. Results of some powder properties showed that NaMMT and KO had superior angles of repose (40.20º and 34.40º, respectively) compared with the reference standard disintegrant MS  (56.00%). Sodium montmorillonite (NaMMT) showed better swelling capacity (1.81) than both KO and MS (1.40 and 1.56, respectively), while MS and NaMMT exhibited comparable water retention capacity  (3.04% and 2.90%, respectively). The porosity of MS (31.94%) was only slightly better than that of  NaMMT (30.00%). For the physical properties of the tablets, the dissolution characteristic of NaMMT was  slightly better than that of MS: for example, the percentage amount of 15% NaMMT and MS dissolved in 0.1M HCl solution at 30minutes duration were 75.40% and 74.10%, respectively; and at 50 minutes  duration, it was 85.10% and 82.10%, respectively. On the other hand, the disintegration property of MS (1.54min) was slightly better than that of NaMMT (2.10min). Kaolinite (KO) failed both the dissolution and integration tests, with only 0.31% dissolving even after 1hr and requiring more than 30min to disintegrate. The friability and hardness tests showed that NaMMT was superior to both MS and KO. Overall, the sodium montmorillonite (NaMMT) was found to hold strong prospect as a disintegrant in the formulation and compounding of certain solid, compact pharmaceutical dosages.

Keywords: Compact dosages, disintegrants, local raw material, montmorillonite clay, pharmaceutics.