Application of Microcrystalline Cellulose Powders Obtained from Gossypiumherbaceum As Dry Binder in the Formulation of Diazepam Tablets

Abstract

Background: Microcrystalline cellulose (MCC) is a popular dry binder in tablet formulation. Differences in its processing methods can significantly affect its tableting properties. Aim: Assessment of the tableting and in-vitro release properties of diazepam tablets formulated with Gossypiumherbaceum (GH) derived MCC that was dried by two different methods. Methods: G.herbaceum bolls were de-lignified in sodium hydroxide solutions to obtain α-cellulose which was hydrolyzed with 2.0 N hydrochloric acid to obtain MCC. The neutralized damp MCC was separated into two portions. One portion was fluid bed dried (MCC-GossF) while the other portion was lyophilized (MCC-GossL). Diazepam tablets were prepared with 20, 30 and 40%w/w of MCC-GossF and MCC-GossL..Avicel PH 102 (AVH-102) served as comparing standard. The formulations were evaluated using standard methods. Results: The powders flowed well and the tablets met with British Pharmacopoiea specifications. Diazepam tablets containing MCC-GossL (DGL) were stronger than those of MCC-GossF (DCF) (p<0.05). The disintegration times were < 2 min and friability ≤ 1%. The strength of tablets containing AVH-102 (DAV) compared well with those of DGL tablets. More than 80% of diazepam was released from the tablets. Conclusion: The GH MCCs served as good dry binders in the formulation of diazepam tablets.