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  • Influence of disintegrants in different substrate physical form on dimensional recovery of multi-component tablet.

Influence of disintegrants in different substrate physical form on dimensional recovery of multi-component tablet.

International journal of pharmaceutics (2014-09-15)
Srimanta Sarkar, Shing Ming Ooi, Celine Valeria Liew, Bing Xun Tan, Paul Wan Sia Heng
ABSTRACT

This study investigated the influence of different disintegrants, present in different substrate physical forms, on dimensional recovery of multi-component tablets prepared at different compression pressures. Formulations containing model drug, metformin, (10%, w/w), different disintegrants (10%, w/w), and lactose (80%, w/w) were compressed directly or after granulation using polyvinyl pyrrolidone (1%, w/w) as binder, into tablets (350 mg, 10mm diameter) at 150, 200, and 250 N/mm(2) compression pressures. Tablets were characterized for immediate dimensional recovery (IR) after ejection from the die, latent dimensional recovery (LR) over 24 h, tensile strength, and disintegration. The IR was predominantly contributed by crystalline components whereas LR was brought about by polymeric materials. With increased compression pressure, higher degree of plastic deformation of the polymeric disintegrants resulted in tablet with lower LR and higher tensile strength. Presence of polyvinyl pyrrolidone in the granules contributed considerably to plastic deformation, and the tablets produced had lower LR, higher tensile strength, and longer disintegration time. This study indicated that use of granules as the feed substrate physical form and a prudent selection of components may enable the coating of resultant tablets immediately after compression without the risk of coat damage due to LR.

MATERIALS
Product Number
Brand
Product Description

Pyrrolidone, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Sodium hydroxyacetate, AldrichCPR
Sigma-Aldrich
2-Pyrrolidinone, ≥99%
Sigma-Aldrich
2-Pyrrolidinone, purum, ≥98.0% (GC)
Sigma-Aldrich
2-Pyrrolidinone, 99%
Sigma-Aldrich
Lactose, tested according to Ph. Eur.