Abstract
Purpose: To determine the potential of some anionic exchange resins as tablet disintegrants.Methods: Dowex1® x2, x4 and x8 resins (crosslinked copolymers of styrene and divinylbenzene with quaternary methyl amine functionality) were evaluated as disintegrant for dibasic calcium phosphate dihydrate tablets. The best resin providing the fastest disintegration and highest hardness of obtained tablets was selected for further investigation. The effect of resin concentration and compression force on the properties of tablets using the selected resin was investigated. In addition, the disintegrant efficacy of the selected resin in the tablet formulations containing either a basic drug, e.g., dextromethorphan hydrobromide (DMP), or an acidic drug, e.g., diclofenac sodium (DCN), was determined in comparison with sodium starch glycolate (SSG).Results: Dowex1®x2 resin exhibited the fastest disintegration (6.0 s) and the highest hardness (103.6 N) of obtained tablets. These disintegrating and tablet properties depended upon the resin concentration and compression force. For DMP, the resin provided faster disintegration and drug release (8.0 s and 100.4 % at 10 min) as compared with SSG (16.2 s and 98.9 % at 30 min). In contrast, the resin caused the depleted release of DCN (61.6 % at 120 min) in spite of providing the faster tablet disintegration (10.0 s) than SSG (15.5 s) due to the ionic binding of the drug and resin.Conclusion: The Dowex1®x2 resin was shown to be a potential disintegrant for the tablets of basic drugs.Keywords: Anionic exchange resin, Disintegrant, Dextromethorphan hydrobromide, Diclofenac sodium, Calcium phosphate
Highlights
Disintegrant is an essential part in the tablet formulation which mostly, unless a proper disintegrant is added, will not disintegrate within the limited time interval specified in the pharmacopoeia [1]
These resins were pharmaceutically used as carriers for sustainedrelease drug delivery systems of acidic drugs e.g. diclofenac sodium [14,15]
The low crosslinked anionic exchange resin Dowex1®x2 can act as a disintegrant due to its high ability for hydration and swelling
Summary
Disintegrant is an essential part in the tablet formulation which mostly, unless a proper disintegrant is added, will not disintegrate within the limited time interval specified in the pharmacopoeia [1]. The use of disintegrant will facilitate the disintegration of tablet into fine fractions by overcoming the cohesive strength introduced by compaction force and binder. This enhances the surface area of drug in contact with the aqueous environment for a more rapid release and bioavailability of drug [1,2]. At the required amounts, these traditional disintegrants individually have certain drawbacks that have limited their widespread use. To this regard, a new group of disintegrants, referred to as “superdisintegrants”, has been developed. Several materials proven to be superdisintegrants are sodium starch glycolate (modified starch), croscarmellose sodium (crosslinked cellulose), crospovidone (crosslinked polyvinylpyrrolidone) and polacrilin potassium (cationic exchange resin) [3,4,5,6]
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