Surface dissolution UV Imaging for characterization of superdisintegrants and their impact on drug dissolution

Publication date: Available online 24 January 2020Source: International Journal of PharmaceuticsAuthor(s): P. Zarmpi, T. Flanagan, E. Meehan, J. Mann, N. FotakiAbstractSuperdisintegrants are a key excipient used in immediate release formulations to promote fast tablet disintegration, therefore understanding the impact of superdisintegrant variability on product performance is important. The current study examined the impact of superdisintegrant critical material attributes (viscosity for sodium starch glycolate (SSG), particle size distribution (PSD) for croscarmellose sodium (CCS)) on their performance (swelling) and on drug dissolution using surface dissolution UV imaging. Acidic and basic pharmacopoeia (compendial) media were used to assess the role of varying pH on superdisintegrant performance and its effect on drug dissolution. A highly soluble (paracetamol) and a poorly soluble (carbamazepine) drug were used as model compounds and drug compacts and drug-excipient compacts were prepared for the dissolution experiments. The presence of a swelled SSG or CCS layer on the compact surface, due to the fast excipient hydration capacity, upon contact with dissolution medium was visualized. The swelling behaviour of superdisintegrants depended on excipient critical material attributes and the pH of the medium. Drug dissolution was faster in presence compared to superdisintegrant absence due to improved compact wetting or compact disintegration. The improvement in drug dissolutio...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research