A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/36 (2006.01) C08B 30/00 (2006.01) C08B 31/18 (2006.01)
Patent
CA 2590821
High-amylose sodium carboxymethyl starch (HASCA), produced by spray- drying (SD), was previously shown to have interesting properties as a promising pharmaceutical sustained drug-release tablet excipient for direct compression, including ease of manufacture and high crushing strength values. This study describes the effects of some important formulation parameters, such as compression force (CF), tablet weight (TW), drug-loading and electrolyte particle size, on acetaminophen-release performances from sustained drug- release matrix tablets based on HASCA. An interesting linear relationship between TW and release time was observed for a typical formulation of the system consisting of 40% w/w acetaminophen as model drug and 27.5% NaCI as model electrolyte dry-mixed with HASCA. Application of the Peppas and Sahlin model gave a better understanding of the mechanisms involved in drug-release from the HASCA matrix system, which is mainly controlled by surface gel layer formation. Indeed, augmenting TW increased the contribution of the diffusion mechanism. CFs ranging from 1 to 2.5 tons/cm2 had no significant influence on the release properties of tablets weighing 400 or 600 mg. NaCI particle size did not affect the acetaminophen- release profile. Finally, these results prove that the new SD process developed for HASCA manufacture is suitable for obtaining similar quality HASCA in terms of release and compression performances.
Bataille Bernard
Baylac Gilles
Brouillet Fabien
Cartilier Louis
Robic
Universite de Montreal
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