RT Journal Article
SR Electronic
T1 Physicochemical Characterization and Dissolution Enhancement of Aceclofenac–Hydroxypropyl β-cyclodextrin Binary Systems
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 378
OP 388
VO 60
IS 6
A1 Dahiya, Sunita
A1 Pathak, Kamla
YR 2006
UL http://journal.pda.org/content/60/6/378.abstract
AB The aim of this study is to prepare and characterize binary systems of aceclofenac (AC) with hydroxypropyl β-cyclodextrin (HPβCD) in equimolar ratio. Solid binary systems of aceclofenac with HPβCD were prepared using cogrinding, kneading, and coevaporating methods, and a physical mixture was prepared for comparison. The binary systems were characterized by differential scanning calorimetry, thermogravimetric analysis, mass spectroscopy, 1H nuclear magnetic resonance (NMR) spectroscopy, scanning electron microscopy, and in vitro dissolution studies. 1H NMR studies showed that AC partially fits into the HPβCD torus cavity with a preferential inclusion of the phenyl ring of the drug. All the binary systems showed superior dissolution and lower dose:solubility ratio (D:S ratio) as compared to pure AC, but the kneaded product exhibited the best dissolution, with complete drug release within 10 min and a D:S ratio of 5 mL. Hence, it was suggested that complexation of aceclofenac with HPβCD may be used as an approach to change the drug from Biopharmaceutics Classification System BCS Class II to BCS Class I without changing its intrinsic permeability.