Acta Pharm. 58 (2008) 309-316
Short communication
Preparation
and evaluation of an ispaghula based directly compressible matrixing agent for
controlled release
ANITA N. LALWANI and JOLLY R. PARIKH
anitanlalwani@yahoo.co.in
K. B. Institute of Pharmaceutical
Education and Research, Gandhinagar-382 023, Gujarat, India
A. R. College of Pharmacy and G. H. Patel
Institute of Pharmacy, Vallabh Vidyanagar-388 120, Gujarat, India
Accepted June 25, 2008
The objective of the present investigation was to prepare and
evaluate an ispaghula husk based directly compressible (DC) adjuvant that can
be used as matrixing agent using an agglomeration technique. Addition of
hydroxylpropyl methylcellulose was found necessary to improve cohesion. Lactose
(X1), calcium hydrogen phosphate diydrate (X2) and Avicel PH101 (X3), used
along with ispaghula in preparation of agglomerates, were selected as three
independent variables in a simplex lattice design affecting compressional and
dissolution characteristics of the drug from the DC adjuvant. The agglomerates
were evaluated for their flow properties. Tablets were prepared using 70%
agglomerates and 30% acetaminophen, a poorly compressible drug, and were
subjected to the in vitro drug release study. Amounts of the drug released
at the end of 60 min (Y60), 300 min (Y300) and 480 min (Y480) were selected as
dependent variables in a simplex lattice design. Batch IH05 that contained
lactose and calcium hydrogen phosphate dihydrate in a 1:2 ratio could control
the release for 12 hours and thus form the basis for twice-a-day dosing.
Keywords: simplex lattice design, ispaghula husk, directly
compressible, matrixing agent, similarity factor