Effect of various type of gelucire on the sustained release performance of calcium alginate bead.
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Date
2009
Authors
Abdullah Al-Sheikh Wace, Mohammed Ali
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Journal ISSN
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Abstract
Sodium alginate is a widely used natural polymer in the pharmaceutical
industry. hnprovement of the sustained release properties of this polymer is
important due to its effectiveness and wide use with different biomaterials and drugs.
Gelucires are a family of compounds prepared from the polyethylene glycol and
different oils. These lipid excipients have different sustained release properties and
some of them are used as immediate release agents e.g. Gelucire 44/14. Beads
formed as a new system using these two main ingredients were prepared by the drop
wise technique. Studies were carried out to characterize and evaluate the beads
produced. They include the dissolution studies, size distribution studies, swelling
studies, microscopic studies, drug entrapment studies and stability studies. The main
factors which might affect the drug release were studied by using a Taguchi
experimental design (Calcium chloride solution concentration, sodium alginate
solution concentration, stirring speed, drying method) and the data was analyzed by a
special program (Design Expert®). Mixing these two excipients give an improved
sustained release properties compared to the formula which used only one of them.
The Gelucire type plays an important role in the sustained release properties
(Gelucire 43/01 give better sustained release profile compared to Gelucire 50/13 and
Gelucire44/14). The drug sustained release property improved and it stayed for
longer time in the beads formed compared to the release from calcium alginate beads
and Gelucire solid dispersions. The optimal conditions for preparing the beads were
10% CaClz, 2% Sodium alginate, 1000 rpm, and Gelucire 43/01. By using the D
optimal design the best drug ratio and the best Gelucire: alginate ratio was predicted
by the program (sodium alginate (solution 2%) 90.16% : Gelucire (43/01) 7.95% :
paracetamol 1.89%) and for nifedipine (sodium alginate (solution 2%) 90.14% :
Gelucire {43/01) 7.90%: nifedipine 1.96%). The predicted results were examined
practically and its give the optimal sustained release profile comparing to the other
formulations. U.S Pharmacopeia recommend that not more than 30% of the drug
should dissolved in !he first hour, between 30% and 55% at hour 4, not less than 60%
at hour 8 and not less than 80% of the drug should dissolved after 12 hours. The
dissolution of the final formula was within the recommended range for both model
drugs (paracetamol and nifedipine).
Description
Keywords
Various Type , Calcium Alginate bead