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FORMULATION AND EVALUATION OF TIZANIDINE HYDROCHLORIDE MICROSPHERES BY USING 32 FULL FACTORIAL DESIGNS

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Author(s): Adimoolam Senthil | Chavda Gajendrasnh Ambuji | Patel Jyotindra Natvarlal | Jimson Jose | Narayana Swamy VB

Journal: International Research Journal of Pharmacy
ISSN 2230-8407

Volume: 2;
Issue: 9;
Start page: 110;
Date: 2011;
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Keywords: Microspheres | Tizanidine hydrochloride | Hydroxypropylmethylcellulose K4M | Carboxymethylcellulose | Glutaraldehyde.

ABSTRACT
Tizanidine hydrochloride is a centrally acting α-2 adrenergic agonist muscle relaxant. In the present study an attempt has been made to formulate and evaluate tizanidine hydrochloride microspheres by using hydroxypropylmethylcellulose K4M and carboxymethyl cellulose as polymers. Tizanidine hydrochloride microspheres were prepared by simple emulsification phase separation technique using glutaraldehyde as a cross-linking agent. Twenty preliminary trial batches, B1-B20 batches of microspheres were prepared by using different volume (2 to 10 ml) of glutaraldehyde as cross-linking agent, cross-linking time 1 to 4 hours and 3:1 ratio of polymer-to-drug with two different polymers. From these twenty batches of each polymer, the optimized formulation is selected based on the percentage of mucoadhesion, drug entrapment efficiency and sphericity of microspheres. A 32 full factorial design was employed to study the effect of independent variables, polymer-to-drug ratio (X1), and stirring speed (X2) on dependent variables percentage of mucoadhesion, drug entrapment efficiency, swelling index and in-vitro drug release study. The drug polymer compatibility studies were carried out using FTIR. Among the two polymers hydroxypropylmethyl cellulose K4M exhibited a high drug entrapment efficiency of 79% and a swelling index 1.260, percentage of mucoadhesive after 1hour was 80% and the drug release was also sustained for more than 10 hours.
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