A Novel Directly Compressible Co-Processed Excipient for Sustained Release Formulation.
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Date
2013-09
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Abstract
A novel directly compressible (DC) co-processed excipient with improved functionality and masking the
undesirable properties of individual excipients was developed without any chemical modification by using
simple laboratory technique. For the development of co-processed excipient, release retarding polymers
such as Polyethylene oxide (Polyox® WSR 301) and hydroxyl propyl methyl cellulose (Methocel® K4M)
were used. Co-processed excipient was prepared in polymers weight ratio of 1:9 to 9:1 by roller
compaction technique. Co-processed excipient prepared from polymers ratio of 7:3 and 8:2 showed good
physico-chemical properties. The developed DC grade co-processed excipient was characterized for DSC,
FTIR, SEM, XRD which confirms the absence of any chemical changes during co-processing. Highly
water soluble Metoprolol succinate and poorly water soluble anhydrous Theophylline was used as model
drugs for Invitro release study. Formulations prepared using co-processed excipient showed sustain drug
release in which initial burst release was controlled by polyethylene oxide and HPMC controls the
extended drug release. Developed formulations were kept for stability study for three month as per ICH
guidelines and found to be stable. Study indicates that use co-processed excipient has added advantage
over polymer with single property and can be used in sustain release formulation irrespective of drug
type.
Description
Keywords
Polyethylene oxide, hydroxyl propyl methyl cellulose, Co-processing, Sustained Release, Dissolution
Citation
Gangurde Avinash, Patole Rahul Kashinath, Sav Ajay Kumar, Amin Purnima Dharnraj. A Novel Directly Compressible Co-Processed Excipient for Sustained Release Formulation. Journal of Applied Pharmaceutical Science. 2013 Sept; 3(9): 89-97.