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Brazilian Journal of Pharmaceutical Sciences
Article . 2012 . Peer-reviewed
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Brazilian Journal of Pharmaceutical Sciences
Article
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Development and evaluation of a hot-melt coating technique for enteric coating

Authors: Patil, Arun Trambak; Khobragade, Deepak Shamrao; Chafle, Sandip Annaji; Ujjainkar, Amol Prasadrao; Umathe, Sudhir Niranjanrao; Lakhotia, Champalal Laxminarayan;

Development and evaluation of a hot-melt coating technique for enteric coating

Abstract

Conventional enteric coating requires the use of organic based polymers which are equally hazardous to the environment and operating personnel. Hot-melt coating avoids the use of solvents and is a safer and time-saving process. The present study was designed to assess the efficacy of hot-melt coating (HMC) as an enteric coating technique. Pellets prepared by extrusion spheronization were selected as the core formulation for a model of the gastric irritant drug diclofenac sodium (DFS) because of their innate advantages over single-unit formulations. Stearic acid (SA) and palmitic acid (PA) were evaluated as enteric hot-melt coating materials. HMC was carried out in a specially modified coating pan by applying SA and PA in molten state onto preheated pellets to achieve a coating level of 5-15 %w/w. Hot-melt coated pellets were evaluated for disintegration pH and in vitro dissolution in the pH range 1.2 to 6.8, along with basic micromeritics. SEM of coated pellets showed a uniform and smooth coating. These results indicated that HMC of both SA and PA exhibited very good enteric coating ability. The coated pellets showed negligible drug release in acidic pH. As the pellets were subsequently transferred to a higher pH level, a gradual increase in release of the drug from the pellets was observed with increasing pH of the dissolution media. The release was dependent upon coating extent, providing sustained enteric release as opposed to abrupt release with mixed release kinetics.

Keywords

Diclofenac sodium, Pílulas^i2^savaliaçãoentér, Diclofenac sodium^i1^spell, Palmitic acid^i1^spell, Diclofenaco sódio, Péletes^i2^savalia, Pellets, Hot-melt coating, Enteric coating, Stearic acid^i1^spell, Palmídico ácido^i2^srevestime, Stearic acid^i1^scoat, Palmídico ácido, Pharmacy and materia medica, Palmitic acid, Diclofenaco sódio^i2^srevestime, Pílulas, Péletes, Enteric coating^i1^sevaluat, Palmídico ácido^i2^spílu, Fusão a quente revestimento^i2^savalia, Esteárico ácido^i2^srevestime, Hot-melt coating^i1^sevaluat, Diclofenaco sódio^i2^spílu, Esteárico ácido, RS1-441, Pellets^i1^sevaluat, Pellets^i1^scoat, Palmitic acid^i1^scoat, Esteárico ácido^i2^spílu, Diclofenac sodium^i1^scoat, Fusão a quente revestimento, Desintegração do pH, Disintegration pH, Stearic acid

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    citations
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    16
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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citations
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
16
Top 10%
Average
Average
Green
gold