Advanced Search

Journal Navigation

Journal Home

Subscriptions

Archive

Contact Us

Table of Contents

Sign In to gain access to subscriptions and/or personal tools.
Journal of Biomaterials Applications
This Article
Right arrow Full Text (PDF)
Right arrow References
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to Saved Citations
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Request Reprints
Right arrow Add to My Marked Citations
Citing Articles
Right arrow Citing Articles via Google Scholar
Right arrow Citing Articles via Scopus
Google Scholar
Right arrow Articles by Murthy, K.S.
Right arrow Articles by Fawzi, M. B.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Murthy, K.S.
Right arrow Articles by Fawzi, M. B.
Social Bookmarking
Add to CiteULike   Add to Complore   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?

In vitro Release Characteristics of Hard Shell Capsule Products Coated with Aqueous- and Organic-Based Enteric Polymers

K.S. Murthy, PH.D., R.PH.

Parke Davis Pharmaceutical Research Warner-Lambert Company 170 Tabor Road Morris Plains, NJ 07950

Daniel A. Kubert, R.PH.

Parke Davis Pharmaceutical Research Warner-Lambert Company 170 Tabor Road Morris Plains, NJ 07950

Mahdi B. Fawzi, PH.D.

Parke Davis Pharmaceutical Research Warner-Lambert Company 170 Tabor Road Morris Plains, NJ 07950

In this article, an overview of the rationale for the use of enteric coated (EC) dosage forms is presented. The benefits and disadvantages inherent in the use of aqueous dispersions and organic solutions of the various polymers to generate these products are discussed. The comparative dissolution stability of a hard shell capsule product coated with enteric polymers applied as either aqueous dispersions, or as organic solutions, were assessed under accelerated conditions of storage. Polymethacrylic acid methacrylate copolymer, cellulose acetate phthalate (CAP) and polyvinyl acetate phthalate (PVAP), along with the corresponding commercially available aqueous dispersions, Eudragit® L30D, Aquateric®, and CoatericTM, were employed in these studies as enteric polymers. Diethyl phthalate (DEP) was used as the plasticizer and procainamide HCl 250 mg capsules served as the substrate. Storage of the coated capsules at 37°C/80% RH and at 45°C for 2 months revealed that, while the stability of Eudragit® L30D coatings are comparable or superior to the corresponding organic-based coatings, CoatericTM films are markedly unstable when compared with PVAP coatings applied through the use of organic vehicles. After storage at 37°C/80% RH, Aquateric®-based capsules demonstrated stability comparable to CAP organic-based coatings only when a protective seal coat was present. The performance failures of the capsules that occur upon storage primarily result in a loss of gastric resistance. Scanning Electron Microscopy (SEM) and thermomechanical analysis (TMA) of the different coatings revealed differences in the film-forming properties of the polymer films and provide an explanation for the changes that occur during storage of the coated capsules.

Key Words: Enteric coating • hard shell capsules • drug release • procainamide HCI • SEM and TMA analysis

Journal of Biomaterials Applications, Vol. 3, No. 1, 52-79 (1988)
DOI: 10.1177/088532828800300103
Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?