Abstract
A comparative study on different enteric-coated hard capsules was performed. The influence of different formulation factors like choice of enteric polymer, triethyl citrate (TEC) concentration (plasticizer), talc concentrations (anti-tacking agent), and different coating process parameters on the sealing performance of the capsule and the disintegration time were investigated. Furthermore, the influence of different disintegration test methods (with disc vs. without disc and 50 mM U.S. Pharmacopoeia (USP) buffer pH 6.8 vs. biopredictive 15 mM phosphate buffer pH 6.5) was evaluated. All formulations showed sufficient but not equivalent acid resistance when tested. Polymer type was the main factor influencing the capsule sealing and disintegration time. In addition, TEC and talc could affect the performance of the formulation. Regarding the choice of the disintegration test method, the presence of a disc had for the most part only limited influence on the results. The choice of disintegration buffer was found to be important in identifying differences between the formulations.
Highlights
Acidic polymers are frequently used as enteric coatings in pharmaceutical practice to delay drug release from oral dosage forms, to protect acid labile drugs from the harsh conditions in the stomach or to protect the stomach from irritation by drugs [1,2]
EC capsules with enteric coating of the capsule shell are attractive in early drug development due to the ability to evaluate the performance of drugs that are available only in limited quantities because of the lower formulation effort [3] or for drugs that are difficult to formulate as a tablet [4,5]
The aim of this study is to investigate important formulation factors like concentration of additives and influence of processing parameters on the performance of enteric coatings applied to hydroxypropyl methylcellulose (HPMC) capsules
Summary
Acidic polymers are frequently used as enteric coatings in pharmaceutical practice to delay drug release from oral dosage forms, to protect acid labile drugs from the harsh conditions in the stomach or to protect the stomach from irritation by drugs [1,2]. Poorly water-soluble drugs or low-dose formulations might be encapsulated as liquid and semi-solid formulations to increase the intestinal absorption or provide a high content uniformity, respectively [6]. Such products are used in cases where the active ingredient is so sensitive that tableting and/or granulation processes could have adverse effects on its stability (e.g., probiotics) [7]
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