Abstract | OBJECTIVES: Enteric-coated microsphere/microtablet pancreatin should stay intact in the stomach and dissolve promptly on entering the duodenum. Postprandial intraluminal pH in the distal duodenum is 5.75 and is lower in exocrine pancreatic insufficiency. The aim of the study was to measure in vitro dissolution times in buffer solutions with pH 4.0-6.0 for five currently available enteric-coated microsphere/microtablet pancreatin preparations. METHODS: The following preparations were tested: Creon, Creon Forte, Pancrease, Pancrease HL and Panzytrat. Two capsules were placed in the buffer solution at 37 degrees C in a USP dissolution testing apparatus. Buffer solutions with pH between 4.0 and 6.0 were used. Solutions were stirred at 125 r.p.m. and the rate of dissolution was monitored by taking 2-mL samples at regular intervals and measuring extinction at 280 nm. Measurements were repeated six times. RESULTS: All preparations failed to dissolve at pH 4.0. At pH 5.0 Pancrease HL showed 43% dissolution within 30 min, all other preparations 15% or less. Panzytrat and Pancrease HL showed more than 50% dissolution within 30 min at pH 5.2. Panzytrat, Pancrease HL and Creon Forte had more than 90% dissolution within 30 min at pH 5.6, and all preparations more than 90% dissolution within 30 min at pH 5.8 and higher. CONCLUSIONS:
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Authors | K H Gan, W P Geus, W Bakker, C B Lamers, H G Heijerman |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 10
Issue 5
Pg. 771-5
(Oct 1996)
ISSN: 0269-2813 [Print] England |
PMID | 8899086
(Publication Type: Comparative Study, Journal Article)
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Chemical References |
- Buffers
- Gastrointestinal Agents
- Tablets, Enteric-Coated
- Pancreatin
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Topics |
- Buffers
- Duodenum
(metabolism)
- Exocrine Pancreatic Insufficiency
(drug therapy)
- Gastrointestinal Agents
(metabolism)
- Hydrogen-Ion Concentration
- Microspheres
- Pancreatin
(metabolism)
- Postprandial Period
- Product Surveillance, Postmarketing
- Reproducibility of Results
- Solubility
- Spectrophotometry, Ultraviolet
- Tablets, Enteric-Coated
- Temperature
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