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Bio-relevant dissolution testing of hard capsules prepared from different shell materials using the dynamic open flow through test apparatus.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences (2013-09-12)
Grzegorz Garbacz, Dominique Cadé, Hassan Benameur, Werner Weitschies
ABSTRACT

Current compendial dissolution and disintegrating testing is unable to mimic physiological conditions affecting gastric drug release from immediate release dosage forms. In order to obtain more realistic data, a novel test setup was developed that we term a 'dynamic open flow through test apparatus'. It is based on the previously described dissolution stress test device and attempts to simulate the intra-gastric dissolution conditions pertinent to immediate release dosage forms administered under fasting conditions with respect to flow rates, intra-gastric temperature profiles and gastric motility. The concept of the dynamic open flow through test apparatus has been tested using five different types of hard capsules: conventional hard gelatin capsules (HGC), three hypromellose based capsules (Vcaps, Vcaps Plus and DRcaps) and pullulan based capsules (Plantcaps). These were of different sizes but all contained 100mg caffeine in each formulation, adjusted to avoid buoyancy by addition of excipient. When the capsules were stressed in the apparatus under the dynamic flow conditions applying mild pressure simulating gastric motility, release from release from Vcaps Plus, Vcaps and Plantcaps capsules was very well comparable to HGC. Capsules are usually swallowed with cold water and the temperature dependency of release from gelatin was noted as a significant factor, since heat exchange in the stomach is slow.

MATERIALS
Product Number
Brand
Product Description

Supelco
Melting point standard 235-237°C, analytical standard
Caffeine for system suitability, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Caffeine, Sigma Reference Standard, vial of 250 mg
Sigma-Aldrich
Caffeine, anhydrous, 99%, FCC, FG
Sigma-Aldrich
Caffeine, anhydrous, tested according to Ph. Eur.
Supelco
Mettler-Toledo Calibration substance ME 18872, Caffeine, analytical standard, for the calibration of the thermosystem 900, traceable to primary standards (LGC)
Sigma-Aldrich
Lactose, tested according to Ph. Eur.
Sigma-Aldrich
Caffeine, powder, ReagentPlus®
Sigma-Aldrich
Caffeine, BioXtra
Sigma-Aldrich
Caffeine, meets USP testing specifications, anhydrous
Supelco
Caffeine Melting Point Standard, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Caffeine, Pharmaceutical Secondary Standard; Certified Reference Material
USP
Caffeine, United States Pharmacopeia (USP) Reference Standard
Caffeine, European Pharmacopoeia (EP) Reference Standard
Supelco
Caffeine, certified reference material, TraceCERT®
USP
Caffeine melting point standard, United States Pharmacopeia (USP) Reference Standard