Abstract
The suitability of the new isomalt grade galenIQ™ 801 for dry granulation and following tableting is evaluated in this study. Isomalt alone, as well as a blend of equal parts with dibasic calcium phosphate, is roll compacted and tableted. Particle size distribution and flowability of the granules and friability and disintegration time of the tablets are determined. Tensile strength of tablets is related to the specific compaction force during roll compaction and the tableting force. In all cases, the tensile strength increases with raising tableting forces. The specific compaction force has a different influence. For isomalt alone the tensile strength is highest for tablets made from granules prepared at 2 kN/cm and 6 kN/cm and decreases at higher values, i.e., >10 kN/cm. Tensile strength of the blend tablets is almost one third lower compared to the strongest tablets of pure isomalt. Friability of pure isomalt tablets is above the limit. Disintegration time is longest when the tensile strength is at its maximum and decreases with higher porosity and lower tensile strengths. Isomalt proves to be suitable for tableting after roll compaction. Even though the capacity as a binder might not be as high as of other excipients, it is a further alternative for the formulation scientist.
Highlights
Isomalt is a polyol derived from sucrose
This study investigates the preservation of its compactibility after roll compaction
Even the lowest specific compaction force of 2 kN/cm improves the flowability of pure isomalt from cohesive
Summary
Isomalt is a polyol derived from sucrose. Advantages of this excipient are its sweet taste, which is supposed to allow taste masking, the low glycemic and insulinemic response [1], and the ability to be Pharmaceutics 2012, 4 compacted directly. Isomalt consists of varying amounts of 1-O-D-glucopyranosyl-D-mannitol dihydrate (GPM) and. Since the water solubility of GPS is higher, the marketed products show deviating physicochemical behavior [3]. Ndindayino et al [4,5] investigated the performance of isomalt in direct compression. It was discovered, that isomalt exhibits plastic deformation and elastic recovery mostly in the die. Isomalt was found to be beneficial as excipient for wet granulation with acetaminophen [7]
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