Preparation and Evaluation of Multi-Particulate System (Pellets) of Prasugrel Hydrochloride

Abstract

Multiparticulate systems (pellets) of prasugrel hydrochloride were prepared by extrusion spheronization method using MCC (micro crystalline cellulose). Optimum spheronization time and method of drying were selected as the process parameters for the preparation of final batches. Various pellet properties were evaluated like size & shape analysis, flow properties, bulk & tapped density, friability, moisture content, drug content, in vitro release rate and in vivo pharmacodynamic studies. All pellet batches showed a narrow particle size distribution, good sphericity and excellent flow properties. Drug content and moisture content of different pellet batches were found in specified limits. The release kinetics of drug loaded MCC pellets followed Peppas model with Fickian diffusion of prasugrel from the pellets. In vivo pharmacodynamic studies exhibited improved bleeding time in pellet group when compared with the marketed tablet formulation.

Preparation and Characterization of a Novel Multiparticulate Dosage Form Carrying Budesonide-Loaded Chitosan Nanoparticles to Enhance the Efficiency of Pellets in the Colon

“…The geometric mean diameter and standard deviation of BCNP were 1082.1 ± 1.3 μm which indicates the suitability of these formulations for consideration as multiparticulate dosage forms [ 85 ]. Additionally, the results of crushing strength (6.3 ± 0.9 N) and elastic modulus (1447.0 ± 170.2 MPa) of BCNP showed that these pellets had suitable mechanical properties for coating steps [ 86 ].…”

Modified Potato Starch as a Potential Retardant for Prolonged Release of Lidocaine Hydrochloride from Methylcellulose Hydrophilic Gel

“…This may confirm the highest slowdown of release in the case of S4 of highly spherical structure, both after 2 and 24 h. The formulation F4 showed the closest values to the statistical significance difference in relation to the reference gel REF in Student’s t -test with Bonferroni correction α = 0.01, p = 0.0130. Kanwar et al [ 34 ] showed the influence of microcrystalline cellulose pellets sphericity on drug release and compared the release to the marketed tablets of prasugrel hydrochloride. The irregular and corrugated structure of S3 could also influence the release process, which was adapted to the first-order model [ 31 ].…”