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Wet granulation as innovative and fast method to prepare controlled release granules based on an ion-exchange resin.
J Pharm Sci. 2008 Mar; 97(3):1313-24.JP

Abstract

The goal of this work was to evaluate the suitability of wet granulation as an innovative and fast method for the preparation of granules containing a drug-resin complex (resinate), having cholestyramine as resin and potassium diclofenac (KD) as drug. Resinate and granules were prepared directly by steam granulation in high shear mixer (method A), using two different amount of resin (granules 1 and 2). For comparison granules 1 were also prepared by conventional batch method followed by steam granulation (method B). All granules showed quite irregular shape, main size fractions between 75 and 500 microm, good flowability and uniform KD distribution. Granules 1A exhibited controlled release profiles at pH 7.4, while granules 2A showed a burst effect due to KD free crystals. FT-IR studies confirmed the complete complexation between resin and KD during the granulation process with method A for granules 1. Finally, the dissolution test of granules 1A in different media revealed a controlled drug release in 12 h, providing the utility of this system for enteric drug delivery. Granules 1B evidenced similar characteristics to those of granules 1A; the drawback of the multistep procedure was related to the long processing time.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, University of Bologna, Via San Donato 19/2, 40127 Bologna, Italy. beatrice.albertini@unibo.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17674405

Citation

Albertini, Beatrice, et al. "Wet Granulation as Innovative and Fast Method to Prepare Controlled Release Granules Based On an Ion-exchange Resin." Journal of Pharmaceutical Sciences, vol. 97, no. 3, 2008, pp. 1313-24.
Albertini B, Passerini N, González-Rodríguez ML, et al. Wet granulation as innovative and fast method to prepare controlled release granules based on an ion-exchange resin. J Pharm Sci. 2008;97(3):1313-24.
Albertini, B., Passerini, N., González-Rodríguez, M. L., Cavallari, C., Cini, M., & Rodriguez, L. (2008). Wet granulation as innovative and fast method to prepare controlled release granules based on an ion-exchange resin. Journal of Pharmaceutical Sciences, 97(3), 1313-24.
Albertini B, et al. Wet Granulation as Innovative and Fast Method to Prepare Controlled Release Granules Based On an Ion-exchange Resin. J Pharm Sci. 2008;97(3):1313-24. PubMed PMID: 17674405.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Wet granulation as innovative and fast method to prepare controlled release granules based on an ion-exchange resin. AU - Albertini,Beatrice, AU - Passerini,Nadia, AU - González-Rodríguez,M L, AU - Cavallari,Cristina, AU - Cini,Maurizio, AU - Rodriguez,Lorenzo, PY - 2007/8/4/pubmed PY - 2008/5/6/medline PY - 2007/8/4/entrez SP - 1313 EP - 24 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 97 IS - 3 N2 - The goal of this work was to evaluate the suitability of wet granulation as an innovative and fast method for the preparation of granules containing a drug-resin complex (resinate), having cholestyramine as resin and potassium diclofenac (KD) as drug. Resinate and granules were prepared directly by steam granulation in high shear mixer (method A), using two different amount of resin (granules 1 and 2). For comparison granules 1 were also prepared by conventional batch method followed by steam granulation (method B). All granules showed quite irregular shape, main size fractions between 75 and 500 microm, good flowability and uniform KD distribution. Granules 1A exhibited controlled release profiles at pH 7.4, while granules 2A showed a burst effect due to KD free crystals. FT-IR studies confirmed the complete complexation between resin and KD during the granulation process with method A for granules 1. Finally, the dissolution test of granules 1A in different media revealed a controlled drug release in 12 h, providing the utility of this system for enteric drug delivery. Granules 1B evidenced similar characteristics to those of granules 1A; the drawback of the multistep procedure was related to the long processing time. SN - 0022-3549 UR - https://www.unboundmedicine.com/medline/citation/17674405/Wet_granulation_as_innovative_and_fast_method_to_prepare_controlled_release_granules_based_on_an_ion_exchange_resin_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(16)32512-6 DB - PRIME DP - Unbound Medicine ER -