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Evaluation of beta-lactose, PVP K12 and PVP K90 as excipients to prepare piroxicam granules using two wet granulation techniques.
Eur J Pharm Biopharm. 2003 Nov; 56(3):479-87.EJ

Abstract

The present investigation aimed at evaluating the use of different excipients, beta-lactose and polyvinylpyrrolidone of two molecular weights (PVP K12 and PVP K90), in the production of improved release piroxicam granules, by wet granulation using both water and steam as granulation liquid. The formulations examined were: piroxicam (Px)/beta-lactose; Px/PVP K12 and Px/PVP K90, each one at a 1:9 weight ratio. The most significant difference between beta-lactose and PVP is that, using the first excipient, both steam and water granules were produced while, when PVP were employed, only steam granules were obtained. Image analysis revealed that beta-lactose steam granules had a larger surface area with respect to water granules, whereas lower values of this parameter were observed in PVP-s granules, confirming the Scanning Electron Microscopy micrographs and the fractal analysis results. As regards the enhancement of the dissolution profiles, the best result was obtained using beta-lactose steam granules followed by PVP K12 ones, even if the reactive dimension values indicated that during the dissolution process PVP K12 granules modified the surface more than beta-lactose granules. As regards PVP K90, this excipient was the one less influencing the granule morphology and the dissolution behaviour. Differential Scanning Calorimetry analysis suggested the partial amorphisation of the drug in the granules containing the three excipients. This result was then confirmed by X-ray powder diffraction analysis. Therefore, beta-lactose and PVP K12 could be proposed as useful excipients to enhance the dissolution rate of Px from granules prepared using the steam granulation technique.

Authors+Show Affiliations

Dipartimento di Scienze Farmaceutiche, Università di Bologna, Bologna, Italy. beatrice@biofarm.unibo.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

14602193

Citation

Albertini, Beatrice, et al. "Evaluation of Beta-lactose, PVP K12 and PVP K90 as Excipients to Prepare Piroxicam Granules Using Two Wet Granulation Techniques." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 56, no. 3, 2003, pp. 479-87.
Albertini B, Cavallari C, Passerini N, et al. Evaluation of beta-lactose, PVP K12 and PVP K90 as excipients to prepare piroxicam granules using two wet granulation techniques. Eur J Pharm Biopharm. 2003;56(3):479-87.
Albertini, B., Cavallari, C., Passerini, N., González-Rodríguez, M. L., & Rodriguez, L. (2003). Evaluation of beta-lactose, PVP K12 and PVP K90 as excipients to prepare piroxicam granules using two wet granulation techniques. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 56(3), 479-87.
Albertini B, et al. Evaluation of Beta-lactose, PVP K12 and PVP K90 as Excipients to Prepare Piroxicam Granules Using Two Wet Granulation Techniques. Eur J Pharm Biopharm. 2003;56(3):479-87. PubMed PMID: 14602193.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of beta-lactose, PVP K12 and PVP K90 as excipients to prepare piroxicam granules using two wet granulation techniques. AU - Albertini,Beatrice, AU - Cavallari,Cristina, AU - Passerini,Nadia, AU - González-Rodríguez,M L, AU - Rodriguez,Lorenzo, PY - 2003/11/7/pubmed PY - 2004/8/18/medline PY - 2003/11/7/entrez SP - 479 EP - 87 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 56 IS - 3 N2 - The present investigation aimed at evaluating the use of different excipients, beta-lactose and polyvinylpyrrolidone of two molecular weights (PVP K12 and PVP K90), in the production of improved release piroxicam granules, by wet granulation using both water and steam as granulation liquid. The formulations examined were: piroxicam (Px)/beta-lactose; Px/PVP K12 and Px/PVP K90, each one at a 1:9 weight ratio. The most significant difference between beta-lactose and PVP is that, using the first excipient, both steam and water granules were produced while, when PVP were employed, only steam granules were obtained. Image analysis revealed that beta-lactose steam granules had a larger surface area with respect to water granules, whereas lower values of this parameter were observed in PVP-s granules, confirming the Scanning Electron Microscopy micrographs and the fractal analysis results. As regards the enhancement of the dissolution profiles, the best result was obtained using beta-lactose steam granules followed by PVP K12 ones, even if the reactive dimension values indicated that during the dissolution process PVP K12 granules modified the surface more than beta-lactose granules. As regards PVP K90, this excipient was the one less influencing the granule morphology and the dissolution behaviour. Differential Scanning Calorimetry analysis suggested the partial amorphisation of the drug in the granules containing the three excipients. This result was then confirmed by X-ray powder diffraction analysis. Therefore, beta-lactose and PVP K12 could be proposed as useful excipients to enhance the dissolution rate of Px from granules prepared using the steam granulation technique. SN - 0939-6411 UR - https://www.unboundmedicine.com/medline/citation/14602193/Evaluation_of_beta_lactose_PVP_K12_and_PVP_K90_as_excipients_to_prepare_piroxicam_granules_using_two_wet_granulation_techniques_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939641103001140 DB - PRIME DP - Unbound Medicine ER -