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The effect of wet granulation on the erosion behaviour of an HPMC-lactose tablet, used as a rate-controlling component in a pulsatile drug delivery capsule formulation.
Eur J Pharm Biopharm. 2004 May; 57(3):541-9.EJ

Abstract

The purpose of this study was to investigate the variability in the performance of a pulsatile capsule delivery system induced by wet granulation of an erodible HPMC tablet, used to seal the contents within an insoluble capsule body. Erodible tablets containing HPMC and lactose were prepared by direct compression (DC) and wet granulation (WG) techniques and used to seal the model drug propranolol inside an insoluble capsule body. Dissolution testing of capsules was performed. Physical characterisation of the tablets and powder blends used to form the tablets was undertaken using a range of experimental techniques. The wet granulations were also examined using the novel technique of microwave dielectric analysis (MDA). WG tablets eroded slower and produced longer lag-times than those prepared by DC, the greatest difference was observed with low concentrations of HPMC. No anomalous physical characteristics were detected with either the tablets or powder blends. MDA indicated water-dipole relaxation times of 2.9, 5.4 and 7.7x10(-8)ms for 15, 24 and 30% HPMC concentrations, respectively, confirming that less free water was available for chain disentanglement at high concentrations. In conclusion, at low HPMC concentrations water mobility is at its greatest during the granulation process, such formulations are therefore more sensitive to processing techniques. Microwave dielectric analysis can be used to predict the degree of polymer spreading in an aqueous system, by determination of the water-dipole relaxation time.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, University of Strathclyde, Glasgow, UK. jrmcconville@mail.utexas.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15093604

Citation

McConville, Jason T., et al. "The Effect of Wet Granulation On the Erosion Behaviour of an HPMC-lactose Tablet, Used as a Rate-controlling Component in a Pulsatile Drug Delivery Capsule Formulation." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 57, no. 3, 2004, pp. 541-9.
McConville JT, Ross AC, Chambers AR, et al. The effect of wet granulation on the erosion behaviour of an HPMC-lactose tablet, used as a rate-controlling component in a pulsatile drug delivery capsule formulation. Eur J Pharm Biopharm. 2004;57(3):541-9.
McConville, J. T., Ross, A. C., Chambers, A. R., Smith, G., Florence, A. J., & Stevens, H. N. (2004). The effect of wet granulation on the erosion behaviour of an HPMC-lactose tablet, used as a rate-controlling component in a pulsatile drug delivery capsule formulation. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 57(3), 541-9.
McConville JT, et al. The Effect of Wet Granulation On the Erosion Behaviour of an HPMC-lactose Tablet, Used as a Rate-controlling Component in a Pulsatile Drug Delivery Capsule Formulation. Eur J Pharm Biopharm. 2004;57(3):541-9. PubMed PMID: 15093604.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of wet granulation on the erosion behaviour of an HPMC-lactose tablet, used as a rate-controlling component in a pulsatile drug delivery capsule formulation. AU - McConville,Jason T, AU - Ross,Alistair C, AU - Chambers,Alan R, AU - Smith,Geoff, AU - Florence,Alastair J, AU - Stevens,Howard N E, PY - 2003/10/22/received PY - 2004/01/20/revised PY - 2004/01/20/accepted PY - 2004/4/20/pubmed PY - 2004/11/17/medline PY - 2004/4/20/entrez SP - 541 EP - 9 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 57 IS - 3 N2 - The purpose of this study was to investigate the variability in the performance of a pulsatile capsule delivery system induced by wet granulation of an erodible HPMC tablet, used to seal the contents within an insoluble capsule body. Erodible tablets containing HPMC and lactose were prepared by direct compression (DC) and wet granulation (WG) techniques and used to seal the model drug propranolol inside an insoluble capsule body. Dissolution testing of capsules was performed. Physical characterisation of the tablets and powder blends used to form the tablets was undertaken using a range of experimental techniques. The wet granulations were also examined using the novel technique of microwave dielectric analysis (MDA). WG tablets eroded slower and produced longer lag-times than those prepared by DC, the greatest difference was observed with low concentrations of HPMC. No anomalous physical characteristics were detected with either the tablets or powder blends. MDA indicated water-dipole relaxation times of 2.9, 5.4 and 7.7x10(-8)ms for 15, 24 and 30% HPMC concentrations, respectively, confirming that less free water was available for chain disentanglement at high concentrations. In conclusion, at low HPMC concentrations water mobility is at its greatest during the granulation process, such formulations are therefore more sensitive to processing techniques. Microwave dielectric analysis can be used to predict the degree of polymer spreading in an aqueous system, by determination of the water-dipole relaxation time. SN - 0939-6411 UR - https://www.unboundmedicine.com/medline/citation/15093604/The_effect_of_wet_granulation_on_the_erosion_behaviour_of_an_HPMC_lactose_tablet_used_as_a_rate_controlling_component_in_a_pulsatile_drug_delivery_capsule_formulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939641104000256 DB - PRIME DP - Unbound Medicine ER -