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Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer.
J Pharm Pharm Sci. 2005 Jun 29; 8(2):132-40.JP

Abstract

PURPOSE

The objective of this work was to prepare theophylline sustained release matrix tablets based on the combination of hydroxypropyl methylcellulose (HPMC K4M and K100M) and different meltable binders by melt granulation in a high-shear mixer.

METHODS

Dissolution profiles of each formulation were compared to those of TheoDur 200 mg tablets and the mean dissolution time (MDT) and similarity factor (f2 factor) were calculated. The matrices swelling behavior was investigated by texture analysis.

RESULTS

The results obtained show that the type of excipient influenced the drug release rate. In particular, the dissolution rate was delayed when lipophilic binders were used and only formulations containing Gelucire 50/13 or PEG 6000 with HPMC K4M had a profile similar to the commercial formulation. The release mechanism of theophylline from the formulations was described by Peppas's equation showing a non-Fickian release mechanism. The investigation of matrices swelling behavior showed that the gel layer thickness increased continuously over the time period studied. Moreover, a correlation between gel layer thickness and strength with the percentage released was found.

CONCLUSIONS

These results suggest that melt granulation could be an easy and fast method to formulate sustained release tablets.

Authors+Show Affiliations

Ochoa L
Laboratory of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of the Basque Country (UPV-EHU), Paseo de la Universidad no. 7, Vitoria-Gasteiz, Spain.
Igartua M
No affiliation info available
Hernández RM
No affiliation info available
Gascón AR
No affiliation info available
Pedraz JL
No affiliation info available

MeSH

Chemistry, PharmaceuticalDelayed-Action PreparationsGelsTablets, Enteric-CoatedTechnology, Pharmaceutical

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

16124924

Citation

Ochoa, Lourdes, et al. "Preparation of Sustained Release Hydrophilic Matrices By Melt Granulation in a High-shear Mixer." Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Societe Canadienne Des Sciences Pharmaceutiques, vol. 8, no. 2, 2005, pp. 132-40.
Ochoa L, Igartua M, Hernández RM, et al. Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer. J Pharm Pharm Sci. 2005;8(2):132-40.
Ochoa, L., Igartua, M., Hernández, R. M., Gascón, A. R., & Pedraz, J. L. (2005). Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer. Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Societe Canadienne Des Sciences Pharmaceutiques, 8(2), 132-40.
Ochoa L, et al. Preparation of Sustained Release Hydrophilic Matrices By Melt Granulation in a High-shear Mixer. J Pharm Pharm Sci. 2005 Jun 29;8(2):132-40. PubMed PMID: 16124924.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer. AU - Ochoa,Lourdes, AU - Igartua,Manuela, AU - Hernández,Rosa Maria, AU - Gascón,Alicia R, AU - Pedraz,José Luis, Y1 - 2005/06/29/ PY - 2005/8/30/pubmed PY - 2006/4/7/medline PY - 2005/8/30/entrez SP - 132 EP - 40 JF - Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques JO - J Pharm Pharm Sci VL - 8 IS - 2 N2 - PURPOSE: The objective of this work was to prepare theophylline sustained release matrix tablets based on the combination of hydroxypropyl methylcellulose (HPMC K4M and K100M) and different meltable binders by melt granulation in a high-shear mixer. METHODS: Dissolution profiles of each formulation were compared to those of TheoDur 200 mg tablets and the mean dissolution time (MDT) and similarity factor (f2 factor) were calculated. The matrices swelling behavior was investigated by texture analysis. RESULTS: The results obtained show that the type of excipient influenced the drug release rate. In particular, the dissolution rate was delayed when lipophilic binders were used and only formulations containing Gelucire 50/13 or PEG 6000 with HPMC K4M had a profile similar to the commercial formulation. The release mechanism of theophylline from the formulations was described by Peppas's equation showing a non-Fickian release mechanism. The investigation of matrices swelling behavior showed that the gel layer thickness increased continuously over the time period studied. Moreover, a correlation between gel layer thickness and strength with the percentage released was found. CONCLUSIONS: These results suggest that melt granulation could be an easy and fast method to formulate sustained release tablets. SN - 1482-1826 UR - https://www.unboundmedicine.com/medline/citation/16124924/Preparation_of_sustained_release_hydrophilic_matrices_by_melt_granulation_in_a_high_shear_mixer_ DB - PRIME DP - Unbound Medicine ER -