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Application of a novel symmetrical shape factor to gastroretentive matrices as a measure of swelling synchronization and its impact on drug release kinetics under standard and modified dissolution conditions.
J Pharm Pharmacol. 2009 Jul; 61(7):861-7.JP

Abstract

OBJECTIVES

We have assessed the kinetics of drug release in relation to the full or partial hydration and swelling of matrices under standard and modified United States Pharmacopeia (USP) apparatus II using a novel index, defined as the symmetrical shape factor. The symmetrical shape factor describes the regularity of the hydration rate of the matrix perimeter relative to its central regions.

METHODS

Monolithic and three-layer matrices based on hypromellose, polyethylene oxide, Kollidon SR, theophylline, diltiazem hydrochloride and alfuzosin hydrochloride were subjected to dissolution testing.

KEY FINDINGS

Our results indicated that Kollidon SR matrices and the three-layer composite systems with and without effervescing components were not significantly affected by the dissolution conditions. However, in the case of the floating monolithic systems based on hypromellose and polyethylene oxide, both release profiles and swelling dynamics in accordance with the similarity factor (f(2)) and symmetrical shape factor values were significantly influenced.

CONCLUSIONS

The symmetrical shape factor values were positively impacted. Consequently the drug release kinetics were more predictable and reproducible. The modified USP method resulted in a more synchronized axial and radial swelling with symmetrical shape factor values approaching unity. Data further indicated that the modified USP method provided for complete matrix hydration and swelling as the dosage form remained fully submerged, allowing for more reliable release mimicking the in-vivo conditions.

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Authors+Show Affiliations

Liu Q
Department of Pharmaceutical Sciences, School of Pharmacy, Temple University, Philadelphia, USA.
Fassihi R
No affiliation info available

MeSH

Delayed-Action PreparationsDiltiazemDrug CarriersExcipientsHypromellose DerivativesKineticsMethylcellulosePolyethylene GlycolsPovidoneQuinazolinesSolubilityTabletsTechnology, PharmaceuticalTheophylline

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19589227

Citation

Liu, Quan, and Reza Fassihi. "Application of a Novel Symmetrical Shape Factor to Gastroretentive Matrices as a Measure of Swelling Synchronization and Its Impact On Drug Release Kinetics Under Standard and Modified Dissolution Conditions." The Journal of Pharmacy and Pharmacology, vol. 61, no. 7, 2009, pp. 861-7.
Liu Q, Fassihi R. Application of a novel symmetrical shape factor to gastroretentive matrices as a measure of swelling synchronization and its impact on drug release kinetics under standard and modified dissolution conditions. J Pharm Pharmacol. 2009;61(7):861-7.
Liu, Q., & Fassihi, R. (2009). Application of a novel symmetrical shape factor to gastroretentive matrices as a measure of swelling synchronization and its impact on drug release kinetics under standard and modified dissolution conditions. The Journal of Pharmacy and Pharmacology, 61(7), 861-7. https://doi.org/10.1211/jpp/61.07.0004
Liu Q, Fassihi R. Application of a Novel Symmetrical Shape Factor to Gastroretentive Matrices as a Measure of Swelling Synchronization and Its Impact On Drug Release Kinetics Under Standard and Modified Dissolution Conditions. J Pharm Pharmacol. 2009;61(7):861-7. PubMed PMID: 19589227.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Application of a novel symmetrical shape factor to gastroretentive matrices as a measure of swelling synchronization and its impact on drug release kinetics under standard and modified dissolution conditions. AU - Liu,Quan, AU - Fassihi,Reza, PY - 2009/7/11/entrez PY - 2009/7/11/pubmed PY - 2009/8/27/medline SP - 861 EP - 7 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 61 IS - 7 N2 - OBJECTIVES: We have assessed the kinetics of drug release in relation to the full or partial hydration and swelling of matrices under standard and modified United States Pharmacopeia (USP) apparatus II using a novel index, defined as the symmetrical shape factor. The symmetrical shape factor describes the regularity of the hydration rate of the matrix perimeter relative to its central regions. METHODS: Monolithic and three-layer matrices based on hypromellose, polyethylene oxide, Kollidon SR, theophylline, diltiazem hydrochloride and alfuzosin hydrochloride were subjected to dissolution testing. KEY FINDINGS: Our results indicated that Kollidon SR matrices and the three-layer composite systems with and without effervescing components were not significantly affected by the dissolution conditions. However, in the case of the floating monolithic systems based on hypromellose and polyethylene oxide, both release profiles and swelling dynamics in accordance with the similarity factor (f(2)) and symmetrical shape factor values were significantly influenced. CONCLUSIONS: The symmetrical shape factor values were positively impacted. Consequently the drug release kinetics were more predictable and reproducible. The modified USP method resulted in a more synchronized axial and radial swelling with symmetrical shape factor values approaching unity. Data further indicated that the modified USP method provided for complete matrix hydration and swelling as the dosage form remained fully submerged, allowing for more reliable release mimicking the in-vivo conditions. SN - 0022-3573 UR - https://www.unboundmedicine.com/medline/citation/19589227/Application_of_a_novel_symmetrical_shape_factor_to_gastroretentive_matrices_as_a_measure_of_swelling_synchronization_and_its_impact_on_drug_release_kinetics_under_standard_and_modified_dissolution_conditions_ L2 - https://doi.org/10.1211/jpp/61.07.0004 DB - PRIME DP - Unbound Medicine ER -