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Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system.
Acta Pharm. 2016 Jun 01; 66(2):173-89.AP

Abstract

The aim of this work was to develop a pulsatile release system with metoprolol for chronotherapeutical use by coating swellable mini-tablets with Eudragit RS. To study the influence of the formulation factors (amount of coating polymer, plasticizer percentage in film coating and swelling agent percentage in mini-tablets), a Box-Behnken design of experiment (DoE) was used. To evaluate the influence of the studied factors on the sigmoid shape of the dissolution profile, piecewise function parameters were used as the responses of DoE. The results show that higher concentrations of coating polymer and higher concentrations of plasticizer polymer led to a thicker and more elastic polymeric film, which led to a delay in drug release. Using the parameters of the piecewise function as DoE responses, an optimum formulation with a sigmoid shape dissolution profile and a 2.5-h lag time followed by rapid drug release were obtained.

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Publisher Full Text (DOI)

Authors

Vonica-Gligor AL
No affiliation info available
Tomuţă I
No affiliation info available
Leucuţa SE
No affiliation info available

MeSH

Acrylic ResinsAdrenergic beta-1 Receptor AntagonistsCitratesDelayed-Action PreparationsDrug CarriersDrug ChronotherapyDrug CompoundingDrug Delivery SystemsKineticsLinear ModelsMetoprololModels, ChemicalPlasticizersPulse Therapy, DrugSolubilityStarchTabletsTechnology, Pharmaceutical

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27279062

Citation

Vonica-Gligor, Andreea Loredana, et al. "Piecewise Function Parameters as Responses of the Design of Experiment in the Development of a Pulsatile Release Chronopharmaceutical System." Acta Pharmaceutica (Zagreb, Croatia), vol. 66, no. 2, 2016, pp. 173-89.
Vonica-Gligor AL, Tomuţă I, Leucuţa SE. Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system. Acta Pharm. 2016;66(2):173-89.
Vonica-Gligor, A. L., Tomuţă, I., & Leucuţa, S. E. (2016). Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system. Acta Pharmaceutica (Zagreb, Croatia), 66(2), 173-89. https://doi.org/10.1515/acph-2016-0025
Vonica-Gligor AL, Tomuţă I, Leucuţa SE. Piecewise Function Parameters as Responses of the Design of Experiment in the Development of a Pulsatile Release Chronopharmaceutical System. Acta Pharm. 2016 Jun 1;66(2):173-89. PubMed PMID: 27279062.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system. AU - Vonica-Gligor,Andreea Loredana, AU - Tomuţă,Ioan, AU - Leucuţa,Sorin E, PY - 2016/02/23/accepted PY - 2016/6/10/entrez PY - 2016/6/10/pubmed PY - 2017/1/18/medline SP - 173 EP - 89 JF - Acta pharmaceutica (Zagreb, Croatia) JO - Acta Pharm VL - 66 IS - 2 N2 - The aim of this work was to develop a pulsatile release system with metoprolol for chronotherapeutical use by coating swellable mini-tablets with Eudragit RS. To study the influence of the formulation factors (amount of coating polymer, plasticizer percentage in film coating and swelling agent percentage in mini-tablets), a Box-Behnken design of experiment (DoE) was used. To evaluate the influence of the studied factors on the sigmoid shape of the dissolution profile, piecewise function parameters were used as the responses of DoE. The results show that higher concentrations of coating polymer and higher concentrations of plasticizer polymer led to a thicker and more elastic polymeric film, which led to a delay in drug release. Using the parameters of the piecewise function as DoE responses, an optimum formulation with a sigmoid shape dissolution profile and a 2.5-h lag time followed by rapid drug release were obtained. SN - 1846-9558 UR - https://www.unboundmedicine.com/medline/citation/27279062/Piecewise_function_parameters_as_responses_of_the_design_of_experiment_in_the_development_of_a_pulsatile_release_chronopharmaceutical_system_ DB - PRIME DP - Unbound Medicine ER -