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A quality by design approach for the development of lyophilized liposomes with simvastatin.(Report)(Author abstract)

To access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jsps.2017.01.007 Byline: Alina Porfire [aporfire@umfcluj.ro] (a,*), Dana Maria Muntean (a), Lucia Rus (b), Bianca Sylvester (a), Ioan Tomuta (a) Keywords Lyophilizati... Full description

Journal Title: Saudi Pharmaceutical Journal 2017, Vol.25(7), p.981
Main Author: Porfire, Alina
Other Authors: Muntean, Dana Maria , Rus, Lucia , Sylvester, Bianca , Tomuta, Ioan
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 1319-0164 ; DOI: 10.1016/j.jsps.2017.01.007
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recordid: gale_ofa522999644
title: A quality by design approach for the development of lyophilized liposomes with simvastatin.(Report)(Author abstract)
format: Article
creator:
  • Porfire, Alina
  • Muntean, Dana Maria
  • Rus, Lucia
  • Sylvester, Bianca
  • Tomuta, Ioan
subjects:
  • Simvastatin – Dosage and Administration
  • Liposomes – Usage
  • Drug Delivery Systems – Testing
ispartof: Saudi Pharmaceutical Journal, 2017, Vol.25(7), p.981
description: To access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jsps.2017.01.007 Byline: Alina Porfire [aporfire@umfcluj.ro] (a,*), Dana Maria Muntean (a), Lucia Rus (b), Bianca Sylvester (a), Ioan Tomuta (a) Keywords Lyophilization; Liposomes; Simvastatin; QbD Abstract Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics. In the case of lyophilized liposomes, the choice of the optimum formulation and technological parameters has to be done, in order to protect the integrity of the liposomal membrane during lyophilization. Thus, the influence of several risk factors (3 formulation factors: PEG proportion, cholesterol concentration, the cryoprotectant to phospholipids molar ratio, and 2 process parameters: the number of extrusions through 100 nm polycarbonate membranes and the freezing conditions prior lyophilization) over the critical quality attributes (CQAs) of lyophilized long circulating liposomes with simvastatin (lyo-LCL-SIM), i.e. the size, the encapsulated SIM concentration, the encapsulated SIM retention, the T.sub.m change and the residual moisture content, was investigated within the current study using the design of experiments tool of QbD. Moreover, the design space for lyo-LCL-SIM was determined, in which the established quality requirements of the product are met, provided that the risk factors vary within the established limits. Author Affiliation: (a) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, Romania (b) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Drug Analysis, Cluj-Napoca, Romania * Corresponding author at: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, "Iuliu HaEieganu" University of Medicine and Pharmacy, 41 Vict
language: eng
source:
identifier: ISSN: 1319-0164 ; DOI: 10.1016/j.jsps.2017.01.007
fulltext: fulltext
issn:
  • 1319-0164
  • 13190164
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titleA quality by design approach for the development of lyophilized liposomes with simvastatin.(Report)(Author abstract)
creatorPorfire, Alina ; Muntean, Dana Maria ; Rus, Lucia ; Sylvester, Bianca ; Tomuta, Ioan
ispartofSaudi Pharmaceutical Journal, 2017, Vol.25(7), p.981
identifierISSN: 1319-0164 ; DOI: 10.1016/j.jsps.2017.01.007
subjectSimvastatin – Dosage and Administration ; Liposomes – Usage ; Drug Delivery Systems – Testing
descriptionTo access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jsps.2017.01.007 Byline: Alina Porfire [aporfire@umfcluj.ro] (a,*), Dana Maria Muntean (a), Lucia Rus (b), Bianca Sylvester (a), Ioan Tomuta (a) Keywords Lyophilization; Liposomes; Simvastatin; QbD Abstract Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics. In the case of lyophilized liposomes, the choice of the optimum formulation and technological parameters has to be done, in order to protect the integrity of the liposomal membrane during lyophilization. Thus, the influence of several risk factors (3 formulation factors: PEG proportion, cholesterol concentration, the cryoprotectant to phospholipids molar ratio, and 2 process parameters: the number of extrusions through 100 nm polycarbonate membranes and the freezing conditions prior lyophilization) over the critical quality attributes (CQAs) of lyophilized long circulating liposomes with simvastatin (lyo-LCL-SIM), i.e. the size, the encapsulated SIM concentration, the encapsulated SIM retention, the T.sub.m change and the residual moisture content, was investigated within the current study using the design of experiments tool of QbD. Moreover, the design space for lyo-LCL-SIM was determined, in which the established quality requirements of the product are met, provided that the risk factors vary within the established limits. Author Affiliation: (a) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, Romania (b) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Drug Analysis, Cluj-Napoca, Romania * Corresponding author at: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, "Iuliu HaEieganu" University of Medicine and Pharmacy, 41 Victor Babeo Street, 400012 Cluj-Napoca, Romania. Article History: Received 21 October 2016; Accepted 20 January 2017 (footnote) Peer review under responsibility of King Saud University.
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titleA quality by design approach for the development of lyophilized liposomes with simvastatin.(Report)(Author abstract)
descriptionTo access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jsps.2017.01.007 Byline: Alina Porfire [aporfire@umfcluj.ro] (a,*), Dana Maria Muntean (a), Lucia Rus (b), Bianca Sylvester (a), Ioan Tomuta (a) Keywords Lyophilization; Liposomes; Simvastatin; QbD Abstract Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics. In the case of lyophilized liposomes, the choice of the optimum formulation and technological parameters has to be done, in order to protect the integrity of the liposomal membrane during lyophilization. Thus, the influence of several risk factors (3 formulation factors: PEG proportion, cholesterol concentration, the cryoprotectant to phospholipids molar ratio, and 2 process parameters: the number of extrusions through 100 nm polycarbonate membranes and the freezing conditions prior lyophilization) over the critical quality attributes (CQAs) of lyophilized long circulating liposomes with simvastatin (lyo-LCL-SIM), i.e. the size, the encapsulated SIM concentration, the encapsulated SIM retention, the T.sub.m change and the residual moisture content, was investigated within the current study using the design of experiments tool of QbD. Moreover, the design space for lyo-LCL-SIM was determined, in which the established quality requirements of the product are met, provided that the risk factors vary within the established limits. Author Affiliation: (a) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, Romania (b) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Drug Analysis, Cluj-Napoca, Romania * Corresponding author at: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, "Iuliu HaEieganu" University of Medicine and Pharmacy, 41 Victor Babeo Street, 400012 Cluj-Napoca, Romania. Article History: Received 21 October 2016; Accepted 20 January 2017 (footnote) Peer review under responsibility of King Saud University.
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abstractTo access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jsps.2017.01.007 Byline: Alina Porfire [aporfire@umfcluj.ro] (a,*), Dana Maria Muntean (a), Lucia Rus (b), Bianca Sylvester (a), Ioan Tomuta (a) Keywords Lyophilization; Liposomes; Simvastatin; QbD Abstract Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics. In the case of lyophilized liposomes, the choice of the optimum formulation and technological parameters has to be done, in order to protect the integrity of the liposomal membrane during lyophilization. Thus, the influence of several risk factors (3 formulation factors: PEG proportion, cholesterol concentration, the cryoprotectant to phospholipids molar ratio, and 2 process parameters: the number of extrusions through 100 nm polycarbonate membranes and the freezing conditions prior lyophilization) over the critical quality attributes (CQAs) of lyophilized long circulating liposomes with simvastatin (lyo-LCL-SIM), i.e. the size, the encapsulated SIM concentration, the encapsulated SIM retention, the T.sub.m change and the residual moisture content, was investigated within the current study using the design of experiments tool of QbD. Moreover, the design space for lyo-LCL-SIM was determined, in which the established quality requirements of the product are met, provided that the risk factors vary within the established limits. Author Affiliation: (a) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, Romania (b) Iuliu Hatieganu University of Medicine and Pharmacy, Dept. of Drug Analysis, Cluj-Napoca, Romania * Corresponding author at: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, "Iuliu HaEieganu" University of Medicine and Pharmacy, 41 Victor Babeo Street, 400012 Cluj-Napoca, Romania. Article History: Received 21 October 2016; Accepted 20 January 2017 (footnote) Peer review under responsibility of King Saud University.
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