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  1. Article ; Online: The Impact of Post-Processing Temperature on PLGA Microparticle Properties.

    Otte, Andrew / Soh, Bong Kwan / Park, Kinam

    Pharmaceutical research

    2023  Volume 40, Issue 11, Page(s) 2677–2685

    Abstract: Purpose: Biodegradable poly(lactide-co-glycolide) (PLGA) microparticles loaded with either risperidone or naltrexone were prepared from an emulsification homogenization process. The objective of this study was to determine the impact the post-treatment ... ...

    Abstract Purpose: Biodegradable poly(lactide-co-glycolide) (PLGA) microparticles loaded with either risperidone or naltrexone were prepared from an emulsification homogenization process. The objective of this study was to determine the impact the post-treatment temperature has on the properties and subsequent performance of the microparticles.
    Methods: The post-treatment temperature of an ethanolic solution was characterized from 10 ~ 35ºC for the naltrexone and risperidone micropartilces.
    Results: The wash temperature resulted in a typical triphasic in vitro release pattern at low wash temperatures or a biphasic pattern consisting of an elevated release rate at higher post-treatment temperatures. The post-treatment temperature largely influences the particle morphology, residual solvent levels, glass transition temperature, and drug loading and is molecule dependent, whereby these characteristics subsequently influence the drug release rate.
    Conclusion: The study highlights the importance of both the post-treatment process and control during manufacturing to obtain a formulation within the desired product profile.
    MeSH term(s) Risperidone ; Polylactic Acid-Polyglycolic Acid Copolymer ; Temperature ; Polyglycolic Acid ; Lactic Acid ; Naltrexone ; Particle Size ; Microspheres
    Chemical Substances Risperidone (L6UH7ZF8HC) ; Polylactic Acid-Polyglycolic Acid Copolymer (1SIA8062RS) ; Polyglycolic Acid (26009-03-0) ; Lactic Acid (33X04XA5AT) ; Naltrexone (5S6W795CQM)
    Language English
    Publishing date 2023-08-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 843063-9
    ISSN 1573-904X ; 0724-8741 ; 0739-0742
    ISSN (online) 1573-904X
    ISSN 0724-8741 ; 0739-0742
    DOI 10.1007/s11095-023-03568-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Liquid crystalline drug delivery vehicles for oral and IV/subcutaneous administration of poorly soluble (and soluble) drugs.

    Otte, Andrew / Soh, Bong-Kwan / Yoon, Gwangheum / Park, Kinam

    International journal of pharmaceutics

    2018  Volume 539, Issue 1-2, Page(s) 175–183

    Abstract: Poorly soluble drug molecules often have low bioavailability issues and absorption problems in the clinical setting. As the number of poorly soluble drugs increases from discovery, developing technologies to enhance their solubility, while also ... ...

    Abstract Poorly soluble drug molecules often have low bioavailability issues and absorption problems in the clinical setting. As the number of poorly soluble drugs increases from discovery, developing technologies to enhance their solubility, while also controlling their release is one of the many challenges facing the pharmaceutical industry today. Liquid crystalline systems, nanoparticulate or macro-matrix, self-assemble in the presence of an aqueous environment and can provide a solubility enhancement, while also controlling the drug release rate. This review examines the fundamentals of liquid crystalline systems through the representative literature, concluding with examples of liquid crystalline systems in clinical trials development. The review focus is on the potential of utilizing liquid crystalline systems for poorly soluble drugs, in the areas of oral delivery and IV/subcutaneous, followed by water soluble molecules. Key considerations in utilizing liquid crystalline systems advantages while also discussing potential areas of key research that may be needed will be highlighted.
    MeSH term(s) Drug Delivery Systems/methods ; Drug Liberation ; Humans ; Liquid Crystals/chemistry ; Solubility
    Language English
    Publishing date 2018-01-31
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2018.01.037
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  3. Article ; Online: The in vivo transformation and pharmacokinetic properties of a liquid crystalline drug delivery system.

    Otte, Andrew / Báez-Santos, Yahira M / Mun, Ellina A / Soh, Bong-Kwan / Lee, Young-Nam / Park, Kinam

    International journal of pharmaceutics

    2017  Volume 532, Issue 1, Page(s) 345–351

    Abstract: A liquid crystalline (LC) system, composed of phosphatidylcholine, sorbitan monoleate, and tocopherol acetate, was investigated to understand the in vivo transformation after subcutaneous injection, coupled with the physicochemical and pharmacokinetic ... ...

    Abstract A liquid crystalline (LC) system, composed of phosphatidylcholine, sorbitan monoleate, and tocopherol acetate, was investigated to understand the in vivo transformation after subcutaneous injection, coupled with the physicochemical and pharmacokinetic properties of the formulation. The rat model was utilized to monitor a pseudo-time course transformation from a precursor LC formulation to the LC matrix, coupled with the blood concentration profiles of the formulations containing leuprolide acetate. Three formulations that result in the H
    Language English
    Publishing date 2017-10-30
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2017.08.098
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  4. Article: Injectable, long-acting PLGA formulations: Analyzing PLGA and understanding microparticle formation

    Park, Kinam / Skidmore, Sarah / Hadar, Justin / Garner, John / Park, Haesun / Otte, Andrew / Soh, Bong Kwan / Yoon, Gwangheum / Yu, Dijia / Yun, Yeonhee / Lee, Byung Kook / Jiang, Xiaohui / Wang, Yan

    Journal of controlled release. 2019 June 28, v. 304

    2019  

    Abstract: Injectable, long-acting depot formulations based on poly(lactide-co-glycolide) (PLGA) have been used clinically since 1989. Despite 30 years of development, however, there are only 19 different drugs in PLGA formulations approved by the U.S. Food and ... ...

    Abstract Injectable, long-acting depot formulations based on poly(lactide-co-glycolide) (PLGA) have been used clinically since 1989. Despite 30 years of development, however, there are only 19 different drugs in PLGA formulations approved by the U.S. Food and Drug Administration (FDA). The difficulty in developing depot formulations stems in large part from the lack of a clear molecular understanding of PLGA polymers and a mechanistic understanding of PLGA microparticles formation. The difficulty is readily apparent by the absence of approved PLGA-based generic products, limiting access to affordable medicines to all patients.PLGA has been traditionally characterized by its molecular weight, lactide:glycolide (L:G) ratio, and end group. Characterization of non-linear PLGA, such as star-shaped glucose-PLGA, has been difficult due to the shortcomings in analytical methods typically used for PLGA. In addition, separation of a mixture of different PLGAs has not been previously identified, especially when only their L:G ratios are different while the molecular weights are the same. New analytical methods were developed to determine the branch number of star-shaped PLGAs, and to separate PLGAs based on L:G ratios regardless of the molecular weight. A deeper understanding of complex PLGA formulations can be achieved with these new characterization methods. Such methods are important for further development of not only PLGA depot formulations with controllable drug release kinetics, but also generic formulations of current brand-name products.
    Keywords Food and Drug Administration ; analytical methods ; drugs ; microparticles ; molecular weight ; polymers
    Language English
    Dates of publication 2019-0628
    Size p. 125-134.
    Publishing place Elsevier B.V.
    Document type Article
    ZDB-ID 632533-6
    ISSN 1873-4995 ; 0168-3659
    ISSN (online) 1873-4995
    ISSN 0168-3659
    DOI 10.1016/j.jconrel.2019.05.003
    Database NAL-Catalogue (AGRICOLA)

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  5. Article ; Online: Injectable, long-acting PLGA formulations: Analyzing PLGA and understanding microparticle formation.

    Park, Kinam / Skidmore, Sarah / Hadar, Justin / Garner, John / Park, Haesun / Otte, Andrew / Soh, Bong Kwan / Yoon, Gwangheum / Yu, Dijia / Yun, Yeonhee / Lee, Byung Kook / Jiang, Xiaohui / Wang, Yan

    Journal of controlled release : official journal of the Controlled Release Society

    2019  Volume 304, Page(s) 125–134

    Abstract: Injectable, long-acting depot formulations based on poly(lactide-co-glycolide) (PLGA) have been used clinically since 1989. Despite 30 years of development, however, there are only 19 different drugs in PLGA formulations approved by the U.S. Food and ... ...

    Abstract Injectable, long-acting depot formulations based on poly(lactide-co-glycolide) (PLGA) have been used clinically since 1989. Despite 30 years of development, however, there are only 19 different drugs in PLGA formulations approved by the U.S. Food and Drug Administration (FDA). The difficulty in developing depot formulations stems in large part from the lack of a clear molecular understanding of PLGA polymers and a mechanistic understanding of PLGA microparticles formation. The difficulty is readily apparent by the absence of approved PLGA-based generic products, limiting access to affordable medicines to all patients. PLGA has been traditionally characterized by its molecular weight, lactide:glycolide (L:G) ratio, and end group. Characterization of non-linear PLGA, such as star-shaped glucose-PLGA, has been difficult due to the shortcomings in analytical methods typically used for PLGA. In addition, separation of a mixture of different PLGAs has not been previously identified, especially when only their L:G ratios are different while the molecular weights are the same. New analytical methods were developed to determine the branch number of star-shaped PLGAs, and to separate PLGAs based on L:G ratios regardless of the molecular weight. A deeper understanding of complex PLGA formulations can be achieved with these new characterization methods. Such methods are important for further development of not only PLGA depot formulations with controllable drug release kinetics, but also generic formulations of current brand-name products.
    MeSH term(s) Delayed-Action Preparations ; Drug Approval ; Drug Carriers/chemistry ; Drug Liberation ; Drugs, Generic/administration & dosage ; Drugs, Generic/chemistry ; Humans ; Injections ; Microspheres ; Molecular Weight ; Pharmaceutical Preparations/administration & dosage ; Pharmaceutical Preparations/chemistry ; Polylactic Acid-Polyglycolic Acid Copolymer/chemistry
    Chemical Substances Delayed-Action Preparations ; Drug Carriers ; Drugs, Generic ; Pharmaceutical Preparations ; Polylactic Acid-Polyglycolic Acid Copolymer (1SIA8062RS)
    Language English
    Publishing date 2019-05-06
    Publishing country Netherlands
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 632533-6
    ISSN 1873-4995 ; 0168-3659
    ISSN (online) 1873-4995
    ISSN 0168-3659
    DOI 10.1016/j.jconrel.2019.05.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Formulation and characterization of a liquid crystalline hexagonal mesophase region of phosphatidylcholine, sorbitan monooleate, and tocopherol acetate for sustained delivery of leuprolide acetate.

    Báez-Santos, Yahira M / Otte, Andrew / Mun, Ellina A / Soh, Bong-Kwan / Song, Chang-Geun / Lee, Young-Nam / Park, Kinam

    International journal of pharmaceutics

    2016  Volume 514, Issue 1, Page(s) 314–321

    Abstract: Although liquid crystal (LC) systems have been studied before, their utility in drug delivery applications has not been explored in depth. This study examined the development of a 1-month sustained release formulation of leuprolide acetate using an in ... ...

    Abstract Although liquid crystal (LC) systems have been studied before, their utility in drug delivery applications has not been explored in depth. This study examined the development of a 1-month sustained release formulation of leuprolide acetate using an in situ-forming LC matrix. The phase progression upon water absorption was tested through construction of ternary phase diagrams of phosphatidylcholine, sorbitan monooleate, and tocopherol acetate (TA) at increasing water content. Small angle X-ray scattering revealed the presence of lamellar and hexagonal mesophases. The physicochemical characteristics and in vitro drug release were evaluated as a function of the ternary component ratio and its resultant phase behavior. Formulations with increased water uptake capacity displayed greater drug release and enhanced erodability. Removal of TA resulted in increased water uptake capacity and drug release, where 8% (w/w) TA was determined as the critical concentration threshold for divergence of release profiles. In conclusion, characterization of the resultant H
    MeSH term(s) Chemistry, Pharmaceutical/methods ; Delayed-Action Preparations/chemistry ; Drug Delivery Systems/methods ; Drug Liberation ; Hexoses/chemistry ; Leuprolide/chemistry ; Liquid Crystals/chemistry ; Phosphatidylcholines/chemistry ; Scattering, Small Angle ; Water/chemistry ; X-Ray Diffraction/methods ; alpha-Tocopherol/chemistry
    Chemical Substances Delayed-Action Preparations ; Hexoses ; Phosphatidylcholines ; Water (059QF0KO0R) ; sorbitan monooleate (06XEA2VD56) ; Leuprolide (EFY6W0M8TG) ; alpha-Tocopherol (H4N855PNZ1)
    Language English
    Publishing date 2016-11-30
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2016.06.138
    Database MEDical Literature Analysis and Retrieval System OnLINE

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