An effective polyvinyl alcohol for the solubilization of poorly water-soluble drugs in solid dispersion formulations

This study aimed to investigate the characteristics of an effective polyvinyl alcohol (PVA) for use in solid dispersion formulations (SDFs), which enable higher dissolution and bioavailability of poorly water-soluble drugs. PVAs with different degrees of hydrolysis and polymerization were evaluated...

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Veröffentlicht in:Journal of drug delivery science and technology Jg. 55; S. 101401
Hauptverfasser: Umemoto, Yoshiaki, Uchida, Shinya, Yoshida, Takatsune, Shimada, Ken, Kojima, Hiroyuki, Takagi, Akira, Tanaka, Shimako, Kashiwagura, Yasuharu, Namiki, Noriyuki
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Sprache:Englisch
Veröffentlicht: Elsevier B.V 01.02.2020
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ISSN:1773-2247
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Abstract This study aimed to investigate the characteristics of an effective polyvinyl alcohol (PVA) for use in solid dispersion formulations (SDFs), which enable higher dissolution and bioavailability of poorly water-soluble drugs. PVAs with different degrees of hydrolysis and polymerization were evaluated using their SDFs with amenamevir prepared by ball milling. The dissolution tests suggested that a lower degree of polymerization (≤600) was preferable and that a 66% degree of hydrolysis (PVA 66) was optimal for solubilizing amenamevir. The versatility of the most effective PVA as revealed in the amenamevir dissolution tests was also confirmed using SDFs with nifedipine and tacrolimus prepared by spray-drying. In addition, to investigate the cause for the difference in solubilizing ability by different degrees of hydrolysis, critical micelle concentrations of PVAs were evaluated using pyrene. This suggested that a surfactant ability could be one of the causes. Furthermore, in vivo absorption studies on amenamevir SDFs were conducted by oral administration to rats. PVA 66 achieved higher bioavailability and more rapid absorption than common SDF carriers, such as hydroxypropylmethylcellulose and hydroxypropylmethylcellulose acetate succinate. Thus, PVA with an approximately 66% degree of hydrolysis was beneficial for the solubilization of poorly water-soluble drugs in SDFs. [Display omitted]
AbstractList This study aimed to investigate the characteristics of an effective polyvinyl alcohol (PVA) for use in solid dispersion formulations (SDFs), which enable higher dissolution and bioavailability of poorly water-soluble drugs. PVAs with different degrees of hydrolysis and polymerization were evaluated using their SDFs with amenamevir prepared by ball milling. The dissolution tests suggested that a lower degree of polymerization (≤600) was preferable and that a 66% degree of hydrolysis (PVA 66) was optimal for solubilizing amenamevir. The versatility of the most effective PVA as revealed in the amenamevir dissolution tests was also confirmed using SDFs with nifedipine and tacrolimus prepared by spray-drying. In addition, to investigate the cause for the difference in solubilizing ability by different degrees of hydrolysis, critical micelle concentrations of PVAs were evaluated using pyrene. This suggested that a surfactant ability could be one of the causes. Furthermore, in vivo absorption studies on amenamevir SDFs were conducted by oral administration to rats. PVA 66 achieved higher bioavailability and more rapid absorption than common SDF carriers, such as hydroxypropylmethylcellulose and hydroxypropylmethylcellulose acetate succinate. Thus, PVA with an approximately 66% degree of hydrolysis was beneficial for the solubilization of poorly water-soluble drugs in SDFs. [Display omitted]
ArticleNumber 101401
Author Yoshida, Takatsune
Umemoto, Yoshiaki
Namiki, Noriyuki
Kojima, Hiroyuki
Takagi, Akira
Uchida, Shinya
Shimada, Ken
Tanaka, Shimako
Kashiwagura, Yasuharu
Author_xml – sequence: 1
  givenname: Yoshiaki
  surname: Umemoto
  fullname: Umemoto, Yoshiaki
  organization: Pharmaceutical Research and Technology Labs, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka, 425-0072, Japan
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  givenname: Shinya
  surname: Uchida
  fullname: Uchida, Shinya
  email: uchidas@u-shizuoka-ken.ac.jp
  organization: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
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  givenname: Takatsune
  surname: Yoshida
  fullname: Yoshida, Takatsune
  organization: Pharmaceutical Science and Technology Labs, Astellas Pharma Inc., 5-2-3 Tokodai, Tsukuba, Ibaraki, 300-2698, Japan
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  givenname: Ken
  surname: Shimada
  fullname: Shimada, Ken
  organization: Pharmaceutical Science and Technology Labs, Astellas Pharma Inc., 5-2-3 Tokodai, Tsukuba, Ibaraki, 300-2698, Japan
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  givenname: Hiroyuki
  surname: Kojima
  fullname: Kojima, Hiroyuki
  organization: Drug Product Development, Technical Operation, Astellas Institute for Regenerative Medicine, 33 Locke Dr, Marlborough, MA, 01752, USA
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  givenname: Akira
  surname: Takagi
  fullname: Takagi, Akira
  organization: Pharmaceutical Research and Technology Labs, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka, 425-0072, Japan
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  givenname: Shimako
  surname: Tanaka
  fullname: Tanaka, Shimako
  organization: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
– sequence: 8
  givenname: Yasuharu
  surname: Kashiwagura
  fullname: Kashiwagura, Yasuharu
  organization: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
– sequence: 9
  givenname: Noriyuki
  surname: Namiki
  fullname: Namiki, Noriyuki
  organization: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
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Keywords Solid dispersion
Amenamevir
Polyvinyl alcohol
Tacrolimus
Rat
Nifedipine
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Snippet This study aimed to investigate the characteristics of an effective polyvinyl alcohol (PVA) for use in solid dispersion formulations (SDFs), which enable...
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SubjectTerms Amenamevir
Nifedipine
Polyvinyl alcohol
Rat
Solid dispersion
Tacrolimus
Title An effective polyvinyl alcohol for the solubilization of poorly water-soluble drugs in solid dispersion formulations
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