Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies
Abstract Orally disintegrating films (ODFs) were prepared from hydroxypropyl methylcellulose (HPMC E6 1.5%, 2.0%, and 2.5%), plasticizers ((glycerin (Gly), propylene glycol (PP), or polyethylene glycol (PEG)), and isosorbide dinitrate using the solvent casting method. Design of experiments (DoE) was...
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| Format: | Article |
| Language: | English |
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Instituto de Tecnologia do Paraná (Tecpar)
2023-11-01
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| Series: | Brazilian Archives of Biology and Technology |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132023000100637&lng=en&tlng=en |
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| author | Larissa Lea da Silva Marcelo Dutra Duque Michele Georges Issa Leticia Norma Carpentieri Rodrigues |
| author_facet | Larissa Lea da Silva Marcelo Dutra Duque Michele Georges Issa Leticia Norma Carpentieri Rodrigues |
| author_sort | Larissa Lea da Silva |
| collection | DOAJ |
| description | Abstract Orally disintegrating films (ODFs) were prepared from hydroxypropyl methylcellulose (HPMC E6 1.5%, 2.0%, and 2.5%), plasticizers ((glycerin (Gly), propylene glycol (PP), or polyethylene glycol (PEG)), and isosorbide dinitrate using the solvent casting method. Design of experiments (DoE) was used considering the amount of film-forming agent (HPMC) and the nature of the plasticizers as independent variables and thickness, mechanical properties, disintegration time, and dissolution efficiency as dependent variables. The best formulation was selected based on the desirability function ( f D). Color analysis was performed using CIE- L a b coordinates. DSC curves and XRPD diffractograms showed ISDN amorphization, probably due to complexation with polymers (HPMC E6 and HPβCD). The polymer (HPMC E6) and plasticizer played a critical role in the mechanical and optical properties of the films; however, these factors had no significant effect on the dissolution efficiency of ISDN. Principal component analysis revealed a more defined distinction of the ODFs according to their chromatic characteristics. ODFs prepared with Gly and PEG 400 were translucent, whereas the other films were transparent. The dissolution efficiency values of the ODFs (F1-9) were higher than those observed for the reference product (88.35(0.01%), indicating increased solubility of ISDN, probably due to complexation with polymers (HPMC E6 and HPβCD). The maximum value obtained for desirability function ( f D ) was 0.86, which corresponded to the use of 1.5% to 2.0% polymer (HPMC E6) and Gly or PP as plasticizers. The F5 formulation showed adequate thickness (85.00(6.38 (m), elongation at break (4.82(0.01%), adhesiveness (0.23(0.09 mJ), dissolution efficiency (95.97(0.01%), and high transparency. |
| first_indexed | 2024-03-11T10:44:22Z |
| format | Article |
| id | doaj.art-cc00d20022034c3faf519a157329879b |
| institution | Directory Open Access Journal |
| issn | 1678-4324 |
| language | English |
| last_indexed | 2024-03-11T10:44:22Z |
| publishDate | 2023-11-01 |
| publisher | Instituto de Tecnologia do Paraná (Tecpar) |
| record_format | Article |
| series | Brazilian Archives of Biology and Technology |
| spelling | doaj.art-cc00d20022034c3faf519a157329879b2023-11-14T07:51:10ZengInstituto de Tecnologia do Paraná (Tecpar)Brazilian Archives of Biology and Technology1678-43242023-11-016610.1590/1678-4324-2023220370Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical StudiesLarissa Lea da Silvahttps://orcid.org/0000-0003-0834-2446Marcelo Dutra Duquehttps://orcid.org/0000-0002-4080-9862Michele Georges Issahttps://orcid.org/0000-0002-6099-3687Leticia Norma Carpentieri Rodrigueshttps://orcid.org/0000-0001-5175-859XAbstract Orally disintegrating films (ODFs) were prepared from hydroxypropyl methylcellulose (HPMC E6 1.5%, 2.0%, and 2.5%), plasticizers ((glycerin (Gly), propylene glycol (PP), or polyethylene glycol (PEG)), and isosorbide dinitrate using the solvent casting method. Design of experiments (DoE) was used considering the amount of film-forming agent (HPMC) and the nature of the plasticizers as independent variables and thickness, mechanical properties, disintegration time, and dissolution efficiency as dependent variables. The best formulation was selected based on the desirability function ( f D). Color analysis was performed using CIE- L a b coordinates. DSC curves and XRPD diffractograms showed ISDN amorphization, probably due to complexation with polymers (HPMC E6 and HPβCD). The polymer (HPMC E6) and plasticizer played a critical role in the mechanical and optical properties of the films; however, these factors had no significant effect on the dissolution efficiency of ISDN. Principal component analysis revealed a more defined distinction of the ODFs according to their chromatic characteristics. ODFs prepared with Gly and PEG 400 were translucent, whereas the other films were transparent. The dissolution efficiency values of the ODFs (F1-9) were higher than those observed for the reference product (88.35(0.01%), indicating increased solubility of ISDN, probably due to complexation with polymers (HPMC E6 and HPβCD). The maximum value obtained for desirability function ( f D ) was 0.86, which corresponded to the use of 1.5% to 2.0% polymer (HPMC E6) and Gly or PP as plasticizers. The F5 formulation showed adequate thickness (85.00(6.38 (m), elongation at break (4.82(0.01%), adhesiveness (0.23(0.09 mJ), dissolution efficiency (95.97(0.01%), and high transparency.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132023000100637&lng=en&tlng=enisosorbide dinitratecyclodextrinsorally disintegrating filmsmechanical propertiesdesirability function |
| spellingShingle | Larissa Lea da Silva Marcelo Dutra Duque Michele Georges Issa Leticia Norma Carpentieri Rodrigues Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies Brazilian Archives of Biology and Technology isosorbide dinitrate cyclodextrins orally disintegrating films mechanical properties desirability function |
| title | Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies |
| title_full | Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies |
| title_fullStr | Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies |
| title_full_unstemmed | Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies |
| title_short | Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies |
| title_sort | isosorbide dinitrate orally disintegrating films cyclodextrins hpmc based mechanical optical and physicochemical studies |
| topic | isosorbide dinitrate cyclodextrins orally disintegrating films mechanical properties desirability function |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132023000100637&lng=en&tlng=en |
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