Challenges of Dissolution Methods Development for Soft Gelatin Capsules
Recently, the development of soft gelatin capsules (SGCs) dosage forms has attracted a great deal of interest in the oral delivery of poorly water-soluble drugs. This is attributed to the increased number of poorly soluble drugs in the pipeline, and hence the challenges of finding innovative ways of...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-02-01
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| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/13/2/214 |
| _version_ | 1827603656607793152 |
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| author | Festo Damian Mohammad Harati Jeff Schwartzenhauer Owen Van Cauwenberghe Shawn D. Wettig |
| author_facet | Festo Damian Mohammad Harati Jeff Schwartzenhauer Owen Van Cauwenberghe Shawn D. Wettig |
| author_sort | Festo Damian |
| collection | DOAJ |
| description | Recently, the development of soft gelatin capsules (SGCs) dosage forms has attracted a great deal of interest in the oral delivery of poorly water-soluble drugs. This is attributed to the increased number of poorly soluble drugs in the pipeline, and hence the challenges of finding innovative ways of developing bioavailable and stable dosage forms. Encapsulation of these drugs into SGCs is one of the approaches that is utilized to deliver the active ingredients to the systemic circulation to overcome certain formulation hurdles. Once formulated, encapsulated drugs in the form of SGCs require suitable in vitro dissolution test methods to ensure drug product quality and performance. This review focuses on challenges facing dissolution test method development for SGCs. A brief discussion of the physicochemical and formulation factors that affect the dissolution properties of SGCs will be highlighted. Likewise, the influence of cross-linking of gelatin on the dissolution properties of SGCs will also be discussed. |
| first_indexed | 2024-03-09T05:44:46Z |
| format | Article |
| id | doaj.art-0c0148d8c9224df28810694d0039f639 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T05:44:46Z |
| publishDate | 2021-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-0c0148d8c9224df28810694d0039f6392023-12-03T12:22:09ZengMDPI AGPharmaceutics1999-49232021-02-0113221410.3390/pharmaceutics13020214Challenges of Dissolution Methods Development for Soft Gelatin CapsulesFesto Damian0Mohammad Harati1Jeff Schwartzenhauer2Owen Van Cauwenberghe3Shawn D. Wettig4School of Pharmacy, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, CanadaDepartment of Natural Sciences, University of Michigan, 2209 Natural Sciences Building, 4901 Evergreen Rd, Dearborn, MI 48128, USACatalent Pharma Solutions, 2125 Ambassador Dr, Windsor, ON N9C 3R5, CanadaSchool of Pharmacy, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, CanadaSchool of Pharmacy, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, CanadaRecently, the development of soft gelatin capsules (SGCs) dosage forms has attracted a great deal of interest in the oral delivery of poorly water-soluble drugs. This is attributed to the increased number of poorly soluble drugs in the pipeline, and hence the challenges of finding innovative ways of developing bioavailable and stable dosage forms. Encapsulation of these drugs into SGCs is one of the approaches that is utilized to deliver the active ingredients to the systemic circulation to overcome certain formulation hurdles. Once formulated, encapsulated drugs in the form of SGCs require suitable in vitro dissolution test methods to ensure drug product quality and performance. This review focuses on challenges facing dissolution test method development for SGCs. A brief discussion of the physicochemical and formulation factors that affect the dissolution properties of SGCs will be highlighted. Likewise, the influence of cross-linking of gelatin on the dissolution properties of SGCs will also be discussed.https://www.mdpi.com/1999-4923/13/2/214soft gelatin capsulesdrug stabilitypoorly soluble drugsgelatin cross-linkingsolubilitydissolution method development |
| spellingShingle | Festo Damian Mohammad Harati Jeff Schwartzenhauer Owen Van Cauwenberghe Shawn D. Wettig Challenges of Dissolution Methods Development for Soft Gelatin Capsules Pharmaceutics soft gelatin capsules drug stability poorly soluble drugs gelatin cross-linking solubility dissolution method development |
| title | Challenges of Dissolution Methods Development for Soft Gelatin Capsules |
| title_full | Challenges of Dissolution Methods Development for Soft Gelatin Capsules |
| title_fullStr | Challenges of Dissolution Methods Development for Soft Gelatin Capsules |
| title_full_unstemmed | Challenges of Dissolution Methods Development for Soft Gelatin Capsules |
| title_short | Challenges of Dissolution Methods Development for Soft Gelatin Capsules |
| title_sort | challenges of dissolution methods development for soft gelatin capsules |
| topic | soft gelatin capsules drug stability poorly soluble drugs gelatin cross-linking solubility dissolution method development |
| url | https://www.mdpi.com/1999-4923/13/2/214 |
| work_keys_str_mv | AT festodamian challengesofdissolutionmethodsdevelopmentforsoftgelatincapsules AT mohammadharati challengesofdissolutionmethodsdevelopmentforsoftgelatincapsules AT jeffschwartzenhauer challengesofdissolutionmethodsdevelopmentforsoftgelatincapsules AT owenvancauwenberghe challengesofdissolutionmethodsdevelopmentforsoftgelatincapsules AT shawndwettig challengesofdissolutionmethodsdevelopmentforsoftgelatincapsules |