Publicação
Development of semi-solid formulations according to the Quality by Design approach
| Resumo: | This dissertation explores the theoretical and practical applications of topical semi-solid dosage forms within the realm of pharmaceutical formulations. Beginning with an overview of creams, gels, ointments, pastes, and plasters, the study delves into their composition, characteristics, and therapeutic applications. Emphasizing the importance of quality assurance and regulatory compliance, critical concepts such as Quality by Design (QbD), Critical Quality Attributes (CQA), Critical Material Attributes (CMA), and Critical Process Parameters (CPP) are elucidated in detail. Various aspects of formulation development, including the role of excipients and the application of Design of Experiments (DoE) methodologies for optimization are also evaluated. Each dosage form is meticulously examined through hypothetical Quality Target Product Profiles (QTTP), offering a structured approach to define and achieve desired product attributes. Furthermore, risk analysis methodologies, such as Failure Mode Effects and Critical Analysis (FMECA) and Ishikawa diagrams, are discussed to underscore their significance in ensuring product robustness and reliability. Theoretical frameworks and practical applications are intertwined to provide a comprehensive understanding of the complexities involved in formulating and optimizing topical pharmaceuticals. The advantages for the application of QbD in the delineation of pharmaceutical products are reducing the cost and time required for pharmacotechnical development, obtaining formulations with optimized quality characteristics, more robust production processes with better performance and more assertive control measures. |
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| Autores principais: | Simões, Joana Raquel dos Santos |
| Assunto: | Topical semi-solid dosage forms Pharmaceutical formulations Quality by Design Formulation development Formas de dosagem semi-sólidas tópicas Formulações farmacêuticas Quality by Design Desenvolvimento de formulações |
| Ano: | 2024 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade de Coimbra |
| Idioma: | inglês |
| Origem: | Estudo Geral - Universidade de Coimbra |
| Resumo: | This dissertation explores the theoretical and practical applications of topical semi-solid dosage forms within the realm of pharmaceutical formulations. Beginning with an overview of creams, gels, ointments, pastes, and plasters, the study delves into their composition, characteristics, and therapeutic applications. Emphasizing the importance of quality assurance and regulatory compliance, critical concepts such as Quality by Design (QbD), Critical Quality Attributes (CQA), Critical Material Attributes (CMA), and Critical Process Parameters (CPP) are elucidated in detail. Various aspects of formulation development, including the role of excipients and the application of Design of Experiments (DoE) methodologies for optimization are also evaluated. Each dosage form is meticulously examined through hypothetical Quality Target Product Profiles (QTTP), offering a structured approach to define and achieve desired product attributes. Furthermore, risk analysis methodologies, such as Failure Mode Effects and Critical Analysis (FMECA) and Ishikawa diagrams, are discussed to underscore their significance in ensuring product robustness and reliability. Theoretical frameworks and practical applications are intertwined to provide a comprehensive understanding of the complexities involved in formulating and optimizing topical pharmaceuticals. The advantages for the application of QbD in the delineation of pharmaceutical products are reducing the cost and time required for pharmacotechnical development, obtaining formulations with optimized quality characteristics, more robust production processes with better performance and more assertive control measures. |
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