Publication
Novel shape in scored orodispersible tablets applying Design of Experiments
| Summary: | Drug Delivery Systems (DDS) are a strategic tool that has become increasingly sophisticated over the years. Their main contributions involve expanding the life cycle of pharmaceutical products, by improving the administration process according to the patient’s needs. Since the drug delivery through oral route still represents the most common and preferred way of drug administration, our work of study relies on the development of orodispersible tablets (ODTs). This dosage form provides a quick onset of action and therefore was chosen as an alternative for paediatric, geriatric and mentally ill patients were the swallowing ability may be compromised. In the present study orodispersible tablets with a new shape were produced by direct compression using furosemide as the model drug. The production with this novel punch design led to scored tablets with a cloverleaf shape, thus allowing dose flexibility. The tablets were evaluated by thickness and diameter, uniformity of weight and of content, uniformity of the tablet’s subunits, resistance to crushing, weight loss, wetting time, water absorption ratio and disintegration time. Through Design of Experiments (DoE) was done a 22x31 full-factorial test that showed the influence of three independent variables (upper punch compression force, tablet weight and speed of rotation of tabletting machine) on the tablet’s properties. The obtained ODTs were according to the limits for both weight and content uniformity and revealed tablet units with very low coefficients of variation and satisfactory mean percentages of furosemide. The results for resistance to crushing revealed very high values corroborated by low friability of tablets. They also showed uniformity of the subdivided tablets with very low mass deviations and minimum percentage of mass lost during breaking process. The biopharmaceutical tests revealed a different outcome of what was expected from this dosage form. All the disintegration and wetting times failed to comply with the required standards along with the water absorption ratio, thus showing space for improvement. |
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| Main Authors: | Penedo, Maria Simões |
| Subject: | Cloverleaf punch Design of Experiments Direct compression Orally disintegrating tablet Divisible Mestrado Integrado - 2017 |
| Year: | 2017 |
| Country: | Portugal |
| Document type: | master thesis |
| Access type: | open access |
| Associated institution: | Universidade de Lisboa |
| Language: | English |
| Origin: | Repositório da Universidade de Lisboa |
| Summary: | Drug Delivery Systems (DDS) are a strategic tool that has become increasingly sophisticated over the years. Their main contributions involve expanding the life cycle of pharmaceutical products, by improving the administration process according to the patient’s needs. Since the drug delivery through oral route still represents the most common and preferred way of drug administration, our work of study relies on the development of orodispersible tablets (ODTs). This dosage form provides a quick onset of action and therefore was chosen as an alternative for paediatric, geriatric and mentally ill patients were the swallowing ability may be compromised. In the present study orodispersible tablets with a new shape were produced by direct compression using furosemide as the model drug. The production with this novel punch design led to scored tablets with a cloverleaf shape, thus allowing dose flexibility. The tablets were evaluated by thickness and diameter, uniformity of weight and of content, uniformity of the tablet’s subunits, resistance to crushing, weight loss, wetting time, water absorption ratio and disintegration time. Through Design of Experiments (DoE) was done a 22x31 full-factorial test that showed the influence of three independent variables (upper punch compression force, tablet weight and speed of rotation of tabletting machine) on the tablet’s properties. The obtained ODTs were according to the limits for both weight and content uniformity and revealed tablet units with very low coefficients of variation and satisfactory mean percentages of furosemide. The results for resistance to crushing revealed very high values corroborated by low friability of tablets. They also showed uniformity of the subdivided tablets with very low mass deviations and minimum percentage of mass lost during breaking process. The biopharmaceutical tests revealed a different outcome of what was expected from this dosage form. All the disintegration and wetting times failed to comply with the required standards along with the water absorption ratio, thus showing space for improvement. |
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