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정제처방과 제조공정을 통한 정제의 부피감소
- Alternative Title
- hanna lee
- Author(s)
- 이한나
- Alternative Author(s)
- hanna lee
- Advisor
- 이범진
- Department
- 일반대학원 약학
- Publisher
- The Graduate School, Ajou University
- Publication Year
- 2015-02
- Language
- eng
- Keyword
- high dose drug; tablet volume; tensile strength
- Alternative Abstract
- This study investigated the ability of various formulations and pharmaceutical processing parameters to reduce the tablet volume for patient centricity. Factors that reduce tablet volume were applied to high-dose drugs (Acetaminophen, Metformin) to achieve a smaller tablet volume. Lactose granules were analyzed to assess variations in tablet volume. The following processing parameters were examined: tableting method (wet or dry granulation, direct compression), screening size for dry milling, kneading time for granulation, and types of kneading solvent. The following tablet formulations were compared for wet granulation: different types of binders, diluents, and disintegrants. The physicochemical properties of the granules, including angle of repose and bulk density, were measured, and the physical properties of tablets, such as tensile strength, disintegration time, and tablet volume, were determined. Wet granulation reduced tablet volume most effectively compared to dry granulation and direct compression. Kneading time, kneading solvent and screening size did not significantly affect tablet volume, but they significantly influenced bulk density, angle of repose and tablet tensile. Regarding formulation parameters, tablets containing PVP K90 for binder had a relatively small volume due to its high viscosity (300~700 mPa.s). The type of diluent used for formulation was a key factor influencing tablet volume. In particular, A-tab produced a relatively small tablet volume due to its high true density (2.89 g/cm3). Contrary disintegrants did not have a significant effect on tablet volume. Aside from the disintegrant parameter, each formulation parameter influenced bulk density, angle of repose and tablet tensile strength. Then, we applied the manufacturing process and formulation that produced the smallest tablet volume and greatest tensile strength to high-dose drug tablets. Our process was feasible for high drug loading (e.g., >90%). Compared with the reference drug tablet, the tablet volume was smaller and the dissolution profiles were similar. These results indicate that various pharmaceutical processing parameters and formulation should be considered to reduce tablet volume for geriatric or pediatric patient centricity.
- Fulltext
- Appears in Collections:
- Graduate School of Ajou University > Department of Pharmacy > 3. Theses(Master)
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