Particle Engineering For Efficient Development Of Pharmaceutical Tablets

Sun, Wei-Jhe
2017-12
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Particle Engineering For Efficient Development Of Pharmaceutical Tablets

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2017-12

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Abstract

Content uniformity (CU) assures that each unit drug product has a statistically similar mass of drug present. Achieving uniform content is a significant challenge for low dose tabletss. Lack of CU can lead to loss of efficacy or cause toxicity. Thus, development of a robust platform formulation and manufacturability process for low dose drug without CU issue is desired. Through API-carrier composite strategy, where API is caged in a mesoporous silica material (Neusilin and Aeroperl), the uniform distribution of APIs in carrier is achieved. Based on the properties of carrier, immediate-release platform formulations are proposed. The performance of platform formulation is robust with good CU, manufacturability, and dissolution behavior. Moreover, low dose tablets can be engendered with distinct functionality using this approach, e.g, sustained-release tablet. Particles with a size too small are referred to as fines, and their generation is undesired in dry granulation process, which affects the flowability of milled granules, causes the tablet weight variation, and reduces CU. Mechanical properties, e.g., Young’s modulus, hardness, tensile strength, are first studied systematically. These properties exhibit good relation with compact porosity/density. The correlation between compact density and percent fines generation is further evaluated, which show stronger compact generates less fines. Furthermore, fines generation can be predicted precisely if the compact density is known, which is analyzed by X-ray micro CT. The understanding of the different factors in fine generation process enables to reduce fines and enhance content uniformity.

Keywords

content uniformity
dry granulation
mechanical property
mesoporous material

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University of Minnesota Ph.D. dissertation.December 2017. Major: Pharmaceutics. Advisor: Changquan Sun. 1 computer file (PDF); xvii, 205 pages.

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Sun, Wei-Jhe. (2017). Particle Engineering For Efficient Development Of Pharmaceutical Tablets. Retrieved from the University Digital Conservancy, https://hdl.handle.net/11299/202130.

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