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A Method for the Tensile Strength Prediction of Tablets with Differing Powder Plasticities
Chemical & Pharmaceutical Bulletin ( IF 1.7 ) Pub Date : 2024-04-09 , DOI: 10.1248/cpb.c24-00090
Takeru Yano 1 , Atsushi Oshiro 1 , Shuji Ohsaki 1 , Hideya Nakamura 1 , Satoru Watano 1
Affiliation  

Tablets are the most commonly used dosage form in the pharmaceutical industry, and their properties such as disintegration, dissolution, and portability are influenced by their strength. However, in industry, the mixing fraction of powders to obtain a tablet compact with sufficient strength is determined based on empirical rules. Therefore, a method for predicting tablet strength based on the properties of a single material is required. The objective of this study was to quantitatively evaluate the relationship between the compression properties and tablet strength of powder mixtures. The compression properties of the powder mixtures with different plasticities were evaluated based on the force-displacement curves obtained from the powder compression tests. Heckel and compression energy analyses were performed to evaluate compression properties. During the compression energy analysis, the ratio of plastic deformation energy to elastic deformation energy (Ep/Ee) was assumed to be the plastic deformability of the powder. The quantitative relationship between the compression properties and tensile strength of the tablets was investigated. Based on the obtained relationship and the compression properties of a single material, a prediction equation was put forward for the compression properties of the powder mixture. Subsequently, a correlation equation for tablet strength was proposed by combining the values of K and Ep/Ee obtained from the Heckel and compression energy analyses, respectively. Finally, by substituting the compression properties of the single material and the mass fraction of the plastic material into the proposed equation, the tablet strength of the powder mixture with different plastic deformabilities was predicted.

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中文翻译:

不同粉末塑性片剂拉伸强度的预测方法

片剂是制药行业最常用的剂型,其崩解、溶出和便携性等特性受到其强度的影响。然而,在工业中,获得具有足够强度的片剂的粉末的混合比例是根据经验规则确定的。因此,需要一种基于单一材料的特性来预测片剂强度的方法。本研究的目的是定量评估粉末混合物的压缩特性和片剂强度之间的关系。根据粉末压缩试验获得的力-位移曲线评价不同塑性粉末混合物的压缩性能。进行赫克尔和压缩能量分析以评估压缩特性。在压缩能分析过程中,假定塑性变形能与弹性变形能之比(E p / E e )为粉末的塑性变形能力。研究了片剂的压缩性能和拉伸强度之间的定量关系。基于所获得的关系和单一材料的压缩性能,提出了粉末混合物压缩性能的预测方程。随后,通过结合分别从 Heckel 和压缩能分析获得的KE p / E e值,提出了片剂强度的相关方程。最后,通过将单一材料的压缩性能和塑性材料的质量分数代入所提出的方程中,预测了具有不同塑性变形能力的粉末混合物的压片强度。

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更新日期:2024-04-09
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