{"title":"A Method for the Tensile Strength Prediction of Tablets with Differing Powder Plasticities","authors":"Takeru Yano, Atsushi Oshiro, Shuji Ohsaki, Hideya Nakamura, Satoru Watano","doi":"10.1248/cpb.c24-00090","DOIUrl":null,"url":null,"abstract":"</p><p>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 (<i>E</i><sub>p</sub>/<i>E</i><sub>e</sub>) 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 <i>K</i> and <i>E</i><sub>p</sub>/<i>E</i><sub>e</sub> 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.</p>\n<p></p>\n<img alt=\"\" src=\"https://www.jstage.jst.go.jp/pub/cpb/72/4/72_c24-00090/figure/72_c24-00090.png\"/>\n<span style=\"padding-left:5px;\">Fullsize Image</span>","PeriodicalId":9773,"journal":{"name":"Chemical & pharmaceutical bulletin","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chemical & pharmaceutical bulletin","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1248/cpb.c24-00090","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
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Abstract
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.
片剂是制药行业中最常用的剂型，其崩解、溶解和便携性等特性受其强度的影响。然而，在工业中，要获得具有足够强度的片剂，需要根据经验规则确定粉末的混合分数。因此，需要一种基于单一材料特性的片剂强度预测方法。本研究旨在定量评估粉末混合物的压缩特性与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，评估了不同塑性粉末混合物的压缩特性。为评估压缩性能，进行了赫克尔分析和压缩能分析。在压缩能分析中，假定塑性变形能与弹性变形能之比（Ep/Ee）为粉末的塑性变形能力。研究了片剂压缩性能与拉伸强度之间的定量关系。根据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，结合分别从赫克尔分析和压缩能分析中获得的 K 值和 Ep/Ee 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料材料的质量分数代入所提出的方程，预测了不同塑性变形能力的粉末混合物的片剂强度。
期刊介绍：
The CPB covers various chemical topics in the pharmaceutical and health sciences fields dealing with biologically active compounds, natural products, and medicines, while BPB deals with a wide range of biological topics in the pharmaceutical and health sciences fields including scientific research from basic to clinical studies. For details of their respective scopes, please refer to the submission topic categories below.
Topics: Organic chemistry
In silico science
Inorganic chemistry
Pharmacognosy
Health statistics
Forensic science
Biochemistry
Pharmacology
Pharmaceutical care and science
Medicinal chemistry
Analytical chemistry
Physical pharmacy
Natural product chemistry
Toxicology
Environmental science
Molecular and cellular biology
Biopharmacy and pharmacokinetics
Pharmaceutical education
Chemical biology
Physical chemistry
Pharmaceutical engineering
Epidemiology
Hygiene
Regulatory science
Immunology and microbiology
Clinical pharmacy
Miscellaneous.
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