Jan Pech, Christoph Kaminski, Matthias Markus, Werner Hoheisel, Roman Heumann, Judith Winck, Markus Thommes
{"title":"吸塑包装中药品稳定性的预测模型。","authors":"Jan Pech, Christoph Kaminski, Matthias Markus, Werner Hoheisel, Roman Heumann, Judith Winck, Markus Thommes","doi":"10.3390/pharmaceutics17091233","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background/Objectives:</b> The principal function of pharmaceutical blister packaging is to provide protection for the drug product. Moisture is regarded as a critical factor in the physical and chemical aging of drug products. The present work proposes a modeling framework to predict the performance of tablet blister materials based on the moisture uptake profile of the drug product as well as degradation characteristics of the drug substance, while the consumption of water due to degradation is included. <b>Methods:</b> The model incorporates three kinetic superimposed processes that define moisture uptake and drug stability. The processes of permeation, sorption and degradation are each described with a rate constant. Based on a mass balance, these rate processes are interconnected and the relative humidity in the blister cavity is predicted. <b>Results:</b> In a case study, the model was applied to demonstrate the feasibility of predicting the stability of blistered tablets. By establishing a correlation between the moisture uptake of the tablet and the drug stability demonstrated in the model, it was feasible to predict the drug content over shelf life. <b>Conclusions:</b> Modeling of the drug stability of blister-packed products enables a rational packaging which offers novel possibilities for reducing material in order to avoid overpackaging of pharmaceutical products. As some of the commonly used barrier materials are considered to not be sustainable, this model can be used to consider a rationally justified reduction or even abandonment of the barrier materials.</p>","PeriodicalId":19894,"journal":{"name":"Pharmaceutics","volume":"17 9","pages":""},"PeriodicalIF":5.5000,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473751/pdf/","citationCount":"0","resultStr":"{\"title\":\"Predictive Modeling of Drug Product Stability in Pharmaceutical Blister Packs.\",\"authors\":\"Jan Pech, Christoph Kaminski, Matthias Markus, Werner Hoheisel, Roman Heumann, Judith Winck, Markus Thommes\",\"doi\":\"10.3390/pharmaceutics17091233\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background/Objectives:</b> The principal function of pharmaceutical blister packaging is to provide protection for the drug product. Moisture is regarded as a critical factor in the physical and chemical aging of drug products. The present work proposes a modeling framework to predict the performance of tablet blister materials based on the moisture uptake profile of the drug product as well as degradation characteristics of the drug substance, while the consumption of water due to degradation is included. <b>Methods:</b> The model incorporates three kinetic superimposed processes that define moisture uptake and drug stability. The processes of permeation, sorption and degradation are each described with a rate constant. Based on a mass balance, these rate processes are interconnected and the relative humidity in the blister cavity is predicted. <b>Results:</b> In a case study, the model was applied to demonstrate the feasibility of predicting the stability of blistered tablets. By establishing a correlation between the moisture uptake of the tablet and the drug stability demonstrated in the model, it was feasible to predict the drug content over shelf life. <b>Conclusions:</b> Modeling of the drug stability of blister-packed products enables a rational packaging which offers novel possibilities for reducing material in order to avoid overpackaging of pharmaceutical products. As some of the commonly used barrier materials are considered to not be sustainable, this model can be used to consider a rationally justified reduction or even abandonment of the barrier materials.</p>\",\"PeriodicalId\":19894,\"journal\":{\"name\":\"Pharmaceutics\",\"volume\":\"17 9\",\"pages\":\"\"},\"PeriodicalIF\":5.5000,\"publicationDate\":\"2025-09-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12473751/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3390/pharmaceutics17091233\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/pharmaceutics17091233","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Predictive Modeling of Drug Product Stability in Pharmaceutical Blister Packs.
Background/Objectives: The principal function of pharmaceutical blister packaging is to provide protection for the drug product. Moisture is regarded as a critical factor in the physical and chemical aging of drug products. The present work proposes a modeling framework to predict the performance of tablet blister materials based on the moisture uptake profile of the drug product as well as degradation characteristics of the drug substance, while the consumption of water due to degradation is included. Methods: The model incorporates three kinetic superimposed processes that define moisture uptake and drug stability. The processes of permeation, sorption and degradation are each described with a rate constant. Based on a mass balance, these rate processes are interconnected and the relative humidity in the blister cavity is predicted. Results: In a case study, the model was applied to demonstrate the feasibility of predicting the stability of blistered tablets. By establishing a correlation between the moisture uptake of the tablet and the drug stability demonstrated in the model, it was feasible to predict the drug content over shelf life. Conclusions: Modeling of the drug stability of blister-packed products enables a rational packaging which offers novel possibilities for reducing material in order to avoid overpackaging of pharmaceutical products. As some of the commonly used barrier materials are considered to not be sustainable, this model can be used to consider a rationally justified reduction or even abandonment of the barrier materials.
PharmaceuticsPharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
7.90
自引率
11.10%
发文量
2379
审稿时长
16.41 days
期刊介绍:
Pharmaceutics (ISSN 1999-4923) is an open access journal which provides an advanced forum for the science and technology of pharmaceutics and biopharmaceutics. It publishes reviews, regular research papers, communications, and short notes. Covered topics include pharmacokinetics, toxicokinetics, pharmacodynamics, pharmacogenetics and pharmacogenomics, and pharmaceutical formulation. Our aim is to encourage scientists to publish their experimental and theoretical details in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.