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The effects of packaging on the stability of a moisture sensitive compound
Packages that provided stability (less than a 10% loss in potency) of a moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25°C/60%RH, 30°C/60%RH and 40°C/75%RH were 2.3, 2.4, and 2.9%, r...
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Published in: | International journal of pharmaceutics 2001-06, Vol.221 (1), p.49-56 |
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creator | Allinson, Jennifer G Dansereau, Richard J Sakr, Adel |
description | Packages that provided stability (less than a 10% loss in potency) of a moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25°C/60%RH, 30°C/60%RH and 40°C/75%RH were 2.3,
2.4, and 2.9%, respectively. The tablet equilibrium moisture content, degradation rate of unpackaged product, and the moisture barrier properties of the packages were used to predict the stability of the packaged product. The physical and chemical stability (HPLC assay) of the products were measured after 2,
4,
6,
8,
12, and 24 weeks at ICH conditions. The Containers-Permeation
1 of polyvinyl chloride blisters, cyclic olefin blisters, aclar blisters, cold-form aluminum blisters was 0.259,
0.040,
0.008 and 0.001 mg per blister per day, respectively. At 6 months at 40°C/75%RH, the percent active was 84% in polyvinyl chloride blisters, 91% in cyclic olefin blisters, 97% in aclar blisters, 100% in cold-form aluminum blisters and 99% in an high density polyethylene bottle with a foil induction seal. The stability results for the packaged product were fairly consistent with the predictions based on the moisture sensitivity of the product and the moisture barrier properties of the respective package. To gain a better prediction, the flux value determined by the Containers-Permeation procedure was adjusted for the internal moisture concentration of the blister. |
doi_str_mv | 10.1016/S0378-5173(01)00670-6 |
format | article |
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2.4, and 2.9%, respectively. The tablet equilibrium moisture content, degradation rate of unpackaged product, and the moisture barrier properties of the packages were used to predict the stability of the packaged product. The physical and chemical stability (HPLC assay) of the products were measured after 2,
4,
6,
8,
12, and 24 weeks at ICH conditions. The Containers-Permeation
1 of polyvinyl chloride blisters, cyclic olefin blisters, aclar blisters, cold-form aluminum blisters was 0.259,
0.040,
0.008 and 0.001 mg per blister per day, respectively. At 6 months at 40°C/75%RH, the percent active was 84% in polyvinyl chloride blisters, 91% in cyclic olefin blisters, 97% in aclar blisters, 100% in cold-form aluminum blisters and 99% in an high density polyethylene bottle with a foil induction seal. The stability results for the packaged product were fairly consistent with the predictions based on the moisture sensitivity of the product and the moisture barrier properties of the respective package. To gain a better prediction, the flux value determined by the Containers-Permeation procedure was adjusted for the internal moisture concentration of the blister.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/S0378-5173(01)00670-6</identifier><identifier>PMID: 11397566</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Biological and medical sciences ; Chemistry, Pharmaceutical ; Chromatography, High Pressure Liquid ; Container's permeation ; Drug Packaging ; Drug Stability ; Drug Storage ; Fick's law ; General pharmacology ; Medical sciences ; Moisture sensitivity ; Package ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Stability ; Tablet ; Tablets</subject><ispartof>International journal of pharmaceutics, 2001-06, Vol.221 (1), p.49-56</ispartof><rights>2001 Elsevier Science B.V.</rights><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-a78dedd49ed2e02f74e881b9f813ed419fb9e2f77d7663b2f7bbf973c3ff7ab3</citedby><cites>FETCH-LOGICAL-c389t-a78dedd49ed2e02f74e881b9f813ed419fb9e2f77d7663b2f7bbf973c3ff7ab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=994658$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11397566$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Allinson, Jennifer G</creatorcontrib><creatorcontrib>Dansereau, Richard J</creatorcontrib><creatorcontrib>Sakr, Adel</creatorcontrib><title>The effects of packaging on the stability of a moisture sensitive compound</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>Packages that provided stability (less than a 10% loss in potency) of a moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25°C/60%RH, 30°C/60%RH and 40°C/75%RH were 2.3,
2.4, and 2.9%, respectively. The tablet equilibrium moisture content, degradation rate of unpackaged product, and the moisture barrier properties of the packages were used to predict the stability of the packaged product. The physical and chemical stability (HPLC assay) of the products were measured after 2,
4,
6,
8,
12, and 24 weeks at ICH conditions. The Containers-Permeation
1 of polyvinyl chloride blisters, cyclic olefin blisters, aclar blisters, cold-form aluminum blisters was 0.259,
0.040,
0.008 and 0.001 mg per blister per day, respectively. At 6 months at 40°C/75%RH, the percent active was 84% in polyvinyl chloride blisters, 91% in cyclic olefin blisters, 97% in aclar blisters, 100% in cold-form aluminum blisters and 99% in an high density polyethylene bottle with a foil induction seal. The stability results for the packaged product were fairly consistent with the predictions based on the moisture sensitivity of the product and the moisture barrier properties of the respective package. To gain a better prediction, the flux value determined by the Containers-Permeation procedure was adjusted for the internal moisture concentration of the blister.</description><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Container's permeation</subject><subject>Drug Packaging</subject><subject>Drug Stability</subject><subject>Drug Storage</subject><subject>Fick's law</subject><subject>General pharmacology</subject><subject>Medical sciences</subject><subject>Moisture sensitivity</subject><subject>Package</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Stability</subject><subject>Tablet</subject><subject>Tablets</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><recordid>eNqFkMlKBDEQQIMoOi6foDQIoofWZNKT5SQirgx4cO4hnVQ02t0Zk25h_t7Mgh49VVH1auEhdEzwJcGEXb1iykU5IZyeY3KBMeO4ZFtoRASnJa0420ajX2QP7af0gTM1JnQX7RFCJZ8wNkLPs3cowDkwfSqCK-bafOo3370VoSv63Eu9rn3j-8Wyq4s2-NQPMdehS77331CY0M7D0NlDtON0k-BoEw_Q7P5udvtYTl8enm5vpqWhQval5sKCtZUEOwY8drwCIUgtnSAUbEWkqyXkMrecMVrnrK6d5NRQ57iu6QE6W6-dx_A1QOpV65OBptEdhCEpjiVmQtAMTtagiSGlCE7No291XCiC1dKhWjlUS0EKE7VyqFieO9kcGOoW7N_URloGTjeATkY3LurO-PTLSVmxicjU9ZqC7OLbQ1TJeOgMWB-zbWWD_-eRH9dgjms</recordid><startdate>20010619</startdate><enddate>20010619</enddate><creator>Allinson, Jennifer G</creator><creator>Dansereau, Richard J</creator><creator>Sakr, Adel</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20010619</creationdate><title>The effects of packaging on the stability of a moisture sensitive compound</title><author>Allinson, Jennifer G ; Dansereau, Richard J ; Sakr, Adel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-a78dedd49ed2e02f74e881b9f813ed419fb9e2f77d7663b2f7bbf973c3ff7ab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Container's permeation</topic><topic>Drug Packaging</topic><topic>Drug Stability</topic><topic>Drug Storage</topic><topic>Fick's law</topic><topic>General pharmacology</topic><topic>Medical sciences</topic><topic>Moisture sensitivity</topic><topic>Package</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Stability</topic><topic>Tablet</topic><topic>Tablets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Allinson, Jennifer G</creatorcontrib><creatorcontrib>Dansereau, Richard J</creatorcontrib><creatorcontrib>Sakr, Adel</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Allinson, Jennifer G</au><au>Dansereau, Richard J</au><au>Sakr, Adel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effects of packaging on the stability of a moisture sensitive compound</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2001-06-19</date><risdate>2001</risdate><volume>221</volume><issue>1</issue><spage>49</spage><epage>56</epage><pages>49-56</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>Packages that provided stability (less than a 10% loss in potency) of a moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25°C/60%RH, 30°C/60%RH and 40°C/75%RH were 2.3,
2.4, and 2.9%, respectively. The tablet equilibrium moisture content, degradation rate of unpackaged product, and the moisture barrier properties of the packages were used to predict the stability of the packaged product. The physical and chemical stability (HPLC assay) of the products were measured after 2,
4,
6,
8,
12, and 24 weeks at ICH conditions. The Containers-Permeation
1 of polyvinyl chloride blisters, cyclic olefin blisters, aclar blisters, cold-form aluminum blisters was 0.259,
0.040,
0.008 and 0.001 mg per blister per day, respectively. At 6 months at 40°C/75%RH, the percent active was 84% in polyvinyl chloride blisters, 91% in cyclic olefin blisters, 97% in aclar blisters, 100% in cold-form aluminum blisters and 99% in an high density polyethylene bottle with a foil induction seal. The stability results for the packaged product were fairly consistent with the predictions based on the moisture sensitivity of the product and the moisture barrier properties of the respective package. To gain a better prediction, the flux value determined by the Containers-Permeation procedure was adjusted for the internal moisture concentration of the blister.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>11397566</pmid><doi>10.1016/S0378-5173(01)00670-6</doi><tpages>8</tpages></addata></record> |
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source | Elsevier:Jisc Collections:Elsevier Read and Publish Agreement 2022-2024:Freedom Collection (Reading list) |
subjects | Biological and medical sciences Chemistry, Pharmaceutical Chromatography, High Pressure Liquid Container's permeation Drug Packaging Drug Stability Drug Storage Fick's law General pharmacology Medical sciences Moisture sensitivity Package Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Stability Tablet Tablets |
title | The effects of packaging on the stability of a moisture sensitive compound |
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