In vitro and in vivo sustained-release characteristics of theophylline matrix tablets and novel cluster tablets
We compared the in vitro/ in vivo properties of theophylline between two sustained-release preparations, which are administered once a day. Tablet A is a swelling/disintegration-type matrix tablet consisting of hydrophobic wax granules and hydrophilic polymer granules (cluster tablets). Tablet B is...
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| Veröffentlicht in: | International journal of pharmaceutics 2007-08, Vol.341 (1), p.105-113 |
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| creator | Hayashi, Tetsuo Kanbe, Hideyoshi Okada, Minoru Kawase, Ichiro Ikeda, Yasuo Onuki, Yoichi Kaneko, Tetsuo Sonobe, Takashi |
| description | We compared the
in vitro/
in vivo properties of theophylline between two sustained-release preparations, which are administered once a day. Tablet A is a swelling/disintegration-type matrix tablet consisting of hydrophobic wax granules and hydrophilic polymer granules (cluster tablets). Tablet B is a matrix tablet consisting of hydrophilic polymer granules.
We conducted a dissolution test with JPXIV
in vitro, and compared the results between the two preparations. Neither pH nor agitation intensity influenced these preparations. After they were immersed in oleic acid, there were no marked changes in the dissolution properties in the dissolution test.
After administration of Tablets A and B containing theophylline at 200
mg to fasted dogs, we compared plasma level profiles of theophylline. The mean plasma level of theophylline gradually increased to a maximum (7.17
μg/mL) 4
h after administration of Tablet A. After administration of Tablet B, a similar finding was noted, with a maximum of 6.09
μg/mL. Tablet B showed a higher coefficient of variation (CV) for the plasma level at each point.
Subsequently, we administered two tablets of preparations A and B containing theophylline at 200
mg to healthy volunteers who had not been fasted, and compared plasma level concentration of theophylline. The mean plasma level of theophylline gradually increased to a maximum (6.09
μg/mL) 12
h after administration of Tablet A, but then decreased, with a half-life of 9.10
h. After administration of Tablet B, a similar finding was noted, with a maximum of 7.87
μg/mL and a half-life of 7.76
h. Tablet A showed a significantly higher plasma concentration 1 and 2
h after administration; however, there were no significant differences at other points. The
C
max of Tablet B was significantly higher than that of Tablet A. However, there were no significant differences in other pharmacokinetic parameters between the two preparations.
The
T
max of Tablet A was 10–12
h after administration, relatively constant. However, that of Tablet B was 10–18
h after administration. The CV for
T
max was 9.8% for Tablet A and 22.0% for Tablet B. After administration of Tablet B, the plasma level of theophylline varied at each point. Based on these results, inter-subject variations after administration of Tablet A may be less marked than those after administration of Tablet B. It is concluded that, the cluster tablets A developed in this study showed significantly less inter-subject variation of theoph |
| doi_str_mv | 10.1016/j.ijpharm.2007.03.048 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_68095944</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S037851730700292X</els_id><sourcerecordid>68095944</sourcerecordid><originalsourceid>FETCH-LOGICAL-c393t-2e823accafc61726c9f2e74e02a00891cc59f337e5956b7f7ee9ae3f41d34b83</originalsourceid><addsrcrecordid>eNqFkMFq3DAQhkVpaTZpH6FFl_ZmR7JsyzqVsLRJIJBL7kI7HrFaZGsraZfk7aPtuuSY0zDMN_8MHyHfOKs54_31rna7_dbEqW4YkzUTNWuHD2TFBykq0cr-I1kxIYeq41JckMuUdoyxvuHiM7ngsuMNb-WKhPuZHl2OgZp5pO7UHANNh5SNm3GsIno0CSmUUwYyRpeyg0SDpXmLYb998b6AdDI5umeazcZjTv_C5nBET8GXLIz_J1_IJ2t8wq9LvSJPf34_re-qh8fb-_XNQwVCiVw1ODTCABgLPZdND8o2KFtkjWFsUBygU1YIiZ3q-o20ElEZFLblo2g3g7giP8-x-xj-HjBlPbkE6L2ZMRyS7gemOtW2BezOIMSQUkSr99FNJr5ozvRJtN7pRbQ-idZM6CK67H1fDhw2E45vW4vZAvxYAJPAeBvNDC69cYMqP_SnoF9nDouNo8OoEzicAUcXEbIeg3vnlVcVJKFe</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>68095944</pqid></control><display><type>article</type><title>In vitro and in vivo sustained-release characteristics of theophylline matrix tablets and novel cluster tablets</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Hayashi, Tetsuo ; Kanbe, Hideyoshi ; Okada, Minoru ; Kawase, Ichiro ; Ikeda, Yasuo ; Onuki, Yoichi ; Kaneko, Tetsuo ; Sonobe, Takashi</creator><creatorcontrib>Hayashi, Tetsuo ; Kanbe, Hideyoshi ; Okada, Minoru ; Kawase, Ichiro ; Ikeda, Yasuo ; Onuki, Yoichi ; Kaneko, Tetsuo ; Sonobe, Takashi</creatorcontrib><description>We compared the
in vitro/
in vivo properties of theophylline between two sustained-release preparations, which are administered once a day. Tablet A is a swelling/disintegration-type matrix tablet consisting of hydrophobic wax granules and hydrophilic polymer granules (cluster tablets). Tablet B is a matrix tablet consisting of hydrophilic polymer granules.
We conducted a dissolution test with JPXIV
in vitro, and compared the results between the two preparations. Neither pH nor agitation intensity influenced these preparations. After they were immersed in oleic acid, there were no marked changes in the dissolution properties in the dissolution test.
After administration of Tablets A and B containing theophylline at 200
mg to fasted dogs, we compared plasma level profiles of theophylline. The mean plasma level of theophylline gradually increased to a maximum (7.17
μg/mL) 4
h after administration of Tablet A. After administration of Tablet B, a similar finding was noted, with a maximum of 6.09
μg/mL. Tablet B showed a higher coefficient of variation (CV) for the plasma level at each point.
Subsequently, we administered two tablets of preparations A and B containing theophylline at 200
mg to healthy volunteers who had not been fasted, and compared plasma level concentration of theophylline. The mean plasma level of theophylline gradually increased to a maximum (6.09
μg/mL) 12
h after administration of Tablet A, but then decreased, with a half-life of 9.10
h. After administration of Tablet B, a similar finding was noted, with a maximum of 7.87
μg/mL and a half-life of 7.76
h. Tablet A showed a significantly higher plasma concentration 1 and 2
h after administration; however, there were no significant differences at other points. The
C
max of Tablet B was significantly higher than that of Tablet A. However, there were no significant differences in other pharmacokinetic parameters between the two preparations.
The
T
max of Tablet A was 10–12
h after administration, relatively constant. However, that of Tablet B was 10–18
h after administration. The CV for
T
max was 9.8% for Tablet A and 22.0% for Tablet B. After administration of Tablet B, the plasma level of theophylline varied at each point. Based on these results, inter-subject variations after administration of Tablet A may be less marked than those after administration of Tablet B. It is concluded that, the cluster tablets A developed in this study showed significantly less inter-subject variation of theophylline plasma levels than the conventional matrix tablets B.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2007.03.048</identifier><identifier>PMID: 17512147</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Administration, Oral ; Animals ; Biological and medical sciences ; Bronchodilator Agents - administration & dosage ; Bronchodilator Agents - blood ; Bronchodilator Agents - chemistry ; Bronchodilator Agents - pharmacokinetics ; Chemistry, Pharmaceutical ; Chromatography, High Pressure Liquid ; Cluster tablets ; Delayed-Action Preparations ; Dogs ; Drug Carriers ; Drug Compounding ; General pharmacology ; Humans ; Hydrogen-Ion Concentration ; Hydrophilic polymer ; Hydrophobic and Hydrophilic Interactions ; Hydrophobic wax ; Male ; Matrix tablets ; Medical sciences ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Polymers - chemistry ; Polysorbates - chemistry ; Solubility ; Surface-Active Agents - chemistry ; Sustained release ; Tablets ; Technology, Pharmaceutical - methods ; Theophylline ; Theophylline - administration & dosage ; Theophylline - blood ; Theophylline - chemistry ; Theophylline - pharmacokinetics ; Waxes - chemistry</subject><ispartof>International journal of pharmaceutics, 2007-08, Vol.341 (1), p.105-113</ispartof><rights>2007</rights><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-2e823accafc61726c9f2e74e02a00891cc59f337e5956b7f7ee9ae3f41d34b83</citedby><cites>FETCH-LOGICAL-c393t-2e823accafc61726c9f2e74e02a00891cc59f337e5956b7f7ee9ae3f41d34b83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S037851730700292X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18968068$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17512147$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hayashi, Tetsuo</creatorcontrib><creatorcontrib>Kanbe, Hideyoshi</creatorcontrib><creatorcontrib>Okada, Minoru</creatorcontrib><creatorcontrib>Kawase, Ichiro</creatorcontrib><creatorcontrib>Ikeda, Yasuo</creatorcontrib><creatorcontrib>Onuki, Yoichi</creatorcontrib><creatorcontrib>Kaneko, Tetsuo</creatorcontrib><creatorcontrib>Sonobe, Takashi</creatorcontrib><title>In vitro and in vivo sustained-release characteristics of theophylline matrix tablets and novel cluster tablets</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>We compared the
in vitro/
in vivo properties of theophylline between two sustained-release preparations, which are administered once a day. Tablet A is a swelling/disintegration-type matrix tablet consisting of hydrophobic wax granules and hydrophilic polymer granules (cluster tablets). Tablet B is a matrix tablet consisting of hydrophilic polymer granules.
We conducted a dissolution test with JPXIV
in vitro, and compared the results between the two preparations. Neither pH nor agitation intensity influenced these preparations. After they were immersed in oleic acid, there were no marked changes in the dissolution properties in the dissolution test.
After administration of Tablets A and B containing theophylline at 200
mg to fasted dogs, we compared plasma level profiles of theophylline. The mean plasma level of theophylline gradually increased to a maximum (7.17
μg/mL) 4
h after administration of Tablet A. After administration of Tablet B, a similar finding was noted, with a maximum of 6.09
μg/mL. Tablet B showed a higher coefficient of variation (CV) for the plasma level at each point.
Subsequently, we administered two tablets of preparations A and B containing theophylline at 200
mg to healthy volunteers who had not been fasted, and compared plasma level concentration of theophylline. The mean plasma level of theophylline gradually increased to a maximum (6.09
μg/mL) 12
h after administration of Tablet A, but then decreased, with a half-life of 9.10
h. After administration of Tablet B, a similar finding was noted, with a maximum of 7.87
μg/mL and a half-life of 7.76
h. Tablet A showed a significantly higher plasma concentration 1 and 2
h after administration; however, there were no significant differences at other points. The
C
max of Tablet B was significantly higher than that of Tablet A. However, there were no significant differences in other pharmacokinetic parameters between the two preparations.
The
T
max of Tablet A was 10–12
h after administration, relatively constant. However, that of Tablet B was 10–18
h after administration. The CV for
T
max was 9.8% for Tablet A and 22.0% for Tablet B. After administration of Tablet B, the plasma level of theophylline varied at each point. Based on these results, inter-subject variations after administration of Tablet A may be less marked than those after administration of Tablet B. It is concluded that, the cluster tablets A developed in this study showed significantly less inter-subject variation of theophylline plasma levels than the conventional matrix tablets B.</description><subject>Administration, Oral</subject><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Bronchodilator Agents - administration & dosage</subject><subject>Bronchodilator Agents - blood</subject><subject>Bronchodilator Agents - chemistry</subject><subject>Bronchodilator Agents - pharmacokinetics</subject><subject>Chemistry, Pharmaceutical</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Cluster tablets</subject><subject>Delayed-Action Preparations</subject><subject>Dogs</subject><subject>Drug Carriers</subject><subject>Drug Compounding</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Hydrogen-Ion Concentration</subject><subject>Hydrophilic polymer</subject><subject>Hydrophobic and Hydrophilic Interactions</subject><subject>Hydrophobic wax</subject><subject>Male</subject><subject>Matrix tablets</subject><subject>Medical sciences</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Polymers - chemistry</subject><subject>Polysorbates - chemistry</subject><subject>Solubility</subject><subject>Surface-Active Agents - chemistry</subject><subject>Sustained release</subject><subject>Tablets</subject><subject>Technology, Pharmaceutical - methods</subject><subject>Theophylline</subject><subject>Theophylline - administration & dosage</subject><subject>Theophylline - blood</subject><subject>Theophylline - chemistry</subject><subject>Theophylline - pharmacokinetics</subject><subject>Waxes - chemistry</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMFq3DAQhkVpaTZpH6FFl_ZmR7JsyzqVsLRJIJBL7kI7HrFaZGsraZfk7aPtuuSY0zDMN_8MHyHfOKs54_31rna7_dbEqW4YkzUTNWuHD2TFBykq0cr-I1kxIYeq41JckMuUdoyxvuHiM7ngsuMNb-WKhPuZHl2OgZp5pO7UHANNh5SNm3GsIno0CSmUUwYyRpeyg0SDpXmLYb998b6AdDI5umeazcZjTv_C5nBET8GXLIz_J1_IJ2t8wq9LvSJPf34_re-qh8fb-_XNQwVCiVw1ODTCABgLPZdND8o2KFtkjWFsUBygU1YIiZ3q-o20ElEZFLblo2g3g7giP8-x-xj-HjBlPbkE6L2ZMRyS7gemOtW2BezOIMSQUkSr99FNJr5ozvRJtN7pRbQ-idZM6CK67H1fDhw2E45vW4vZAvxYAJPAeBvNDC69cYMqP_SnoF9nDouNo8OoEzicAUcXEbIeg3vnlVcVJKFe</recordid><startdate>20070816</startdate><enddate>20070816</enddate><creator>Hayashi, Tetsuo</creator><creator>Kanbe, Hideyoshi</creator><creator>Okada, Minoru</creator><creator>Kawase, Ichiro</creator><creator>Ikeda, Yasuo</creator><creator>Onuki, Yoichi</creator><creator>Kaneko, Tetsuo</creator><creator>Sonobe, Takashi</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>20070816</creationdate><title>In vitro and in vivo sustained-release characteristics of theophylline matrix tablets and novel cluster tablets</title><author>Hayashi, Tetsuo ; Kanbe, Hideyoshi ; Okada, Minoru ; Kawase, Ichiro ; Ikeda, Yasuo ; Onuki, Yoichi ; Kaneko, Tetsuo ; Sonobe, Takashi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-2e823accafc61726c9f2e74e02a00891cc59f337e5956b7f7ee9ae3f41d34b83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Administration, Oral</topic><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Bronchodilator Agents - administration & dosage</topic><topic>Bronchodilator Agents - blood</topic><topic>Bronchodilator Agents - chemistry</topic><topic>Bronchodilator Agents - pharmacokinetics</topic><topic>Chemistry, Pharmaceutical</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Cluster tablets</topic><topic>Delayed-Action Preparations</topic><topic>Dogs</topic><topic>Drug Carriers</topic><topic>Drug Compounding</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Hydrogen-Ion Concentration</topic><topic>Hydrophilic polymer</topic><topic>Hydrophobic and Hydrophilic Interactions</topic><topic>Hydrophobic wax</topic><topic>Male</topic><topic>Matrix tablets</topic><topic>Medical sciences</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Polymers - chemistry</topic><topic>Polysorbates - chemistry</topic><topic>Solubility</topic><topic>Surface-Active Agents - chemistry</topic><topic>Sustained release</topic><topic>Tablets</topic><topic>Technology, Pharmaceutical - methods</topic><topic>Theophylline</topic><topic>Theophylline - administration & dosage</topic><topic>Theophylline - blood</topic><topic>Theophylline - chemistry</topic><topic>Theophylline - pharmacokinetics</topic><topic>Waxes - chemistry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hayashi, Tetsuo</creatorcontrib><creatorcontrib>Kanbe, Hideyoshi</creatorcontrib><creatorcontrib>Okada, Minoru</creatorcontrib><creatorcontrib>Kawase, Ichiro</creatorcontrib><creatorcontrib>Ikeda, Yasuo</creatorcontrib><creatorcontrib>Onuki, Yoichi</creatorcontrib><creatorcontrib>Kaneko, Tetsuo</creatorcontrib><creatorcontrib>Sonobe, Takashi</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>Hayashi, Tetsuo</au><au>Kanbe, Hideyoshi</au><au>Okada, Minoru</au><au>Kawase, Ichiro</au><au>Ikeda, Yasuo</au><au>Onuki, Yoichi</au><au>Kaneko, Tetsuo</au><au>Sonobe, Takashi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>In vitro and in vivo sustained-release characteristics of theophylline matrix tablets and novel cluster tablets</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2007-08-16</date><risdate>2007</risdate><volume>341</volume><issue>1</issue><spage>105</spage><epage>113</epage><pages>105-113</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>We compared the
in vitro/
in vivo properties of theophylline between two sustained-release preparations, which are administered once a day. Tablet A is a swelling/disintegration-type matrix tablet consisting of hydrophobic wax granules and hydrophilic polymer granules (cluster tablets). Tablet B is a matrix tablet consisting of hydrophilic polymer granules.
We conducted a dissolution test with JPXIV
in vitro, and compared the results between the two preparations. Neither pH nor agitation intensity influenced these preparations. After they were immersed in oleic acid, there were no marked changes in the dissolution properties in the dissolution test.
After administration of Tablets A and B containing theophylline at 200
mg to fasted dogs, we compared plasma level profiles of theophylline. The mean plasma level of theophylline gradually increased to a maximum (7.17
μg/mL) 4
h after administration of Tablet A. After administration of Tablet B, a similar finding was noted, with a maximum of 6.09
μg/mL. Tablet B showed a higher coefficient of variation (CV) for the plasma level at each point.
Subsequently, we administered two tablets of preparations A and B containing theophylline at 200
mg to healthy volunteers who had not been fasted, and compared plasma level concentration of theophylline. The mean plasma level of theophylline gradually increased to a maximum (6.09
μg/mL) 12
h after administration of Tablet A, but then decreased, with a half-life of 9.10
h. After administration of Tablet B, a similar finding was noted, with a maximum of 7.87
μg/mL and a half-life of 7.76
h. Tablet A showed a significantly higher plasma concentration 1 and 2
h after administration; however, there were no significant differences at other points. The
C
max of Tablet B was significantly higher than that of Tablet A. However, there were no significant differences in other pharmacokinetic parameters between the two preparations.
The
T
max of Tablet A was 10–12
h after administration, relatively constant. However, that of Tablet B was 10–18
h after administration. The CV for
T
max was 9.8% for Tablet A and 22.0% for Tablet B. After administration of Tablet B, the plasma level of theophylline varied at each point. Based on these results, inter-subject variations after administration of Tablet A may be less marked than those after administration of Tablet B. It is concluded that, the cluster tablets A developed in this study showed significantly less inter-subject variation of theophylline plasma levels than the conventional matrix tablets B.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>17512147</pmid><doi>10.1016/j.ijpharm.2007.03.048</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0378-5173 |
| ispartof | International journal of pharmaceutics, 2007-08, Vol.341 (1), p.105-113 |
| issn | 0378-5173 1873-3476 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_68095944 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Administration, Oral Animals Biological and medical sciences Bronchodilator Agents - administration & dosage Bronchodilator Agents - blood Bronchodilator Agents - chemistry Bronchodilator Agents - pharmacokinetics Chemistry, Pharmaceutical Chromatography, High Pressure Liquid Cluster tablets Delayed-Action Preparations Dogs Drug Carriers Drug Compounding General pharmacology Humans Hydrogen-Ion Concentration Hydrophilic polymer Hydrophobic and Hydrophilic Interactions Hydrophobic wax Male Matrix tablets Medical sciences Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Polymers - chemistry Polysorbates - chemistry Solubility Surface-Active Agents - chemistry Sustained release Tablets Technology, Pharmaceutical - methods Theophylline Theophylline - administration & dosage Theophylline - blood Theophylline - chemistry Theophylline - pharmacokinetics Waxes - chemistry |
| title | In vitro and in vivo sustained-release characteristics of theophylline matrix tablets and novel cluster tablets |
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