MARC details
| 000 -LEADER |
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| fixed length control field |
03859nam a22002657i 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20210308125659.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
210307s2003 -usa|||| m||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
EG-NcFUE |
| Description conventions |
rda |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Edition number |
21 |
| Classification number |
615.1 |
| Item number |
P.H.E |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
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| Personal name |
Patel, Himanshu |
| Relator term |
author. |
| 245 14 - TITLE STATEMENT |
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| Title |
The effect of formulation and processing variables on the stability of levothyroxine sodium tablets / |
| Statement of responsibility, etc |
Himanshu Patel ؛committee chair adel sakr. |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
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| Place of publication, distribution, etc |
Cincinnati, Ohio : |
| Name of publisher, distributor, etc |
University of Cincinnati, |
| Date of publication, distribution, etc |
2003. |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
144 pages : |
| Other physical details |
illustrations ; |
| Dimensions |
30 cm. |
| 336 ## - CONTENT TYPE |
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| Source |
rdacontent |
| Content type term |
text |
| 337 ## - MEDIA TYPE |
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| Source |
rdamedia |
| Media type term |
unmediated |
| 338 ## - CARRIER TYPE |
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| Source |
rdacarrier |
| Carrier type term |
volume |
| 500 ## - GENERAL NOTE |
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| General note |
Includes abstract |
| 502 ## - DISSERTATION NOTE |
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| Dissertation note |
Thesis (Ph.D.)--University of Cincinnati, 2003 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
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| Bibliography, etc |
Includes bibliographical references |
| 520 ## - SUMMARY, ETC. |
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| Summary, etc |
Abstract: These series of experiments were devised to <br/> study the effects of various formulation and processing <br/> variables on the stability of levothyroxine. The studies <br/> were performed with levothyroxine drug substance (powder <br/> or solution), excipient slurries with levothyroxine at <br/> 50ʻC and tablet-incorporated levothyroxine under ICH <br/> accelerated stability conditions. Additionally, stability <br/> of tablets manufactured by wet granulation and / or direct<br/> compression at different compression pressures was <br/> evaluated under ICH accelerated stability conditions. It <br/> was found that the active, levothyroxine, was stable when <br/> stored for six months at 40ʻC/75% Relative Humidity (RH) <br/> in open or closed containers; also, it was non-hygroscopic<br/> under normal operating conditions (>30%RH). In diluent <br/> slurries when stored at 50ʻC for one month, levothyroxine <br/> was more stable at pH 11 than at pH 3. Levothyroxine <br/> tablets manufactured with dibasic calcium phosphate or <br/> mannitol and stored under accelerated stability conditions<br/> met USP assay requirements at three months, but not at six<br/> months. Tablets manufactured with lactose anhydrous, <br/> starch, and microcrystalline cellulose failed to meet USP <br/> requirements at three months. After six months at <br/> accelerated stability conditions, tablets manufactured <br/> with basic pH modifiers had less than 5% loss in potency, <br/> and thus, they met USP assay requirements. Therefore, it <br/> was concluded that excipients used in the manufacture of <br/> levothyroxine tablets affected levothyroxine stability. <br/> The use of desiccant for while storing levothyroxine <br/> tablets, didn't appear to affect their stability at ICH <br/> accelerated stability conditions. Furthermore, the use of <br/> basic pH modifiers is a technique for improving tablet- <br/> incorporated levothyroxine stability. After 3 months <br/> storage at ICH accelerated stability conditions the <br/> tablets manufactured by wet granulation or direct <br/> compression did not show significant difference in <br/> stability. Thus, the type of manufacturing method does not<br/> influence the stability of levothyroxine tablets, <br/> manufactured with / without sodium carbonate and using <br/> dibasic calcium phosphate as diluent. Interestingly, it <br/> was found that the initial assay value of levothyroxine <br/> tablets (compressed at 2000 and 6000 lbs) was lower than <br/> that of the uncompressed granules/powder. Thus tablet <br/> compression appears to affect the stability of <br/> levothyroxine. It was concluded that formulation and <br/> processing variables affect the stability of levothyroxine<br/> tablets |
| 650 00 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
levothyroxine sodium |
| General subdivision |
medicine |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Sakr, Adel Mohamed, |
| Relator term |
supervisor. |
| 9 (RLIN) |
33831 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Thesis |