PHASE TRANSFORMATION AND PHARMACEUTICS PROFILE CHARACTERIZATION OF LAMIVUDINE PSEUDOPOLYMORPHS
Lamivudine, a NRTI antiretroviral drug is known to have two polymorphic and pseudopolymorphic forms. The objective of this study is to determine the differences in the pharmaceutics profile and to characterize processing-induced phase transformation between form II (anhydrate) and III (hemihydrat...
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| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/70471 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | Lamivudine, a NRTI antiretroviral drug is known to have two polymorphic and pseudopolymorphic
forms. The objective of this study is to determine the differences in the pharmaceutics profile and
to characterize processing-induced phase transformation between form II (anhydrate) and III
(hemihydrate). The characterization of the pharmaceutics profile includes flowability by
determining the compressibility index and Hausner ratio; compressibility, tabletability and
compactibility profile; and intrinsic dissolution rate evaluation. The characterization of processing
effects on phase transformation includes the determination of lamivudine phase content in the
granules and tablet after wet granulation and compaction using PXRD. The results show that form
II has better flowability, but worse mechanical profile, and a faster intrinsic dissolution rate than
form III. The granulation process could not induce phase transformation but decrease the
crystallinity. In addition, compaction without the presence of excipients decreases the crystallinity,
meanwhile compaction with the presence of excipient could increase the crystallinity. These
behaviors can be attributed to the crystal structure. |
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