PHASE TRANSFORMATION AND PHARMACEUTICS PROFILE CHARACTERIZATION OF LAMIVUDINE PSEUDOPOLYMORPHS

• Main Author: Zhafir, Hilmy
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/70471
• Institution: Institut Teknologi Bandung

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.