The aim of the study is to formulate Raltegravir tablets,
enhancing its solubility by solid dispersion technique. Raltegravir is an anti
retroviral drug belongs to BCS Class II. Phase solubility studies of
Raltegravir are conducted in presence of Beta cyclodextrin according to the
method described by Higuchi and Connors. The value of stability constants
indicated that the complex formed between Raltegravir-β-CD are stable in all
cases. In distilled water, the solubility of a solid dispersion was determined
and compared to the solubility of a pure drug. The solubility of Raltegravir
has increased with increasing the concentration of cyclodextrin and maximum
amount of solubility was observed at a ratio of 1:3. Among all the methods,
solubility of Raltegravir was found to have increased value in physical
trituration method (80%) and maximum solubility was observed by solvent
evaporation method (93%). Among all the methods, percentage drug release of
Raltegravir was found to have increased value in physical trituration method
(91%) and maximum drug release was observed in solvent evaporation method
(96%).Disintegration time for all the formulation blend of Raltegravir was
conducted, the results in ranged from 25 ± 0.04to 130 ±0.04 sec. F3&F6
formulation, formulated using the combination of excipients i.e., 5% cross
carmellose exhibited disintegration time of 25±0.03&40 ± 0.03 sec .out of
which F3 formulation disintegrated the drug in less period of time .Thus F3
formulation was found to be an Optimized formulation. Pre-compression
parameters were studied and the results were within limits. The result
indicates all the granules were observed to have good flow and good
compressibility properties. Post compression result indicates that all the
tablets in the batch were observed to have uniform weight variation and
mechanical strength, the drug release data of the F3 formulation fits well into
the Zero - order kinetics, which states that the system is concentration
independent. Even after three months, the optimised formulation (F3) was
determined to be stable with no change in physical properties.
Author(s) Details:
M. P. Kusuma,
RBVRR Women's College of Pharmacy, Barkatpura, Hyderabad, India.
Sumanya,
RBVRR Women's College of Pharmacy, Barkatpura, Hyderabad, India.
Please see the link here: https://stm.bookpi.org/ACPR-V5/article/view/13300
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