Phase Solubility results
The phase-solubility diagram (figure 1) obtained was classified as AL type(20) because the apparent solubility of ISH increased linearly with β-CD concentration over the entire concentration range studies, thereby suggesting the formation of a water soluble complex. A slope value of less than one indicated that an inclusion complex in a molar stoichiometric ratio of 1:1 was formed between the drug and β-CD in solution. The stability constant (718.58 M–1), computed from the slope and intercept of the phase solubility diagram, indicated considerable interaction between the hydrophobic drug and the hydrophobic cavity of β-CD. The values of stability constants described in the literature ranged from 100 to 20,000 M–1 for …show more content…
The bitterness score of the original product was 2. The taste was slightly bitter till 300 seconds but it becomes moderately bitter (level 3) after 300 seconds. However, after taste masking the drug with β-cyclodextrin and aspartame, no bitter taste was observed. Stability studies
After subjecting the formulation F9 for stability study, from the data, (Table 4) the formulation was found to be stable under the conditions mentioned before, since there was no significant change (p< 0.05) in physical form of tablets, changes in drug content, in vitro disintegration time and in vitro dissolution after six months.
CONCLUSION
The results of phase solubility observed that the formation of 1:1 complex between ISH and β-CD. The study of solid state characterization for complex indicated the conversion of crystalline form of ISH to amorphous form. It can be concluded form the results that the inclusion complexation of ISH in β-CD resulted in an improvement of the dissolution and facilitate the taste masking of ISH. The optimized batch of taste masked FDT showed rapid and complete drug release at the end of 10min. The bitter taste of drug was masked by β-CD and aspartame and formulation was found to be stable for the period of six
The phase-solubility diagram (figure 1) obtained was classified as AL type(20) because the apparent solubility of ISH increased linearly with β-CD concentration over the entire concentration range studies, thereby suggesting the formation of a water soluble complex. A slope value of less than one indicated that an inclusion complex in a molar stoichiometric ratio of 1:1 was formed between the drug and β-CD in solution. The stability constant (718.58 M–1), computed from the slope and intercept of the phase solubility diagram, indicated considerable interaction between the hydrophobic drug and the hydrophobic cavity of β-CD. The values of stability constants described in the literature ranged from 100 to 20,000 M–1 for …show more content…
The bitterness score of the original product was 2. The taste was slightly bitter till 300 seconds but it becomes moderately bitter (level 3) after 300 seconds. However, after taste masking the drug with β-cyclodextrin and aspartame, no bitter taste was observed. Stability studies
After subjecting the formulation F9 for stability study, from the data, (Table 4) the formulation was found to be stable under the conditions mentioned before, since there was no significant change (p< 0.05) in physical form of tablets, changes in drug content, in vitro disintegration time and in vitro dissolution after six months.
CONCLUSION
The results of phase solubility observed that the formation of 1:1 complex between ISH and β-CD. The study of solid state characterization for complex indicated the conversion of crystalline form of ISH to amorphous form. It can be concluded form the results that the inclusion complexation of ISH in β-CD resulted in an improvement of the dissolution and facilitate the taste masking of ISH. The optimized batch of taste masked FDT showed rapid and complete drug release at the end of 10min. The bitter taste of drug was masked by β-CD and aspartame and formulation was found to be stable for the period of six